chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Severe itching; redness; welts; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Right on 19May2021 19:00 (at the age of 46-years-old) (Batch/Lot Number: EW0168, Expiration date: unknown) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date. The patient known allergies was none. Concomitant medication included minocycline taken for an unspecified indication, start and stop date were not reported. on 20May2021 19:00 the patient experienced severe itching, redness, welts. Started taking antihistamine on 21May2021. The problem still persist after taking the antihistamine for a week. Went to the Urgent Care on 29May2021. The Nurse Practitioner prescribed methylprednisolone tablets and cream. she have taken Day 1 dose of the methylprednisolone and still no relief. she regret getting the vaccine. Outcome of events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not COVID prior vaccination and not tested covid post vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: unknown), via intramuscular route of administration, in the left arm on 28May2021 at 11:20 (at the age of 61-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history includes thyroid and anaphylaxis. The concomitant medications include unspecified thyroid medications. The patient was allergic to shrimps and peanuts. No other vaccines were administered in in previous 4 weeks of vaccination. On 28may2021, almost immediately after the vaccination, the patient experienced hives on face and all over the body, rash and slightly elevated heartbeat. The patient treated the hives with a homeopathic treatment (capsicum) for allergic reactions. She used in the past that helps stop the progression of the allergic reaction. She denies any swelling of the lips, face or throat. No difficulty breathing. she was not sure if the elevated heartbeat was because she was nervous about the hives or if it was related to the vaccine. The patient stated that the hives resolved after 24 hours and are now completely gone. She wants to know if it was advisable to proceed with the second dose of the vaccine given the nature of her reaction. She did provide her health care provider information to DSU on Saturday when she filed the report. She saw what people report, also she doesn't know that she should have the second vaccine or not and she like to finish the vaccine but just don't know if that recommended if that's ok or not. she also called and reported this information to the CDC for statistical purposes. If she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. She referred her to speak to her health care provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Also used information from attached document to explain differences of non-severe allergic reaction versus severe allergic reaction. Also referred to HCP for further guidance on proceeding with second dose of the Pfizer COVID-19 vaccine. The second dose was scheduled on 18Jun2021. The reporter assessed all events as non-serious. The outcome of the events rash and urticaria was recovered on an unknown date in 2021, and the outcome of elevated heartbeat was unknown. No follow-up attempts possible. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: unknown), via intramuscular route of administration, in the left arm on 28May2021 at 11:20 (at the age of 61-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history includes thyroid and anaphylaxis. The concomitant medications include unspecified thyroid medications. The patient was allergic to shrimps and peanuts. No other vaccines were administered in in previous 4 weeks of vaccination. On 28may2021, almost immediately after the vaccination, the patient experienced hives on face and all over the body, rash and slightly elevated heartbeat. The patient treated the hives with a homeopathic treatment (capsicum) for allergic reactions. She used in the past that helps stop the progression of the allergic reaction. She denies any swelling of the lips, face or throat. No difficulty breathing. she was not sure if the elevated heartbeat was because she was nervous about the hives or if it was related to the vaccine. The patient stated that the hives resolved after 24 hours and are now completely gone. She wants to know if it was advisable to proceed with the second dose of the vaccine given the nature of her reaction. She did provide her health care provider information to DSU on Saturday when she filed the report. She saw what people report, also she doesn't know that she should have the second vaccine or not and she like to finish the vaccine but just don't know if that recommended if that's ok or not. she also called and reported this information to the CDC for statistical purposes. If she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. She referred her to speak to her health care provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Also used information from attached document to explain differences of non-severe allergic reaction versus severe allergic reaction. Also referred to HCP for further guidance on proceeding with second dose of the Pfizer COVID-19 vaccine. The second dose was scheduled on 18Jun2021. The reporter assessed all events as non-serious. The outcome of the events rash and urticaria was recovered on an unknown date in 2021, and the outcome of elevated heartbeat was unknown. No follow-up attempts possible. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Cardiac  Arrest, Death..... 20 hours after shot
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Cardiac  Arrest, Death..... 20 hours after shot
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Death, Myocardial infarction, Unresponsive to stimuli
Clinical narrative: Cardiac  Arrest, Death..... 20 hours after shot
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood culture, Blood magnesium, Blood potassium, Chest X-ray
Clinical narrative: Patient received J&J Covid19 vaccine on 5/25, and developed fevers, mialgias, hives, and pruritis primarily in proximal medial thighs and flexor surfaces of elbows. I have concern for serum sickness like reaction.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Headache, Hyperglycaemia, Hypokalaemia, Liver function test
Clinical narrative: Patient received J&J Covid19 vaccine on 5/25, and developed fevers, mialgias, hives, and pruritis primarily in proximal medial thighs and flexor surfaces of elbows. I have concern for serum sickness like reaction.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Myalgia, Oedema, Pyrexia, Troponin
Clinical narrative: Patient received J&J Covid19 vaccine on 5/25, and developed fevers, mialgias, hives, and pruritis primarily in proximal medial thighs and flexor surfaces of elbows. I have concern for serum sickness like reaction.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis, Urticaria
Clinical narrative: Patient received J&J Covid19 vaccine on 5/25, and developed fevers, mialgias, hives, and pruritis primarily in proximal medial thighs and flexor surfaces of elbows. I have concern for serum sickness like reaction.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pruritus, Pyrexia, Urticaria
Clinical narrative: Patient received J&J Covid19 vaccine on 5/25, and developed fevers, mialgias, hives, and pruritis primarily in proximal medial thighs and flexor surfaces of elbows. I have concern for serum sickness like reaction.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Rash, Urine analysis, White blood cell count increased
Clinical narrative: whole body has hives; Blisters; It hurts; I can't sleep; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Lot Number: LW0150 and expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 12Apr2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date,it was reported that her whole body has hives and blisters; it hurts and she can't sleep. Therapeutic measures were taken as a result of hives, blisters, it hurts, i can't sleep included went to Doctor, urgent care (16May2021) they gave me all the medication for reaction like Famotidine (20mg tablet), they gave me 10 mg Hydrocodone (not clarified) intramuscular. They gave me Sarna (not clarified) topical, they gave me Prednisolone (20 mg tablet), Hydroxyzine hcl 25 mg tablet, they gave me Zyrtec 10 mg. Consumer wanted to know what happed to her and she wanted to know.The outcome of the events was unknown.  Follow up attempts are needed. Further information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Insomnia, Pain, Urticaria
Clinical narrative: whole body has hives; Blisters; It hurts; I can't sleep; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Lot Number: LW0150 and expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 12Apr2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date,it was reported that her whole body has hives and blisters; it hurts and she can't sleep. Therapeutic measures were taken as a result of hives, blisters, it hurts, i can't sleep included went to Doctor, urgent care (16May2021) they gave me all the medication for reaction like Famotidine (20mg tablet), they gave me 10 mg Hydrocodone (not clarified) intramuscular. They gave me Sarna (not clarified) topical, they gave me Prednisolone (20 mg tablet), Hydroxyzine hcl 25 mg tablet, they gave me Zyrtec 10 mg. Consumer wanted to know what happed to her and she wanted to know.The outcome of the events was unknown.  Follow up attempts are needed. Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Erythema, Pruritus, Skin abrasion
Clinical narrative: Anaphylactic reaction, sent to ED. Received Epi pen, dexamethasone, benadryl, pepcid, methylprednisolne.  Sx resolve after observation and pt sent home
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Anaphylactic reaction, sent to ED. Received Epi pen, dexamethasone, benadryl, pepcid, methylprednisolne.  Sx resolve after observation and pt sent home
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction, sent to ED. Received Epi pen, dexamethasone, benadryl, pepcid, methylprednisolne.  Sx resolve after observation and pt sent home
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bedridden, Impaired work ability, Influenza like illness, Malaise, Pain in extremity
Clinical narrative: felt very sick; have a lot of pain in my arm; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received second dose of bnt162b2 (Solution for injection, Batch/lot number and expiry date: not reported), via an unspecified route of administration on 28Apr2021 as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant were not reported. The patient previously received first dose of bnt162b2, via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation and did not feel anything. On an unspecified date, the patient experienced felt very sick and have a lot of pain in my arm. I received the coronavirus vaccines at (vaccination facility name). I received both vaccines. The second one was on 28Apr2021. The first vaccine I didn't feel anything but the second one I felt very sick for over a week, I still have a lot of pain in my arm that got the shot, I would like some help please. I talked to my doctor and she didn't really do anything. The clinical outcome of felt very sick and have a lot of pain in my arm were unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Vaccination complication
Clinical narrative: felt very sick; have a lot of pain in my arm; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received second dose of bnt162b2 (Solution for injection, Batch/lot number and expiry date: not reported), via an unspecified route of administration on 28Apr2021 as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant were not reported. The patient previously received first dose of bnt162b2, via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation and did not feel anything. On an unspecified date, the patient experienced felt very sick and have a lot of pain in my arm. I received the coronavirus vaccines at (vaccination facility name). I received both vaccines. The second one was on 28Apr2021. The first vaccine I didn't feel anything but the second one I felt very sick for over a week, I still have a lot of pain in my arm that got the shot, I would like some help please. I talked to my doctor and she didn't really do anything. The clinical outcome of felt very sick and have a lot of pain in my arm were unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: felt very sick; have a lot of pain in my arm; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received second dose of bnt162b2 (Solution for injection, Batch/lot number and expiry date: not reported), via an unspecified route of administration on 28Apr2021 as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant were not reported. The patient previously received first dose of bnt162b2, via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation and did not feel anything. On an unspecified date, the patient experienced felt very sick and have a lot of pain in my arm. I received the coronavirus vaccines at (vaccination facility name). I received both vaccines. The second one was on 28Apr2021. The first vaccine I didn't feel anything but the second one I felt very sick for over a week, I still have a lot of pain in my arm that got the shot, I would like some help please. I talked to my doctor and she didn't really do anything. The clinical outcome of felt very sick and have a lot of pain in my arm were unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Influenza like illness, Limb deformity, Pain in extremity, Vaccination site pain
Clinical narrative: felt very sick; have a lot of pain in my arm; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received second dose of bnt162b2 (Solution for injection, Batch/lot number and expiry date: not reported), via an unspecified route of administration on 28Apr2021 as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant were not reported. The patient previously received first dose of bnt162b2, via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation and did not feel anything. On an unspecified date, the patient experienced felt very sick and have a lot of pain in my arm. I received the coronavirus vaccines at (vaccination facility name). I received both vaccines. The second one was on 28Apr2021. The first vaccine I didn't feel anything but the second one I felt very sick for over a week, I still have a lot of pain in my arm that got the shot, I would like some help please. I talked to my doctor and she didn't really do anything. The clinical outcome of felt very sick and have a lot of pain in my arm were unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Illness, Influenza like illness, Limb discomfort, Pain
Clinical narrative: felt very sick; have a lot of pain in my arm; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received second dose of bnt162b2 (Solution for injection, Batch/lot number and expiry date: not reported), via an unspecified route of administration on 28Apr2021 as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant were not reported. The patient previously received first dose of bnt162b2, via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation and did not feel anything. On an unspecified date, the patient experienced felt very sick and have a lot of pain in my arm. I received the coronavirus vaccines at (vaccination facility name). I received both vaccines. The second one was on 28Apr2021. The first vaccine I didn't feel anything but the second one I felt very sick for over a week, I still have a lot of pain in my arm that got the shot, I would like some help please. I talked to my doctor and she didn't really do anything. The clinical outcome of felt very sick and have a lot of pain in my arm were unknown.   Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT GIVEN DILUTED JNJ COVID VACCINE; WRONG TECHNIQUE IN DRUG USAGE PROCESS; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: 23-JUN-2021) .3 ml, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced subject given diluted JNJ covid vaccine. On 02-JUN-2021, the subject experienced wrong technique in drug usage process. On 02-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of the poor quality vaccine administered, wrong technique in drug usage process and patient given diluted JNJ covid vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210607539 and 20210608711.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Poor quality product administered, Wrong technique in product usage process
Clinical narrative: PATIENT GIVEN DILUTED JNJ COVID VACCINE; WRONG TECHNIQUE IN DRUG USAGE PROCESS; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: 23-JUN-2021) .3 ml, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced subject given diluted JNJ covid vaccine. On 02-JUN-2021, the subject experienced wrong technique in drug usage process. On 02-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of the poor quality vaccine administered, wrong technique in drug usage process and patient given diluted JNJ covid vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210607539 and 20210608711.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Postmenopause, Ultrasound scan vagina, Vaginal haemorrhage
Clinical narrative: sore arm; tired; This is a spontaneous report from a contactable female consumer. A female patient with unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as unknown dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient's family medical history includes heart conditions, caller stated about her parents and sister. On an unspecified date, after the vaccination, the patient experienced sore arm and fatigue. Patient also stated that, her dad and sister have heart conditions but have been fine, no one had any effects other than like sore arm and tired. The reporter assessed all events as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650887 Same reporter/drug/events, different patients
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Investigation, Postmenopausal haemorrhage, Pregnancy test, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: sore arm; tired; This is a spontaneous report from a contactable female consumer. A female patient with unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as unknown dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient's family medical history includes heart conditions, caller stated about her parents and sister. On an unspecified date, after the vaccination, the patient experienced sore arm and fatigue. Patient also stated that, her dad and sister have heart conditions but have been fine, no one had any effects other than like sore arm and tired. The reporter assessed all events as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650887 Same reporter/drug/events, different patients
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tired; This is a spontaneous report from a contactable female consumer. A female patient with unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as unknown dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient's family medical history includes heart conditions, caller stated about her parents and sister. On an unspecified date, after the vaccination, the patient experienced sore arm and fatigue. Patient also stated that, her dad and sister have heart conditions but have been fine, no one had any effects other than like sore arm and tired. The reporter assessed all events as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650887 Same reporter/drug/events, different patients
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Error: Booster Given Too Early
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chest X-ray normal, Full blood count normal, Lung disorder, Pain
Clinical narrative: HERPES FLARED; DAILY FEVER OF 100; REALLY BAD BRONCHITIS; ACHING; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included mono, and concurrent conditions included non-smoker, non alcohol user, and herpes, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient was previously treated with cannabis sativa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F, and COVID-19 virus test (NR: not provided) Negative, Negative. On MAY-2021, the subject experienced really bad bronchitis. On MAY-2021, the subject experienced aching. On MAY-2021, the subject experienced daily fever of 100. On 01-MAY-2021, the subject experienced herpes flared. On 17-MAY-2021, Laboratory data included: CBC (NR: not provided) Normal. On 20-MAY-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Pulmonary function test (NR: not provided) Normal. Laboratory data (dates unspecified) included: Epstein-Barr virus test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: budesonide/formoterol fumarate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from really bad bronchitis, and had not recovered from daily fever of 100, aching, and herpes flared. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: HERPES FLARED; DAILY FEVER OF 100; REALLY BAD BRONCHITIS; ACHING; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included mono, and concurrent conditions included non-smoker, non alcohol user, and herpes, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient was previously treated with cannabis sativa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F, and COVID-19 virus test (NR: not provided) Negative, Negative. On MAY-2021, the subject experienced really bad bronchitis. On MAY-2021, the subject experienced aching. On MAY-2021, the subject experienced daily fever of 100. On 01-MAY-2021, the subject experienced herpes flared. On 17-MAY-2021, Laboratory data included: CBC (NR: not provided) Normal. On 20-MAY-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Pulmonary function test (NR: not provided) Normal. Laboratory data (dates unspecified) included: Epstein-Barr virus test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: budesonide/formoterol fumarate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from really bad bronchitis, and had not recovered from daily fever of 100, aching, and herpes flared. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Bronchitis, Chest X-ray, Epstein-Barr virus test, Full blood count
Clinical narrative: HERPES FLARED; DAILY FEVER OF 100; REALLY BAD BRONCHITIS; ACHING; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included mono, and concurrent conditions included non-smoker, non alcohol user, and herpes, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient was previously treated with cannabis sativa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F, and COVID-19 virus test (NR: not provided) Negative, Negative. On MAY-2021, the subject experienced really bad bronchitis. On MAY-2021, the subject experienced aching. On MAY-2021, the subject experienced daily fever of 100. On 01-MAY-2021, the subject experienced herpes flared. On 17-MAY-2021, Laboratory data included: CBC (NR: not provided) Normal. On 20-MAY-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Pulmonary function test (NR: not provided) Normal. Laboratory data (dates unspecified) included: Epstein-Barr virus test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: budesonide/formoterol fumarate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from really bad bronchitis, and had not recovered from daily fever of 100, aching, and herpes flared. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes virus infection, Pain, Pulmonary function test, SARS-CoV-2 test
Clinical narrative: HERPES FLARED; DAILY FEVER OF 100; REALLY BAD BRONCHITIS; ACHING; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included mono, and concurrent conditions included non-smoker, non alcohol user, and herpes, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient was previously treated with cannabis sativa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F, and COVID-19 virus test (NR: not provided) Negative, Negative. On MAY-2021, the subject experienced really bad bronchitis. On MAY-2021, the subject experienced aching. On MAY-2021, the subject experienced daily fever of 100. On 01-MAY-2021, the subject experienced herpes flared. On 17-MAY-2021, Laboratory data included: CBC (NR: not provided) Normal. On 20-MAY-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Pulmonary function test (NR: not provided) Normal. Laboratory data (dates unspecified) included: Epstein-Barr virus test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: budesonide/formoterol fumarate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from really bad bronchitis, and had not recovered from daily fever of 100, aching, and herpes flared. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO A 16 YEAR OLD; OFF label Use; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's weight was 210 pounds, and height was not reported. The patient's concurrent conditions included non alcoholic, and other pre-existing medical conditions included patient had no known allergies ,not experienced any acute illness, no previous reactions post vaccination, not received any other covid 19 vaccine and no covid positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A,expiry: 23-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination.  No concomitant medications were reported. On 03-JUN-2021, the subject experienced vaccine administered to a 16 year old accidentally. On 03-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to a 16 year old accidentally and off label use was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO A 16 YEAR OLD; OFF label Use; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's weight was 210 pounds, and height was not reported. The patient's concurrent conditions included non alcoholic, and other pre-existing medical conditions included patient had no known allergies ,not experienced any acute illness, no previous reactions post vaccination, not received any other covid 19 vaccine and no covid positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A,expiry: 23-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination.  No concomitant medications were reported. On 03-JUN-2021, the subject experienced vaccine administered to a 16 year old accidentally. On 03-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to a 16 year old accidentally and off label use was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Erythema, Hypoaesthesia oral, Pain
Clinical narrative: CANNOT MOVE HANDS WITHOUT PAIN, PAIN IN FEET AND LEG; NUMBNESS TONGUE AND WHOLE MOUTH; FLAVOR OF ANESTHESIA IN MOUTH; FACE AND CHEST GOT RED; VEINS IN HANDS SWOLLEN AND IN ARMS TO ELBOW SWOLLEN; LOT OF PAIN; CANNOT WALK WITHOUT PAIN; PAIN BEHIND KNEES; PAIN IN VEINS IN LEGS; UNABLE TO SLEEP; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included scleroderma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included prednisone for scleroderma.  On 2021, the subject experienced pain in veins in legs. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced cannot walk without pain. On 2021, the subject experienced pain behind knees. On APR-2021, the subject experienced veins in hands swollen and in arms to elbow swollen. On APR-2021, the subject experienced lot of pain. On 01-APR-2021, the subject experienced numbness tongue and whole mouth. On 01-APR-2021, the subject experienced flavor of anesthesia in mouth. On 01-APR-2021, the subject experienced face and chest got red. On MAY-2021, the subject experienced cannot move hands without pain, pain in feet and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness tongue and whole mouth, flavor of anesthesia in mouth, and face and chest got red on 05-APR-2021, and had not recovered from veins in hands swollen and in arms to elbow swollen, cannot move hands without pain, pain in feet and leg, pain in veins in legs, pain behind knees, unable to sleep, cannot walk without pain, and lot of pain. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Erythema, Gait disturbance, Hypoaesthesia oral, Insomnia
Clinical narrative: CANNOT MOVE HANDS WITHOUT PAIN, PAIN IN FEET AND LEG; NUMBNESS TONGUE AND WHOLE MOUTH; FLAVOR OF ANESTHESIA IN MOUTH; FACE AND CHEST GOT RED; VEINS IN HANDS SWOLLEN AND IN ARMS TO ELBOW SWOLLEN; LOT OF PAIN; CANNOT WALK WITHOUT PAIN; PAIN BEHIND KNEES; PAIN IN VEINS IN LEGS; UNABLE TO SLEEP; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included scleroderma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included prednisone for scleroderma.  On 2021, the subject experienced pain in veins in legs. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced cannot walk without pain. On 2021, the subject experienced pain behind knees. On APR-2021, the subject experienced veins in hands swollen and in arms to elbow swollen. On APR-2021, the subject experienced lot of pain. On 01-APR-2021, the subject experienced numbness tongue and whole mouth. On 01-APR-2021, the subject experienced flavor of anesthesia in mouth. On 01-APR-2021, the subject experienced face and chest got red. On MAY-2021, the subject experienced cannot move hands without pain, pain in feet and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness tongue and whole mouth, flavor of anesthesia in mouth, and face and chest got red on 05-APR-2021, and had not recovered from veins in hands swollen and in arms to elbow swollen, cannot move hands without pain, pain in feet and leg, pain in veins in legs, pain behind knees, unable to sleep, cannot walk without pain, and lot of pain. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Taste disorder, Vascular pain, Vasodilatation
Clinical narrative: CANNOT MOVE HANDS WITHOUT PAIN, PAIN IN FEET AND LEG; NUMBNESS TONGUE AND WHOLE MOUTH; FLAVOR OF ANESTHESIA IN MOUTH; FACE AND CHEST GOT RED; VEINS IN HANDS SWOLLEN AND IN ARMS TO ELBOW SWOLLEN; LOT OF PAIN; CANNOT WALK WITHOUT PAIN; PAIN BEHIND KNEES; PAIN IN VEINS IN LEGS; UNABLE TO SLEEP; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included scleroderma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included prednisone for scleroderma.  On 2021, the subject experienced pain in veins in legs. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced cannot walk without pain. On 2021, the subject experienced pain behind knees. On APR-2021, the subject experienced veins in hands swollen and in arms to elbow swollen. On APR-2021, the subject experienced lot of pain. On 01-APR-2021, the subject experienced numbness tongue and whole mouth. On 01-APR-2021, the subject experienced flavor of anesthesia in mouth. On 01-APR-2021, the subject experienced face and chest got red. On MAY-2021, the subject experienced cannot move hands without pain, pain in feet and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness tongue and whole mouth, flavor of anesthesia in mouth, and face and chest got red on 05-APR-2021, and had not recovered from veins in hands swollen and in arms to elbow swollen, cannot move hands without pain, pain in feet and leg, pain in veins in legs, pain behind knees, unable to sleep, cannot walk without pain, and lot of pain. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Vaccination site pain
Clinical narrative: Sharp pain in his arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0172) via an unspecified route of administration (Age at vaccination 61-year) in Left Arm on 06May2021 13:30 as single dose for COVID-19 immunization. It was reported that the second dose of the COVID vaccine given over 21 days after the first dose. Medical history included allergy to animal (The only allergies he has are to dogs, cats, horses, seasonal allergy); ragweed; blood pressure measurement, He takes a blood pressure medicine and a cholesterol medicine. He started taking all of his medications after age 55, blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide taken for blood pressure measurement; amlodipine besilate taken for blood pressure measurement; lisinopril taken for blood pressure measurement; rosuvastatin taken for blood cholesterol from an unspecified start date and ongoing. On 06May2021 the patient experienced sharp pain in his arm. On an unspecified date the patient underwent lab tests and procedures which included blood test: nothing for his arm. The seriousness of the event was reported as non-serious. The clinical outcome of the event was not recovered.  Batch/Lot number was obtained. Further information has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: Sharp pain in his arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0172) via an unspecified route of administration (Age at vaccination 61-year) in Left Arm on 06May2021 13:30 as single dose for COVID-19 immunization. It was reported that the second dose of the COVID vaccine given over 21 days after the first dose. Medical history included allergy to animal (The only allergies he has are to dogs, cats, horses, seasonal allergy); ragweed; blood pressure measurement, He takes a blood pressure medicine and a cholesterol medicine. He started taking all of his medications after age 55, blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide taken for blood pressure measurement; amlodipine besilate taken for blood pressure measurement; lisinopril taken for blood pressure measurement; rosuvastatin taken for blood cholesterol from an unspecified start date and ongoing. On 06May2021 the patient experienced sharp pain in his arm. On an unspecified date the patient underwent lab tests and procedures which included blood test: nothing for his arm. The seriousness of the event was reported as non-serious. The clinical outcome of the event was not recovered.  Batch/Lot number was obtained. Further information has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sharp pain in his arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0172) via an unspecified route of administration (Age at vaccination 61-year) in Left Arm on 06May2021 13:30 as single dose for COVID-19 immunization. It was reported that the second dose of the COVID vaccine given over 21 days after the first dose. Medical history included allergy to animal (The only allergies he has are to dogs, cats, horses, seasonal allergy); ragweed; blood pressure measurement, He takes a blood pressure medicine and a cholesterol medicine. He started taking all of his medications after age 55, blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide taken for blood pressure measurement; amlodipine besilate taken for blood pressure measurement; lisinopril taken for blood pressure measurement; rosuvastatin taken for blood cholesterol from an unspecified start date and ongoing. On 06May2021 the patient experienced sharp pain in his arm. On an unspecified date the patient underwent lab tests and procedures which included blood test: nothing for his arm. The seriousness of the event was reported as non-serious. The clinical outcome of the event was not recovered.  Batch/Lot number was obtained. Further information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure decreased, Fatigue, Feeling abnormal, Heart rate increased, Unresponsive to stimuli
Clinical narrative: Lightheadedness; Numbness and weakness in both arms; BP dropped from 130/70 to 119/64; Heart rate spike from 65bpm to 167bpm; shortness of breath; body shaking badly
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood magnesium, Blood pressure decreased, Blood thyroid stimulating hormone, Chest X-ray, Dizziness
Clinical narrative: Lightheadedness; Numbness and weakness in both arms; BP dropped from 130/70 to 119/64; Heart rate spike from 65bpm to 167bpm; shortness of breath; body shaking badly
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Full blood count, Glomerular filtration rate, Heart rate increased
Clinical narrative: Lightheadedness; Numbness and weakness in both arms; BP dropped from 130/70 to 119/64; Heart rate spike from 65bpm to 167bpm; shortness of breath; body shaking badly