chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Vaccination site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second 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 SITE WARMTH (Vaccination site warmth). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-318263, MOD-2021-318424 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: it's feeling the mucus on his system; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (it's feeling the mucus on his system) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SECRETION DISCHARGE (it's feeling the mucus on his system). At the time of the report, SECRETION DISCHARGE (it's feeling the mucus on his system) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: joint pain; all over aches snd pains in my muscles; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) and MYALGIA (all over aches snd pains in my muscles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first 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. On an unknown date, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (all over aches snd pains in my muscles). At the time of the report, ARTHRALGIA (joint pain) and MYALGIA (all over aches snd pains in my muscles) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Head discomfort, Hypokinesia, Sinus disorder, Somnolence
Clinical narrative: coughing; head has been plugged up; nose and sinuses really; cannot lay down; slept three nights sitten up; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), HEAD DISCOMFORT (head has been plugged up), SINUS DISORDER (nose and sinuses really), HYPOKINESIA (cannot lay down) and SOMNOLENCE (slept three nights sitten up) in a 0-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04813218) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ATORVASTATIN and OXYCODONE for an unknown indication.    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, the patient experienced COUGH (coughing), HEAD DISCOMFORT (head has been plugged up), SINUS DISORDER (nose and sinuses really), HYPOKINESIA (cannot lay down) and SOMNOLENCE (slept three nights sitten up). At the time of the report, COUGH (coughing), HEAD DISCOMFORT (head has been plugged up), SINUS DISORDER (nose and sinuses really), HYPOKINESIA (cannot lay down) and SOMNOLENCE (slept three nights sitten up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medication included Prostate medication and Androgens.  Treatment medication use was not provided by the reporter.  Caller got tested for COVID.   Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Follow-up contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 patients administered dose out of a vial that was in the fridge for 31 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients administered dose out of a vial that was in the fridge for 31 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients administered dose out of a vial that was in the fridge for 31 days). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (2 patients administered dose out of a vial that was in the fridge for 31 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  concomitant information provided by the reporter No treatment information provided by the reporter  It was reported that Pharmacist did not know if it was consumer's 1st or second dose .2 doses administered out of a vial that was in the adverse events fridge for 31 days.
Sex: U
Vaccine: COVID19
Symptoms: Glossodynia, Hypoaesthesia oral, Stomatitis
Clinical narrative: sores on tongue; sores on tongue and inside mouth; lips feel numb; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (sores on tongue), STOMATITIS (sores on tongue and inside mouth) and HYPOAESTHESIA ORAL (lips feel numb) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GLOSSODYNIA (sores on tongue), STOMATITIS (sores on tongue and inside mouth) and HYPOAESTHESIA ORAL (lips feel numb). At the time of the report, GLOSSODYNIA (sores on tongue), STOMATITIS (sores on tongue and inside mouth) and HYPOAESTHESIA ORAL (lips feel numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Is it normal to have a reaction a week after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Is it normal to have a reaction a week after getting the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Is it normal to have a reaction a week after getting the vaccine). At the time of the report, VACCINATION COMPLICATION (Is it normal to have a reaction a week after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided.  No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Myalgia, Vaccination site warmth
Clinical narrative: Little discomfort; Body aches; Injection arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection arm was warm), DISCOMFORT (Little discomfort) and MYALGIA (Body aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid operation (Thyroid removed). Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, FOLIC ACID, CALCIUM and MELOXICAM for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection arm was warm). On 05-Feb-2021, the patient experienced DISCOMFORT (Little discomfort) and MYALGIA (Body aches). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of Every 4 hours. At the time of the report, VACCINATION SITE WARMTH (Injection arm was warm), DISCOMFORT (Little discomfort) and MYALGIA (Body aches) outcome was unknown.            Treatment details include ice.   This case was linked to MOD-2021-318648, MOD-2021-318659 (Patient Link).
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: sore arm; fatigue; felt a feverish sensation; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (felt a feverish sensation) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Sanofi Pasteur quadrivalent influenza vaccine (Sanofi Pasteur quadrivalent influenza vaccine) in 2017. Past adverse reactions to the above products included Adverse event with Sanofi Pasteur quadrivalent influenza vaccine.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (felt a feverish sensation). At the time of the report, MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (felt a feverish sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        My allergist/immunologist and cardiologist were very pleased my COVID vaccinations went so well.  Patient was having hereditary alpha tryptasemia genetic trait, confirmed by a Gene-by-Gene genetic test.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received includes Added reporter details (Non-significant information).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got COVID after the first; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got COVID after the first) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I got COVID after the first). At the time of the report, COVID-19 (I got COVID after the first) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose > 35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) 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 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). On 13-Apr-2021, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is in another country and hence could not take her second dose. She was asked to take the second dose of Pfizer vaccine on 14-SEP-2021 and she has to start over.  Concomitant medications were not provide  No treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity
Clinical narrative: My right arm has been numb; My right arm has been causing pain and discomfort; My right arm has been causing pain and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (My right arm has been numb), PAIN IN EXTREMITY (My right arm has been causing pain and discomfort) and LIMB DISCOMFORT (My right arm has been causing pain and discomfort) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced HYPOAESTHESIA (My right arm has been numb), PAIN IN EXTREMITY (My right arm has been causing pain and discomfort) and LIMB DISCOMFORT (My right arm has been causing pain and discomfort). At the time of the report, HYPOAESTHESIA (My right arm has been numb), PAIN IN EXTREMITY (My right arm has been causing pain and discomfort) and LIMB DISCOMFORT (My right arm has been causing pain and discomfort) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Delusion, Hallucination, Memory impairment, Mental disorder
Clinical narrative: Hallucinations; Psychological problems/unable to speak for herself; Memory problems/getting lost; Delusions; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations), MENTAL DISORDER (Psychological problems/unable to speak for herself), MEMORY IMPAIRMENT (Memory problems/getting lost) and DELUSION (Delusions) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Embolic shower (similar to stroke) in 2012 and Accident (Car accident) in 2012. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criteria hospitalization and medically significant), MENTAL DISORDER (Psychological problems/unable to speak for herself) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Memory problems/getting lost) (seriousness criterion hospitalization) and DELUSION (Delusions) (seriousness criterion hospitalization). The patient was hospitalized for 10 days due to DELUSION, HALLUCINATION, MEMORY IMPAIRMENT and MENTAL DISORDER. At the time of the report, HALLUCINATION (Hallucinations), MENTAL DISORDER (Psychological problems/unable to speak for herself), MEMORY IMPAIRMENT (Memory problems/getting lost) and DELUSION (Delusions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Patient's parent reported that patient has been in the hospital for 10 days. Patient was unable to speak for herself after receiving the vaccination. Patient experienced psychological problems within a week after vaccination, which turned out to delusions, hallucinations. Doctors were trying to understand the reactions.  Company Comment: This case concerns a 26 year-old, female subject with a history of Embolic Shower,  who experienced the unexpected events of Hallucinations and Mental Disorder. The event occurred approximately unknown date,  after the first dose of Moderna Covid-19 vaccine.  The medical history, Embolic shower and use of concomitant medication Duloxetine remains a confounder. The benefit-risk relationship of mRNA-1273, is not affected by this report.; Sender's Comments: This case concerns a 26 year-old, female subject with a history of Embolic Shower,  who experienced the unexpected events of Hallucinations and Mental Disorder. The event occurred approximately unknown date,  after the first dose of Moderna Covid-19 vaccine.  The medical history, Embolic shower and use of concomitant medication Duloxetine remains a confounder. The benefit-risk relationship of mRNA-1273, is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporte.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her left arm). At the time of the report, PAIN IN EXTREMITY (pain in her left arm) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Inappropriate schedule of product administration, Pain, Pruritus
Clinical narrative: Inappropriate schedule of vaccine administered; itch; blisters; redness; pain; rash generally came up on leg and face / Skin behind rear covered in rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MIRTAZAPINE, CITALOPRAM, OMEPRAZOLE and SIMVASTATIN for an unknown indication.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No treatment information was provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Inappropriate schedule of vaccine administered; itch; blisters; redness; pain; rash generally came up on leg and face / Skin behind rear covered in rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MIRTAZAPINE, CITALOPRAM, OMEPRAZOLE and SIMVASTATIN for an unknown indication.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose less than 25 days after the first; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days after the first) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days after the first). On 06-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days after the first) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Swelling face
Clinical narrative: injection site pain; puffy face; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain) and SWELLING FACE (puffy face) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 017E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced INJECTION SITE PAIN (injection site pain) and SWELLING FACE (puffy face). At the time of the report, INJECTION SITE PAIN (injection site pain) and SWELLING FACE (puffy face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-319707 (Patient Link).
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 years old son got the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years old son got the first dose) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years old son got the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years old son got the first dose) had resolved.            The pediatrician called and  apologized for the administration error since the patient's son was not eligible to get the vaccine. No concomitant medication reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Brain neoplasm
Clinical narrative: discovered a tumor in left side of the brain; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN NEOPLASM (discovered a tumor in left side of the brain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced BRAIN NEOPLASM (discovered a tumor in left side of the brain) (seriousness criteria hospitalization and medically significant). At the time of the report, BRAIN NEOPLASM (discovered a tumor in left side of the brain) outcome was unknown.            No concomitant medication details were provided. No treatment medication details were provided.  Reporter advised patient was now in ICU and that patient that he was probably in his 50s.  This case concerns a male patient with no relevant medical history reported, who experienced the unexpected event of brain neoplasm. The events occurred after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a male patient with no relevant medical history reported, who experienced the unexpected event of brain neoplasm. The events occurred after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Cough
Clinical narrative: coughing; Her ribs are still a little sore today; This is a spontaneous report from a contactable Consumer (patient herself). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on 17Jul2021 as single dose for COVID-19 immunisation (Age at Vaccination was 69 years). The patient's medical history included diabetes, High blood pressure, Hiatal hernia, vertigo, COPD, hypertension, cardiac and asthma (family history). Concomitant medications included Insulin and Aspirin (Acetylsalicylic acid) taken for cardiac disorder. It was stated that, prior vaccinations (within 4 weeks) were she doubts that seriously but, can't say for sure. On 26Jul2021, it was reported that, the patient experienced she was been into have little bit of coughing, she was having some coughing and her ribs are still a little sore today. No therapeutic measures were taken as a result of events. She did not visit Emergency Room or Physician Office for the events. The seriousness of the events was considered as non-serious. The outcome of the event coughing was unknown and for her ribs are still a little sore today was not recovered.  Follow-up attempts have been completed and no further information is expected. Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Electrocardiogram, Heart rate abnormal, Insomnia
Clinical narrative: pounding in my heart; I have like trembling in my legs and then a radiation going through my body; I feel like there is some anxiety; I am having a hard time going to sleep; Mucus spilting up mucus 30 minutes after injection; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Aug2021, the patient experienced pounding in heart, had like trembling in legs and then a radiation going through body (ICE cold), feel like there was some anxiety, having a hard time going to sleep and mucus spilting up mucus 30 minutes after injection. It was reported that, the patient tried to lay down but was experiencing it is like pounding and she had like trembling in her legs and then a radiation went through her body and she also took some Calcium Magnesium, so she did not know if that was supposed to calm her, calm her down but she felt like there was some trembling going on her legs. The patient wanted to report that she was looping a pounding in her heart and she was having a hard time going to sleep. She feels like there was some anxiety. She reported she was going to call the advisor she was in the stress right now and she was not getting anywhere. She went to the ER and then administered 25mg antihistamine (Benadryl) on 03Aug2021. They ran an EKG and blood work full panel. Results were ok and she was sent home. Her symptoms samed all elevated after 30 minutes of taking Benadryl. She was fine the following day. The patient took Benadryl and antihistamines for Anxiety-legs, trembling-mucus. The patient was not taking any other products together with those Benadryl. Admission to hospital due to the event was reported as no. The patient underwent lab tests and procedures which included blood work: unknown result (Result work ok), EKG: unknown result, heart rate abnormal: abnormal, on an unspecified date. Therapeutic measures were taken as a result of events. At the time of report the patient was not taking any medication. The outcome of the events pounding in my heart and I feel like there is some anxiety was reported as not recovered. The outcome of the events I have like trembling in my legs and then a radiation going through my body and I am having a hard time going to sleep was reported as recovered. The outcome of the event mucus spilting up mucus 30 minutes after injection was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge, Tremor
Clinical narrative: pounding in my heart; I have like trembling in my legs and then a radiation going through my body; I feel like there is some anxiety; I am having a hard time going to sleep; Mucus spilting up mucus 30 minutes after injection; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Aug2021, the patient experienced pounding in heart, had like trembling in legs and then a radiation going through body (ICE cold), feel like there was some anxiety, having a hard time going to sleep and mucus spilting up mucus 30 minutes after injection. It was reported that, the patient tried to lay down but was experiencing it is like pounding and she had like trembling in her legs and then a radiation went through her body and she also took some Calcium Magnesium, so she did not know if that was supposed to calm her, calm her down but she felt like there was some trembling going on her legs. The patient wanted to report that she was looping a pounding in her heart and she was having a hard time going to sleep. She feels like there was some anxiety. She reported she was going to call the advisor she was in the stress right now and she was not getting anywhere. She went to the ER and then administered 25mg antihistamine (Benadryl) on 03Aug2021. They ran an EKG and blood work full panel. Results were ok and she was sent home. Her symptoms samed all elevated after 30 minutes of taking Benadryl. She was fine the following day. The patient took Benadryl and antihistamines for Anxiety-legs, trembling-mucus. The patient was not taking any other products together with those Benadryl. Admission to hospital due to the event was reported as no. The patient underwent lab tests and procedures which included blood work: unknown result (Result work ok), EKG: unknown result, heart rate abnormal: abnormal, on an unspecified date. Therapeutic measures were taken as a result of events. At the time of report the patient was not taking any medication. The outcome of the events pounding in my heart and I feel like there is some anxiety was reported as not recovered. The outcome of the events I have like trembling in my legs and then a radiation going through my body and I am having a hard time going to sleep was reported as recovered. The outcome of the event mucus spilting up mucus 30 minutes after injection was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity, Vaccination site pain
Clinical narrative: developed pain on her left arm just above the elbow going to the mid part of her chest; developed pain on her left arm just above the elbow going to the mid part of her chest; developed pain on her left arm just above the elbow going to the mid part of her chest; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Jul2021 (age at vaccination 50 years) as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number was not reported), via an unspecified route of administration, on 22Jun2021 (age at vaccination 50 years) as dose 1, single for COVID-19 immunization. On an unknown date in Jul2021, patient developed pain on her left arm where she had the shot  just above the elbow going to the mid part of her chest. It was reported that she had her second Covid vaccine on 16Jul2021 and since then has had pain from her left arm where she had the shot to the middle of her chest. Stated that she thought that it would ease up and it has not. Stated that it was concerning her. Wanted to know if someone reported this before and if this was something that she should go to the hospital about. The patient had not yet recovered from the events.  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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Tinnitus, Vertigo
Clinical narrative: loud tinnitus; vertigo; An increase in frequency of and intensity of migraines; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 56-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EN6204) via an unspecified route of administration in right arm on 19Mar2021 13:00 as dose 1, single (at the age of 56-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included migraines, seizure disorder, three years of out breast cancer, high blood pressure. Patient known allergies included allergies to penicillin. 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 concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced very loud tinnitus in right ear, self spinning vertigo and an increase in frequency of and intensity of migraines on 23Mar2021. The adverse events resulted in a visit to Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of loud tinnitus, vertigo, migraines. The outcome of the event was not recovered.  No Follow-up attempts are possible. Information about lot/batch number cannot be obtained.  Follow-up attempts have been completed and No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Some blood in her underwear that was a purplish color; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received unknown dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration on 04Aug2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. Patient medical history in 2005, patient had hysterectomy. She had some bleeding from the incision two years ago, but no longer gets periods from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, It was reported that after working out on thursday patient had some blood in her underwear that was a purplish color which occurred again today and wants to know if this is a known side effect. Responded that the authorized EUA Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine does not list menstrual changes as adverse reaction from clinical studies and post authorization experience. The outcome of event was unknown.  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: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Vomiting
Clinical narrative: Vomiting; Having chills, very cold and feeling very chilly; Having chills, very cold and feeling very chilly; This is a spontaneous report from contactable consumer or other non-healthcare professional. This consumer reported for a patient (reporter's wife).  A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number and Expiration Date were not reported), via an unspecified route of administration administered in left arm on 07Aug2021 at 01:30 (52-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The reporter stated that they are trying to find out if the patient has asthma and they are not sure but the doctor says that she might have some asthma (Further not clarified hence, not captured in tab). The patient's concomitant medications were not reported. The patient had not received any vaccine within four weeks. On an unspecified date in Aug 2021, the patient experienced vomiting, chills, very cold and feeling very chilly. The reporter stated that he and his wife had (further clarification unknown) COVID shot today with Pfizer and the patient was vomiting and had chills. The patient was very cold and feeling very chilly. So, the reporter put a few blankets on the patient and she stopped vomiting but the reporter thought it is out of her system but she had spent several hours talking about maybe 7 or 8 hours ago when they took the shot. The patient did not receive any treatment but all she did was sit straight and that made her feel better and she had her chills right after. The reporter just wanted to know how serious it is, the patient's vomiting stopped but she is still getting some chills the reporter thinks but how will this go away. The outcome of the event vomiting was recovered on an unspecified date in 2021 and other event were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Eye pain, Fatigue, Headache
Clinical narrative: Injection site pain/swelling; Injection site pain/swelling; arm pain; severe muscle aches and muscle fatigue x3 days; severe muscle aches and muscle fatigue x3 days; low grade fever nightly x3 days; headache; eye balls ached; some nausea; diarrhea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received bnt162b2 (COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 16Jul2021 18:15 (Lot Number: EW0181) as dose 1, single at the age of 60-year-old for COVID-19 immunisation. The patient was not pregnant. Medical history included HTN (hypertension),  hypothyroidism, DJD (degenerative joint disease), secondary hyperparathyroidism, known allergies PCN (penicillin). No other vaccine in four weeks. There were other medications in two weeks. There were concomitant medications. The patient experienced injection site pain/swelling, arm pain, severe muscle aches and muscle fatigue x3 days (as reported), low grade fever nightly x3 days (as reported), headache, eye balls ached x4 days, some nausea x3 days (as reported); diarrhea and fatigue persisting x2 weeks on 16Jul2021 21:00. No treatment received. No covid prior vaccination. No Covid tested post vaccination. The patient underwent lab tests and procedures which included fever: low grade. The outcome of severe muscle aches and muscle fatigue x3 days, low grade fever nightly x3 days, some nausea was recovered on 18Jul2021. The outcome of diarrhea and fatigue was recovered in Jul2021. The outcome of other events was recovered in2021.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Injection site pain/swelling; Injection site pain/swelling; arm pain; severe muscle aches and muscle fatigue x3 days; severe muscle aches and muscle fatigue x3 days; low grade fever nightly x3 days; headache; eye balls ached; some nausea; diarrhea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received bnt162b2 (COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 16Jul2021 18:15 (Lot Number: EW0181) as dose 1, single at the age of 60-year-old for COVID-19 immunisation. The patient was not pregnant. Medical history included HTN (hypertension),  hypothyroidism, DJD (degenerative joint disease), secondary hyperparathyroidism, known allergies PCN (penicillin). No other vaccine in four weeks. There were other medications in two weeks. There were concomitant medications. The patient experienced injection site pain/swelling, arm pain, severe muscle aches and muscle fatigue x3 days (as reported), low grade fever nightly x3 days (as reported), headache, eye balls ached x4 days, some nausea x3 days (as reported); diarrhea and fatigue persisting x2 weeks on 16Jul2021 21:00. No treatment received. No covid prior vaccination. No Covid tested post vaccination. The patient underwent lab tests and procedures which included fever: low grade. The outcome of severe muscle aches and muscle fatigue x3 days, low grade fever nightly x3 days, some nausea was recovered on 18Jul2021. The outcome of diarrhea and fatigue was recovered in Jul2021. The outcome of other events was recovered in2021.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain/swelling; Injection site pain/swelling; arm pain; severe muscle aches and muscle fatigue x3 days; severe muscle aches and muscle fatigue x3 days; low grade fever nightly x3 days; headache; eye balls ached; some nausea; diarrhea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received bnt162b2 (COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 16Jul2021 18:15 (Lot Number: EW0181) as dose 1, single at the age of 60-year-old for COVID-19 immunisation. The patient was not pregnant. Medical history included HTN (hypertension),  hypothyroidism, DJD (degenerative joint disease), secondary hyperparathyroidism, known allergies PCN (penicillin). No other vaccine in four weeks. There were other medications in two weeks. There were concomitant medications. The patient experienced injection site pain/swelling, arm pain, severe muscle aches and muscle fatigue x3 days (as reported), low grade fever nightly x3 days (as reported), headache, eye balls ached x4 days, some nausea x3 days (as reported); diarrhea and fatigue persisting x2 weeks on 16Jul2021 21:00. No treatment received. No covid prior vaccination. No Covid tested post vaccination. The patient underwent lab tests and procedures which included fever: low grade. The outcome of severe muscle aches and muscle fatigue x3 days, low grade fever nightly x3 days, some nausea was recovered on 18Jul2021. The outcome of diarrhea and fatigue was recovered in Jul2021. The outcome of other events was recovered in2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her arms, legs, and torso; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient.   A female young patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Expiry Date, NDC number: not provided) via an unspecified route of administration on 06Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included Penicillin allergy (had a previous allergic reaction to penicillin) from an unknown date and unknown if ongoing and no other products were provided. The reporter stated that the patient developed a rash on her arms, legs and torso (on an unspecified date in Aug2021). The mother of the patient gave antihistamines to treat; it was not anaphylaxis, but the patient was treated with antihistamines. The reporter was seeking information if the patient should receive a second of the Pfizer BioNtech COVID 19 vaccine in a clinic versus pharmacy for safety reasons due to previous reaction to the first vaccine, he read on the withheld website that a major rash was a contraindication. The reporter told the patients mother that he would reach out and find out more information for her. The event outcome was unknown.  No follow-up attempts were needed. No further information was expected.  Follow-up (17Sep2021): 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.