chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Inflammation
Clinical narrative: Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose). On 19-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose) had resolved.            Concomitant medication include  regular medications and did not provide names of the medications. No treatment information was provided   This case was linked to MOD-2022-442530 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inflammation was under the same arm as the injection shoulder / inflammation under the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation was under the same arm as the injection shoulder / inflammation under the arm pit) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 013L20A and 039K20A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (FLU) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation was under the same arm as the injection shoulder / inflammation under the arm pit). At the time of the report, INFLAMMATION (inflammation was under the same arm as the injection shoulder / inflammation under the arm pit) outcome was unknown.            After the booster dose, on Jan 2022, the patient reported inflammation under the arm pit and stated that inflammation was under the same arm as the injection shoulder. The patient also said that he got the flu shot at the same time as the booster dose.  Concomitant medications included regular medications (names not provided).  No treatment was received for the event.   This case was linked to MOD-2022-442376 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Inflammation
Clinical narrative: inflammation was under the same arm as the injection shoulder / inflammation under the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation was under the same arm as the injection shoulder / inflammation under the arm pit) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 013L20A and 039K20A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (FLU) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation was under the same arm as the injection shoulder / inflammation under the arm pit). At the time of the report, INFLAMMATION (inflammation was under the same arm as the injection shoulder / inflammation under the arm pit) outcome was unknown.            After the booster dose, on Jan 2022, the patient reported inflammation under the arm pit and stated that inflammation was under the same arm as the injection shoulder. The patient also said that he got the flu shot at the same time as the booster dose.  Concomitant medications included regular medications (names not provided).  No treatment was received for the event.   This case was linked to MOD-2022-442376 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Vaccination site pain
Clinical narrative: experiencing soreness in her left arm; she received a 0.5mL booster instead of the 0.25mL; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experiencing soreness in her left arm) and ACCIDENTAL OVERDOSE (she received a 0.5mL booster instead of the 0.25mL) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 007M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Jan-2022, the patient experienced VACCINATION SITE PAIN (experiencing soreness in her left arm) and ACCIDENTAL OVERDOSE (she received a 0.5mL booster instead of the 0.25mL). On 06-Jan-2022, ACCIDENTAL OVERDOSE (she received a 0.5mL booster instead of the 0.25mL) had resolved. At the time of the report, VACCINATION SITE PAIN (experiencing soreness in her left arm) had not resolved.            No concomitant medications were reported.  Treatment information was not provided. Patient received a 0.5 milliliter booster instead of 0.25 milliliter at roughly 6.15 AM on 06 January 2022. The only symptom that the patient was experiencing is soreness in her left arm.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised given 0.25ml for the 3rd dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised given 0.25ml for the 3rd dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 04-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised given 0.25ml for the 3rd dose). On 04-Dec-2021, ACCIDENTAL UNDERDOSE (immunocompromised given 0.25ml for the 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Platelet count, Thrombocytosis
Clinical narrative: platelets have gone up, really high; Second dose after more than 36 days since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after more than 36 days since the first dose) and THROMBOCYTOSIS (platelets have gone up, really high) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041521A and 053E4A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included Sickness with Flu vaccine.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after more than 36 days since the first dose). On an unknown date, the patient experienced THROMBOCYTOSIS (platelets have gone up, really high). On 21-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after more than 36 days since the first dose) had resolved. At the time of the report, THROMBOCYTOSIS (platelets have gone up, really high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: normal (normal) four hundreds, about 445 Normal and high (High) High.         She has bloodwork done every 6 months and they used to be in the four hundreds, about 445, which could be normal. No concomitant medications were reported. No treatment medications were reported. Patient was concerned will they platelets come back down and anything close to 600 is a problem.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: received her second dose of the Moderna Covid-19 vaccine and reports that she had a temperature of 102 degrees Farenheight.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (received her second dose of the Moderna Covid-19 vaccine and reports that she had a temperature of 102 degrees Farenheight.) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (received her second dose of the Moderna Covid-19 vaccine and reports that she had a temperature of 102 degrees Farenheight.). At the time of the report, PYREXIA (received her second dose of the Moderna Covid-19 vaccine and reports that she had a temperature of 102 degrees Farenheight.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees 102 degrees Farenheight..         No concomitant and treatment medications were reported. The patient had received her second dose of the Moderna Covid-19 vaccine and had a temperature of 102 degrees Farenheight.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: Hives; anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 0U9C21A and D39A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). On 04-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Anaphylactic reaction, at a dose of solumedrol steroid injection; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at a dose of Medrol steroid pack. At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) and URTICARIA (Hives) outcome was unknown.            Concomitant medications were not provided.  Company Comment: This is a spontaneous case concerning a 31-year-old, male patient with no medical history, who experienced the expected serious event of Anaphylactic reaction and non-serious event Utricaria. The event Anaphylactic reaction occurred on an unknown day and event utricaria occurred 8 days after the third dose of mRNA-1273 vaccine. Patient was treated with Methyl prednisolone, Clarithromycin, Benadryl, prednisone and Medrol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-422917 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 31-year-old, male patient with no medical history, who experienced the expected serious event of Anaphylactic reaction and non-serious event Utricaria. The event Anaphylactic reaction occurred on an unknown day and event utricaria occurred 8 days after the third dose of mRNA-1273 vaccine. Patient was treated with Methyl prednisolone, Clarithromycin, Benadryl, prednisone and Medrol. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Shingles) 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 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 HERPES ZOSTER (Shingles) (seriousness criterion hospitalization). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided.  Company Comment: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of Herpes zoster, which was severe and required hospitalization. The event occurred at an unknown time after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to hospitalization.   This case was linked to MOD-2021-425619, MOD-2021-425615 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of Herpes zoster, which was severe and required hospitalization. The event occurred at an unknown time after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to hospitalization.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2022: No new information received
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: sore arm; tired after his first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore arm) and FATIGUE (tired after his first vaccination) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced ARTHRALGIA (sore arm) and FATIGUE (tired after his first vaccination). At the time of the report, ARTHRALGIA (sore arm) and FATIGUE (tired after his first vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       There was no medical history reported. There was no treatment medication reported. Reported information included, patient received first vaccination in his left arm shoulder deltoid muscle   This case was linked to MOD-2022-440662, MOD-2022-440667 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat; Runny nose; Allergy symptoms; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and HYPERSENSITIVITY (Allergy symptoms) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Due to the state she lives in).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-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 OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and HYPERSENSITIVITY (Allergy symptoms). In October 2021, OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose) had resolved. At the time of the report, HYPERSENSITIVITY (Allergy symptoms) outcome was unknown.            Concomitant medications includes Blood pressure medication, allergy medications and supplements. Patient stated that she started taking supplements a year and half ago to cut back on blood pressure medications due to side effects she had from blood pressure medication. Treatment information includes patient was taking 2 types of allergy medications.  Patient's other medical history includes Blood pressure. Patient had booster dose on 19-Nov-2021 of Lot number 076C21A.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: area on my arm where I had the injection hurts sometimes/My husband gets the same feeling sometimes where he got his vaccine; This is a spontaneous report received from a contactable reporter (consumer).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "area on my arm where I had the injection hurts sometimes/My husband gets the same feeling sometimes where he got his vaccine".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100950817 same reporter/drug/event, different patient
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Oral pain, Rash
Clinical narrative: Rash on my neck; Mouth is hurting; Mouth hurts; Mouth started hurting at the night; Mouth is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 (Lot number: FA7484) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 31Jul2021 02:30, outcome "not recovered", described as "Rash on my neck"; ORAL PAIN (non-serious) with onset 31Jul2021 02:30, outcome "not recovered", described as "Mouth is hurting; Mouth hurts; Mouth started hurting at the night"; MOUTH SWELLING (non-serious) with onset 31Jul2021 02:30, outcome "not recovered", described as "Mouth is swollen". Therapeutic measures were not taken as a result of rash, oral pain, mouth swelling.  Additional information: The patient stated that she took the Pfizer vaccine yesterday, she had a rash on her neck, her mouth is hurting, her mouth is swollen. She stated that she did not receive any treatment, she just had an ice pack on it. The patient did not receive any other vaccine in four weeks.  Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chills, Diarrhoea, Dyspnoea
Clinical narrative: Diarrhea; My whole body hurts; my whole back hurts; My whole body hurts; my whole back hurts; I can't breath very well; shortness of breath; not been able to sleep; sweat; headaches; chills; Muscle ache; chest tightening; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 31Jul2021 13:30 (Lot number: FA7485) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included Covid-19, start date: Jan2021 (unspecified if ongoing), in January2021. There were no concomitant medications. The following information was reported DYSPNOEA (non-serious) with onset 31Jul2021, outcome not recovered; INSOMNIA (non-serious) with onset 31Jul2021, outcome not recovered; HYPERHIDROSIS (non-serious) with onset 31Jul2021, outcome not recovered; HEADACHE (non-serious) with onset 31Jul2021, outcome not recovered; CHILLS (non-serious) with onset 31Jul2021, outcome not recovered; MYALGIA (non-serious) with onset 31Jul2021, outcome not recovered; CHEST DISCOMFORT (non-serious) with onset 31Jul2021, outcome not recovered; PYREXIA (non-serious) with onset 31Jul2021, outcome not recovered; DIARRHOEA (non-serious), outcome unknown; PAIN (non-serious), BACK PAIN (non-serious), outcome unknown; DYSPNOEA (non-serious) with onset 31Jul2021, outcome not recovered. Therapeutic measures were taken as a result of headache, pyrexia.  Additional info- It was reported that patient  took the 1st dose of the Pfizer COVID vaccine two days ago, later in call confirmed to 31Jul2021, and he can't sleep, zero, like he may get 30 minutes of sleep and then he gets up for 2 hours. He also woke up in a pool of sweat this morning, like his body, his head, shorts and shirt were all completely soaked. He has massive, massive headaches, his chest feels like something is pushing on his chest, he has chills and he has a fever. He doesn't know what he can take or what to do. He had COVID in Jan2021 and this is 10 times worse than what he had and he had a pretty bad case. Patient also had a query he could take aspirin for fever and headache because Tylenol for fever and headache, it's killing him.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Insomnia, Myalgia, Pain
Clinical narrative: Diarrhea; My whole body hurts; my whole back hurts; My whole body hurts; my whole back hurts; I can't breath very well; shortness of breath; not been able to sleep; sweat; headaches; chills; Muscle ache; chest tightening; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 31Jul2021 13:30 (Lot number: FA7485) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included Covid-19, start date: Jan2021 (unspecified if ongoing), in January2021. There were no concomitant medications. The following information was reported DYSPNOEA (non-serious) with onset 31Jul2021, outcome not recovered; INSOMNIA (non-serious) with onset 31Jul2021, outcome not recovered; HYPERHIDROSIS (non-serious) with onset 31Jul2021, outcome not recovered; HEADACHE (non-serious) with onset 31Jul2021, outcome not recovered; CHILLS (non-serious) with onset 31Jul2021, outcome not recovered; MYALGIA (non-serious) with onset 31Jul2021, outcome not recovered; CHEST DISCOMFORT (non-serious) with onset 31Jul2021, outcome not recovered; PYREXIA (non-serious) with onset 31Jul2021, outcome not recovered; DIARRHOEA (non-serious), outcome unknown; PAIN (non-serious), BACK PAIN (non-serious), outcome unknown; DYSPNOEA (non-serious) with onset 31Jul2021, outcome not recovered. Therapeutic measures were taken as a result of headache, pyrexia.  Additional info- It was reported that patient  took the 1st dose of the Pfizer COVID vaccine two days ago, later in call confirmed to 31Jul2021, and he can't sleep, zero, like he may get 30 minutes of sleep and then he gets up for 2 hours. He also woke up in a pool of sweat this morning, like his body, his head, shorts and shirt were all completely soaked. He has massive, massive headaches, his chest feels like something is pushing on his chest, he has chills and he has a fever. He doesn't know what he can take or what to do. He had COVID in Jan2021 and this is 10 times worse than what he had and he had a pretty bad case. Patient also had a query he could take aspirin for fever and headache because Tylenol for fever and headache, it's killing him.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; My whole body hurts; my whole back hurts; My whole body hurts; my whole back hurts; I can't breath very well; shortness of breath; not been able to sleep; sweat; headaches; chills; Muscle ache; chest tightening; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 31Jul2021 13:30 (Lot number: FA7485) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included Covid-19, start date: Jan2021 (unspecified if ongoing), in January2021. There were no concomitant medications. The following information was reported DYSPNOEA (non-serious) with onset 31Jul2021, outcome not recovered; INSOMNIA (non-serious) with onset 31Jul2021, outcome not recovered; HYPERHIDROSIS (non-serious) with onset 31Jul2021, outcome not recovered; HEADACHE (non-serious) with onset 31Jul2021, outcome not recovered; CHILLS (non-serious) with onset 31Jul2021, outcome not recovered; MYALGIA (non-serious) with onset 31Jul2021, outcome not recovered; CHEST DISCOMFORT (non-serious) with onset 31Jul2021, outcome not recovered; PYREXIA (non-serious) with onset 31Jul2021, outcome not recovered; DIARRHOEA (non-serious), outcome unknown; PAIN (non-serious), BACK PAIN (non-serious), outcome unknown; DYSPNOEA (non-serious) with onset 31Jul2021, outcome not recovered. Therapeutic measures were taken as a result of headache, pyrexia.  Additional info- It was reported that patient  took the 1st dose of the Pfizer COVID vaccine two days ago, later in call confirmed to 31Jul2021, and he can't sleep, zero, like he may get 30 minutes of sleep and then he gets up for 2 hours. He also woke up in a pool of sweat this morning, like his body, his head, shorts and shirt were all completely soaked. He has massive, massive headaches, his chest feels like something is pushing on his chest, he has chills and he has a fever. He doesn't know what he can take or what to do. He had COVID in Jan2021 and this is 10 times worse than what he had and he had a pretty bad case. Patient also had a query he could take aspirin for fever and headache because Tylenol for fever and headache, it's killing him.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Ear disorder, Fatigue
Clinical narrative: wheezing in chest; sore throat; diarrhea; fever all day 99-102; chills; fatigue; severe congestion; cannot pop ears; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 23Jul2021 (Lot number: EW0186) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. Concomitant medication(s) included: VYVANSE. The following information was reported: WHEEZING (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "wheezing in chest"; OROPHARYNGEAL PAIN (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "sore throat"; DIARRHOEA (non-serious) with onset 27Jul2021 06:00, outcome "recovered", described as "diarrhea"; PYREXIA (non-serious) with onset 27Jul2021 06:00, outcome "recovered", described as "fever all day 99-102"; CHILLS (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "fatigue"; NASAL CONGESTION (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "severe congestion"; EAR DISORDER (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "cannot pop ears"; COUGH (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of wheezing, oropharyngeal pain, diarrhoea, pyrexia, chills, fatigue, nasal congestion, ear disorder, cough.  Clinical information included: Woke up tuesday with sore throat, diarrhea all day, fever all day 99-102, chills, fatigue, severe congestion. Since Tuesday have lost the fever and diarrhea but have continued with congestion and sore throat and now cannot pop ears. Still have fatigue and congestion and now have a cough and wheezing in chest. No other vaccine in four weeks. Covid prior vaccination was reported as no. The patient tested covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Polymerase chain reaction, Pyrexia, Wheezing
Clinical narrative: wheezing in chest; sore throat; diarrhea; fever all day 99-102; chills; fatigue; severe congestion; cannot pop ears; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 23Jul2021 (Lot number: EW0186) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. Concomitant medication(s) included: VYVANSE. The following information was reported: WHEEZING (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "wheezing in chest"; OROPHARYNGEAL PAIN (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "sore throat"; DIARRHOEA (non-serious) with onset 27Jul2021 06:00, outcome "recovered", described as "diarrhea"; PYREXIA (non-serious) with onset 27Jul2021 06:00, outcome "recovered", described as "fever all day 99-102"; CHILLS (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "fatigue"; NASAL CONGESTION (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "severe congestion"; EAR DISORDER (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "cannot pop ears"; COUGH (non-serious) with onset 27Jul2021 06:00, outcome "not recovered", described as "cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of wheezing, oropharyngeal pain, diarrhoea, pyrexia, chills, fatigue, nasal congestion, ear disorder, cough.  Clinical information included: Woke up tuesday with sore throat, diarrhea all day, fever all day 99-102, chills, fatigue, severe congestion. Since Tuesday have lost the fever and diarrhea but have continued with congestion and sore throat and now cannot pop ears. Still have fatigue and congestion and now have a cough and wheezing in chest. No other vaccine in four weeks. Covid prior vaccination was reported as no. The patient tested covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, International normalised ratio, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: I ended up with a rash Saturday; itch; pink color blister located on left (Lt) breast.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jul2021 10:15 (Lot number: EW0167) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TENORMIN taken for hypertension (ongoing); HYZAAR taken for hypertension (ongoing); GLUCOPHAGE XR taken for type 2 diabetes mellitus (ongoing); PRAVAZ taken for blood cholesterol increased (ongoing). The following information was reported: RASH (non-serious) with onset 31Jul2021, outcome "recovered" (03Aug2021), described as "I ended up with a rash Saturday"; PRURITUS (non-serious) with onset 31Jul2021, outcome "recovered" (03Aug2021), described as "itch"; BLISTER (non-serious) with onset 31Jul2021, outcome "recovered" (03Aug2021), described as "pink color blister located on left (Lt) breast.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus, blister.  Additional information: Patient had no family medical history. Patient had the vaccine done Friday this Friday and ended up with a rash Saturday. Patient had no prior vaccination. Patient noticed a cluster of pink color blister located on left (Lt) breast. Ugly. Itching was terrible. Patient immediately applied calamine lotion [treatment]. Privacy (sister) witnessed the heinous sight.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Positron emission tomogram
Clinical narrative: The joint pain is in her shoulders, wrist, fingers, elbows, knees, hips, ankles, and toes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Lot number: EW0162) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (First dose; left arm;, Lot no: ER8734), administration date: 08Apr2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "Severe Joint pain", "pain in her neck". The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "The joint pain is in her shoulders, wrist, fingers, elbows, knees, hips, ankles, and toes". The event "the joint pain is in her shoulders, wrist, fingers, elbows, knees, hips, ankles, and toes" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia.  Additional information:Concomitant Products Tylenol patient Took right before the vaccine. The caller wants to report a potential side effect. The caller took the second vaccine at the end of April, since the first dose she has had severe joint pain throughout her body. The joint pain was in her shoulders, wrist, fingers, elbows, knees, hips, ankles, and toes. At first the caller's doctor said to wait 8 weeks after the second dose to see if it will go away but it was still persisting. The caller has has an appointment tomorrow with a rheumatologist. The caller knows that there has been reports of joint and muscle pain which actually goes away after about 8 weeks. Its has now been 4 months for the caller with no signs of the joint pain going away. This event began a week after the first vaccine. The caller's doctor ran an autoimmune scan and blood work. The caller has low titters for RA but the doctor ran it a week after the second dose so it could be that. The caller states that we can contact her PCP for this information. Time the Vaccination Was Given: 1:00 or 2:00.Prior Vaccinations (within 4 weeks): None.The caller's neck seems to have pain in her neck and her doctor thinks it was an infection. It happened around the time of the first vaccine so the caller doesn't know if it is related. They caller took 3 different antibiotics and that didn't do anything. The caller is unsure of the names of two of the vaccines, one started with a C and the last one she took was Amoxicillin. The caller does not know the lot, NDC, and expiration date for the 3 antibiotics.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Pyrexia, Rash macular, Skin induration
Clinical narrative: red spot; his left arm and it had a hard spot on it; his left arm and it had a hard spot on it and it was hot; had a fever; arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jul2021 (Lot number: FA7485) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 2021, when the patient was 13 years old, for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset 30Jul2021, outcome "not recovered", described as "red spot"; SKIN INDURATION (non-serious) with onset 30Jul2021, outcome "not recovered", described as "his left arm and it had a hard spot on it"; FEELING HOT (non-serious) with onset 30Jul2021, outcome "unknown", described as "his left arm and it had a hard spot on it and it was hot"; PYREXIA (non-serious) with onset 30Jul2021, outcome "recovered" (2021), described as "had a fever"; PAIN IN EXTREMITY (non-serious) with onset 30Jul2021, outcome "not recovered", described as "arm was sore".  Additional information: The patient had the COVID vaccine on 29Jul2021, and he didn't feel bad that day or that evening but the next day, (on 30Jul2021), his arm was really, really, really sore.  At the time of this report, the patient did not have a fever and it looks like it was pretty much all gone on his arm.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Hypokinesia, Illness
Clinical narrative: Sick; Neither one of us can even lift our heads; we had high temperatures up to 112; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 26Jul2021 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick"; HYPOKINESIA (non-serious), outcome "unknown", described as "Neither one of us can even lift our heads"; PYREXIA (non-serious), outcome "unknown", described as "we had high temperatures up to 112". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness, hypokinesia, pyrexia.  Additional information: This report was reported by the wife of the patient.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100991739 similar report from same reporter
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Allergy to vaccine
Clinical narrative: I am allergic to the flu and pneumonia vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation; influenza vaccine (FLU VACCINE) (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset 2021, outcome "unknown", described as "I am allergic to the flu and pneumonia vaccines". Additional information were as follows: "I am allergic to the flu and pneumonia vaccines. My doctor advised me to find out if there are any of the ingredients in the Pfizer vaccine that are in the flu and pneumonia vaccines. If not, then I will be able to take the vaccine!"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: experiencing really bad muscle and joint aches/ore joint aches because it is in her elbows and underneath her armpits/her thighs hurt really bad; experiencing really bad muscle and joint aches/bad muscle aches all over her body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jul2021 (Lot number: FA7485) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Booster vaccine (eight weeks prior that is required every ten years, not sure of the product name), for immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 30Jul2021, outcome "not recovered", described as "experiencing really bad muscle and joint aches/ore joint aches because it is in her elbows and underneath her armpits/her thighs hurt really bad"; MYALGIA (non-serious) with onset 30Jul2021, outcome "not recovered", described as "experiencing really bad muscle and joint aches/bad muscle aches all over her body". Therapeutic measures were taken as a result of arthralgia, myalgia.  Additional information: The patient did not receive any vaccines within four week. The patient reported that she had it about almost a week tomorrow. Had like for the past 3-4 days really bad muscle aches all over her body. The patient stated it probably more joint aches because it was in her elbows and underneath her armpits and those kinds of places. Then stated her thighs hurt really bad. Finally clarified she was having really bad muscle and joint aches. Overall since Friday (30Jul2021), it had gotten worse. But the past two days it had been the same. The patient took one Tylenol pill and reported that it didn't do anything.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Capillary fragility test, Nausea, Rash erythematous
Clinical narrative: red rash; very itchy; Nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 11Apr2021 17:00 (Lot number: EW0153) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Levothyroxine sodium, notes: Levothyroxine sodium 112 mcg PO (per oral) QD (once a day). The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 12Apr2021, outcome "recovered", described as "red rash"; RASH PRURITIC (non-serious) with onset 12Apr2021, outcome "recovered", described as "very itchy"; NAUSEA (non-serious) with onset 12Apr2021, outcome "unknown", described as "Nausea". The events "red rash" and "very itchy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash erythematous, rash pruritic. No follow-up attempts are possible. No further information is expected.