chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm shoulder deltoid muscle.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle.). At the time of the report, VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No Treatment information was reported.   This case was linked to MOD-2022-461876, MOD-2022-461877 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: white patches on their skin/vitaligo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: VITILIGO (non-serious), outcome "unknown", described as "white patches on their skin/vitaligo".  Additional information: Pfizer had to pay 2.3 billion, the highest amount ever levied against a pharmaceutical company iin the past. Reporter stated that she heard today that someone at Pfizer was arrested for fraud regarding vaccine efficacy and adverse side effects. Reporter queried that "Have they heard any internal communication on that or can they verify the accuracy of that". Reporter also queried that Can "Afib" be a side effect after receiving the Pfizer Covid 19 vaccine, Had that been reported. Reporter stated that her 87 year old husband had a blood clot in his brain after getting the Pfizer Covid vaccine. He couldn't walk and was in the hospital for two weeks and was doing physical therapy now. His doctor said the vaccine could have contributed to it. She stated that she called twice to report it, first on the day it happened when he couldn't walk and then when he was in the hospital. She got a report number but it was "in the other room" and did not provide it. She also said she knew someone who was "paralyzed" after getting the vaccine, someone who had a stroke in the eye, and 2 others who developed white patches on their skin/vitaligo after getting the vaccine. She stated she didn't have their information but she said they all received the Pfizer Covid 19 vaccine.   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) : PFIZER INC-202101530935 same reporter/product/event, different patient
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation
Clinical narrative: maybe had a little weird feeling, like a foggy feeling; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Sep2021 13:00 (Lot number: FC3183) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: Additional Information for Other Conditions: Diagnosed about 2 years ago., takes Trilogy for that; "Blood pressure" (unspecified if ongoing), notes: takes a low dose of a blood pressure pill, he believes is Lisinopril; "heartburn" (unspecified if ongoing), notes: He takes a low dose of a blood pressure pill on Lisinopril, heartburn which he believes is Prilosec; "polyps" (unspecified if ongoing), notes: supposed to have surgery on his nose for like polyps; "Breathing probs" (unspecified if ongoing), notes: Turbinate Reduction: 02Dec2021; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal, start date: 01Apr2020; PRILOSEC [OMEPRAZOLE] taken for dyspepsia; ALBUTEROL SULFATE taken for chronic obstructive pulmonary disease, start date: 20Feb2020 (ongoing); ROSUVASTATIN CALCIUM, start date: 01Apr2020, stop date: 01Apr2020; ESCITALOPRAM taken for anxiety, start date: 06May2021, stop date: 06May2021; FLU VACCINE VII taken for immunisation, administration date 02Apr2021. Vaccination history included: Covid-19 vaccine (DOSE 1, Lot Number : CN6200, Anatomical Location : Arm Right.), administration date: 24Feb2021, for covid-19 immunisation; Covid-19 vaccine (DOSE 2, Lot Number : EN6207, Anatomical Location : Arm Right.), administration date: 17Mar2021, for Covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 21Sep2021 13:00, outcome "unknown", described as "Booster"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "maybe had a little weird feeling, like a foggy feeling".  Additional information: The caller states he had the two first ones and then the third one. He just wanted to tell Pfizer that it saved his life. His whole family, well pretty much two family members, got vaccinated, and he is not saying it was Pfizer vaccines. Some might have been Pfizer, some might have been Moderna, but he is the only one in his family who hasn't gotten this stuff. He lives in (Withheld), and it is a bad place to be right now. He guesses the Delta stuff went through and he got the booster shot and he didn't get any of it. He might have had a touch of it, but he had no symptoms. He clarifies he is referring to the shots for COVID. The caller clarifies he might have a little weird feeling, he doesn't know, it was like a foggy feeling, but everybody was getting it (Covid), but he didn't get it. He was thinking that these shots really saved him.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: malaise; headache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 21 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 21 years 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), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization.  The following information was reported: MALAISE (non-serious) with onset 22Dec2021, outcome "unknown", described as "malaise"; HEADACHE (non-serious) with onset 22Dec2021, outcome "unknown", described as "headache".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Asthma, Potentiating drug interaction
Clinical narrative: asthma; Asking if there is an interaction between Ivermectin and Covid 19 Vaccine; 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 (159558). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single for covid-19 immunisation; ivermectin (IVERMECTIN) (ongoing) (Batch/Lot number: unknown) at 15 mg 1x/day for covid-19. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Caller clarifies that she had Covid before the first two vaccines, not after. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "asthma"; POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "Asking if there is an interaction between Ivermectin and Covid 19 Vaccine".  Additional information: Dosages regimen for concomitant: 15mg once a day for 6 days straight and now taking it once a week for 3 more weeks for a total of 45 tablets Reporter states she just started Ivermectin 2 weeks ago and she was not taking it when she received the first two doses. Reporter states she was taking Ivermectin for long haul Covid symptoms also clarifies that she had Covid before the first two vaccines, not after. She takes Ivermectin 15mg once a week and she took 15mg once a day for 6 days straight and now she is only taking it once a week for 3 more weeks for a total of 45 tablets.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Nausea, Oral herpes
Clinical narrative: tired; very achy; feverish; chills; nauseous; heart was racing; cold sore on my right lip; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 20:15 (Lot number: fe13594) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood presure" (ongoing), notes: blood presure being treated with irbesartan 75mg. Concomitant medication(s) included: IRBESARTAN. Past drug history included: Pennicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ewer8134, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 28May2021, when the patient was 53 years old, for COVID-19 immunization, reaction(s): "Fever", "achey", "Chill", "exhausted"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0170, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 07May2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 20:15, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "tired"; PAIN (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "very achy"; PYREXIA (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "feverish"; CHILLS (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "nauseous"; PALPITATIONS (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "heart was racing"; ORAL HERPES (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "cold sore on my right lip". Therapeutic measures were not taken as a result of fatigue, pain, pyrexia, chills, nausea, palpitations, oral herpes.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia
Clinical narrative: tired; very achy; feverish; chills; nauseous; heart was racing; cold sore on my right lip; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 20:15 (Lot number: fe13594) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood presure" (ongoing), notes: blood presure being treated with irbesartan 75mg. Concomitant medication(s) included: IRBESARTAN. Past drug history included: Pennicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ewer8134, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 28May2021, when the patient was 53 years old, for COVID-19 immunization, reaction(s): "Fever", "achey", "Chill", "exhausted"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0170, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 07May2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 20:15, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "tired"; PAIN (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "very achy"; PYREXIA (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "feverish"; CHILLS (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "nauseous"; PALPITATIONS (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "heart was racing"; ORAL HERPES (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "cold sore on my right lip". Therapeutic measures were not taken as a result of fatigue, pain, pyrexia, chills, nausea, palpitations, oral herpes.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation
Clinical narrative: Booster; the joint pain cause we have a third back; 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 female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (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 no: 1), administration date: 06Mar2021, for COVID-19 immunization, reaction(s): "they kind of pinch your skin"; Covid-19 vaccine (Dose no: 2), for COVID-19 immunization, reaction(s): "they kind of pinch your skin". The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021, outcome "unknown", described as "Booster"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "the joint pain cause we have a third back".  Additional information: Received call from consumer. She and her husband both got Pfizer COVID booster shot today. He got arm pain and it shot down to his leg on right side and that is the side he got the vaccine on. She wanted to find out if that has been reported or not. While reporting for her husband, she mentioned that while getting the other two vaccines, they kind of pinch your skin and this one here, she just put it straight through. This report completed for her injection going straight through. Caller said, we have that anyway, the joint pain cause we have a third back, or very bad back, and we've had them before, the day we got shot, he got back pain and pain shooting on his legs after we got them. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Muscle fatigue, Nausea, Pyrexia
Clinical narrative: Booster; Nausea; extreme muscle fatigue; fever; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown., prev dose brand name unknown: COVID19 Vaccine), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown., prev dose brand name unknown: COVID19 Vaccine), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset Dec2021, outcome "unknown", described as "Nausea"; MUSCLE FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "extreme muscle fatigue"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "chills". Therapeutic measures were not taken as a result of nausea, muscle fatigue, pyrexia, chills.  Additional information: It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. The reporter considered the events as non-serious. The device date was on 28Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Ultrasound uterus
Clinical narrative: Heavy irregular menstrual flow; terrible cramping; irregular and heavy menses; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Nov2021 13:00 (Lot number: 330268D) at the age of 39 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: Bnt162b2 (Dose Number: 1, Batch/Lot No: Elo14d, Location of injection: Arm Left, Vaccine Administration Time: 12:00, Route of Administration: Intramuscular), administration date: 12Dec2020, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "Heavy irregular menstrual flow", "irregular and heavy menses", "Terrible cramping"; Bnt162b2 (Dose Number: 2, Batch/Lot No: Eliz83, Location of injection: Arm Right, Vaccine Administration Time: 12:00, Route of Administration: Intramuscular), administration date: 12Jan2021, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "Heavy irregular menstrual flow", "irregular and heavy menses", "Terrible cramping". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 02Dec2021 16:00, outcome "not recovered", described as "Heavy irregular menstrual flow"; DYSMENORRHOEA (non-serious) with onset 02Dec2021 16:00, outcome "not recovered", described as "terrible cramping"; MENSTRUATION IRREGULAR (non-serious) with onset 02Dec2021 16:00, outcome "not recovered", described as "irregular and heavy menses". The events "heavy irregular menstrual flow", "terrible cramping" and "irregular and heavy menses" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding, dysmenorrhoea, menstruation irregular.  Additional Information: Heavy irregular menstrual flow after initial vaccines. Labs ultrasound biopsies came back negative. After about 7 months symptoms began to improve. Received her booster and symptoms are back. Terrible cramping, irregular and heavy menses.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pyrexia
Clinical narrative: Booster; developed fever after receiving the Pfizer COVID-19 vaccine; 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 male patient received bnt162b2 (BNT162B2) (Lot number: 30135BA, Expiration Date: 28Feb2022) 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), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PYREXIA (non-serious), outcome "unknown", described as "developed fever after receiving the Pfizer COVID-19 vaccine".  Additional information: Caller wants to clarify if the lot number reflected on his vaccination card for his booster dose which has different format as compared to his first and second dose of the Pfizer Covid-19 vaccine. He would like to know if the booster dose he got was not fake and he want to verify if the lot number of his booster dose is authentic or not. And in response It was confirmed that the lot number 30135BA was authentic
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Condition aggravated
Clinical narrative: Hair loss; Hair loss was reported as worsened.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6203) at the age of 70 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 (DOSE 1, SINGLE, First Covid vaccine: 15Feb2021, Lot Number / Expiry Date: EN5319 , Route, Anatomical Location: left arm, No. of Previous Doses: NA), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "Hair loss"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Hair loss was reported as worsened."  Additional information: Patient states her hair was falling out. She used to have a full head of hair, like a rug, and now her hair was thin, like a sheet of paper, or like a sheet on her bed. She was mad, as she used to have a full head of hair and it was now a crappy color and falling out. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chills, Computerised tomogram, Feeling abnormal, Headache
Clinical narrative: nausea; chills; achiness; headache; excruciating; sore throat; CT scan with nuclear dye as a workup for a condition she has been experiencing with her heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "achiness"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "excruciating"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "CT scan with nuclear dye as a workup for a condition she has been experiencing with her heart". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain
Clinical narrative: nausea; chills; achiness; headache; excruciating; sore throat; CT scan with nuclear dye as a workup for a condition she has been experiencing with her heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "achiness"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "excruciating"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "CT scan with nuclear dye as a workup for a condition she has been experiencing with her heart". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Breast swelling, Headache, Insomnia, Myalgia
Clinical narrative: Headache; Bone pain; Generalized muscle pain; Had swelling in the injection side underneath the breast and to the arm; Had swelling in the injection side underneath the breast and to the arm; Had swelling in the injection side underneath the breast and to the arm; Has not been able to sleep due to the pain; Has not been able to sleep due to the pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 49 years 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: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; BONE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Bone pain"; MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "Generalized muscle pain"; VACCINATION SITE SWELLING (non-serious), BREAST SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Had swelling in the injection side underneath the breast and to the arm"; INSOMNIA (non-serious), PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Has not been able to sleep due to the pain". Therapeutic measures were taken as a result of headache, bone pain, myalgia, vaccination site swelling, breast swelling, peripheral swelling, insomnia, pain.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Vaccination site swelling
Clinical narrative: Headache; Bone pain; Generalized muscle pain; Had swelling in the injection side underneath the breast and to the arm; Had swelling in the injection side underneath the breast and to the arm; Had swelling in the injection side underneath the breast and to the arm; Has not been able to sleep due to the pain; Has not been able to sleep due to the pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 49 years 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: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; BONE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Bone pain"; MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "Generalized muscle pain"; VACCINATION SITE SWELLING (non-serious), BREAST SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Had swelling in the injection side underneath the breast and to the arm"; INSOMNIA (non-serious), PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Has not been able to sleep due to the pain". Therapeutic measures were taken as a result of headache, bone pain, myalgia, vaccination site swelling, breast swelling, peripheral swelling, insomnia, pain.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Cold sweat, Muscular weakness, Paraesthesia, Presyncope
Clinical narrative: Severe tinnitus in right ear; Paresthesias in upper limbs for 2-3 days; intense vertigo; vomiting; cold sweats; tremors; intestinal colic; Similar symptoms to severe vasovagal response; Weakness in legs when walking; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 13:00 (Lot number: EN6204) at the age of 48 years as single dose for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Colon irritable" (unspecified if ongoing), notes: Other medical history: Colon irritable; "adverse reaction to opiates" (unspecified if ongoing), notes: Known allergies:  adverse reaction to opiates. Concomitant medication(s) included: CANDESARTAN; ONDANSETRON. The following information was reported: PARAESTHESIA (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "Paresthesias in upper limbs for 2-3 days"; VERTIGO (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "intense vertigo"; VOMITING (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "vomiting"; COLD SWEAT (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "cold sweats"; TREMOR (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "tremors"; ABDOMINAL PAIN (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "intestinal colic"; PRESYNCOPE (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "Similar symptoms to severe vasovagal response"; MUSCULAR WEAKNESS (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "Weakness in legs when walking"; TINNITUS (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Severe tinnitus in right ear". The events "paresthesias in upper limbs for 2-3 days", "intense vertigo", "vomiting", "tremors", "intestinal colic", "similar symptoms to severe vasovagal response", "weakness in legs when walking" and "severe tinnitus in right ear" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of paraesthesia, vertigo, vomiting, cold sweat, tremor, abdominal pain, presyncope, muscular weakness, tinnitus. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Tremor, Vertigo, Vomiting
Clinical narrative: Severe tinnitus in right ear; Paresthesias in upper limbs for 2-3 days; intense vertigo; vomiting; cold sweats; tremors; intestinal colic; Similar symptoms to severe vasovagal response; Weakness in legs when walking; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 13:00 (Lot number: EN6204) at the age of 48 years as single dose for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Colon irritable" (unspecified if ongoing), notes: Other medical history: Colon irritable; "adverse reaction to opiates" (unspecified if ongoing), notes: Known allergies:  adverse reaction to opiates. Concomitant medication(s) included: CANDESARTAN; ONDANSETRON. The following information was reported: PARAESTHESIA (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "Paresthesias in upper limbs for 2-3 days"; VERTIGO (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "intense vertigo"; VOMITING (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "vomiting"; COLD SWEAT (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "cold sweats"; TREMOR (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "tremors"; ABDOMINAL PAIN (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "intestinal colic"; PRESYNCOPE (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "Similar symptoms to severe vasovagal response"; MUSCULAR WEAKNESS (non-serious) with onset 11Mar2021 02:00, outcome "recovering", described as "Weakness in legs when walking"; TINNITUS (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Severe tinnitus in right ear". The events "paresthesias in upper limbs for 2-3 days", "intense vertigo", "vomiting", "tremors", "intestinal colic", "similar symptoms to severe vasovagal response", "weakness in legs when walking" and "severe tinnitus in right ear" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of paraesthesia, vertigo, vomiting, cold sweat, tremor, abdominal pain, presyncope, muscular weakness, tinnitus. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bursitis
Clinical narrative: she has bursitis; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) 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 1, single (Lot Number: Not provided)), administration date: 23Feb2021, for Covid-19 Immunisation. The following information was reported: BURSITIS (non-serious) with onset 2021, outcome "unknown", described as "she has bursitis". Therapeutic measures were taken as a result of bursitis.  Additional Information: The patent said that she had bursitis and received a cortisone injection 3 days after the second dose. She wanted to know if this was okay and if the vaccine was still going to be as effective.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Pain
Clinical narrative: aches / pains; headache; nausea; fatigue; no appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Clot" (unspecified if ongoing), notes: patient was on blood thinner; "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN taken for blood cholesterol. Vaccination history included: Bnt162b2 (in left arm at 12:00 as dose 1, single), administration date: 26Jan2021, when the patient was 81 years old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 28Feb2021, outcome "unknown", described as "aches / pains"; HEADACHE (non-serious) with onset 28Feb2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset 28Feb2021, outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious) with onset 28Feb2021, outcome "not recovered", described as "no appetite". The events "aches / pains", "headache", "nausea", "fatigue" and "no appetite" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain, headache, nausea, fatigue, decreased appetite.  Additional information: It was reported that patient was taking an unspecified blood thinner. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Events were experienced two and a half weeks ago and the patient still had nausea, was "very titrated" and had no appetite. On 02Mar2021, the patient received ninth dose of unspecified product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vaccination site pain
Clinical narrative: Dizziness (intense); Nausea; minimal pain at injection site; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 14:15 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 03Mar2021 15:30, outcome "recovered" (Mar2021), described as "Dizziness (intense)"; NAUSEA (non-serious) with onset 03Mar2021 15:30, outcome "recovered" (Mar2021), described as "Nausea"; VACCINATION SITE PAIN (non-serious) with onset 03Mar2021 15:30, outcome "recovered" (Mar2021), described as "minimal pain at injection site". Therapeutic measures were not taken as a result of dizziness, nausea, vaccination site pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 03Mar2021 at 15:30, the patient experienced dizziness (intense), nausea, and minimal pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anger, Computerised tomogram, Headache, Nervousness
Clinical narrative: severe headaches; she was very angry; she was scared; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: HEADACHE (non-serious), outcome "recovered", described as "severe headaches"; ANGER (non-serious), outcome "unknown", described as "she was very angry"; NERVOUSNESS (non-serious), outcome "unknown", described as "she was scared". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient requested information about how many people from the general population have developed severe headaches as an adverse reaction looking to get enough information to take a decision by herself about if she should get the second dose of the Pfizer's COVID-19 vaccine. She reported that she received the first dose of the Pfizer's COVID-19 vaccine and after that she developed a severe headache that lasted for 13 days and she had to go through a CT scan to complete the diagnosis of her headache. She also reported that she had ready an Epipen just in case she needed to use if after the administration of the second dose of the vaccine. She could not get an answer on how to prevent a headache as an adverse reaction. She could not get an answer about what to do with her symptoms and she stated that she was very angry. She was scared to get the second dose of the vaccine and she wanted to take an informed decision about the administration of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  Additional information: Caller was a 71-year-old female who along with her husband has received both doses of the Pfizer Covid-19 vaccine. The second dose was administered 25Feb2021. She stated that she had no issues with the second dose and only arm soreness after the first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia
Clinical narrative: extreme fatigue; Weakness; muscle aches; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Mar2021 08:30 (Batch/Lot number: unknown) at the age of 53 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Sjogren's syndrome" (unspecified if ongoing); "Levaquin Allergy" (unspecified if ongoing). Concomitant medication included: ATENOLOL. The following information was reported: FATIGUE (non-serious) with onset 23Mar2021 18:30, outcome "recovering", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 23Mar2021 18:30, outcome "recovering", described as "Weakness"; MYALGIA (non-serious) with onset 23Mar2021 18:30, outcome "recovering", described as "muscle aches". Therapeutic measures were not taken as a result of fatigue, asthenia, myalgia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced extreme fatigue, weakness and muscle aches after 10 hours of vaccination on 23Mar2021. Adverse events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Night sweats, Pain, Somnolence
Clinical narrative: sleepiness; night sweats; nausea; body aches; chills; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 76-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 21Feb2021 18:45 (Lot number: EN6200) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: known allergies: Yes; "Rheumatoid arthritis" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing), notes: celiacs. Concomitant medication(s) included: LEFLUNOMIDE; LAMOTRIGINE; FLUTICASONE; AMLODIPINE. The following information was reported: SOMNOLENCE (non-serious) with onset 23Feb2021 14:30, outcome "recovering", described as "sleepiness"; NIGHT SWEATS (non-serious) with onset 23Feb2021 14:30, outcome "recovering", described as "night sweats"; NAUSEA (non-serious) with onset 23Feb2021 14:30, outcome "recovering", described as "nausea"; PAIN (non-serious) with onset 23Feb2021 14:30, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 23Feb2021 14:30, outcome "recovering", described as "chills". Therapeutic measures were not taken as a result of somnolence, night sweats, nausea, pain, chills. Additional Information: The patient had unspecified known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Feb2021 at 14:30, the patient experienced body aches, chills, nausea, night sweats and sleepiness, for around 2 days after with lingering symptoms for a few days.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331137 Same reporter/ patient, different AE/ drug dose