chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Muscular weakness
Clinical narrative: The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 006M20A) for COVID-19 vaccination.     No medical history and allergies were reported by the reporter.  Concomitant products included PROPRANOLOL, TICAGRELOR (BRILINTA), LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], BUSPIRONE, VITAMIN D [VITAMIN D NOS], MONTELUKAST, CITALOPRAM, FISH OIL, LORAZEPAM, MULTIVITAMINS [VITAMINS NOS], ESTROGENS CONJUGATED (PREMARIN) and ROSUVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021) outcome was unknown.            Patient didn't have COVID-19 test or diagnosis previously.  Patient went to the cardiologist on 06-Jun-2022 for treatment.     This case was linked to MOD-2022-600726 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: muscle weakness; joint pain; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness) and ARTHRALGIA (joint pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 006B21A and 006M20A) for COVID-19 prophylaxis.     Patient did not have any allergies related to medications, food and other products. Patient never diagnosed or tested positive with COVID-19.  Concomitant products included PROPRANOLOL, TICAGRELOR (BRILINTA), LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], BUSPIRONE, VITAMIN D NOS, MONTELUKAST, CITALOPRAM, FISH OIL, LORAZEPAM, MULTIVITAMINS [VITAMINS NOS], ESTROGENS CONJUGATED (PREMARIN) and ROSUVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness) and ARTHRALGIA (joint pain). At the time of the report, MUSCULAR WEAKNESS (muscle weakness) and ARTHRALGIA (joint pain) had not resolved.            On 06-Jun-2022, patient went to the cardiologist.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-600711 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Muscular weakness
Clinical narrative: muscle weakness; joint pain; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness) and ARTHRALGIA (joint pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 006B21A and 006M20A) for COVID-19 prophylaxis.     Patient did not have any allergies related to medications, food and other products. Patient never diagnosed or tested positive with COVID-19.  Concomitant products included PROPRANOLOL, TICAGRELOR (BRILINTA), LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], BUSPIRONE, VITAMIN D NOS, MONTELUKAST, CITALOPRAM, FISH OIL, LORAZEPAM, MULTIVITAMINS [VITAMINS NOS], ESTROGENS CONJUGATED (PREMARIN) and ROSUVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness) and ARTHRALGIA (joint pain). At the time of the report, MUSCULAR WEAKNESS (muscle weakness) and ARTHRALGIA (joint pain) had not resolved.            On 06-Jun-2022, patient went to the cardiologist.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-600711 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received dose 24 hours after puncture; Vial was first punctured on 22-jun-2022, post punctured stored at fridge and administered on 23-Jun-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose 24 hours after puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 22-jun-2022, post punctured stored at fridge and administered on 23-Jun-2022) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 017C21A and 003C21A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis. The patient had not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Chronic kidney disease, Chronic obstructive pulmonary disease and Drug allergy (Antidepressant). Concomitant products included TRAZODONE for Insomnia, BUPRENORPHINE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE), LISINOPRIL, GABAPENTIN and METHOCARBAMOL for an unknown indication.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Jun-2022 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In June 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 22-jun-2022, post punctured stored at fridge and administered on 23-Jun-2022). On 23-Jun-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose 24 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose 24 hours after puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 22-jun-2022, post punctured stored at fridge and administered on 23-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator 21-Jun-2022, and the vail was first punctured on 22-jun-2022 at 09:00 am and the vaccine was administered 23-jun-2022 at 09:00 am 24 hours after first Puncture. Post puncture the vail was stored in fridge.  The vial had not undergone any temperature excursion and the vial was never placed at room temperature   No treatment medications were reported   This case was linked to MOD-2022-600919 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Illness
Clinical narrative: cant be heard well because of the Moderna COVID-19 vaccination; sick as a dog; This spontaneous case was reported by a patient and describes the occurrence of HYPOACUSIS (cant be heard well because of the Moderna COVID-19 vaccination) and ILLNESS (sick as a dog) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     Patient not had Allergies. Not tested covid positive or diagnosed covid infection.  Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (first Pfizer COVID-19 vaccine) on 14-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (Lot number of the second Pfizer COVID-19 vaccine was EN6206) on 17-Mar-2021 and Pfizer COVID-19 vaccination (Lot number of the first Pfizer COVID-19 booster vaccine was FE3590) on 26-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and Pfizer COVID-19 vaccination.    On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced HYPOACUSIS (cant be heard well because of the Moderna COVID-19 vaccination) and ILLNESS (sick as a dog). At the time of the report, HYPOACUSIS (cant be heard well because of the Moderna COVID-19 vaccination) and ILLNESS (sick as a dog) outcome was unknown.            No concomitant medication was reported. Patient got the second Moderna COVID-19 booster vaccine on 30-Jun-2022. Patient informed that if she stayed with Pfizer she wouldn't have gotten sick.  No treatment drug details was reported.   Reporter did not allow further contact
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave Expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-590501 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-590501:Master case
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (gave expired vaccine to patient) in a 59-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 067H21A) for COVID-19 immunization. No medical history reported. On Apr 19, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 19 2022, patient administered expired product (gave expired vaccine to patient). At the time of the report, administered expired product (gave expired vaccine to patient) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment details. Vaccine expired on Apr 3, 2022.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave Expired vaccine to 8 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine to 8 patients) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine to 8 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine to 8 patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (gave expired vaccine) in a 38-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 067H21A) for COVID-19 immunization. No medical history reported. On May 11, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 11, 2022, patient administered expired product (gave expired vaccine). At the time of the report, administered expired product (gave expired vaccine) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave Expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave Expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2022-590501 (Patient Link).
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (gave expired vaccine) in a 36-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine), batch/lot# 067H21A) for COVID-19 immunization. No medical history reported. On Apr 25, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form.  On Apr 25, 2022, patient administered expired product (gave expired vaccine). At the time of the report, administered expired product (gave expired vaccine) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to USMODERNATX, INC.MOD2022590501 (E2B linked report).
Sex: U
Vaccine: COVID19
Symptoms: Left ventricular failure
Clinical narrative: diastolic heart failure; This spontaneous case was reported by a patient and describes the occurrence of LEFT VENTRICULAR FAILURE (diastolic heart failure) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LEFT VENTRICULAR FAILURE (diastolic heart failure) (seriousness criterion medically significant). At the time of the report, LEFT VENTRICULAR FAILURE (diastolic heart failure) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient was said that stuff was bad. It caused patient diastolic heart failure.  Treatment information was not provided.  Company comment: This spontaneous case concerns a patient of unknown age and gender, without any reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest left ventricular failure (described as diastolic heart failure), which occurred at an unknown interval after receiving a dose of mRNA1273. Patient reported that post vaccination she had diastolic heart failure.  Further details regarding the clinical course and treatment were not provided.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-600918 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, without any reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest left ventricular failure (described as diastolic heart failure), which occurred at an unknown interval after receiving a dose of mRNA1273. Patient reported that post vaccination she had diastolic heart failure.  Further details regarding the clinical course and treatment were not provided.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of vaccination site pain (her arm hurt for a little, then it went away but if she carries something heavy it hurts) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 054B21A and 011B21A) for COVID-19 vaccination. Patient was not allergic to medications, food and other products. Patient did not have COVID-19 positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. On Jun 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 6, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form.  On an unknown date, patient experienced vaccination site pain (her arm hurt for a little, then it went away but if she carries something heavy it hurts). At the time of the report, vaccination site pain (her arm hurt for a little, then it went away but if she carries something heavy it hurts): resolved.  No concomitant medications reported. The AE did not cause patient to seek medical care (i.e. office visit, urgent care, ER, hospitalization). The patient has not experienced a similar event in the past. No treatment reported. This case linked to MOD-2022-601085 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: can't even take a shower and put her arm behind her back; when she sleeps her arm is numb; She is still hurting/if she carries something heavy it hurts; her armpit hurts right now/she can't wear a bra.; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (can't even take a shower and put her arm behind her back), HYPOAESTHESIA (when she sleeps her arm is numb), PAIN IN EXTREMITY (She is still hurting/if she carries something heavy it hurts) and AXILLARY PAIN (her armpit hurts right now/she can't wear a bra.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 054B21A and 011B21A) for COVID-19 vaccination.     Patient had no allergies. Patient had no history related to mentioned adverse event. Patient had no acute or chronic illnesses at the time of vaccination. Patient never has had COVID 19 positive test or diagnosis. Patient did not receive other manufacturer vaccines one month prior to Moderna COVID 19 vaccine.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (can't even take a shower and put her arm behind her back), HYPOAESTHESIA (when she sleeps her arm is numb), PAIN IN EXTREMITY (She is still hurting/if she carries something heavy it hurts) and AXILLARY PAIN (her armpit hurts right now/she can't wear a bra.). At the time of the report, MOBILITY DECREASED (can't even take a shower and put her arm behind her back), HYPOAESTHESIA (when she sleeps her arm is numb), PAIN IN EXTREMITY (She is still hurting/if she carries something heavy it hurts) and AXILLARY PAIN (her armpit hurts right now/she can't wear a bra.) had not resolved.            No concomitant medications were reported. Patient received first booster dose. Patient did not seek medical care due to adverse event (urgent care, office visit, ER or hospitalization). No treatment medications were reported.   This case was linked to MOD-2022-601045 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case reported by a non-health professional, describes the occurrence of immunization reaction (bad side effects from two of the shots) in an adult female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 prophylaxis. No medical history information reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form.  On an unknown date, patient experienced immunization reaction (bad side effects from two of the shots). At the time of the report, immunization reaction (bad side effects from two of the shots) outcome unknown. No concomitant medication or treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I have had worsening reactions after each COVID vaccine dose I had received/Adverse effect.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I have had worsening reactions after each COVID vaccine dose I had received/Adverse effect.) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I have had worsening reactions after each COVID vaccine dose I had received/Adverse effect.). At the time of the report, IMMUNISATION REACTION (I have had worsening reactions after each COVID vaccine dose I had received/Adverse effect.) outcome was unknown.            Patient date of birth was reported  Concomitant medications details were not reported by the reporter.  The patient had reported had worsening reactions after each COVID vaccine dose that patient had received. Patient reported that patient was not confident in medical opinion of the lack of side effects from vaccines prefer to build natural immunity.   Treatment details were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise
Clinical narrative: The last dose which was Moderna made me feel not well and I had to miss work; The last dose which was Moderna made me feel not well and I had to miss work; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (The last dose which was Moderna made me feel not well and I had to miss work) and IMPAIRED WORK ABILITY (The last dose which was Moderna made me feel not well and I had to miss work) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (The last dose which was Moderna made me feel not well and I had to miss work) and IMPAIRED WORK ABILITY (The last dose which was Moderna made me feel not well and I had to miss work). At the time of the report, MALAISE (The last dose which was Moderna made me feel not well and I had to miss work) and IMPAIRED WORK ABILITY (The last dose which was Moderna made me feel not well and I had to miss work) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient's Year of birth was reported. No concomitant medication were reported. No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: I have no energy.; Because since the 2nd in June 2021 I am always tired I have to take naps during the day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I have no energy.) and FATIGUE (Because since the 2nd in June 2021 I am always tired I have to take naps during the day) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (I have no energy.) and FATIGUE (Because since the 2nd in June 2021 I am always tired I have to take naps during the day). At the time of the report, ASTHENIA (I have no energy.) and FATIGUE (Because since the 2nd in June 2021 I am always tired I have to take naps during the day) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant medication reported.  Patient year of birth was reported.  No Treatment medication reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was given on 13-Aug-21 and second dose was given in Dec-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 13-Aug-21 and second dose was given in Dec-2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 13-Aug-21 and second dose was given in Dec-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 13-Aug-21 and second dose was given in Dec-2021) outcome was unknown.            No concomitant medication information provided. It was unknown if patient was enrolled in Covid-19 vaccine trial. No treatment information provided.   This case was linked to MOD-2022-601340 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2022: Follow up contains no new information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: pain; Headache; body aches; a little fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (pain), HEADACHE (Headache), MYALGIA (body aches) and PYREXIA (a little fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 27-Jan-2021, Pfizer vaccine on 17-Feb-2021 and Pfizer vaccine (1st booster) on 21-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 06-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2022, the patient experienced PAIN (pain), HEADACHE (Headache), MYALGIA (body aches) and PYREXIA (a little fever). At the time of the report, PAIN (pain), HEADACHE (Headache), MYALGIA (body aches) and PYREXIA (a little fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. It was reported, patient experienced similar symptoms to what she experienced after the Pfizer vaccine. Concomitant product use was not provided by the reporter.
Age: 1.0
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of underdose (12-month-old received underdosed Moderna vaccine. 0.2 instead of 0.25) in a 12-month-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced an underdose (12-month-old received underdosed Moderna vaccine. 0.2 instead of 0.25). At the time of the report, underdose (12-month-old received underdosed Moderna vaccine. 0.2 instead of 0.25) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: covid-19; covid-19; This is a literature report for the following literature source(s).  A 40-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, 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 immunization. The patient's relevant medical history included: "obesity" (ongoing); "chronic kidney disease" (ongoing); "hypertension" (ongoing). 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 "covid-19". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Positive, notes: testing positive for SARS-CoV-2 by home nasal antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202200910723 Same patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram thorax, Drug ineffective, Nasopharyngeal swab
Clinical narrative: covid-19; covid-19; This is a literature report for the following literature source(s): .  A 75-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, 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: "coronary artery disease" (ongoing); "chronic obstructive pulmonary disease" (ongoing); "diabetes mellitus" (ongoing). 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 "covid-19". The patient underwent the following laboratory tests and procedures: Computerised tomogram thorax: mild ground-glass and 8 reticular opacities, notes: mild ground-glass and 8 reticular opacities consistent with COVID-19 pneumonia; Nasopharyngeal swab: Positive, notes: after testing positive for SARS-CoV-2 by nasopharyngeal PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid 19 cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-PV202200012045 Same patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccination failure; covid-19; This is a literature report for the following literature source(s):.  A 69-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, 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: "hypertension" (ongoing); "obesity" (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19  and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200910724 Same patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: covid-19; covid-19; This is a literature report for the following literature source(s):.  A 70-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, 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: "prostate cancer" (ongoing); "hypertension" (ongoing); "dyslipidemia" (ongoing); "obesity" (ongoing). 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 "covid-19". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202200910725 Same patient;
Age: 1.08
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Product administered at inappropriate site, Pyrexia
Clinical narrative: prolonged high fever; Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left Thigh; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 13-month-old female patient received BNT162b2 (BNT162B2), on 23Jun2022 at 11:45 as dose 1, single (Lot number: FT9142) at the age of 13 months, in left thigh for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: mmr, administration date: 05May2022, when the patient was 12-month-old, for Immunisation, reaction(s): "Diarrhea". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 23Jun2022 at 11:45, outcome "unknown", described as "Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left Thigh"; PYREXIA (medically significant) with onset 25Jun2022, outcome "not recovered", described as "prolonged high fever". The event "prolonged high fever" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (01Jul2022) gone down, notes: almost 105 degrees to 102 degrees. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 reported.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Lot number: ER8732), in left arm, on 12May2021 as dose 2, single (Lot number: EW0173), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: on days 5, 6; (Jun2022) Positive, notes: test turned positive day 7 and stronger on day 8. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Anti-viral details: product=COVID 19 Treatment, brand-Paxlovid, treatment start date: 23Jun2022, treatment stop date: 27Jun2022, indication-Treatment of COVID-19.  AE treatment Paxlovid 2nd course, Device Date: 03Jul2022. Reported Event: Completed 5 day course, tested negative on days 5, 6 and then on day 7 symptoms returned and test turned positive day 7 and stronger on day 8. Adverse event start date 30Jun2022
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Nov2014. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Covid-19 treatment with Paxlovid from 28Jun2022. Patient was taking other medications/ products within 2 weeks of starting Covid-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: 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) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 at 14:45 as dose 1, single (Lot number: EK9231), in right arm, on 26Jan2021 at 13:15 as dose 2, single (Lot number: EL3249), in left arm, on 16Aug2021 at 14:00 as dose 3 (booster), single (Lot number: FC3181), in right arm and on 18Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "bicuspid aortic valve" (unspecified if ongoing); "Known allergy:nickel" (unspecified if ongoing), notes: Known allergy:nickel. Concomitant medication(s) included: ADVAIR, start date: 01Dec2020, stop date: Jun2022; ROSUVASTATIN, start date: 02Jan2021, stop date: Jun2022; PROTONIX [OMEPRAZOLE], start date: 06Nov2020; SINGULAIR, start date: 05Dec2020. Past drug history included: Avelox, reaction(s): "Known allergy:Avelox", notes: Known allergy:Avelox; Thimerosol, reaction(s): "Known allergy:thimerosol", notes: Known allergy:thimerosol. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. ae treatment paxlovid, Sudafed, albuterol, cough med, known allergies Avelox, nickel, thimerosol, other medical history Asthma, COPD, bicuspid aortic valve.; Sender's Comments: As there is limited information in the case provided, the causal association between the events, vaccination failure and covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 2 (booster), single (Lot number: Fj1620), in left arm and on 11Jun2022 at 11:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 26Mar2021 at 10:15 as dose 1, single (Lot number: 180502), in left arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. The patient received treatment product=COVID 19 Treatment, brand=Paxlovid, treatment start date=23Jun2022, treatment stop date=28Jun2022. The seriousness criteria did not results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient received Paxlovid as treatment drug of covid 19. start date of  Paxlovid is 23jun2022 and stop date is 27Jun2022. The action taken for MODERNA COVID-19 VACCINE was not applicable.  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 and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded.