chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site mass
Clinical narrative: Booster; Woke up with like a red like bump where I got the shot; Woke up with like a red like bump where I got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FG3527) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Woke up with like a red like bump where I got the shot".  Additional information: patient got Pfizer booster on Friday and did not had any reaction and then Saturday, woke up with like a red like bump where patient got the shot and still have it today.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pain, Pruritus
Clinical narrative: the bump area itches; red bump at the injection site, like a big circle; it only hurts when she touches it; red bump at the injection site, like a big circle; it only hurts when she touches it; Off label use; booster; Interchange of vaccine products; 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 23-year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 19Nov2021 16:00 (Lot number: FG3527, Expiration Date: 31May2022) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Janssen (1st dose: 10Mar2021, Lot: 1805018, Expiry: 25May2021), administration date: 10Mar2021, for COVID-19 immunizatiion; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 19Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; VACCINATION SITE MASS (non-serious), PAIN (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "red bump at the injection site, like a big circle; it only hurts when she touches it"; PRURITUS (non-serious), outcome "unknown", described as "the bump area itches".  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: the bump area itches; red bump at the injection site, like a big circle; it only hurts when she touches it; red bump at the injection site, like a big circle; it only hurts when she touches it; Off label use; booster; Interchange of vaccine products; 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 23-year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 19Nov2021 16:00 (Lot number: FG3527, Expiration Date: 31May2022) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Janssen (1st dose: 10Mar2021, Lot: 1805018, Expiry: 25May2021), administration date: 10Mar2021, for COVID-19 immunizatiion; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 19Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; VACCINATION SITE MASS (non-serious), PAIN (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "red bump at the injection site, like a big circle; it only hurts when she touches it"; PRURITUS (non-serious), outcome "unknown", described as "the bump area itches".  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Mobility decreased, Pain in extremity
Clinical narrative: difficulty lifting her arm; sore arm; Stated that she received the booster at 4pm on 19 Nov; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 19Nov2021 16:00 (Lot number: FD0809, Expiration Date: 22Jan2022) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: EP6955  , Expiration date: 30Jun2021, Route: Intramuscular), administration date: 20Mar2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Second dose, Lot: EP6955 , Expiration date: 30Jun2021, Route: Intramuscular), administration date: 10Apr2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 16:00, outcome "unknown", described as "Stated that she received the booster at 4pm on 19 Nov"; MOBILITY DECREASED (non-serious) with onset 20Nov2021, outcome "recovering", described as "difficulty lifting her arm"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2021 21:00, outcome "recovering", described as "sore arm". Therapeutic measures were taken as a result of mobility decreased, pain in extremity.  Additional information: There was no patient history. It was reported that the patient could lift her arm more easily last night and that she took Tylenol on 19Nov2021 and she iced her arm on Saturday.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Eating disorder, Headache
Clinical narrative: Shaking; Vomiting/puking; Diarrhea; Joint pain; Fever; Chills; Muscle pain; Headache; I can't eat; Gagging; I haven't been able to sleep; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 13:00 (Lot number: FH8030) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL taken for hypertension; AMLODIPINE taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1, Single (The first two, patient got at the health department)), for COVID-19 immunization; Bnt162b2 (Dose 2, Single (The first two, patient got at the health department)), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021 13:00, outcome "unknown", described as "Booster"; TREMOR (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Shaking"; VOMITING (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Vomiting/puking"; DIARRHOEA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Diarrhea"; ARTHRALGIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Joint pain"; PYREXIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Chills"; MYALGIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Muscle pain"; HEADACHE (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Headache"; INSOMNIA (non-serious) with onset 21Nov2021 09:30, outcome "unknown", described as "I haven't been able to sleep"; RETCHING (non-serious) with onset 22Nov2021, outcome "unknown", described as "Gagging"; EATING DISORDER (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "I can't eat".  Additional information: Patient had no prior vaccination (4 Weeks). On 21Nov2021, since morning at 9:30 hours, patient had not been able to sleep. On 22Nov2021, at 01:00 hour (morning), patient was shaking so bad and mean puking, it was happening, and stated that this was supposed to be good for her. So, patient mean it just doesn't make any sense. Patient mean, that she can't eat, had diarrhea, vomiting, joint pain, fever, chills, muscle pain and headache. On 22Nov2021, patient opened the refrigerator to get even a drink and she just started gagging. Patient stated that this is how the government is helping us. Patient stated that she had to call and tell somebody that this booster shot, this was cruel and inhumane.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Insomnia, Myalgia, Pyrexia, Retching
Clinical narrative: Shaking; Vomiting/puking; Diarrhea; Joint pain; Fever; Chills; Muscle pain; Headache; I can't eat; Gagging; I haven't been able to sleep; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 13:00 (Lot number: FH8030) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL taken for hypertension; AMLODIPINE taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1, Single (The first two, patient got at the health department)), for COVID-19 immunization; Bnt162b2 (Dose 2, Single (The first two, patient got at the health department)), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021 13:00, outcome "unknown", described as "Booster"; TREMOR (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Shaking"; VOMITING (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Vomiting/puking"; DIARRHOEA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Diarrhea"; ARTHRALGIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Joint pain"; PYREXIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Chills"; MYALGIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Muscle pain"; HEADACHE (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Headache"; INSOMNIA (non-serious) with onset 21Nov2021 09:30, outcome "unknown", described as "I haven't been able to sleep"; RETCHING (non-serious) with onset 22Nov2021, outcome "unknown", described as "Gagging"; EATING DISORDER (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "I can't eat".  Additional information: Patient had no prior vaccination (4 Weeks). On 21Nov2021, since morning at 9:30 hours, patient had not been able to sleep. On 22Nov2021, at 01:00 hour (morning), patient was shaking so bad and mean puking, it was happening, and stated that this was supposed to be good for her. So, patient mean it just doesn't make any sense. Patient mean, that she can't eat, had diarrhea, vomiting, joint pain, fever, chills, muscle pain and headache. On 22Nov2021, patient opened the refrigerator to get even a drink and she just started gagging. Patient stated that this is how the government is helping us. Patient stated that she had to call and tell somebody that this booster shot, this was cruel and inhumane.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Shaking; Vomiting/puking; Diarrhea; Joint pain; Fever; Chills; Muscle pain; Headache; I can't eat; Gagging; I haven't been able to sleep; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 13:00 (Lot number: FH8030) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL taken for hypertension; AMLODIPINE taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1, Single (The first two, patient got at the health department)), for COVID-19 immunization; Bnt162b2 (Dose 2, Single (The first two, patient got at the health department)), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021 13:00, outcome "unknown", described as "Booster"; TREMOR (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Shaking"; VOMITING (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Vomiting/puking"; DIARRHOEA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Diarrhea"; ARTHRALGIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Joint pain"; PYREXIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Chills"; MYALGIA (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Muscle pain"; HEADACHE (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "Headache"; INSOMNIA (non-serious) with onset 21Nov2021 09:30, outcome "unknown", described as "I haven't been able to sleep"; RETCHING (non-serious) with onset 22Nov2021, outcome "unknown", described as "Gagging"; EATING DISORDER (non-serious) with onset 22Nov2021 01:00, outcome "unknown", described as "I can't eat".  Additional information: Patient had no prior vaccination (4 Weeks). On 21Nov2021, since morning at 9:30 hours, patient had not been able to sleep. On 22Nov2021, at 01:00 hour (morning), patient was shaking so bad and mean puking, it was happening, and stated that this was supposed to be good for her. So, patient mean it just doesn't make any sense. Patient mean, that she can't eat, had diarrhea, vomiting, joint pain, fever, chills, muscle pain and headache. On 22Nov2021, patient opened the refrigerator to get even a drink and she just started gagging. Patient stated that this is how the government is helping us. Patient stated that she had to call and tell somebody that this booster shot, this was cruel and inhumane.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Burning sensation, Hypersensitivity, Immunisation
Clinical narrative: Booster; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; I got this block but I did touch it but now I have seen it but it hurts me; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FH8028) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 Immunization; Bnt162b2 (2nd Dose), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; HYPERSENSITIVITY (non-serious), PRURITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I am having allergic reactions; I am itchy like allergic reaction in different parts of my body"; MASS (non-serious), AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I have a lump under my left armpit. I have a lump and it hurts, it is swelled up"; BREAST PAIN (non-serious), BURNING SENSATION (non-serious) all with onset 19Nov2021, outcome "unknown" and all described as "My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot"; PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "I got this block but I did touch it but now I have seen it but it hurts me".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain, Pruritus, Swelling
Clinical narrative: Booster; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; I got this block but I did touch it but now I have seen it but it hurts me; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FH8028) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 Immunization; Bnt162b2 (2nd Dose), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; HYPERSENSITIVITY (non-serious), PRURITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I am having allergic reactions; I am itchy like allergic reaction in different parts of my body"; MASS (non-serious), AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I have a lump under my left armpit. I have a lump and it hurts, it is swelled up"; BREAST PAIN (non-serious), BURNING SENSATION (non-serious) all with onset 19Nov2021, outcome "unknown" and all described as "My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot"; PAIN (non-serious) with onset 19Nov2021, outcome "unknown", described as "I got this block but I did touch it but now I have seen it but it hurts me".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Breast pain, Burning sensation, Hypersensitivity, Injection site mass, Pruritus
Clinical narrative: I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: FH8028) 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: HYPERSENSITIVITY (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "I am having allergic reactions; I am itchy like allergic reaction in different parts of my body"; INJECTION SITE MASS (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "I have a lump under my left armpit. I have a lump and it hurts, it is swelled up"; BREAST PAIN (non-serious), BURNING SENSATION (non-serious), outcome "unknown" and all described as "My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: FH8028) 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: HYPERSENSITIVITY (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "I am having allergic reactions; I am itchy like allergic reaction in different parts of my body"; INJECTION SITE MASS (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "I have a lump under my left armpit. I have a lump and it hurts, it is swelled up"; BREAST PAIN (non-serious), BURNING SENSATION (non-serious), outcome "unknown" and all described as "My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot".  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: have not had a menstrual cycle since having the vaccine in April; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 12Apr2021 14:00 (Lot number: EW0172) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. Concomitant medication(s) included: LOW-OGESTREL taken for contraception, start date: 2016. The patient reported taking an unspecified drug and had allergy. The following information was reported: MENSTRUAL DISORDER (medically significant) with onset 12Apr2021, outcome "not recovered", described as "have not had a menstrual cycle since having the vaccine in April". Therapeutic measures were not taken as a result of menstrual disorder.   The reporter considered "have not had a menstrual cycle since having the vaccine in april" not related to bnt162b2.; Sender's Comments: Based on the currently available information the possibility of causal association between the event Amenorrhea and the suspect drug BNT162B2  cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101649201 same patient, suspect drug and event; different dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Wound infection
Clinical narrative: Wound infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EL9269) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st , Time: 1 PM, Site and Route of injection:, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 14Jan2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: WOUND INFECTION (non-serious) with onset 27Sep2021, outcome "recovered" (06Oct2021), described as "Wound infection". Therapeutic measures were taken as a result of wound infection. No follow-up attempts are possible. No further information is expected.  Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.  Additional information: treatment drug: Cephalexin
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Muscle spasms, Pain in extremity, Ultrasound scan
Clinical narrative: Booster; Left leg is really bothering me, it is cramping, it is aching, just all the way from my ankle to my thigh; Left leg is really bothering me, it is cramping, it is aching, just all the way from my ankle to my thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, I had my first 2 Pfizer vaccine doses back in Mar), administration date: Mar2021, for COVID-19 IMMUNIZATION, reaction(s): "Headache"; Bnt162b2 (DOSE 1, SINGLE, I had my first 2 Pfizer vaccine doses back in Mar), administration date: Mar2021, for COVID-19 immunization, reaction(s): "Not feeling well for a day"; Bnt162b2 (DOSE 2, SINGLE, I had my first 2 Pfizer vaccine doses back in Mar), administration date: Mar2021, for COVID-19 immunization, reaction(s): "Headache", "Not feeling well for a day". The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious), MUSCLE SPASMS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Left leg is really bothering me, it is cramping, it is aching, just all the way from my ankle to my thigh". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Consumer stated, that patient had first 2 Pfizer vaccine doses back in March and patient just got the booster on Friday of last week, so like 5 days ago and patient first 2 (incomplete sentence), patient only reaction was, just headache, you know like mild, not feeling well for a day and then this time, after the booster, patient left leg was really bothering me, it was cramping, it was aching, just all the way from my ankle to my thigh and patient even went on Sunday to get checked, an ultrasound to make sure there was nothing in there but it was okay. Patient don't know what to do. 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 completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Myalgia, Pain in extremity, Scan
Clinical narrative: Booster; typical achiness the day after the shot; weird pain in her left leg; I had a headache; you know just typical reaction; 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 34 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Mar2021, for Covid-19 immunization; Bnt162b2 (Dose: 2, Patient stated she had the typical flu like symptoms, fatigue and headache noting primarily after the second shot), administration date: Mar2021, for Covid-19 immunization, reaction(s): "fatigue", "headache", "typical flu like symptoms". The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; MYALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "typical achiness the day after the shot"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "weird pain in her left leg"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "I had a headache; you know just typical reaction". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated she had the booster shot last Friday, five days ago. Patient reported the typical achiness the day after the shot and then the next day she had weird pain in her left leg that is freaking her out. Patient reported she went to the hospital two days after the shot and had her leg scanned because she was very concerned. Patient asked was this permanent. It was reported that in general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Patient stated she was very concerned about the leg pain she has after getting the booster dose.  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 completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101653985 same patient/drug, different dose/event
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Electrocardiogram, Pain in extremity
Clinical narrative: chest pain; Rash in left arm that grew to the size of entire upper arm; pain throughout the entire left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 (Lot number: 30130BA) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bipolar" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; BUSPIRONE; ESTRADIOL; SPIRONOLACTONE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0169, Location of injection: Arm Left), administration date: 02Aug2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 03Sep2021, outcome "recovered with sequelae", described as "chest pain"; RASH (non-serious) with onset 03Sep2021, outcome "recovered with sequelae", described as "Rash in left arm that grew to the size of entire upper arm"; PAIN IN EXTREMITY (non-serious) with onset 03Sep2021, outcome "recovered with sequelae", described as "pain throughout the entire left arm". The events "chest pain", "rash in left arm that grew to the size of entire upper arm" and "pain throughout the entire left arm" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, rash, pain in extremity.  Additional information: The patient did not have covid prior vaccination. The patient did not receive any other vaccine in four weeks. Pain medication was taken for treatment.    Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: chest pain; Rash in left arm that grew to the size of entire upper arm; pain throughout the entire left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 (Lot number: 30130BA) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bipolar" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; BUSPIRONE; ESTRADIOL; SPIRONOLACTONE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0169, Location of injection: Arm Left), administration date: 02Aug2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 03Sep2021, outcome "recovered with sequelae", described as "chest pain"; RASH (non-serious) with onset 03Sep2021, outcome "recovered with sequelae", described as "Rash in left arm that grew to the size of entire upper arm"; PAIN IN EXTREMITY (non-serious) with onset 03Sep2021, outcome "recovered with sequelae", described as "pain throughout the entire left arm". The events "chest pain", "rash in left arm that grew to the size of entire upper arm" and "pain throughout the entire left arm" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, rash, pain in extremity.  Additional information: The patient did not have covid prior vaccination. The patient did not receive any other vaccine in four weeks. Pain medication was taken for treatment.    Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: 1st dose on Monday and started having symptoms of a yeast infection on Thursday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) 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: FUNGAL INFECTION (non-serious) with onset Nov2021, outcome "unknown", described as "1st dose on Monday and started having symptoms of a yeast infection on Thursday".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Lip swelling, Urticaria
Clinical narrative: 5 hours after vaccination my daughter started having hives and swollen lips, and ears.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, C-reactive protein increased, Chest pain, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: Pt began experiencing intermittent palpitations and chest pain four days after event, which are still ongoing 4 months later without a clear etiology. EKG with sinus tachycardia, ECHO was normal. Troponins normal. She did have elevated CRP at time of initial symptoms which is now improving. She has been seen by cardiology without any clear dx thus far. Several ED trips for chest pain, palpitations as well as a few primary care visits.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Enterovirus test positive, Full blood count normal, Human rhinovirus test positive, Metabolic function test normal
Clinical narrative: Pt began experiencing intermittent palpitations and chest pain four days after event, which are still ongoing 4 months later without a clear etiology. EKG with sinus tachycardia, ECHO was normal. Troponins normal. She did have elevated CRP at time of initial symptoms which is now improving. She has been seen by cardiology without any clear dx thus far. Several ED trips for chest pain, palpitations as well as a few primary care visits.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Respiratory viral panel, SARS-CoV-2 test negative, Sinus tachycardia, Troponin normal
Clinical narrative: Pt began experiencing intermittent palpitations and chest pain four days after event, which are still ongoing 4 months later without a clear etiology. EKG with sinus tachycardia, ECHO was normal. Troponins normal. She did have elevated CRP at time of initial symptoms which is now improving. She has been seen by cardiology without any clear dx thus far. Several ED trips for chest pain, palpitations as well as a few primary care visits.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site coldness, Joint range of motion decreased, Neck pain
Clinical narrative: Felt a cold feeling immediately in the area of the shot. In the evening of the first day of the shot, began to feel very sore in the left arm & shoulder. Went to bed at midnight. Woke up every hour with very sore shoulder. By 5:00 am, could not bare the pain in the arm & shoulder. Extremely uncomfortable. Very difficult to lift left arm to do anything. Pain also up to neck area with a headache. Have fought headaches for 60 years. Had examine & advised that I have with the authorities and curvature of the spine. May have been cause by an accident when I was 20 years old.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder, Spinal deformity
Clinical narrative: Felt a cold feeling immediately in the area of the shot. In the evening of the first day of the shot, began to feel very sore in the left arm & shoulder. Went to bed at midnight. Woke up every hour with very sore shoulder. By 5:00 am, could not bare the pain in the arm & shoulder. Extremely uncomfortable. Very difficult to lift left arm to do anything. Pain also up to neck area with a headache. Have fought headaches for 60 years. Had examine & advised that I have with the authorities and curvature of the spine. May have been cause by an accident when I was 20 years old.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: OTC meds for fever and cold/mucus; OTC meds for fever and cold/mucus; Fever/ OTC meds for fever; Vomited; Chills; Headache; Dizziness; Nauseous; Tired; Stuffy nose still; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 18:30 (Lot number: FK127) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: OTC allergy pills cetirizine. Concomitant medication(s) included: FLU taken for immunisation, administration date 18Nov2021; CETIRIZINE taken for hypersensitivity; BENADRYL. The following information was reported: NASOPHARYNGITIS (non-serious), SECRETION DISCHARGE (non-serious) all with onset 24Nov2021 04:00, outcome "recovered with sequelae" and all described as "OTC meds for fever and cold/mucus"; PYREXIA (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Fever/ OTC meds for fever"; VOMITING (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Vomited"; CHILLS (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Chills"; HEADACHE (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Headache"; DIZZINESS (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Dizziness"; NAUSEA (non-serious) with onset 24Nov2021 04:00, outcome "recovered" (Nov2021), described as "Nauseous"; FATIGUE (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Tired"; NASAL CONGESTION (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Stuffy nose still". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nasopharyngitis, secretion discharge, pyrexia. Additional comment: Patient was not reported Covid prior to vaccination and has not been tasted for Covid post vaccination. Other medical history and allergies were reported as none.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Nausea, Pyrexia, Secretion discharge
Clinical narrative: OTC meds for fever and cold/mucus; OTC meds for fever and cold/mucus; Fever/ OTC meds for fever; Vomited; Chills; Headache; Dizziness; Nauseous; Tired; Stuffy nose still; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 18:30 (Lot number: FK127) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: OTC allergy pills cetirizine. Concomitant medication(s) included: FLU taken for immunisation, administration date 18Nov2021; CETIRIZINE taken for hypersensitivity; BENADRYL. The following information was reported: NASOPHARYNGITIS (non-serious), SECRETION DISCHARGE (non-serious) all with onset 24Nov2021 04:00, outcome "recovered with sequelae" and all described as "OTC meds for fever and cold/mucus"; PYREXIA (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Fever/ OTC meds for fever"; VOMITING (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Vomited"; CHILLS (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Chills"; HEADACHE (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Headache"; DIZZINESS (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Dizziness"; NAUSEA (non-serious) with onset 24Nov2021 04:00, outcome "recovered" (Nov2021), described as "Nauseous"; FATIGUE (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Tired"; NASAL CONGESTION (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Stuffy nose still". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nasopharyngitis, secretion discharge, pyrexia. Additional comment: Patient was not reported Covid prior to vaccination and has not been tasted for Covid post vaccination. Other medical history and allergies were reported as none.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: OTC meds for fever and cold/mucus; OTC meds for fever and cold/mucus; Fever/ OTC meds for fever; Vomited; Chills; Headache; Dizziness; Nauseous; Tired; Stuffy nose still; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 18:30 (Lot number: FK127) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: OTC allergy pills cetirizine. Concomitant medication(s) included: FLU taken for immunisation, administration date 18Nov2021; CETIRIZINE taken for hypersensitivity; BENADRYL. The following information was reported: NASOPHARYNGITIS (non-serious), SECRETION DISCHARGE (non-serious) all with onset 24Nov2021 04:00, outcome "recovered with sequelae" and all described as "OTC meds for fever and cold/mucus"; PYREXIA (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Fever/ OTC meds for fever"; VOMITING (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Vomited"; CHILLS (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Chills"; HEADACHE (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Headache"; DIZZINESS (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Dizziness"; NAUSEA (non-serious) with onset 24Nov2021 04:00, outcome "recovered" (Nov2021), described as "Nauseous"; FATIGUE (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Tired"; NASAL CONGESTION (non-serious) with onset 24Nov2021 04:00, outcome "recovered with sequelae", described as "Stuffy nose still". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nasopharyngitis, secretion discharge, pyrexia. Additional comment: Patient was not reported Covid prior to vaccination and has not been tasted for Covid post vaccination. Other medical history and allergies were reported as none.