chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Crying, Feeding disorder, Pain in extremity
Clinical narrative: Bell's Palsy; Soreness in arm; Cries all the time; Can't eat or drink right; Doesn't want to go out in public; Swelling; Redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arm), CRYING (Cries all the time), FEEDING DISORDER (Can't eat or drink right), SOCIAL AVOIDANT BEHAVIOUR (Doesn't want to go out in public), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness). The patient was hospitalized on 14-May-2021 due to BELL'S PALSY. At the time of the report, BELL'S PALSY (Bell's Palsy), PAIN IN EXTREMITY (Soreness in arm), CRYING (Cries all the time), FEEDING DISORDER (Can't eat or drink right), SOCIAL AVOIDANT BEHAVIOUR (Doesn't want to go out in public), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Computerised tomogram: Diagnosed with Bell's palsy.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included steroids, eye drops, and eye ointment which was given at the emergency room  It was reported that the patient was not taking any prior concomitant medications.  The pharmacy where she received her first dose told her she should not get the second dose.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Social avoidant behaviour, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Bell's Palsy; Soreness in arm; Cries all the time; Can't eat or drink right; Doesn't want to go out in public; Swelling; Redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arm), CRYING (Cries all the time), FEEDING DISORDER (Can't eat or drink right), SOCIAL AVOIDANT BEHAVIOUR (Doesn't want to go out in public), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness). The patient was hospitalized on 14-May-2021 due to BELL'S PALSY. At the time of the report, BELL'S PALSY (Bell's Palsy), PAIN IN EXTREMITY (Soreness in arm), CRYING (Cries all the time), FEEDING DISORDER (Can't eat or drink right), SOCIAL AVOIDANT BEHAVIOUR (Doesn't want to go out in public), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Computerised tomogram: Diagnosed with Bell's palsy.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included steroids, eye drops, and eye ointment which was given at the emergency room  It was reported that the patient was not taking any prior concomitant medications.  The pharmacy where she received her first dose told her she should not get the second dose.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Fatigue
Clinical narrative: Bell Palsy; tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell Palsy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by reporter.  Concomitant products included CARVEDILOL (COREG) and RAMIPRIL for an unknown indication.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (tiredness). On 15-May-2021, the patient experienced BELL'S PALSY (Bell Palsy) (seriousness criterion medically significant). On 21-Feb-2021, FATIGUE (tiredness) outcome was unknown. At the time of the report, BELL'S PALSY (Bell Palsy) outcome was unknown.  The patient went to the Emergency Room on 15-May-2021 and was diagnosed with Bell Palsy.  No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-137738 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Lymphadenopathy, Pyrexia, Ultrasound scan
Clinical narrative: Whole left breast and under arm swelled up; Under arm swelled up; Slight fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST SWELLING (Whole left breast and under arm swelled up) and LYMPHADENOPATHY (Under arm swelled up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAST SWELLING (Whole left breast and under arm swelled up) (seriousness criterion hospitalization), LYMPHADENOPATHY (Under arm swelled up) (seriousness criterion hospitalization) and PYREXIA (Slight fever). At the time of the report, BREAST SWELLING (Whole left breast and under arm swelled up), LYMPHADENOPATHY (Under arm swelled up) and PYREXIA (Slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) Normal.         On the advice of their primary care doctor, the patient went to the hospital for 4-5 hours. The health care professional at the hospital performed an ultrasound and results came back normal. They received a big bill from the hospital visit.   Very limited information regarding these events has been provided at this time. Further information has been requested.   No Concomitant product use was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Condition aggravated, Dyspnoea, Headache
Clinical narrative: autoimmune condition symptoms aggravated; underlying conditions aggravated; she felt it is difficult for her to normally breath because of lymph nodes pressure on her throat; she kept on getting flu symptoms on and off; Her face feels hot; achy body/muscle pains somedays it resolves quickly but for some days it can last hours; Bad headache; joint pain; lymph nodes in the neck swelled up; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune condition symptoms aggravated) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sjogren's syndrome, Peripheral neuropathy, Graves' disease, Atrial fibrillation and Thyroid disorder.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes in the neck swelled up). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune condition symptoms aggravated) (seriousness criterion medically significant), CONDITION AGGRAVATED (underlying conditions aggravated), INFLUENZA LIKE ILLNESS (she kept on getting flu symptoms on and off), HOT FLUSH (Her face feels hot), MYALGIA (achy body/muscle pains somedays it resolves quickly but for some days it can last hours) and ARTHRALGIA (joint pain). an unknown date, the patient experienced DYSPNOEA (she felt it is difficult for her to normally breath because of lymph nodes pressure on her throat) and HEADACHE (Bad headache). At the time of the report, AUTOIMMUNE DISORDER (autoimmune condition symptoms aggravated), CONDITION AGGRAVATED (underlying conditions aggravated), DYSPNOEA (she felt it is difficult for her to normally breath because of lymph nodes pressure on her throat), INFLUENZA LIKE ILLNESS (she kept on getting flu symptoms on and off), HOT FLUSH (Her face feels hot), LYMPHADENOPATHY (lymph nodes in the neck swelled up), MYALGIA (achy body/muscle pains somedays it resolves quickly but for some days it can last hours), HEADACHE (Bad headache) and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant medications reported as unspecified thyroid and atrial fibrillation medication. Treatment included acetaminophen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-139250 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Influenza like illness, Lymphadenopathy, Myalgia
Clinical narrative: autoimmune condition symptoms aggravated; underlying conditions aggravated; she felt it is difficult for her to normally breath because of lymph nodes pressure on her throat; she kept on getting flu symptoms on and off; Her face feels hot; achy body/muscle pains somedays it resolves quickly but for some days it can last hours; Bad headache; joint pain; lymph nodes in the neck swelled up; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune condition symptoms aggravated) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sjogren's syndrome, Peripheral neuropathy, Graves' disease, Atrial fibrillation and Thyroid disorder.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes in the neck swelled up). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune condition symptoms aggravated) (seriousness criterion medically significant), CONDITION AGGRAVATED (underlying conditions aggravated), INFLUENZA LIKE ILLNESS (she kept on getting flu symptoms on and off), HOT FLUSH (Her face feels hot), MYALGIA (achy body/muscle pains somedays it resolves quickly but for some days it can last hours) and ARTHRALGIA (joint pain). an unknown date, the patient experienced DYSPNOEA (she felt it is difficult for her to normally breath because of lymph nodes pressure on her throat) and HEADACHE (Bad headache). At the time of the report, AUTOIMMUNE DISORDER (autoimmune condition symptoms aggravated), CONDITION AGGRAVATED (underlying conditions aggravated), DYSPNOEA (she felt it is difficult for her to normally breath because of lymph nodes pressure on her throat), INFLUENZA LIKE ILLNESS (she kept on getting flu symptoms on and off), HOT FLUSH (Her face feels hot), LYMPHADENOPATHY (lymph nodes in the neck swelled up), MYALGIA (achy body/muscle pains somedays it resolves quickly but for some days it can last hours), HEADACHE (Bad headache) and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant medications reported as unspecified thyroid and atrial fibrillation medication. Treatment included acetaminophen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-139250 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Emotional distress, Loss of personal independence in daily activities
Clinical narrative: acuate shortnee of breath; weak and feeble/turned into a skeleton; cannot perform daily activities smoothly; suffering badly; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (acuate shortnee of breath), ASTHENIA (weak and feeble/turned into a skeleton), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) and EMOTIONAL DISTRESS (suffering badly) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No reported medical history.  Concomitant products included METFORMIN.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-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 experienced DYSPNOEA (acuate shortnee of breath) (seriousness criterion hospitalization), ASTHENIA (weak and feeble/turned into a skeleton) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) (seriousness criterion medically significant) and EMOTIONAL DISTRESS (suffering badly) (seriousness criterion medically significant). The patient was hospitalized from 13-Apr-2021 to 17-Apr-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (acuate shortnee of breath), ASTHENIA (weak and feeble/turned into a skeleton), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) and EMOTIONAL DISTRESS (suffering badly) outcome was unknown.            Treatment information also included Levothyroxine, Lisinopril and Metoprolol. Patient was discharged from hospital without any improvement and there is no benefit in patient's health.  Very limited information regarding the event onset date has been provided at this time and is insufficient for causality assessment. A causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding the event onset date has been provided at this time and is insufficient for causality assessment. A causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dysphagia, Facial pain, Heart rate, Hemiplegia
Clinical narrative: pressure on right side; paralysis on right side of body; numbness; sharp pain from neck up to face; sharp pain from neck up to face; racing of the heart with heart rate of 140; unable to swallow; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPLEGIA (paralysis on right side of body) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced DYSPHAGIA (unable to swallow). On 18-May-2021, the patient experienced HEMIPLEGIA (paralysis on right side of body) (seriousness criterion medically significant), HYPOAESTHESIA (numbness), NECK PAIN (sharp pain from neck up to face), FACIAL PAIN (sharp pain from neck up to face) and PALPITATIONS (racing of the heart with heart rate of 140). On an unknown date, the patient experienced DISCOMFORT (pressure on right side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-May-2021, DYSPHAGIA (unable to swallow) had resolved. At the time of the report, HEMIPLEGIA (paralysis on right side of body), HYPOAESTHESIA (numbness), NECK PAIN (sharp pain from neck up to face), FACIAL PAIN (sharp pain from neck up to face), PALPITATIONS (racing of the heart with heart rate of 140) and DISCOMFORT (pressure on right side) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Heart rate: 140 (High) 140.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications included Tylenol  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neck pain, Palpitations
Clinical narrative: pressure on right side; paralysis on right side of body; numbness; sharp pain from neck up to face; sharp pain from neck up to face; racing of the heart with heart rate of 140; unable to swallow; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPLEGIA (paralysis on right side of body) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced DYSPHAGIA (unable to swallow). On 18-May-2021, the patient experienced HEMIPLEGIA (paralysis on right side of body) (seriousness criterion medically significant), HYPOAESTHESIA (numbness), NECK PAIN (sharp pain from neck up to face), FACIAL PAIN (sharp pain from neck up to face) and PALPITATIONS (racing of the heart with heart rate of 140). On an unknown date, the patient experienced DISCOMFORT (pressure on right side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-May-2021, DYSPHAGIA (unable to swallow) had resolved. At the time of the report, HEMIPLEGIA (paralysis on right side of body), HYPOAESTHESIA (numbness), NECK PAIN (sharp pain from neck up to face), FACIAL PAIN (sharp pain from neck up to face), PALPITATIONS (racing of the heart with heart rate of 140) and DISCOMFORT (pressure on right side) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Heart rate: 140 (High) 140.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications included Tylenol  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lower limb fracture, Product dose omission issue
Clinical narrative: broke her left knee; More than 36 days since receiving first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOWER LIMB FRACTURE (broke her left knee) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]), APIXABAN (ELIQUIS), FAMOTIDINE and METHOCARBAMOL (ROBAXIN) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced LOWER LIMB FRACTURE (broke her left knee) (seriousness criterion hospitalization). On 26-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days since receiving first dose). The patient was hospitalized from 25-Apr-2021 to 16-May-2021 due to LOWER LIMB FRACTURE. On 26-Apr-2021, PRODUCT DOSE OMISSION ISSUE (More than 36 days since receiving first dose) had resolved. On 16-May-2021, LOWER LIMB FRACTURE (broke her left knee) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Company comment: This report also refers to a case of product dose omission issue for mRNA-1273 (lot # 031A21A) with associated reported serious AE of lower limb fracture. Very limited information has been provided. Further information has been requested.; Sender's Comments: This report also refers to a case of product dose omission issue for mRNA-1273 (lot # 031A21A) with associated reported serious AE of lower limb fracture. Very limited information has been provided. Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis
Clinical narrative: lower leg was swollen and started to get bigger and bigger; blood clot in the right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot in the right leg) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AL20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included PANTOPRAZOLE for GERD, TRAZODONE for Sleeplessness, SIMVASTATIN and CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (blood clot in the right leg) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (lower leg was swollen and started to get bigger and bigger). The patient was treated with RIVAROXABAN (XARELTO) for Thrombosis, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clot in the right leg) and PERIPHERAL SWELLING (lower leg was swollen and started to get bigger and bigger) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes Benapraxine for to simmer down.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: This is a follow-up spontaneous report from a contactable consumer. A 69-years-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced sick on an unspecified date with outcome of unknown. No follow up attempts are possible; Information about Lot and batch number could not be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: My son started having involuntary muscle movements the day after his first covid shot. He seems to be getting worse.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Significant worsening of Tinnitus
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: developing a headache; This is a spontaneous report from a contactable consumer (patient, self-reporting). A female patient (Age: 69; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for an COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. A patient experienced PMH of headaches and calling to see if she can take Excedrin migraine. She thinks she may be developing a headache. Outcome of the events was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable nurse (patient). A 65-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL 3249) via an unspecified route of administration in left arm on 27Jan2021 at 12.30 as 2nd single dose for COVID-19 immunisation. The patient had other medical history. The patient concomitant medications were not reported. The patient had no allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9213 and expiry date was not reported) in left arm on 06Jan2021 at 08:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not have COVID-19 prior to vaccination. On 28Jan2021 at 04:00 (16 hours after second dose), the patient experienced fever 101 (unspecified unit) chills, joint aches and headache. The fever was lasted 12 hours, even though taking Ibuprofen and TYLENOL for the event. No symptoms were appeared after 30 hours post 2nd injection. Low grade temperature 99.5 and chills was showed 48 hour later. The patient was not tested for covid post vaccination. The outcome of the events was recovered on an unspecified date in Jan 2021. Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain in extremity, Rhinorrhoea, Smear test
Clinical narrative: Headache; Arm sore; Runny nose; Cough; This is a spontaneous report from a contactable Other Health Professional (patient). A 37-year-old non pregnant adult female patient received first dose bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EK4176), administered in left arm via intramuscular, on 06Jan2021 (at the age of 37-years-old) as SINGLE DOSE for covid-19 immunization. Medical history included supraventricular tachycardia, hypertension, drug hypersensitivity (known allergies: Sulfa drugs). Concomitant medications received within 2 weeks of vaccination included metoprolol succinate, losartan, atomoxetine hydrochloride (STRATTERA), Amfetamine aspartate, Amfetamine sulfate, Dexamfetamine saccharate, Dexamfetamine sulfate (ADDERALL) and fexofenadine hydrochloride (ALLEGRA). On 07Jan2021, the patient experienced headache, arm sore, runny nose and cough. No treatment was received for the adverse events. The outcome of the events was recovered. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab smear test was negative on 10Jan2021 POC COVID-19 ID NOW. The most recent covid-19 vaccine was administered at hospital. The patient receives no other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had allergies to medications, food, or other products included sulfa drugs.  (Follow-up (01Feb2021): Follow up received from contactable Other Health Professional (patient) reported new information included: suspect dosage and event information for dose 2.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tremor
Clinical narrative: She experienced headache; Low grade fever; Body aches; Chills; Uncontrollable shakes; High fever; This is a report combining information from duplicate reports 2021146061 and 2021099401. The current and all subsequent information will be reported under manufacturer report number 2021099401. This is a spontaneous report from a contactable consumer. A 52-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Deltoid Left on 27Jan2021 as 2nd dose single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose on 07Jan2021. Medical history included menopausal symptoms, hot flush and insomnia from an unknown date and unknown if ongoing. Concomitant medications included zolpidem tartrate taken for menopausal symptoms, hot flush, insomnia, start and stop date were not reported, multivitamins taken for an unspecified indication, start and stop date were not reported. Over the counter medication for menopausal symptoms. Had hot flashes and was not sleeping well so she started it. She has been on it for 3 months. Product spelling confirmed and documented by caller. Caller states she is healthy and is an avid runner. She is very active. Time the Vaccination Was Given as she received both doses around noon. On an unspecified date patient experienced she experienced headache, low grade fever, body aches, chills, uncontrollable shakes and high fever. She noticed the headache the day after she got the vaccine, but it has gotten worse. She still has the headache. She felt good the day she got the vaccination. The next day she was achy, but she took Tylenol and was able to go to work. Saturday night she had uncontrollable shakes and high fever. She has this constant headache. The outcome of the event headache was not recovered whereas the other events was unknown.  Follow-up (01Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported with patient general information.  Follow-up (11Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding confirmation of start date of second dose. This report included that query raised on the date of first and second dose and kept the first dose date in error.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This is a Spontaneous report from a contactable female consumer (reported for herself) via a Pfiz-er sponsored program Pfizer First Connect.   The female patient of an unspecified age received first dose of BNT162B2 (BNT162B2; Solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced a severe headache. It was reported that, received Covid-19 vaccine first dose and experienced a severe headache. Asking if she needed to rush him to the doctor. Unable to gather personal information as caller hangs up. The outcome of the event of headache was unknown.  information on the LOT/Batch number had been requested  Follow-up attempts were completed. No further information was expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Chills, Diarrhoea
Clinical narrative: High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping; diarrhea (1st dose only); lose of taste and smell; lose of taste and smell; This is a spontaneous report from a contactable other hcp (patient).   A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: E49899, dose 1 via an unspecified route of administration in right arm on 22Dec2020 at 15:15 as 1ST DOSE, SINGLE for covid-19 immunization (48-years-old at the time of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. The patient relevant medical history included asthma, back injury, drug hypersensitivity, allergies: NSAIDS, mushroom allergy, seafood allergy, (Allergies to medications, food, or other products: Yes, sodium benzoate, ASA, NSAIDS, mushrooms, seafood). The patient concomitant medications included Multivitamin, D3, Iron, Mg Citrat and flax seed oil. The patient previously took sodium benzoate and experienced drug hypersensitivity, ASA, and experienced drug hypersensitivity. On 04Jan2021, the patient experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, diarrhea (1st dose only), and loss of taste and smell. No treatment received for the adverse event. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. On 05Jan2021, the patient underwent lab tests and procedures which included sars-cov-2 test was negative (Covid test type post vaccination was Nasal Swab).  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping; diarrhea (1st dose only); lose of taste and smell; lose of taste and smell; This is a spontaneous report from a contactable other hcp (patient).   A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: E49899, dose 1 via an unspecified route of administration in right arm on 22Dec2020 at 15:15 as 1ST DOSE, SINGLE for covid-19 immunization (48-years-old at the time of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. The patient relevant medical history included asthma, back injury, drug hypersensitivity, allergies: NSAIDS, mushroom allergy, seafood allergy, (Allergies to medications, food, or other products: Yes, sodium benzoate, ASA, NSAIDS, mushrooms, seafood). The patient concomitant medications included Multivitamin, D3, Iron, Mg Citrat and flax seed oil. The patient previously took sodium benzoate and experienced drug hypersensitivity, ASA, and experienced drug hypersensitivity. On 04Jan2021, the patient experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, diarrhea (1st dose only), and loss of taste and smell. No treatment received for the adverse event. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. On 05Jan2021, the patient underwent lab tests and procedures which included sars-cov-2 test was negative (Covid test type post vaccination was Nasal Swab).  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Lymphadenopathy, Pain
Clinical narrative: fever; aches; chills; headache; feeling light headed; swollen glands under my arm on injection arm.; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Jan2021 21:00  (age at vaccination 38-year-old) at 2ND DOSE, SINGLE for covid-19 immunisation. Public Health Clinic/(Name) facility where the most recent COVID-19 vaccine was administered. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. No allergies to medications, food, or other products. Historical vaccine included the first dose of BNT162b2 (BNT162b2 , Lot# EL8982 and Expiration date were unknown) administered in arm left on 14Jan2021 at 04:00 PM. On 31Jan2021 16:00, the patient experienced fever, aches, chills, headache, feeling light headed, swollen glands under my arm on injection arm. The patient was not treatment for adverse event. The outcome of events were not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; aches; chills; headache; feeling light headed; swollen glands under my arm on injection arm.; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Jan2021 21:00  (age at vaccination 38-year-old) at 2ND DOSE, SINGLE for covid-19 immunisation. Public Health Clinic/(Name) facility where the most recent COVID-19 vaccine was administered. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. No allergies to medications, food, or other products. Historical vaccine included the first dose of BNT162b2 (BNT162b2 , Lot# EL8982 and Expiration date were unknown) administered in arm left on 14Jan2021 at 04:00 PM. On 31Jan2021 16:00, the patient experienced fever, aches, chills, headache, feeling light headed, swollen glands under my arm on injection arm. The patient was not treatment for adverse event. The outcome of events were not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I've been having fever; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration on 28Jan2021 as UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she had vaccine on 28Jan2021 (yesterday) and had fever since last night and today. The patient enquired that is it true that Tylenol should not be taken when you take the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: fever; Chills; Tiredness; Headache; Muscle pains; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and Expiration date not reported), via an unspecified route of administration in arm left on 01Feb2021 (at the age of 33-year-old), as a single dose for covid-19 immunisation. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and Expiration date not reported), via an unspecified route of administration in arm left on 11Jan2021 15:30 as a single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever, chills, tiredness, headache and muscle pains on 02Feb2021 03:00. The seriousness of all the events was reported as non-serious. The patient did not receive any treatment for the events. The outcome of all the events was reported as recovering.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other hcp. A 52-years-old male patient received second vaccination dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, expiration date not reported), via intramuscular, administered in left arm on 30Jan2021 08:30 (at the age of 52-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first vaccination dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302), via intramuscular, administered in left arm on 09Jan2021 09:00 AM (at the age of 52-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks. On unspecified date in 2021, 24/48 hours after the second shot, patient experienced major headache, sore and achy all over, fever around 100 and little nauseous. Patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was tested for COVID-19 (Aegis) nasal swab which showed negative on 29Jan2021 and on 01Feb2021, patient tested sars-cov-2 test with pending result. Patient did not receive treatment for the adverse event. Reporter assessed the case as non-serious with no seriousness criteria (results in death/ life threatening/ caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect). At the time of report, patient was recovering from all the events. Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable other hcp. A 52-years-old male patient received second vaccination dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, expiration date not reported), via intramuscular, administered in left arm on 30Jan2021 08:30 (at the age of 52-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first vaccination dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302), via intramuscular, administered in left arm on 09Jan2021 09:00 AM (at the age of 52-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks. On unspecified date in 2021, 24/48 hours after the second shot, patient experienced major headache, sore and achy all over, fever around 100 and little nauseous. Patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was tested for COVID-19 (Aegis) nasal swab which showed negative on 29Jan2021 and on 01Feb2021, patient tested sars-cov-2 test with pending result. Patient did not receive treatment for the adverse event. Reporter assessed the case as non-serious with no seriousness criteria (results in death/ life threatening/ caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect). At the time of report, patient was recovering from all the events. Follow-up attempts are completed. No further information is expected.