chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: When nurse was administering dose in patient arm the connection between  needle spilled out; Syringe connection issue; A spontaneous report was received from a pharmacist concerning a patient (age and gender not provided) who received Moderna's COVID-19 vaccine (mRNA-1273) and when nurse was administering dose in patient arm the connection between needle spilled out.   The patient's medical history was not provided. Concomitant product use was not provided.  On 05 Feb 2021 the patient was set to receive their second of two planned doses of mRNA-1273 (Lot #: 013L20a) intramuscularly for prophylaxis of COVID-19 infection.    When the nurse was administering the dose in the patient's arm, the connection between the needle spilled out. The nurse's assessment was that she didn't think the patient received the dose or maybe little of the dose.   Action taken with mRNA-1273 in response to the event was unknown.  The event, when nurse was administering dose in patient arm the connection between needle spilled out, was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 013L20a with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Received second dose of Moderna vaccine and should have received second dose of Pfizer vaccine; A spontaneous report  was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) but the patient received second dose of Moderna vaccine and should have received second dose of Pfizer vaccine.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On an unknown date, the patient received their first of two planned doses of Pfizer COVID-19 vaccine for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the patient received their second of two planned doses of COVID-19 vaccine, but was administered Moderna's  mRNA-1273 vaccine instead of Pfizer's.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event, patient received second dose of Moderna vaccine and should have received second dose of Pfizer vaccine, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of Wrong product administered for mRNA-1273, lot #
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: syringe that was found to be leaking during administration, may not have received full dose; received the second dose from a syringe that was found to be leaking during administration; A spontaneous report  was received from a pharmacist concerning a patient, unknown age, who received the Moderna's COVID-19 vaccine (mRNA-1273) from a syringe that was found to be leaking during administration, patient may not have received the full 0.5ml dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On 09 Feb 2021, a pharmacist reported a patient received the second dose of the Moderna COVID-19 vaccine from a syringe that was found to be leaking during administration and the patient may not have received the full 0.5ml dose. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcomes of the events were considered resolved.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Device connection issue and Underdose without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the first dose of the Moderna COVID-19 vaccine on day one, and then received the second dose of the Moderna COVID-19 vaccine only 5 days later; A spontaneous report (United States) was received from a pharmacist concerning a patient, unknown age, who received the first dose Moderna's COVID-19 vaccine (mRNA-1273) and then received the second dose only 5 days later.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided). 5 days later, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On 09 Feb 2021, a pharmacist reported a patient received the first dose of the Moderna COVID-19 vaccine on day one, and then received the second dose of the vaccine only 5 days later. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, Received the first dose of the Moderna COVID-19 vaccine on day one, and then received the second dose of the Moderna COVID-19 vaccine only 5 days later, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: first dose administered to a 17 year old; A spontaneous report was received from a consumer's guardian concerning a 17 year old female patient who was administered a COVID vaccine at an inappropriate age. The reporter requested to enroll their 17 year old child into the pediatric clinical trial.  The reporter wants to know what to do about the second dose.      The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number :041L20A) on 12 Jan 2021 for prophylaxis of COVID-19 infection.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event administered a COVID vaccine at an inappropriate age was considered as resolved.; Reporter's Comments: This report refers to a case of 17 year old female patient  administered vaccine ( inappropriate age at vaccine administration) for mRNA-1273, lot #041L20A). There was no associated AEs with the event of inappropriate age at vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Migraine, Pyrexia, Syncope
Clinical narrative: Patient fainted; Migraine; Shortness of breath; Felt very tired; Fever; A spontaneous report was received from a consumer who was also a 34-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced fainting (syncope), migraine, shortness of breath (dyspnoea), fever (pyrexia), and felt very tired (fatigue).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included fexofenadine hydrochloride and birth control.  On 17 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.   On 18 Jan 2021, the patient fainted. She felt very tired, had migraine, fever, and shortness of breath. The symptoms continued on and off. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcomes of the events fainted, migraine, shortness of breath, fever, and felt very tired, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the reported  events, a causal relationship cannot be excluded. Fever and fatigue are consistent with the known safety profile of the vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Pain, Pyrexia
Clinical narrative: body is very sore; severe chill rigors; couldn't get out of the bed because the rigors were so intense that legs would not support her; a slight fever; This is a spontaneous report from a contactable consumer reported for herself. A 75-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 30Jan2021 11:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included venlafaxine, levothyroxine, diclofenac, gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the 1st dose of BNT162B2 on 09Jan2021 11:30 AM for covid-19 immunization. Initially the patient noticed a slight fever 11 hours after vaccine on 31Jan2021. Then about 12 hours after her vaccine on 31Jan2021, she had severe chill rigors for about 2.5 hours. She couldn't get out of the bed because the rigors were so intense that her legs would not support her. On 31Jan2021 12:00 AM, (12 hours after the rigors), her entire body was very sore, feeling as if she had been run over by a truck. No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  Information on the Lot/Batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Electrocardiogram, Headache, Hypertension
Clinical narrative: Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood pressure 193/94; shakiness; This is a spontaneous report from a contactable consumer (patient) reported for that a 73-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) , via an unspecified route of administration on 30Jan2021 14:30 at single dose at right arm for covid-19 immunisation.  Medical history included blood pressure.  Concomitant medication included pantoprazole, metoprolol, atorvastatin, metformin. The patient previously took Cefdinir and experienced allergy.  The patient experienced dizziness with very high blood pressure 193/94, also shakiness, major headache on 30Jan2021 16:30. Adverse event result doctor or other healthcare professional office/clinic visit. The patient had EKG. Therapeutic measures were taken as a result of events included unspecified medication. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Dizziness with very high blood pressure 193/94; Major Headache; Dizziness with very high blood pressure 193/94; shakiness; This is a spontaneous report from a contactable consumer (patient) reported for that a 73-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) , via an unspecified route of administration on 30Jan2021 14:30 at single dose at right arm for covid-19 immunisation.  Medical history included blood pressure.  Concomitant medication included pantoprazole, metoprolol, atorvastatin, metformin. The patient previously took Cefdinir and experienced allergy.  The patient experienced dizziness with very high blood pressure 193/94, also shakiness, major headache on 30Jan2021 16:30. Adverse event result doctor or other healthcare professional office/clinic visit. The patient had EKG. Therapeutic measures were taken as a result of events included unspecified medication. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: right side of face drooping, diagnosis Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: El8982), via an unspecified route of administration on 29Jan2021 09:00 at single dose on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot: El3246) received on 08Jan2021 at 03:00 pm on left arm for COVID-19 immunization. The patient experienced right side of face drooping, diagnosis as bell's palsy on 31Jan2021 06:00 with outcome of not recovered. Treatment received for the event included prescriptions. This event resulted in emergency room/department or urgent care. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Discomfort
Clinical narrative: passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Loss of consciousness, Nasopharyngitis, Pain
Clinical narrative: passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Disease recurrence, Headache, Pyrexia, Seizure
Clinical narrative: spiked a fever of 101.3; spiked a fever of 101.3 which cause a 20 minute seizure; spiked a fever of 101.3 which cause a 20 minute seizure; headache; This is a spontaneous report from a contactable consumer reported for himself. A 33-years-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at right arm on 25Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included seizure disorder and other neurological issues, allergy to latex. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), omeprazole, lacosamide (VIMPAT), lamotrigine (LAMOTRIGINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included 1st dose of BNT162B2 (lot number: EK9231) on 04Jan2021 12:00 PM at left arm for COVID-19 immunization when he was 32-years-old. The patient had a headache throughout the following day and evening on 26Jan2021.  On 27Jan2021 spiked a fever of 101.3 which cause a 20 minute seizure. He was hospitalized for 2 days. Events resulted in emergency room/department or urgent care, hospitalization. Treatment was received for the adverse event in hospital. The events outcome was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The report was reported as serious with seriousness criteria-caused hospitalization.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Culture throat, Influenza virus test, Pneumonia, SARS-CoV-2 test
Clinical narrative: very sick/high fever/get weaker/diagnosed with double pneumonia; This is a spontaneous report from a contactable consumer (patient wife).  A 72-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EL3247, intramuscular in left arm on 15Jan2021 (at 1500 or 1600) at single dose to prevent covid. There were no relevant medical history or concomitant medications. There were no additional vaccines administered on same date of the BNT162B2. There was no prior Vaccinations (within 4 weeks). The reporter stated on 16Jan2021 the patient got very very sick. He started running a fever, a high fever a high temperature all day on 16Jan2021 through 17Jan2021. On 17Jan2021 night the reporter took him to the emergency room and they said it was from the covid shot. The patient began to get weaker on 17Jan2021 (not resolved) and still with a fever (resolved in Jan2021) and they said it was the shot. They went to a walk in clinic where they did a covid test on 17Jan2021 which was negative and they gave him medicine for possible pneumonia. But he didn't get any better. They went to another clinic where he had 3 more tests on 17Jan2021, "a covid test, a throat culture/ strep test and a flu test that all came back negative". On 18Jan2021 his family doctor advised him to go the hospital and he was diagnosed with double pneumonia which was resolving. The reporter stated that the event required a visit to Emergency Room and Physician Office. The reporter wanted to know if he will be able to get the second shot and asking if the first dose of the covid vaccine give him pneumonia. The medicine they gave him did not seem to be doing a lot of good, he was admitted for 3 days last week (since Jan2021 to Jan2021) and he received iv antibiotics. The medicine that was not doing good she clarified was oral pills of azithromycin (Lot: KJ9712, Expiration: Jan2022. NDC: 0781808926)that was to be taken at home. The outcome of the event was not resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: serious all-over body aches; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 13:15 at single dose in left arm for COVID-19 immunization. Medical history included Hypertension, allergies to Mango. Concomitant medication included lisinopril and colecalciferol (VITAMIN D). The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no immediate discomfort. No sore arm at all. But 2 days after the shot on 28Jan2021 18:00 she experienced serious all-over body aches. They were painful, and lasted about 30 hours. No treatment was received for the event. The outcome of the event was resolved.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile dysfunction - trouble maintaining an erection; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 15Jan2021 13:30 at single dose in left arm for COVID-19 immunization. Medical history included Churg Strauss and vasculitis. The patient had no covid prior vaccination and did not had covid tested post vaccination. The patient had no known allergies. No other vaccine in four weeks. Concomitant medications included other medications in two weeks yes, but no changes to medication within months. The patient experienced erectile dysfunction - trouble maintaining an erection on 18Jan2021.  No treatment was received. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Eye haemorrhage, Headache, Internal haemorrhage, Mass
Clinical narrative: experienced bleeding from her eyes and red blood circles around her eyes; bleeding internally; head breaking out in lumps and pustules and itching; head breaking out in lumps and pustules and itching; head breaking out in lumps and pustules and itching; she experienced a strange headache in the frontal area; she almost vomited; noticed a strong taste of chemicals; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunization. Medical history included poisoned with chemicals, sensitive to chemicals, thoracic aortic aneurysm and was taking the blood thinner for that reason. Concomitant medications included 14 prescription drugs including a blood thinner. The patient received the first dose of the Pfizer-Biontech Covid-19 vaccine on Thursday, 25Jan2021. About 20 minutes after the injection, she experienced a strange headache in the frontal area. While walking out of the clinic, she almost vomited and noticed a strong taste of chemicals. On Friday night, 26Jan2021, she experienced her head breaking out in lumps and pustules and itching. On Friday and Saturday, she experienced bleeding from her eyes and red blood circles around her eyes. The consumer thought she was bleeding internally. The outcome of all events was unknown.  Information on Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pustule, Vomiting
Clinical narrative: experienced bleeding from her eyes and red blood circles around her eyes; bleeding internally; head breaking out in lumps and pustules and itching; head breaking out in lumps and pustules and itching; head breaking out in lumps and pustules and itching; she experienced a strange headache in the frontal area; she almost vomited; noticed a strong taste of chemicals; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunization. Medical history included poisoned with chemicals, sensitive to chemicals, thoracic aortic aneurysm and was taking the blood thinner for that reason. Concomitant medications included 14 prescription drugs including a blood thinner. The patient received the first dose of the Pfizer-Biontech Covid-19 vaccine on Thursday, 25Jan2021. About 20 minutes after the injection, she experienced a strange headache in the frontal area. While walking out of the clinic, she almost vomited and noticed a strong taste of chemicals. On Friday night, 26Jan2021, she experienced her head breaking out in lumps and pustules and itching. On Friday and Saturday, she experienced bleeding from her eyes and red blood circles around her eyes. The consumer thought she was bleeding internally. The outcome of all events was unknown.  Information on Lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: appendicitis; This is a spontaneous report from a contactable consumer reported for self. This 42-Year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. No Covid prior vaccination. No known allergies. No other vaccine in four weeks. Facility type Vaccine: Hospital. He developed appendicitis after the vaccine on 11Jan2021. First symptoms appeared three days after first dose. Checked into hospital for an appendectomy the following day. Treatment was appendectomy. Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. Lab data included Nasal Swab on 15Jan2021: Negative. Outcome of the event was recovering.  Information on Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Spouse awoke 20Dec and found spouse dead; This is a spontaneous report from a Pfizer sponsored report. A non-contactable consumer (patient's husband) reported that a female patient of an unspecified age (Age: 89, Units: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899, Expiry date: unknown), intramuscular on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that spouse awoke  and found spouse dead on 20Dec2020. Patient was not transferred to hospital. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Spouse awoke 20Dec and found spouse dead
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm about 3 days; Initial information was received on 28-Jan-2021regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had sore arm about 3 days (pain in extremity), when received vaccine INFLUENZA VACCINE..  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sore arm about 3 days (pain in extremity), (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE..  it was, sore arm about 3 days, currently all gone, having his/her second shot 2/17 put an ice pack on for 15 minutes It was unknown if the patient experienced any additional symptoms/events.   No laboratory data was provided.  The patient received ice pack on for 15 minutes as a corrective treatment.  At the time of report, the patient was recovered form event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Almost killed me never again; Initial information was received on 01-Feb-2021 regarding an unsolicited non-valid non-serious case from a consumer/non-health care professional via social media.  This is a non valid case as event is unevaluable.  This case involves a patient (unspecified age and gender) who had almost killed me never again(unevaluable event), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Diabetes mellitus, Cardiac disorder and Chronic obstructive pulmonary disease.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious almost killed me never again (unevaluable event) unknown latency following the administration of INFLUENZA VACCINE.   No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19
Clinical narrative: patient still got covid; Initial information received on 19-Jan-2021 regarding an unsolicited valid serious case from non-healthcare professional.   This case involves patient (unknown demographics) who had covid (covid-19), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed covid (covid-19) (serious ) (Unknown latency), following the administration of INFLUENZA VACCINE. Covid-19 was assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for the event.  Information regarding the batch/lot number should be requested.; Sender's Comments: This case involves patient of unknown age who presented with covid-19, after vaccination with INFLUENZA VACCINE .Time to onset is unknown. Moreover, concomitant medication, family history, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Sore left arm from elbow to shoulder lasted 24 hours. Could not lift my left arm straight up above my head.  Difficult time carryiing any weight in my left arm.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Electric shock sensation, Immediate post-injection reaction, Injection site pain
Clinical narrative: patient says at insertion of syringe into arm she experienced what she says is an electrical current in her arm.  The injection hurt immediately and thereafter.  that afternoon and night 48 hrs patient could not lift her arm above her waist and was in significant pain in her shoulder.  Patient has had previous bursitis in both shoulders.  Patient claims that injection site location may have caused her bursitis to flare up.  patient used cold compresses for 48 hrs and then switched to warm.  as of 48 hrs patient still in pain and cannot lift arm above waist.  Arm was also sore at injection site.  Patient did not feel it was neceassary to go to dr but would monitor symptoms over next couple days.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Mobility decreased
Clinical narrative: patient says at insertion of syringe into arm she experienced what she says is an electrical current in her arm.  The injection hurt immediately and thereafter.  that afternoon and night 48 hrs patient could not lift her arm above her waist and was in significant pain in her shoulder.  Patient has had previous bursitis in both shoulders.  Patient claims that injection site location may have caused her bursitis to flare up.  patient used cold compresses for 48 hrs and then switched to warm.  as of 48 hrs patient still in pain and cannot lift arm above waist.  Arm was also sore at injection site.  Patient did not feel it was neceassary to go to dr but would monitor symptoms over next couple days.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient was at vaccine clinic today for her 2nd dose. She reported to the vaccinator she had a mild reaction with the first dose. Verified with pharmacist we would observe her for an additional 30 minutes as a precaution. She received her vaccination and was sitting in a chair talking with another associate. Associate when she reported she began to feel dizzy, lightheaded, nausea and felt like she might pass out. Patient at this point laid on the floor and put her feet up, a cart was brought to the room and patient was able to get up and climb onto the cart with no difficulty. VSS, respirs easy and non labored. Patient laid on cart supine for approximately 10-15 minutes and then the HOB was elevated aprox 30-40 degrees, she was sitting up on the cart talking with another associate/friend drinking small water bottle provided and eating a bag of chips. She finished the water and stated she felt sick to her stomach, she was offered crackers. She did not appear to be in any respiratory distress at this time. She remained sitting up on the cart resting when she stated she was beginning to feel like she "does when she has a tree nut reaction" she then asked if she could get an "epi shot", we advised she was breathing easy and her oxygen saturation was WNL and did not meet criteria to receive an epi shot. Pt became upset and voiced "this is how I get when I have a reaction and I can breathe fine until I can't". Associate was advised if she felt she might need an epinephrine injection, she should consider being evaluated in the emergency department. She agreed to be transported to the emergency department to be evaluated for a possible reaction to the vaccine. Emergency department was notified of patient, patient was transported by cart to the ED accompanied by RN. report given to ED staff. ED Visit to Hospital Emergency dept: : ED Visit at hospital resulted in patient receiving 2 doses of Epinephrine, solu-medrol and Benadryl.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Rash macular
Clinical narrative: Large erythematous, itchy, round spot at the injection site.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature decreased, Body temperature increased, Chills
Clinical narrative: That afternoon I walked, but cut it off at just over 2 miles as I was getting tired. Around 6 I had bad chills, a low fever 99.9, Around 8 nauseous and headache, 9:30 I started throwing up with urination at the same time.. This happened maybe 4 times until around 3 am.. I was really weak. Over temp around 101. On 29th: Took 2 Advil and kept the water down. Slept all day and weak, Hurt all over especially the entire left arm and hips.  Temp 102.6 overnight..  On 30th, Temp stayed just over 100, took Advil, ate soup and slept most of day. Around 4 pm temp down to 99. On 31th, Sunday, I will could do much, but did sit up much of day and ate light meal. Fever broke in the afternoon. I did not call a doctor as I always thought I would be better soon. On Monday, Feb 1, I went for my previously scheduled Mammograms. The next day I received a call that I needed to come back. When I went in on the 8th for more mammogram views and ultrasounds, they found 3 places of concern. I am scheduled for a needle biopsy on this Thursday.. I told them that I had received my Covid19 vaccinations and they mentioned that they have seen differences in tissue after the shots. I did not see a doctor on the first and not sure if the breast tissue or mass is a consequence or not.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Mammogram abnormal, Micturition urgency
Clinical narrative: That afternoon I walked, but cut it off at just over 2 miles as I was getting tired. Around 6 I had bad chills, a low fever 99.9, Around 8 nauseous and headache, 9:30 I started throwing up with urination at the same time.. This happened maybe 4 times until around 3 am.. I was really weak. Over temp around 101. On 29th: Took 2 Advil and kept the water down. Slept all day and weak, Hurt all over especially the entire left arm and hips.  Temp 102.6 overnight..  On 30th, Temp stayed just over 100, took Advil, ate soup and slept most of day. Around 4 pm temp down to 99. On 31th, Sunday, I will could do much, but did sit up much of day and ate light meal. Fever broke in the afternoon. I did not call a doctor as I always thought I would be better soon. On Monday, Feb 1, I went for my previously scheduled Mammograms. The next day I received a call that I needed to come back. When I went in on the 8th for more mammogram views and ultrasounds, they found 3 places of concern. I am scheduled for a needle biopsy on this Thursday.. I told them that I had received my Covid19 vaccinations and they mentioned that they have seen differences in tissue after the shots. I did not see a doctor on the first and not sure if the breast tissue or mass is a consequence or not.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: That afternoon I walked, but cut it off at just over 2 miles as I was getting tired. Around 6 I had bad chills, a low fever 99.9, Around 8 nauseous and headache, 9:30 I started throwing up with urination at the same time.. This happened maybe 4 times until around 3 am.. I was really weak. Over temp around 101. On 29th: Took 2 Advil and kept the water down. Slept all day and weak, Hurt all over especially the entire left arm and hips.  Temp 102.6 overnight..  On 30th, Temp stayed just over 100, took Advil, ate soup and slept most of day. Around 4 pm temp down to 99. On 31th, Sunday, I will could do much, but did sit up much of day and ate light meal. Fever broke in the afternoon. I did not call a doctor as I always thought I would be better soon. On Monday, Feb 1, I went for my previously scheduled Mammograms. The next day I received a call that I needed to come back. When I went in on the 8th for more mammogram views and ultrasounds, they found 3 places of concern. I am scheduled for a needle biopsy on this Thursday.. I told them that I had received my Covid19 vaccinations and they mentioned that they have seen differences in tissue after the shots. I did not see a doctor on the first and not sure if the breast tissue or mass is a consequence or not.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: That afternoon I walked, but cut it off at just over 2 miles as I was getting tired. Around 6 I had bad chills, a low fever 99.9, Around 8 nauseous and headache, 9:30 I started throwing up with urination at the same time.. This happened maybe 4 times until around 3 am.. I was really weak. Over temp around 101. On 29th: Took 2 Advil and kept the water down. Slept all day and weak, Hurt all over especially the entire left arm and hips.  Temp 102.6 overnight..  On 30th, Temp stayed just over 100, took Advil, ate soup and slept most of day. Around 4 pm temp down to 99. On 31th, Sunday, I will could do much, but did sit up much of day and ate light meal. Fever broke in the afternoon. I did not call a doctor as I always thought I would be better soon. On Monday, Feb 1, I went for my previously scheduled Mammograms. The next day I received a call that I needed to come back. When I went in on the 8th for more mammogram views and ultrasounds, they found 3 places of concern. I am scheduled for a needle biopsy on this Thursday.. I told them that I had received my Covid19 vaccinations and they mentioned that they have seen differences in tissue after the shots. I did not see a doctor on the first and not sure if the breast tissue or mass is a consequence or not.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELL'S PALSY. PATIENT WENT TO ER ON 2/13/21 AND WAS DIAGNOSED.  FOLLOWED UP WITH PRIMARY CARE DOCTOR 2/15/2021. 2/13/21 PREDNISONE 10MG TAPER: 50MGX4DAY,  40MGX2 DAY, 30MGX2DAY, 20MGX2DAY, 10MGX2DAY 2/15/21 ACYCLOVIR 800MG  1 FIVE TIMES A DAY FOR 7 DAYS,   BACITRACIN OPTHAMIC OINT AT BEDTIME.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Injection site swelling, Nausea
Clinical narrative: 103 temperature Body Aches Chills fatigue Nausea injection site swelling joint pain
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 103 temperature Body Aches Chills fatigue Nausea injection site swelling joint pain
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Ear discomfort, Swollen tongue, Throat tightness, Tongue pruritus
Clinical narrative: Within 3-5 seconds R ear felt blocked Within 5 minutes tongue felt itchy and swollen and difficulty swallowing - eased after 5 minutes  after 20 minutes - felt a constriction in throat and required effort to swallow
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Current: COVID arm- small patch around injection site became red on day 8, Feb.11. It is not Feb.15, and the red itchy patch has grown to 2 1/2 " by 2 1/2".  For the first 2-3 days, I had headaches, chills, extreme fatigue and had difficulty breathing. I had chest pressure the first day.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Current: COVID arm- small patch around injection site became red on day 8, Feb.11. It is not Feb.15, and the red itchy patch has grown to 2 1/2 " by 2 1/2".  For the first 2-3 days, I had headaches, chills, extreme fatigue and had difficulty breathing. I had chest pressure the first day.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection pain
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching in middle of back
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Scab, Skin disorder
Clinical narrative: Scabs on hands looks like scars, Bumps on forehead and head. Used Cortizone on scars and forehead, as well as head. This has been going on since the 02/07/2021.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site pain
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Very itchy Rash on thighs , some on legs.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: The day after my 2nd Moderna dose,  my left arm (site of injection) developed a red rash. The site was already painful about 8 hrs after the injection.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Rash erythematous
Clinical narrative: Chills throughout the night, headache, red rash in area of shot, bodily aches
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Member felt dizzy and light headed after receiving approximately 10 minutes after receiving 2nd vaccine.  Remained A/O x's 4
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Pyrexia
Clinical narrative: Severe chills, weakness, aches, fever-onset about 1:00  AM; resolved by 6:00 AM 2/13/2021
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Injection site rash, Pain
Clinical narrative: Fever of 101.7 orally, chills, body aches, lack of appetite, no energy on Oct 10th. Rash at injection site for a 8 cm area on Oct 12
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101.7 orally, chills, body aches, lack of appetite, no energy on Oct 10th. Rash at injection site for a 8 cm area on Oct 12
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound scan abnormal
Clinical narrative: Deep Vein Thrombosis, both legs below knee 11 days after first vaccine injection
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Haematoma, Lymphadenopathy
Clinical narrative: Hematoma in neck above collar bone and swelling in lymph node under right arm and around hematoma.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Vomiting
Clinical narrative: HA, emesis, temp 100.5, chills
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Neck pain, Pyrexia
Clinical narrative: About 30 hours after COVID19 vaccination, I experienced severe neck pain, fever, chills and weakness. The fever, chills and weakness has subsided but the neck pain continues in the are of my cervical spine.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: The the day after receiving the vaccine my arm was sore in the upper arm. On the night of the 12th I noticed a rash. It was smaller then hives, 3inches above my elbow to my shoulder. It is itching and now my whole arm hurt. I put some Cortizone 10 on it last night but it did not help. It kept me up most of last night. I called my doctor this morning, and I spoke with Dr. nurse who told me to put cold compresses on it.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain in extremity, Pyrexia
Clinical narrative: 18 hours after dose, chills, low-grade fever, joint pain, arm soreness laying about 18 hours Treatment-Advil every 6 hours