chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Cardiac disorder, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Heart issue; Arthritis; MARKETING PROGRAM NAME NOT AVAILABLE.  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4340975-00 (Company).  A 57 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Apr2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single and intramuscular, administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant) all with onset Aug2021, outcome "recovered" and all described as "COVID-19"; CARDIAC DISORDER (hospitalization) with onset Aug2021, outcome "recovered", described as "Heart issue"; ARTHRITIS (non-serious), outcome "recovered", described as "Arthritis". The patient was hospitalized for drug ineffective, suspected covid-19, cardiac disorder (start date: Aug2021). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) covid-19. The action taken for adalimumab was unknown.  Clinical course: Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Covid -19 and heart issue was not provided. The reporter's causality for the event(s) of arthritis with Humira (Adalimumab) was a reasonable possibility. Company's opinion is that there is no reasonable possibility that the events of Covid -19 and arthritis are related to Humira (Adalimumab). Company's opinion is that the event of heart issue is not assessable. Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran): The reporter's causality for the events of Covid -19, arthritis and heart issue was not reported.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and may be influenced by multiple factors, including the virulence of the infecting pathogen, inherent disease condition, concurrent medical conditions, and concomitant medications, however, a contributory role of the suspect drug cannot be excluded for the reported events of drug ineffective and COVID 19.  Reported event of cardiac disorder and arthritis could be due to an intercurrent medical condition, unrelated to the suspect drug.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate abnormal
Clinical narrative: headaches for almost three weeks; My heart rate feels off; my overall body feels unstable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2022 13:00 (Lot number: FK9729) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROPRANOLOL. The following information was reported: HEADACHE (non-serious) with onset 18Mar2022, outcome "not recovered", described as "headaches for almost three weeks"; HEART RATE ABNORMAL (non-serious) with onset 18Mar2022, outcome "not recovered", described as "My heart rate feels off"; FEELING ABNORMAL (non-serious) with onset 18Mar2022, outcome "not recovered", described as "my overall body feels unstable". The events "headaches for almost three weeks", "my heart rate feels off" and "my overall body feels unstable" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of headache, heart rate abnormal, feeling abnormal.  Additional information: Facility type vaccine Hospital. The patient had not received other vaccine in four weeks. The patient had received Propranolol medication in two weeks. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient had not received covid prior vaccination and not tested for covid post vaccination. There were no known allergies and no other medical history.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: My period stopped; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete: MANUFACTURER UNKNOWN), for Covid-19 Immunization.  The following information was reported: AMENORRHOEA (non-serious), outcome "unknown", described as "My period stopped".  Additional information: The patient received the booster shot for Covid-19 and her period stopped. Should she be worried. Is there anything she can do.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: F
Vaccine: FLUC3
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Influenza A; This spontaneous case from the United States was received on 28-Mar-2022 from other non-healthcare professional (patient's parent) and concerned a 5-year-old, female patient.  The patient's medical history and concomitant medication were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On 27-Mar-2022, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient was tested positive on antigen test for Influenza A. Differentiation of H1N1 and H3N2 was not performed.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of 'influenza A virus infection' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 5-year-old patient was tested positive on antigen test for Influenza A an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. Due to lack of information regarding temporal relationship, causality for the reported event is unassessable.; Sender's Comments: A 5-year-old patient was tested positive on antigen test for Influenza A an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. Due to lack of information regarding temporal relationship, causality for the reported event is unassessable.
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Anaphylactic reaction, Dyspnoea, Flushing, Heart rate increased, Imaging procedure
Clinical narrative: Antiphylactic reaction; Flushed; Trouble breathing; Mouth swelled up; Heartrate high; This spontaneous case was received on 29-Mar-2022 from other non-healthcare professional (the patient's mother) via Med Communications (reference number: SEQW22-01089) and concerned a 14-year-old, male patient.  The patient's concurrent condition included Von Willebrand's disease. The patient was not taking any concomitant medications.  On 22-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prevention. The batch number reported was 308460 and expiry date was 30-Jun-2022.  On the same day, 30 seconds after receiving Flucelvax Quadrivalent, the patient developed anaphylactic reaction. He experienced flushing and trouble breathing. The patient's mouth swelled up and his heart rate was high. The pharmacist called 911 and the patient was taken to hospital by ambulance. At the hospital the patient was given unspecified steroids and the imaging was taken as reported, but no details provided. The patient was not admitted to the hospital and was sent home with unspecified medications.   On an unspecified date, the patient had recovered from the events.  On an unspecified date, the patient was followed up with an allergist, but no details provided.  The reporter assessed the events as related to Flucelvax Quadrivalent. The patient's mother wanted to get some information on reimbursement for hospital bills and doctor visits after the reaction.  The events were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 14-year-old male patient experienced anaphylactic reaction 30 seconds after receiving Flucelvax Quadrivalent vaccine as reported. The patient experienced dyspnea, mouth swelling, increased heart rate and flushing. Based on information provided and plausible temporal relationship, causality for the reported events is assessed as possibly related. Information provided meets level 2 of Brighton Collaboration criteria for anaphylaxis.; Reporter's Comments: The reporter (the patient's mother) assessed the events as related to Flucelvax Quadrivalent as she wanted to get some information on reimbursement for hospital bills and doctor visits after the reaction.; Sender's Comments: A 14-year-old male patient experienced anaphylactic reaction 30 seconds after receiving Flucelvax Quadrivalent vaccine as reported. The patient experienced dyspnea, mouth swelling, increased heart rate and flushing. Based on information provided and plausible temporal relationship, causality for the reported events is assessed as possibly related. Information provided meets level 2 of Brighton Collaboration criteria for anaphylaxis.
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Immediate post-injection reaction, Mouth swelling
Clinical narrative: Antiphylactic reaction; Flushed; Trouble breathing; Mouth swelled up; Heartrate high; This spontaneous case was received on 29-Mar-2022 from other non-healthcare professional (the patient's mother) via Med Communications (reference number: SEQW22-01089) and concerned a 14-year-old, male patient.  The patient's concurrent condition included Von Willebrand's disease. The patient was not taking any concomitant medications.  On 22-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prevention. The batch number reported was 308460 and expiry date was 30-Jun-2022.  On the same day, 30 seconds after receiving Flucelvax Quadrivalent, the patient developed anaphylactic reaction. He experienced flushing and trouble breathing. The patient's mouth swelled up and his heart rate was high. The pharmacist called 911 and the patient was taken to hospital by ambulance. At the hospital the patient was given unspecified steroids and the imaging was taken as reported, but no details provided. The patient was not admitted to the hospital and was sent home with unspecified medications.   On an unspecified date, the patient had recovered from the events.  On an unspecified date, the patient was followed up with an allergist, but no details provided.  The reporter assessed the events as related to Flucelvax Quadrivalent. The patient's mother wanted to get some information on reimbursement for hospital bills and doctor visits after the reaction.  The events were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 14-year-old male patient experienced anaphylactic reaction 30 seconds after receiving Flucelvax Quadrivalent vaccine as reported. The patient experienced dyspnea, mouth swelling, increased heart rate and flushing. Based on information provided and plausible temporal relationship, causality for the reported events is assessed as possibly related. Information provided meets level 2 of Brighton Collaboration criteria for anaphylaxis.; Reporter's Comments: The reporter (the patient's mother) assessed the events as related to Flucelvax Quadrivalent as she wanted to get some information on reimbursement for hospital bills and doctor visits after the reaction.; Sender's Comments: A 14-year-old male patient experienced anaphylactic reaction 30 seconds after receiving Flucelvax Quadrivalent vaccine as reported. The patient experienced dyspnea, mouth swelling, increased heart rate and flushing. Based on information provided and plausible temporal relationship, causality for the reported events is assessed as possibly related. Information provided meets level 2 of Brighton Collaboration criteria for anaphylaxis.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: I am suffering from pain that started after getting my first Pfizer vaccination shot on 3/19/21.  The pain has not gone away and so I went to see my doctor . My first Pfizer dose was given to me at Church: CDC Booking # 169333 03/19/21 @3:30pm.  I have pain in my right arm since my vaccine and have limited motion in my arm before pain increases
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; accidently administered an expired dose of MMR II to a patient; This spontaneous report was received from a registered nurse and refers to a 61-year-old patient of an unknown gender. The patient's medical history was not reported. The patient's concurrent conditions included non hodgkin's lymphoma in remission. Concomitant therapies were not reported. On 16-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) once (lot #T007234, expiration date: 27-FEB-2022) (formulation, dose and route of administration were not reported) for prophylaxis. The vaccine had no prior temperature excursions. No adverse events were reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got both doses of Shingrix, has shingles/suspected vaccination failure; has shingles that's starting now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 03-APR-2022 Reporter's Comments: This case was received from patient's son/daughter via interactive digital media. The patient got both doses of Shingrix vaccine about 5 years ago but had shingles that was starting now. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Incomplete course of vaccination, Pyrexia
Clinical narrative: Chills; Fever; Headache; has declined to receive second dose; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills, fever, headache and incomplete course of vaccination. Shingrix was discontinued. On an unknown date, the outcome of the chills, fever and headache were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the chills, fever and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments: The reporter stated that the patient experienced fever, chills and headache following one dose of Shingrix. The reporter learned of this event through a colleague, so she did not have the date of administration, lot number or expiration date of first dose. The reporter stated the side effects did resolve but she did not know the duration. The patient declined to receive second dose. The reporter consented to follow up. Additional Supportive Information: The patient declined to receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: FLUX
Symptoms: Pericardial effusion
Clinical narrative: diagnosed with pericardial effusion; This case was reported by a consumer via call center representative and described the occurrence of pericardial effusion in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine (intramuscular). On an unknown date, less than 2 years after receiving Flu vaccine, the patient experienced pericardial effusion (serious criteria GSK medically significant). On an unknown date, the outcome of the pericardial effusion was not recovered/not resolved.   It was unknown if the reporter considered the pericardial effusion to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 1-Apr-2022 Reporter's Comments: The caller was the patient. The patient stated that she received a GlaxoSmithKline Flu vaccine (unknown name) in 2016 and was diagnosed with pericardial effusion in 2017. No Lot number or Expiration date was known. The patient provided health care professional information. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Flu vaccine in an unknown arm.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2020 and 2nd dose was not administer yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th November 2020 with batch number LS42K and expiry date 4th December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-Apr-2022 Reporter's Comments: The patient did not administer 2nd dose yet. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 2nd dose of the Moderna COVID19 vaccine 22 days after the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna COVID19 vaccine 22 days after the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna COVID19 vaccine 22 days after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna COVID19 vaccine 22 days after the 1st dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  Reporter did not information on the event at the time of the report.  No treatment medication were provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine was initially stored in the refrigerator on 09-Mar-2022 and expired on 01-Apr-2022; Patient received an expired COVID-19 vaccine as a 2nd Booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired COVID-19 vaccine as a 2nd Booster dose) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 09-Mar-2022 and expired on 01-Apr-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B and 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired COVID-19 vaccine as a 2nd Booster dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 09-Mar-2022 and expired on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired COVID-19 vaccine as a 2nd Booster dose) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 09-Mar-2022 and expired on 01-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vial was initially stored in the refrigerator on 09 March 2022. The vial did not undergo any temperature excursions. Patient did not experienced any symptoms post administration of expired vaccine.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: The follow up received contains no new information. On 04-Apr-2022: The follow up received contains no new information. On 05-Apr-2022: The follow up received contains the date of vial was initially stored in the refrigerator updated.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypokinesia, Illness, Nausea
Clinical narrative: Tendinitis 1.5 week after the first shot; Sick after first shot; Fever 100F after first shot; Nausea after first shot; Chills after first shot; Bad Headache after first shot; Could not run any more after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could not run any more after first shot), TENDONITIS (Tendinitis 1.5 week after the first shot), ILLNESS (Sick after first shot), PYREXIA (Fever 100F after first shot) and NAUSEA (Nausea after first shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HYPOKINESIA (Could not run any more after first shot), ILLNESS (Sick after first shot), PYREXIA (Fever 100F after first shot), NAUSEA (Nausea after first shot), CHILLS (Chills after first shot) and HEADACHE (Bad Headache after first shot). On 01-Dec-2021, the patient experienced TENDONITIS (Tendinitis 1.5 week after the first shot). The patient was treated with Physical therapy for Hypokinesia and Physical therapy for Tendonitis. On 23-Nov-2021, ILLNESS (Sick after first shot), PYREXIA (Fever 100F after first shot), NAUSEA (Nausea after first shot), CHILLS (Chills after first shot) and HEADACHE (Bad Headache after first shot) had resolved. At the time of the report, HYPOKINESIA (Could not run any more after first shot) had not resolved and TENDONITIS (Tendinitis 1.5 week after the first shot) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided.  It was reported that patient did not take any medications. Patient was an athletic and had been running since she was in her 20's. She never had tendinitis in the past. Reporter stated that she believes it was caused by the vaccine. Patient did not saw the doctor yet. She was making an appointment with her PCP.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tendonitis
Clinical narrative: Tendinitis 1.5 week after the first shot; Sick after first shot; Fever 100F after first shot; Nausea after first shot; Chills after first shot; Bad Headache after first shot; Could not run any more after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could not run any more after first shot), TENDONITIS (Tendinitis 1.5 week after the first shot), ILLNESS (Sick after first shot), PYREXIA (Fever 100F after first shot) and NAUSEA (Nausea after first shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HYPOKINESIA (Could not run any more after first shot), ILLNESS (Sick after first shot), PYREXIA (Fever 100F after first shot), NAUSEA (Nausea after first shot), CHILLS (Chills after first shot) and HEADACHE (Bad Headache after first shot). On 01-Dec-2021, the patient experienced TENDONITIS (Tendinitis 1.5 week after the first shot). The patient was treated with Physical therapy for Hypokinesia and Physical therapy for Tendonitis. On 23-Nov-2021, ILLNESS (Sick after first shot), PYREXIA (Fever 100F after first shot), NAUSEA (Nausea after first shot), CHILLS (Chills after first shot) and HEADACHE (Bad Headache after first shot) had resolved. At the time of the report, HYPOKINESIA (Could not run any more after first shot) had not resolved and TENDONITIS (Tendinitis 1.5 week after the first shot) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided.  It was reported that patient did not take any medications. Patient was an athletic and had been running since she was in her 20's. She never had tendinitis in the past. Reporter stated that she believes it was caused by the vaccine. Patient did not saw the doctor yet. She was making an appointment with her PCP.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing/I'm cold all the time), TREMOR (Shaking), DECREASED APPETITE (No appetite), ABDOMINAL DISCOMFORT (my stomach's upset) and DYSPNOEA (Short of breath) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acid reflux (esophageal), Allergy to antibiotic (Tetracycline) and Drug allergy (Aspirin). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal).    On 30-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced SLEEP DISORDER (Woke up in the middle of night). On 31-Mar-2022, the patient experienced FEELING COLD (Freezing/I'm cold all the time), TREMOR (Shaking), DECREASED APPETITE (No appetite), VOMITING (I vomited) and FATIGUE (So  tired). On 05-Apr-2022, the patient experienced ABDOMINAL DISCOMFORT (my stomach's upset), DYSPNOEA (Short of breath), CHEST PAIN (Pain in my chest) and NAUSEA (Nausea). At the time of the report, FEELING COLD (Freezing/I'm cold all the time), TREMOR (Shaking) and ABDOMINAL DISCOMFORT (my stomach's upset) had not resolved, DECREASED APPETITE (No appetite), DYSPNOEA (Short of breath), CHEST PAIN (Pain in my chest), SLEEP DISORDER (Woke up in the middle of night), VOMITING (I vomited) and FATIGUE (So  tired) outcome was unknown and NAUSEA (Nausea) was resolving.            The patient reported patient woke up in the middle of the night & was freezing & shaking, then vomited. Patient went back to bed, but patients body was shaking for 1 hr before patient fell back asleep. Patient woke up so tired and had no appetite. The patient ate chicken soup. On 05 Apr 2022 the patient felt better but still had some nausea & stomach's upset. When  the patient went for walk she was short of breath. Patient reported that she was not sick with the other shots of vaccine. The patient had never tested positive for COVID-19. It was unknown if the patient experienced all the events in the past. All the events dose not caused the patient to seek medical care and it was reported that on 5 April 2022 symptoms were ongoing but improved. The patient Denied the history of cardiac issues.  No treatment information was reported.   This case was linked to MOD-2022-533446 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Nausea, Sleep disorder, Tremor, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing/I'm cold all the time), TREMOR (Shaking), DECREASED APPETITE (No appetite), ABDOMINAL DISCOMFORT (my stomach's upset) and DYSPNOEA (Short of breath) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acid reflux (esophageal), Allergy to antibiotic (Tetracycline) and Drug allergy (Aspirin). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal).    On 30-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced SLEEP DISORDER (Woke up in the middle of night). On 31-Mar-2022, the patient experienced FEELING COLD (Freezing/I'm cold all the time), TREMOR (Shaking), DECREASED APPETITE (No appetite), VOMITING (I vomited) and FATIGUE (So  tired). On 05-Apr-2022, the patient experienced ABDOMINAL DISCOMFORT (my stomach's upset), DYSPNOEA (Short of breath), CHEST PAIN (Pain in my chest) and NAUSEA (Nausea). At the time of the report, FEELING COLD (Freezing/I'm cold all the time), TREMOR (Shaking) and ABDOMINAL DISCOMFORT (my stomach's upset) had not resolved, DECREASED APPETITE (No appetite), DYSPNOEA (Short of breath), CHEST PAIN (Pain in my chest), SLEEP DISORDER (Woke up in the middle of night), VOMITING (I vomited) and FATIGUE (So  tired) outcome was unknown and NAUSEA (Nausea) was resolving.            The patient reported patient woke up in the middle of the night & was freezing & shaking, then vomited. Patient went back to bed, but patients body was shaking for 1 hr before patient fell back asleep. Patient woke up so tired and had no appetite. The patient ate chicken soup. On 05 Apr 2022 the patient felt better but still had some nausea & stomach's upset. When  the patient went for walk she was short of breath. Patient reported that she was not sick with the other shots of vaccine. The patient had never tested positive for COVID-19. It was unknown if the patient experienced all the events in the past. All the events dose not caused the patient to seek medical care and it was reported that on 5 April 2022 symptoms were ongoing but improved. The patient Denied the history of cardiac issues.  No treatment information was reported.   This case was linked to MOD-2022-533446 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient had schedule to receive a procedure on the 13th April 2022; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Patient had schedule to receive a procedure on the 13th April 2022) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (NOS) in 2010 and Immunocompromised.   On 04-Apr-2022, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient had schedule to receive a procedure on the 13th April 2022). At the time of the report, VACCINATION COMPLICATION (Patient had schedule to receive a procedure on the 13th April 2022) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow-up document received includes no new information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Humerus fracture, Myalgia, Nausea, Pyrexia, Upper limb fracture
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of UPPER LIMB FRACTURE (Had 5 fractures in her shoulder), HUMERUS FRACTURE (Humerus bone was turned), PYREXIA (fever/third dose was worse than the first two), MYALGIA (body aches/third dose was worse than the first two) and NAUSEA (nausea (3days)/third dose was worse than the first two) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 027A21A and 036B21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised.On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 24-Oct-2021, 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 UPPER LIMB FRACTURE (Had 5 fractures in her shoulder), HUMERUS FRACTURE (Humerus bone was turned), PYREXIA (fever/third dose was worse than the first two), MYALGIA (body aches/third dose was worse than the first two) and NAUSEA (nausea (3days)/third dose was worse than the first two). At the time of the report, UPPER LIMB FRACTURE (Had 5 fractures in her shoulder) and HUMERUS FRACTURE (Humerus bone was turned) had not resolved, PYREXIA (fever/third dose was worse than the first two) and MYALGIA (body aches/third dose was worse than the first two) outcome was unknown and NAUSEA (nausea (3days)/third dose was worse than the first two) had resolved. The  concomitant medications on use were not provided.The patient reported that she was immunocompromised. Patient stated that the third dose was worse than the first two. Patient had 5 fractures in her shoulder and her humerus bone was turned. Patient stated that her doctor told her to let it heal.No treatment information was provided. This case was linked to MOD-2022-533476, MOD-2022-533467 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Immunisation reaction, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (worse reaction after getting the 1st booster dose), PYREXIA (after the 1st booster dose, she had fever for 1 day) and ACCIDENTAL OVERDOSE (full dose for the booster dose in a non immunocompromised patient) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 039K20-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (annually). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Blood pressure high (concomitant, but controlled with a lot of medications).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In September 2021, the patient experienced VACCINATION COMPLICATION (worse reaction after getting the 1st booster dose) and PYREXIA (after the 1st booster dose, she had fever for 1 day). On 26-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (full dose for the booster dose in a non immunocompromised patient). In September 2021, PYREXIA (after the 1st booster dose, she had fever for 1 day) had resolved. At the time of the report, VACCINATION COMPLICATION (worse reaction after getting the 1st booster dose) and ACCIDENTAL OVERDOSE (full dose for the booster dose in a non immunocompromised patient) outcome was unknown.            Patient had concomitant high blood pressure but controlled with a lot of concomitant medications. It was reported that patient had the annual flu vaccine but does not remember exact date of administration. Patient did not have Covid-19 prior to or after the getting the vaccines. No information on treatment medications was reported.   This case was linked to MOD-2022-533361, MOD-2022-533519 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: painful/pain in left underarm; reactive lymph node; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (painful/pain in left underarm) and VACCINATION SITE LYMPHADENOPATHY (reactive lymph node) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (painful/pain in left underarm) and VACCINATION SITE LYMPHADENOPATHY (reactive lymph node). At the time of the report, VACCINATION SITE PAIN (painful/pain in left underarm) and VACCINATION SITE LYMPHADENOPATHY (reactive lymph node) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: no results provided no results provided.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were reported.  The patient received the second vaccination on 09-Apr-2021 with Lot number as 030B21A, expiration dates as 20Sep2021 and received the injection on right arm.   After receiving the first dose of the Moderna vaccine, patient had pain in left underarm and a reactive lymph node. This has continued for the past year.  Patient had seen 2 doctors who performed a sonogram, but did not offer any treatment options as surgery would have the possibility of nerve damage.  Patient has not tried any medications or treatments to help with the symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: She experienced a slight redness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (She experienced a slight redness on her arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Medical history also included adverse reaction with shingles.  Previously administered products included for Product used for unknown indication: Flu shot (She did not had events with the Flu shot), Penicillin and Cipro. Past adverse reactions to the above products included Adverse event NOS with Cipro and Penicillin; and No adverse event with Flu shot. Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (She experienced a slight redness on her arm). At the time of the report, ERYTHEMA (She experienced a slight redness on her arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient mentioned that it was not the first time she experienced as she "had it with the shingles, the cipro and penicillin" but not with the flu shot. Patient believed she had a problem with the binder. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-533436, MOD-2022-533363 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was refrigerated more than 12 hours after 1st puntured/ kept less than 10 minutes in room temperature  while drawing; Expired moderna vaccine dose administered to patient/Dose administered greater than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine dose administered to patient/Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was refrigerated more than 12 hours after 1st puntured/ kept less than 10 minutes in room temperature  while drawing) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine dose administered to patient/Dose administered greater than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was refrigerated more than 12 hours after 1st puntured/ kept less than 10 minutes in room temperature  while drawing). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine dose administered to patient/Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was refrigerated more than 12 hours after 1st puntured/ kept less than 10 minutes in room temperature  while drawing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 22-Mar-2022  Date and time the vial was first punctured on 04-Apr-2022 at 09.00 am PST  There was no temperature excursion.   No treatment medication were provided.   This case was linked to MOD-2022-533520 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick since April; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick since April) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick since April). At the time of the report, ILLNESS (sick since April) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.  The patient was sick since April of unknown year. The reporter asked if there was any compensation program and did provide any further AE details.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired 1st Moderna Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired 1st Moderna Booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired 1st Moderna Booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired 1st Moderna Booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.