chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 16 year-old received first dose of Moderna; first dose was 0.25 ml; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old received first dose of Moderna) and UNDERDOSE (first dose was 0.25 ml) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old received first dose of Moderna) and UNDERDOSE (first dose was 0.25 ml). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old received first dose of Moderna) and UNDERDOSE (first dose was 0.25 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment drugs were provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Dec-2021 at 3:49 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Non-significant Follow up appended.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Dec-2021 at 3:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 17-Dec-2021 at 3:40 PM, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Vaccine was expired on 24 October 2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Non significant Follow up received, updated reporter details.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:49 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Dec-2021 at 3:49 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 17-Dec-2021 at 3:49 PM, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Vaccine was expired on 24 October 2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Non significant Follow up, contains no new information.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: sick for 3 days after dose 2; days 1 and 2 fever of 102 degree F after dose 2; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 3 days after dose 2) and PYREXIA (days 1 and 2 fever of 102 degree F after dose 2) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 045B21A) for COVID-19 vaccination.     Concurrent medical conditions included Constipation (in October it was very serious and she started taking Miralax.). Concomitant products included MACROGOL 3350 (MIRALAX) for Constipation.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (sick for 3 days after dose 2) and PYREXIA (days 1 and 2 fever of 102 degree F after dose 2). In 2021, ILLNESS (sick for 3 days after dose 2) and PYREXIA (days 1 and 2 fever of 102 degree F after dose 2) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 102 degree fahrenheit (High) 102 degree Fahrenheit.         it was reported that the second dose was the worst. No concomitant medication details was provided.   This case was linked to MOD-2021-418177, MOD-2021-418186 (Patient Link).   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: he was a little bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (he was a little bit swollen) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (he was a little bit swollen). At the time of the report, SWELLING (he was a little bit swollen) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided. Patient was not an alcoholic or a smoker. After the first dose Patient was a little bit swollen for a couple of days and after that it had resolved.   This case was linked to MOD-2021-418161 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up received contains non-significant information (E-mail ID confirmed).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Swelling face
Clinical narrative: tingling and numbness in arms and legs; Severe headaches; swollen face; tingling and numbness in arms and legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Aug2021 15:15 (Lot number: FC3183) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL. Past drug history included: Codine, reaction(s): "Drug allergy", notes: known allergies: Codine. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 23Aug2021 06:00, outcome "not recovered" and all described as "tingling and numbness in arms and legs"; HEADACHE (non-serious) with onset 23Aug2021 06:00, outcome "not recovered", described as "Severe headaches"; SWELLING FACE (non-serious) with onset 23Aug2021 06:00, outcome "not recovered", described as "swollen face". Therapeutic measures were not taken as a result of hypoaesthesia, headache, swelling face, paraesthesia.  Additional information: Patient did not receive any other vaccine in four weeks. Other medication in two weeks was Estradiol. Patient did not have covid prior vaccination. Patient did not tested covid post vaccination. Facility type vaccine: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Pain, Walking disability
Clinical narrative: severe neurological complications; pain; inability to walk; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 30 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 30 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: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "severe neurological complications"; PAIN (non-serious), outcome "unknown", described as "pain"; WALKING DISABILITY (non-serious), outcome "unknown", described as "inability to walk".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Pain, Paraesthesia
Clinical narrative: achiness/ ache; chills; Fevering/ feverish; increased heart rate; left arm (Coded to: Tingling); This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Mar2021 (Lot number: EN6199) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FISH OIL, start date: Jan2019; KYOLIC taken for prophylaxis, start date: Jan2019; VITAMIN D [COLECALCIFEROL], start date: Jan2019. The following information was reported: HEART RATE INCREASED (non-serious) with onset 11Mar2021, outcome "unknown", described as "increased heart rate"; PARAESTHESIA (non-serious) with onset 11Mar2021, outcome "unknown", described as "left arm (Coded to: Tingling)"; PAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "achiness/ ache"; CHILLS (non-serious) with onset 01Apr2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "Fevering/ feverish". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, paraesthesia.  Additional information: Caller said that on her first dose, she had no reaction and had a little bit in the beginning but immediately went away. For the second dose, she had vomiting, diarrhea, and headache in which she had to go to the emergency care. Caller also added that she did have the usual "achiness, chills, and fevering from it". First dose injected in her arm. Multivitamin took one a day by mouth on an unknown date in Jan2019. Increased heart rate: Caller said after her first dose given, she had increased heart rate and tingling in her left arm that dissipated over ten minutes or so. She said there was no treatment done, it was while she was still there at vaccination site, so they had her stay there for a little bit longer.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: achiness/ ache; chills; Fevering/ feverish; increased heart rate; left arm (Coded to: Tingling); This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Mar2021 (Lot number: EN6199) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FISH OIL, start date: Jan2019; KYOLIC taken for prophylaxis, start date: Jan2019; VITAMIN D [COLECALCIFEROL], start date: Jan2019. The following information was reported: HEART RATE INCREASED (non-serious) with onset 11Mar2021, outcome "unknown", described as "increased heart rate"; PARAESTHESIA (non-serious) with onset 11Mar2021, outcome "unknown", described as "left arm (Coded to: Tingling)"; PAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "achiness/ ache"; CHILLS (non-serious) with onset 01Apr2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "Fevering/ feverish". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, paraesthesia.  Additional information: Caller said that on her first dose, she had no reaction and had a little bit in the beginning but immediately went away. For the second dose, she had vomiting, diarrhea, and headache in which she had to go to the emergency care. Caller also added that she did have the usual "achiness, chills, and fevering from it". First dose injected in her arm. Multivitamin took one a day by mouth on an unknown date in Jan2019. Increased heart rate: Caller said after her first dose given, she had increased heart rate and tingling in her left arm that dissipated over ten minutes or so. She said there was no treatment done, it was while she was still there at vaccination site, so they had her stay there for a little bit longer.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Severe hives all over legs come and go; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "TP/ait- no pancreas" (unspecified if ongoing); "TP/ait- no spleen" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: LYRICA (within two weeks of vaccination). Vaccination history included: Bnt162b2 (Dose 1, lot number unknown), for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 03Aug2021, outcome "not recovered", described as "Severe hives all over legs come and go". The event "severe hives all over legs come and go" was 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 urticaria.  Additional information:No other vaccine in four weeks. No covid prior vaccination. The patient tested for covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.A 64-year-old male patient received bnt162b2 (COMIRNATY), administration date 23Mar2021 (Lot number: ER8727) at the age of 63 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 number: 1, Lot number: EN6202), administration date: 04Mar2021, when the patient was 63 years old, for Covid-19 immunization, reaction(s): "No side effects".The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 2021, outcome "unknown", described as "I got the 3rd vaccine because of the COPD". Additional information: The patient reported that he had no problem with it, he was still great, he felt great with no side effects at all. The patient took both shots and the booster. The patient got the third vaccine because of the COPD. And it was like disease. Date of administration of third dose: 20Oct2021 (lot EW0185). NDC number, UPC number and expiry date were reported as unknown. No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Influenza like illness, Overdose, Pain
Clinical narrative: sore arm; red swollen; red swollen; painfull; Flu-like symptoms; Dose: 3rd; the undiluted vial was administered to a patient with 0.3 mL; the undiluted vial was administered to a patient with 0.3 mL; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 83 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 28Oct2021 11:45 (Lot number: 320308D, Expiration Date: 28Feb2022) at the age of 83 years as dose 3 (booster), 0.3 ml 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: IMMUNISATION (non-serious) with onset 28Oct2021 11:45, outcome "unknown", described as "Dose: 3rd"; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 28Oct2021, outcome "unknown" and all described as "the undiluted vial was administered to a patient with 0.3 mL"; PAIN IN EXTREMITY (non-serious) with onset 29Oct2021, outcome "unknown", described as "sore arm"; ERYTHEMA (non-serious), SWELLING (non-serious) all with onset 29Oct2021, outcome "unknown" and all described as "red swollen"; PAIN (non-serious) with onset 29Oct2021, outcome "unknown", described as "painfull"; INFLUENZA LIKE ILLNESS (non-serious) with onset 29Oct2021, outcome "unknown", described as "Flu-like symptoms".  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). The patient had provided information regarding the reported adverse event(s) with the use of the product, the Pfizer product had a causal effect to the adverse event. NDC number of COVID-19 Vaccine: 59267100001. It was unknown that prior vaccinations within 4 weeks. It was unknown that there was specific relevant test for thromboembolic events with thrombocytopenia.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product preparation error, Swelling
Clinical narrative: sore arm; red swollen; red swollen; painfull; Flu-like symptoms; Dose: 3rd; the undiluted vial was administered to a patient with 0.3 mL; the undiluted vial was administered to a patient with 0.3 mL; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 83 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 28Oct2021 11:45 (Lot number: 320308D, Expiration Date: 28Feb2022) at the age of 83 years as dose 3 (booster), 0.3 ml 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: IMMUNISATION (non-serious) with onset 28Oct2021 11:45, outcome "unknown", described as "Dose: 3rd"; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 28Oct2021, outcome "unknown" and all described as "the undiluted vial was administered to a patient with 0.3 mL"; PAIN IN EXTREMITY (non-serious) with onset 29Oct2021, outcome "unknown", described as "sore arm"; ERYTHEMA (non-serious), SWELLING (non-serious) all with onset 29Oct2021, outcome "unknown" and all described as "red swollen"; PAIN (non-serious) with onset 29Oct2021, outcome "unknown", described as "painfull"; INFLUENZA LIKE ILLNESS (non-serious) with onset 29Oct2021, outcome "unknown", described as "Flu-like symptoms".  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). The patient had provided information regarding the reported adverse event(s) with the use of the product, the Pfizer product had a causal effect to the adverse event. NDC number of COVID-19 Vaccine: 59267100001. It was unknown that prior vaccinations within 4 weeks. It was unknown that there was specific relevant test for thromboembolic events with thrombocytopenia.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: we have a weird circle on our arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.This report is for 1st of 2 patients.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "we have a weird circle on our arm".  Additional information: Patient reported that he and his wife got the Pfizer shot couple of months ago and now we have a weird circle on our arm.   The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :PFIZER INC-202101512081 same product and event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen, Blood oestrogen decreased, Depressed mood, Disturbance in attention
Clinical narrative: Low Estrogen; can't sleep; can't focus; depressed; has anxiety; can't concentrate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-160615 (Moderna), MOD21-160642 (Moderna).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: BLOOD OESTROGEN DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Low Estrogen"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "can't sleep"; VISION BLURRED (non-serious) with onset 2021, outcome "unknown", described as "can't focus"; DEPRESSED MOOD (non-serious) with onset 2021, outcome "unknown", described as "depressed"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "has anxiety"; DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "unknown", described as "can't concentrate". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Vision blurred
Clinical narrative: Low Estrogen; can't sleep; can't focus; depressed; has anxiety; can't concentrate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-160615 (Moderna), MOD21-160642 (Moderna).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: BLOOD OESTROGEN DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Low Estrogen"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "can't sleep"; VISION BLURRED (non-serious) with onset 2021, outcome "unknown", described as "can't focus"; DEPRESSED MOOD (non-serious) with onset 2021, outcome "unknown", described as "depressed"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "has anxiety"; DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "unknown", described as "can't concentrate". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen, Blood oestrogen decreased, Depressed mood, Disturbance in attention
Clinical narrative: Low estrogen; can't concentrate; can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): MOD21-160615 (Moderna), MOD21-160642 (Moderna).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BLOOD OESTROGEN DECREASED (non-serious), outcome "unknown", described as "Low estrogen"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "can't concentrate"; VISION BLURRED (non-serious), outcome "unknown", described as "can't focus"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "depressed"; ANXIETY (non-serious), outcome "unknown", described as "has anxiety". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Vision blurred
Clinical narrative: Low estrogen; can't concentrate; can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): MOD21-160615 (Moderna), MOD21-160642 (Moderna).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BLOOD OESTROGEN DECREASED (non-serious), outcome "unknown", described as "Low estrogen"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "can't concentrate"; VISION BLURRED (non-serious), outcome "unknown", described as "can't focus"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "depressed"; ANXIETY (non-serious), outcome "unknown", described as "has anxiety". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen, Blood oestrogen decreased, Depressed mood, Disturbance in attention
Clinical narrative: Low estrogen; can't concentrate; can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient and reporting similar event(s) under the same suspect product(s) for 10 patients. This consumer reported for an unknown patient that:  A patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD OESTROGEN DECREASED (non-serious), outcome "unknown", described as "Low estrogen"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "can't concentrate"; VISION BLURRED (non-serious), outcome "unknown", described as "can't focus"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "depressed"; ANXIETY (non-serious), outcome "unknown", described as "has anxiety". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632 same drug and AE, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Vision blurred
Clinical narrative: Low estrogen; can't concentrate; can't focus; can't sleep; depressed; has anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient and reporting similar event(s) under the same suspect product(s) for 10 patients. This consumer reported for an unknown patient that:  A patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD OESTROGEN DECREASED (non-serious), outcome "unknown", described as "Low estrogen"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "can't concentrate"; VISION BLURRED (non-serious), outcome "unknown", described as "can't focus"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "depressed"; ANXIETY (non-serious), outcome "unknown", described as "has anxiety". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632 same drug and AE, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: has a really bad headache; feels like she's going to throw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2), administration date 10Nov2021 (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: HEADACHE (non-serious) with onset 10Nov2021, outcome "not recovered", described as "has a really bad headache"; VOMITING (non-serious) with onset 10Nov2021, outcome "not recovered", described as "feels like she's going to throw up". Additional information: The reporter was calling on behalf of her mother (Withheld). The patient received the Pfizer covid vaccine today and she now had a really bad headache and feels like she's going to throw up. Reporter asked is this normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (15Dec2021): 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.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Hypertensive crisis, Rash
Clinical narrative: blood pressure went up to 200/ 190; rash on arm; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 07Dec2021, this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter (consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient. An 83 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left (Batch/Lot number: unknown) at the age of 83 years (as reported) as dose 2, single for COVID-19 immunization. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medications included: ATENOLOL taken for hypertension (ongoing); FUROSEMIDE (ongoing); AMLODIPINE (ongoing); LOSARTAN (ongoing); CLONIDINE (ongoing); HYDRALAZINE (ongoing). Vaccination history included: Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (left arm, intramuscular), for COVID-19 immunization, reaction: "mild flu like symptoms" for 1 week after vaccination. The following information was reported: HYPERTENSIVE CRISIS (hospitalization) with onset 30May2021, outcome "recovered" (31May2021), described as "blood pressure went up to 200/ 190"; RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "rash on arm". The patient was hospitalized for hypertensive crisis (start date: 30May2021, discharge date: 31May2021, hospitalization duration: 1 day. The event "blood pressure went up to 200/ 190" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (30May2021) went up to 200/ 190; computerised tomogram: (2021) was all normal. Specific relevant test for thromboembolic events with thrombocytopenia: None. Additional information included: Blood pressure went up to 200/ 190. The doctors could not find any reason for the sudden spike. Patient had a CT scan- all normal.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Swelling
Clinical narrative: Booster; My armpit are swollen; 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 17Nov2021 (Lot number: FF8839) as dose 3 (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) with onset 17Nov2021, outcome "unknown", described as "Booster"; SWELLING (non-serious) with onset 17Nov2021, outcome "unknown", described as "My armpit are swollen". Additional information: When the agent asked the patient to spell the first and last name, patient stated that she just had the same conversation with the other agent. The patient said the agent just cut off phone with someone else and took my all the information filed type of report was transferring me to someone back who can answer my medical question. The patient was enquiring if there was any way the agent can see that because patient just did it like.  The patient stated that the agent was trying to transfer me to medical professional that can answer my question because the patient mentioning that she just got the Pfizer booster shot and her armpit are swollen, so the asked the agent if this was one of the side effects of if the event was normal. The patient concern that she should be worried, and the agent said she couldn't answer that question. But one of the medical people could and gave the patient a number which was the same number the patient called then. The patient said that if the agent was going to give the number, she has the same number. The patient was informed by the agent that after dialing Pfizer Medical information contact, press option 3 and timings are 8 am to 8 pm as per EST from Monday to Friday. In response the patient stated, it didn't give her option 3, she press option 3 when the recording says please listen to all the options because our main option was change right. It listed 1, listed 2, listed 3, the patient pressed option 3. When she pressed option 3 you came on the line. When the agent enquired about LOT#, NDC#, UPC# and expiration date, the patient stated that she gave that to agent already, the agent had all the details of the patient. The patient was informed about to transfer the call in Pfizer Medical Information, the patient stated that it would be better if she just call back in the morning.  Further probing could not be done as the patient was not willing to share the information. Hence, limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: I got my Pfizer booster shot last Monday; started breaking out head to toe with the rash again; 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 Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Knee replacement", start date: Apr2021 (unspecified if ongoing), notes: in Apr2021 I had 'knee' replacement done. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Mar2021, for Covid-19 immunization; Bnt162b2 (2nd dose, Now they put me on prednisone(Intent Treatment) and I was on prednisone for like two or three months to be honest with you. They couldn't figure out they can't figure out what's wrong with me), administration date: 2021, for Covid-19 immunization, reaction(s): "shortness of breath", "head to toe rash". The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "I got my Pfizer booster shot last Monday"; RASH (non-serious) with onset 2021, outcome "not recovered", described as "started breaking out head to toe with the rash again".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: menstral cycle was moved from 5 days a month to 2-3 weeks per month/ this went on for 5 months; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 19-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 30Apr2021 (Lot number: ER8733) at the age of 19 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 01May2021, outcome "recovered" (Oct2021), described as "menstral cycle was moved from 5 days a month to 2-3 weeks per month/ this went on for 5 months". The event "menstral cycle was moved from 5 days a month to 2-3 weeks per month/ this went on for 5 months" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heavy menstrual bleeding.  Additional information: The patient has no known allergies. The patient also received the second dose of BNT162B2, administered in the left arm on 24May2021 (Lot number: EW0171) for COVID-19 immunisation. She did not receive any other vaccines within four weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen painful lymph nodes on clavicle on left side, same side shot administered; Swollen painful lymph nodes on clavicle on left side, same side shot administered; dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 11:15 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. Vaccination history included: Bnt162b2 (Dose Number: 2, administration time: 08:15 AM, dose vaccine location: Left arm), administration date: 30Mar2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, administration time: 11:15 AM, dose vaccine location: Left arm), administration date: 01Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 11:15, outcome "unknown", described as "dose 3"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 18Nov2021, outcome "not recovered" and all described as "Swollen painful lymph nodes on clavicle on left side, same side shot administered". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient had no known allergies. 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 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "BMI 25" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunisation. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tinnitus". Therapeutic measures were taken as a result of tinnitus. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took paracetamol (TYLENOL) as treatment for the event and "turned off right away". The patient experienced tinnitus for 4 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm at injection site was much more sore than previous injections; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 22Mar2021 (Lot number: EP7534) at the age of 40 years as dose 1, single; and administered in the left arm, administration date 15Apr2021 (Lot number: EN0612) as dose 2, single both for COVID-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medications included: CELEXA [CELECOXIB]; TRULICITY; SYNJARDY; BUPROPION. Past drug history included: Codine, reactions: "known allergies: Codine". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "arm at injection site was much more sore than previous injections".  Additional information: The patient received the third dose of BNT162B2 and reported that her arm at injection site was much more sore than previous injections.  No follow-up attempts are possible. No further information is expected.