chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: developed appendicitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Lot number: EW0161) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZIPRASIDONE; HYDROXYZINE; TRAZODONE; ALBUTEROL HFA. Vaccination history included: Bnt162b2 (Dose 1, Single, Date: 26Mar2021 , Batch/Lot No: ER8732), administration date: 26Mar2021, for COVID-19 immunization. The following information was reported: APPENDICITIS (medically significant) with onset 19Apr2021, outcome "unknown", described as "developed appendicitis". Therapeutic measures were taken as a result of appendicitis and included treatment with appendectomy. Clinical course: The patient received the Pfizer, COVID Vaccine back in April and after his second dose had a serious adverse reaction. He actually had appendicitis. He had to have an appendectomy. So, the patient wanted to report this as a side effect and see if it was possibly related. It happened about two days after his second shot. Anatomical site of administration: Reporter stated that he believed it was his left arm  but he was not quite sure but he thought it was his left arm. Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. Currently available information is insufficient to determine a causal relationship with the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain, Tinnitus
Clinical narrative: Felt lethargy, aching, and tinnitus within hours of receiving shot. While other symptoms have gone away, the tinnitus has not.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: I felt fine all afternoon and evening. Went to bed at 1:00 AM. I woke up at 2:00 AM with teeth rattling shivers. I?m drinking non-caffeine green tea hoping to reduce the shivers.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram ambulatory, Palpitations
Clinical narrative: Racing heart rate
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Adverse reaction, Somnolence, Suspected COVID-19
Clinical narrative: DID NOT WAKE UP; SUSPECTED COVID-19 INFECTION; STOMACH ACHE; SIDE EFFECTS; This spontaneous report received from a parent concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drinks, and smoker, and other pre-existing medical conditions included: The patient had done drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced did not wake up, suspected covid-19 infection, stomach ache, and side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, stomach ache, did not wake up and side effects was not reported. This report was non-serious. Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age, race, and unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced suspected covid-19 infection (fever, a change in smells, mainly propane, methane, ammonia, and onions all smell like rotten fish and some smells which cannot be described). On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority. This case, from the same reporter is linked to 20220116664.; Sender's Comments: V0; 20220116907-COVID-19 VACCINE suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a 53-year-old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (dose series was 1) (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, route of admin, and batch number were not reported) dose and frequency were not reported from an unspecified date to 15-OCT-2021 for psoriatic arthritis. No concomitant medications were reported. On 24-NOV-2021, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine was not applicable and action taken with adalimumab was not reported. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220117270 -Covid-19 vaccine suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age, sex, race, and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient got covid-19, omicron (suspected covid-19 infection) and was quite symptomatic. The patient also experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected covid-19 infection (omicron) and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211211.; Sender's Comments: V0; 20220118479-COVID-19 VACCINE suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: CAN NOT FEEL THE THUMB AND TWO FOREFINGERS IN NON-SHOT ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced can not feel the thumb and two forefingers in non-shot arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of can not feel the thumb and two forefingers in non-shot arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069821A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: The follow up information contains significant information due to suspect lot number updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore left arm after her booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore left arm after her booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore left arm after her booster dose). At the time of the report, MYALGIA (Sore left arm after her booster dose) outcome was unknown.            No concomitant and treatment medications were provided. The patient had a sore left arm after her booster dose. Patient reports no other adverse reactions.   This case was linked to MOD-2022-448733 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dependence on respirator
Clinical narrative: My friend is in the hospital and is on the ventilator; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received BNT162B2 (BNT162B2), administration date Dec2021 (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: DEPENDENCE ON RESPIRATOR (hospitalization, medically significant) with onset Dec2021, outcome "unknown", described as "My friend is in the hospital and is on the ventilator". It was reported that, the patient was on the ventilator after receiving a Pfizer Covid Vaccine. The reporter was emotional about the covid vaccine mandating being push by the government. It was reported that, the reporter had never seen so many people have heart attacks as the reporter had in the last year. The reporter states that this was a genocide and it was happening right now. Pfizer, Moderna and Johnson & Johnson were all involved in this. The reporter also stated that, this vaccine has only be around a year please take it off the market because it was harming and killing many people.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Myocardial infarction, Palpitations, SARS-CoV-2 test
Clinical narrative: Heart attack; Very high anxiety; Heart racing; uncomfortable chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 14:00 (Lot number: EW0179) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing, notes: Was covid prior vaccination) Concomitant medication(s) included: LUNESTA. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 28Apr2021, when the patient was 54 years old, for COVID-19 immunization.  The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 13Jun2021, outcome "recovered with sequelae" (2021), described as "Heart attack"; ANXIETY (non-serious) with onset 13Jun2021, outcome "recovered with sequelae" (2021), described as "Very high anxiety"; PALPITATIONS (non-serious) with onset 13Jun2021, outcome "recovered with sequelae" (2021), described as "Heart racing"; CHEST DISCOMFORT (non-serious) with onset 13Jun2021, outcome "recovered with sequelae" (2021), described as "uncomfortable chest". The events "heart attack", "very high anxiety", "heart racing" and "uncomfortable chest" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Jun2021) negative, notes: Nasal Swab; (03Jul2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of myocardial infarction, anxiety, palpitations, chest discomfort. The events were not life threatening, did not caused/prolonged hospitalization, did not result in death, did not result in disabling/incapacitating nor a congenital anomaly/birth defect. The patient did not receive any other vaccine in four weeks. The events were not life threatening, did not caused/prolonged hospitalization, did not result in death, did not result in disabling/incapacitating nor a congenital anomaly/birth defect. The patient was covid prior vaccination and tested covid post vaccination. The patient had no known allergies. After the second source, patient became very anxious. Very high anxiety (which the patient never had). The patient actually thought had a heart attack while on vacation.It was significant anxiety for about 5-6 hours - heart racing, uncomfortable chest. The patient was checking while on vacation before but this started before vacation, continued on vacation and then continues after vacation for about 3-4 months. At the time of report now just have light anxiety but it had not gone away. The patient saw a heart doctor.   No follow-up attempts are possible. No further information is expected.   Follow-Up (03Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back pain, X-ray
Clinical narrative: Doctor said it was arthritis from X-ray; a lot of pain in my back/soreness in my back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EN6201) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN. Vaccination history included: Bnt162b2 (First Dose, Lot No: EL9262, administration time=12:00 PM,, vaccine location=left arm), administration date: 23Jan2021, when the patient was 75 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19 and Since the vaccination not been tested for COVID-19. The following information was reported: ARTHRITIS (disability) with onset 16Mar2021 07:30, outcome "not recovered", described as "Doctor said it was arthritis from X-ray"; BACK PAIN (disability) with onset 16Mar2021 07:30, outcome "not recovered", described as "a lot of pain in my back/soreness in my back". The events "doctor said it was arthritis from x-ray" and "a lot of pain in my back/soreness in my back" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: x-ray: (16Mar2021) arthritis, notes: Doctor said it was arthritis from X-ray. Therapeutic measures were taken as a result of arthritis, back pain which was PT. Chiropractor, Tylenol.   Clinical course: In March she woke up with a lot of pain in my back. she have never had back issues. Doctor said it was arthritis from X-ray. Have been through PT and a chiropractor and nothing gets rid of the soreness in my back. When she get up in the morning she have to hold on to the sink to wash her hands. After an hour she can move around but the pain and soreness never leave. she feel this is a result of the vaccine.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Feb2021 (Lot number: EL3249, Expiration Date: May2021) at the age of 74 years as dose 1, single and intramuscular, administration date 09Mar2021 (Lot number: EN9581, Expiration Date: May2021) as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous, administration date Oct2020 (Lot number: 1156892) as 150 mg (1 in 12 wk) and subcutaneous, administration date 18Dec2021 (ongoing) (Lot number: 1156892) as 150 mg (1 in 12 wk) for psoriasis. Relevant medical history included: "Atrial Fibrillation", start date: 1996 (unspecified if ongoing); "Non-smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation; AMBIEN taken for insomnia. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 15Feb2021, outcome "recovered" (10Mar2021), described as "Injection site pain". The action taken for risankizumab was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have covid-19 now, and was wondering how long Pfizer recommends between onset of symptoms and getting the booster shot?; I have covid-19 now, and was wondering how long Pfizer recommends between onset of symptoms and getting the booster shot?; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. No PQC was present. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have covid-19 now and was wondering how long Pfizer recommends between onset of symptoms and getting the booster shot?".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Autonomic nervous system imbalance, Ventricular tachycardia
Clinical narrative: I was diagnosed with dysautonomia, VTACH, and other cardiac arrhythmias; cardiac arrhythmias; VTACH; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old patient received bnt162b2 (BNT162B2), administration date 15Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I also had covid 7 months prior to my vaccine" (unspecified if ongoing), notes: I also had covid 7 months prior to my vaccine with no lasting side effects. The patient's concomitant medications were not reported. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (hospitalization) with onset 16Jul2021, outcome "unknown", described as "I was diagnosed with dysautonomia, VTACH, and other cardiac arrhythmias"; ARRHYTHMIA (hospitalization, medically significant) with onset 16Jul2021, outcome "unknown", described as "cardiac arrhythmias"; VENTRICULAR TACHYCARDIA (hospitalization, medically significant) with onset 16Jul2021, outcome "unknown", described as "VTACH". Therapeutic measures were taken as a result of autonomic nervous system imbalance, arrhythmia, ventricular tachycardia. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: The patient also had covid 7 months prior to my vaccine with no lasting side effects.; Sender's Comments: Based on the available reported information, the causal association between the events Dysautonomia, Arrhythmia, Ventricular tachycardia, and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Culture throat, Heart rate increased, Ovarian germ cell cancer, Teratoma
Clinical narrative: Teratoma growth on ovary - removed on 20Jul2021; Teratoma growth on ovary - removed on 20Jul2021; Slight tightness in throat; Rapid heart rate; slight tightness in chest upon breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 15:15 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Teratoma growth on ovary - removed on 20 July 2021" (unspecified if ongoing), notes: Teratoma growth on ovary - removed on 20Jul2021; "Sulfa drugs allergy" (unspecified if ongoing); "cipro Allergy" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. Past drug history included: Bactrim, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 09Apr2021. The following information was reported: OVARIAN GERM CELL CANCER (medically significant), TERATOMA (non-serious), outcome "unknown" and all described as "Teratoma growth on ovary - removed on 20Jul2021"; THROAT TIGHTNESS (non-serious) with onset 30Apr2021 17:00, outcome "recovered" (2021), described as "Slight tightness in throat"; HEART RATE INCREASED (non-serious) with onset 30Apr2021 17:00, outcome "recovered" (2021), described as "Rapid heart rate"; CHEST DISCOMFORT (non-serious) with onset 30Apr2021 17:00, outcome "recovered" (2021), described as "slight tightness in chest upon breathing". The patient underwent the following laboratory tests and procedures: culture throat: (12Jul2021) negative; (20Jul2021) negative; (11Sep2021) negative; (16Nov2021) negative. Therapeutic measures were taken as a result of ovarian germ cell cancer, teratoma. Therapeutic measures were not taken as a result of throat tightness, heart rate increased, chest discomfort. Slight tightness in throat approx. 45minutes after that seemed to go away the later Rapid heart rate and slight tightness in chest upon breathing approx 1.5 hours after. Patient received no other vaccine in four weeks. Patient had administered birth control pills in past.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Teratoma growth on ovary - removed on 20Jul2021; Teratoma growth on ovary - removed on 20Jul2021; Slight tightness in throat; Rapid heart rate; slight tightness in chest upon breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 15:15 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Teratoma growth on ovary - removed on 20 July 2021" (unspecified if ongoing), notes: Teratoma growth on ovary - removed on 20Jul2021; "Sulfa drugs allergy" (unspecified if ongoing); "cipro Allergy" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. Past drug history included: Bactrim, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 09Apr2021. The following information was reported: OVARIAN GERM CELL CANCER (medically significant), TERATOMA (non-serious), outcome "unknown" and all described as "Teratoma growth on ovary - removed on 20Jul2021"; THROAT TIGHTNESS (non-serious) with onset 30Apr2021 17:00, outcome "recovered" (2021), described as "Slight tightness in throat"; HEART RATE INCREASED (non-serious) with onset 30Apr2021 17:00, outcome "recovered" (2021), described as "Rapid heart rate"; CHEST DISCOMFORT (non-serious) with onset 30Apr2021 17:00, outcome "recovered" (2021), described as "slight tightness in chest upon breathing". The patient underwent the following laboratory tests and procedures: culture throat: (12Jul2021) negative; (20Jul2021) negative; (11Sep2021) negative; (16Nov2021) negative. Therapeutic measures were taken as a result of ovarian germ cell cancer, teratoma. Therapeutic measures were not taken as a result of throat tightness, heart rate increased, chest discomfort. Slight tightness in throat approx. 45minutes after that seemed to go away the later Rapid heart rate and slight tightness in chest upon breathing approx 1.5 hours after. Patient received no other vaccine in four weeks. Patient had administered birth control pills in past.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
Clinical narrative: Menstrual changes and blood clotting, irregular cycle
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Intermittent fever of 99.0-100.1 persisting 3 days after dose was received Body aches and chills persisting 3 days after dose was received Egg sized area of swelling to the right axillary area with tenderness noted approximately 2 days after dose received Decreased appetite
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Intermittent fever of 99.0-100.1 persisting 3 days after dose was received Body aches and chills persisting 3 days after dose was received Egg sized area of swelling to the right axillary area with tenderness noted approximately 2 days after dose received Decreased appetite
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Extremely itchy chronic hives 14 days after receiving my booster shot. Will not go away.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Diarrhoea, Pancreatic disorder, SARS-CoV-2 test positive
Clinical narrative: Covid-19 breakthrough. Vaccinated on 04/12/2021. 68 y/o PMH COPD, GERD, HTN, HLD, OSA, DM2 presents with 4-5 day history of increasing upper quadrant abdominal pain. CT showed pancreatic lesion so patient referred to AHWP for evaluation. Incidentally found to be Covid +.  Patient denies c/o N/V, fever, chills, cough, congestion, CP.  One episode of diarrhea. Treated with Pepcid, Zofran, and Morphine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Covid-19 breakthrough. Vaccinated on 04/12/2021. 68 y/o PMH COPD, GERD, HTN, HLD, OSA, DM2 presents with 4-5 day history of increasing upper quadrant abdominal pain. CT showed pancreatic lesion so patient referred to AHWP for evaluation. Incidentally found to be Covid +.  Patient denies c/o N/V, fever, chills, cough, congestion, CP.  One episode of diarrhea. Treated with Pepcid, Zofran, and Morphine.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 14:00 (Lot number: EL3247) at the age of 52 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 1, single on 03Feb2021 at 14:00 in the left arm), administration date: 03Feb2021, when the patient was 52 years old, for COVID-19 immunization.The following information was reported: CHILLS (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "Chills"; HEADACHE (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "Headache"; PAIN (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "bodyache"; PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "sore arm". Therapeutic measures were not taken as a result of chills, headache, pain, pain in extremity.Additional information: The patient was vaccinated at the workplace clinic. No other vaccine in four weeks. No covid prior vaccination nor covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Asthenia, Blood pressure measurement, Cold sweat, Fatigue
Clinical narrative: arm was sore; woke up drenched in sweat; felt drained / lack of energy; clammy; muscle pains; having very vivid, unusual dreams including snakes and dinosaurs chasing him; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1 single for covid-19 immunisation. Relevant medical history included: "back pain" (unspecified if ongoing), notes: smoke medical marijuana for back pain, few glasses of wine a few days a week. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "woke up drenched in sweat"; ASTHENIA (non-serious), outcome "unknown", described as "felt drained / lack of energy"; COLD SWEAT (non-serious), outcome "unknown", described as "clammy"; MYALGIA (non-serious), outcome "unknown", described as "muscle pains"; ABNORMAL DREAMS (non-serious), outcome "unknown", described as "having very vivid, unusual dreams including snakes and dinosaurs chasing him"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". 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.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Hyperhidrosis, Myalgia, Pain in extremity
Clinical narrative: arm was sore; woke up drenched in sweat; felt drained / lack of energy; clammy; muscle pains; having very vivid, unusual dreams including snakes and dinosaurs chasing him; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1 single for covid-19 immunisation. Relevant medical history included: "back pain" (unspecified if ongoing), notes: smoke medical marijuana for back pain, few glasses of wine a few days a week. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "woke up drenched in sweat"; ASTHENIA (non-serious), outcome "unknown", described as "felt drained / lack of energy"; COLD SWEAT (non-serious), outcome "unknown", described as "clammy"; MYALGIA (non-serious), outcome "unknown", described as "muscle pains"; ABNORMAL DREAMS (non-serious), outcome "unknown", described as "having very vivid, unusual dreams including snakes and dinosaurs chasing him"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness/dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 08Mar2021, outcome "not recovered", described as "dizziness/dizzy".  Upon Follow-up (12Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient that, The caller is calling on behalf of his wife about the Covid vaccine, Pfizer. The patient got the vaccine on Saturday and everything was fine, a couple of days later the patient was dizzy when she was working out. Today the patient woke up and she's so dizzy when she sat up in bed, it was pretty disruptive, The patient is so dizzy when she gets up she has to hold on to things. The patient drank 3 glasses of water and ate a bowl of oatmeal but now she is back in bed. The caller wants help with his wife and wants to know what they should do.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Injection site, muscle, body pain; Injection site, muscle, body pain; Injection site, muscle, body pain; Headaches; Tiredness; Feeling unwell; Nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Mar2021 02:00 (Lot number: EN6206) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (vaccination time: 13:00, DOSE 1, SINGLE , Lot number: EN6200 , Route of administration: Intramuscular , Vaccine location: Left arm), administration date: 18Feb2021, when the patient was 74 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), MYALGIA (non-serious), PAIN (non-serious) all with onset 12Mar2021 16:00, outcome "recovering" and all described as "Injection site, muscle, body pain"; HEADACHE (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Headaches"; FATIGUE (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Tiredness"; MALAISE (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Feeling unwell"; NAUSEA (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Nausea". Therapeutic measures were taken as a result of vaccination site pain, myalgia, pain, headache, fatigue, malaise.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified blood pressure medication within two weeks of vaccination. Therapeutic measures were taken as a result of the events (except nausea) which included treatment with acetaminophen (TYLENOL) every 4 hours on an unknown date. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Injection site, muscle, body pain; Injection site, muscle, body pain; Injection site, muscle, body pain; Headaches; Tiredness; Feeling unwell; Nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Mar2021 02:00 (Lot number: EN6206) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (vaccination time: 13:00, DOSE 1, SINGLE , Lot number: EN6200 , Route of administration: Intramuscular , Vaccine location: Left arm), administration date: 18Feb2021, when the patient was 74 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), MYALGIA (non-serious), PAIN (non-serious) all with onset 12Mar2021 16:00, outcome "recovering" and all described as "Injection site, muscle, body pain"; HEADACHE (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Headaches"; FATIGUE (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Tiredness"; MALAISE (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Feeling unwell"; NAUSEA (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Nausea". Therapeutic measures were taken as a result of vaccination site pain, myalgia, pain, headache, fatigue, malaise.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified blood pressure medication within two weeks of vaccination. Therapeutic measures were taken as a result of the events (except nausea) which included treatment with acetaminophen (TYLENOL) every 4 hours on an unknown date. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Dizziness, Gait inability, Head discomfort
Clinical narrative: dizzy; very wobbly and weak; she felt pain at back of head along with fullness; she felt pain at back of head along with fullness; Tingling; was unable to walk as her  legs felt wobby and she was dizzy; it just got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; ASTHENIA (non-serious), outcome "unknown", described as "very wobbly and weak"; HEADACHE (non-serious), HEAD DISCOMFORT (non-serious), outcome "unknown" and all described as "she felt pain at back of head along with fullness"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling"; GAIT INABILITY (non-serious), outcome "unknown", described as "was unable to walk as her legs felt wobby and she was dizzy"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "it just got worse".  Additional information: It was reported that she got her vaccine on 09Mar2021, and she had a reaction. It wasn't a very good one. There was no pain by the way with the shot, but as soon as that thing went in to her arm, she started getting dizzy and she felt weird. Her head felt like it wanted to explode and it was kind a scared so after she was done she sat there a few minutes and then she got up but she had a hard time walking, clumbsy or she don't know whatever you would call it. So she went to the chair to sit for the 15 minutes but it just got worse. So she had a ride, she didn't want to make them wait but at the same time she didn't feel very comfortable about leaving because she was wobbling and very dizzy. So she just wanted to let you know that and she also wanted to ask because she also have an appointment for number 2 but she don't think she was a really good candidate for this, so can you help me with that?" Later in the call the patient stated, she don't want to miss the shot but she was afraid what happened before was only going to get worse she heard from the second shot."    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: dizzy; very wobbly and weak; she felt pain at back of head along with fullness; she felt pain at back of head along with fullness; Tingling; was unable to walk as her  legs felt wobby and she was dizzy; it just got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; ASTHENIA (non-serious), outcome "unknown", described as "very wobbly and weak"; HEADACHE (non-serious), HEAD DISCOMFORT (non-serious), outcome "unknown" and all described as "she felt pain at back of head along with fullness"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling"; GAIT INABILITY (non-serious), outcome "unknown", described as "was unable to walk as her legs felt wobby and she was dizzy"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "it just got worse".  Additional information: It was reported that she got her vaccine on 09Mar2021, and she had a reaction. It wasn't a very good one. There was no pain by the way with the shot, but as soon as that thing went in to her arm, she started getting dizzy and she felt weird. Her head felt like it wanted to explode and it was kind a scared so after she was done she sat there a few minutes and then she got up but she had a hard time walking, clumbsy or she don't know whatever you would call it. So she went to the chair to sit for the 15 minutes but it just got worse. So she had a ride, she didn't want to make them wait but at the same time she didn't feel very comfortable about leaving because she was wobbling and very dizzy. So she just wanted to let you know that and she also wanted to ask because she also have an appointment for number 2 but she don't think she was a really good candidate for this, so can you help me with that?" Later in the call the patient stated, she don't want to miss the shot but she was afraid what happened before was only going to get worse she heard from the second shot."    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: her arm complete sore and puffy, just a little swollenness; her arm complete sore and puffy, just a little swollenness; The arm she was given the injection is really sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 11Mar2021, outcome "recovering" and all described as "her arm complete sore and puffy, just a little swollenness"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "The arm she was given the injection is really sore".  Additional information: patient mentions that she has Tramadol and wanted to know if that medication she could take for the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.