chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; loss of appetite; No other symptoms other than loss of appetite and weariness.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old patient of unknown gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 10:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications. The patient had no reported allergies to medication, food or other products but could be sensitive to drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 16:00 the patient experienced fever that lasted until early morning of 05Apr2021. Fever ran as high as 102 degrees Fahrenheit, never dropping below 101 through 04Apr2021. No other symptoms other than loss of appetite and weariness were reported. The events resulted in doctor or other healthcare professional office/clinic visit. On 05Apr2021, the patient underwent lab tests which included nasal swab and the result was negative. No therapeutic measures were taken as a result of the events. The clinical outcome of the event fever was recovered on 05Apr2021 while the events loss of appetite and weariness were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pronounced headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 09:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 09:15 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 11:15, approximately two hours after second dose of injection, the patient experienced pronounced headache. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event pronounced headache was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, COVID-19, Chest pain, Chills, Dyspnoea
Clinical narrative: started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; chills and fatigue; chills and fatigue; started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; This is a spontaneous report from a contactable consumer. This consumer (patient) reported himself that a 37-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, lot/Batch: EN6207), via intramuscular route of administration in left arm on 20Apr2021 at 12:15 (at the age of vaccination 37-years-old) as single dose for COVID-19 immunisation on workplace clinic. The patient's medical history included spleen ruptured when he was 18. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, lot/Batch: EN5318), via Intramuscular route of administration in left arm on 03Mar2021 at 12:15 as historical vaccination single dose for COVID-19 immunisation. On 21April21 at 03:00, the patient started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place", had chills and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. No treatment received for adverse event. The outcome of the adverse event was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate irregular
Clinical narrative: started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; chills and fatigue; chills and fatigue; started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place; This is a spontaneous report from a contactable consumer. This consumer (patient) reported himself that a 37-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, lot/Batch: EN6207), via intramuscular route of administration in left arm on 20Apr2021 at 12:15 (at the age of vaccination 37-years-old) as single dose for COVID-19 immunisation on workplace clinic. The patient's medical history included spleen ruptured when he was 18. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, lot/Batch: EN5318), via Intramuscular route of administration in left arm on 03Mar2021 at 12:15 as historical vaccination single dose for COVID-19 immunisation. On 21April21 at 03:00, the patient started to have chest pain and shortness of breath- irregular heartbeat and "blood pressure was all over the place", had chills and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. No treatment received for adverse event. The outcome of the adverse event was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 2 days after my first dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiration date was unknown) via an unspecified route of administration on 06Apr2021 (at the age of 23-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was none. The patient concomitant medications in two weeks included fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Other vaccines in four weeks prior to vaccination was none. The patient reported that, tested positive for covid-19 2 days after my first dose of the vaccine on 08Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test that was positive on 08Apr2021. Patient reported that, she tested positive for COVID-19 2 days after her first dose of the vaccine on 06Apr2021 after experiencing what she believed were side effects. The patient underwent lab tests and procedures which included SARS-CoV-2 test; Positive on 08Apr2021. The outcome of event tested positive for COVID-19 2 days after my first dose of the vaccine was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Gastroenteritis viral, Nausea, Pain in extremity
Clinical narrative: stomach flu; diarrhea.; no appetite; nausea; Sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stomach flu, diarrhea, no appetite, nausea and sore arm on an unspecified. It was reported that patient was due to receive her second dose of COVID vaccine on 06May2021. She has been having symptoms of what she believes to be a stomach flu for the past 1-2 weeks. Patient reported that symptoms were "off-and-on" over the time period and included diarrhea and no appetite.  She was asking if she should still receive her second dose as scheduled. Patient did not attribute symptoms to her first dose of vaccine, she noted that she did fine with the first shot and only reported a sore arm. Patient was not thinking her symptoms and the first dose of vaccine are related. The patient would like to speak to the nurse who would be administering the shot. The patient had previous stomach virus with diarrhea and nausea and stuff like that and has had it for the past week. She wanted to know would this bring any more harm to her by getting second shot. Outcome of event stomach flu and diarrhea was not resolved. Outcome of remining events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the temporal relationship, the association between the events stomach flu, diarrhea, no appetite, and nausea with BNT162b2 can not be fully excluded. There is a reasonable possibility that the event sore arm was related to BNT162b2 based on known drug safety profile.  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.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: Vomitting; diarrhea; body aches; fever; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER2613), via an unspecified route of administration in the left arm on 11Apr2021 at 17:00 (at the age of 25-year-old), dose 1, single for COVID-19 immunisation. The patient had no medical history. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), mirtazapine (REMERON), aripiprazole (ABILIFY), paracetamol (TYLENOL), and ethinylestradiol, levonorgestrel (FALMINA). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at pharmacy or drug store. On 13Apr2021 at 04:00, the patient experienced vomiting, diarrhea, body aches, fever. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovered.  No follow-up attempts are possible; No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills; fever; muscle aches (entire body).; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955), via an intramuscular route of administration in the right arm on 07Apr2021 at 08:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and insomnia. Concomitant medications included trazadone 100 mg SID (MANUFACTURER UNKNOWN) and levocetirizine SID (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an intramuscular route of administration in the right arm on 17Mar2021 at 08:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. On 07Apr2021 at 23:30, 14 hours post injection, the patient experienced chills, fever and muscle aches (entire body). On an unspecified date, the patient received oral TYLENOL as needed as treatment for the adverse events. The clinical outcomes of the events chills, fever and muscle aches (entire body) was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Joint pains just about everywhere that have not diminished. Both wrists get so sore he can barely use hands after any major activity. Also neck, back, hands fingers, and some previously injured areas are affected too; sore neck, back, hands fingers, and some previously injured areas are affected too.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161), via an unspecified route of administration in the left arm on 04May2021 at 09:30 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. Medical history included heart/vascular disorder, asthma, arthritis and migraine. The patient received unspecified medications within two weeks of vaccination. The patient past drug history included ACE inhibitors on an unknown date for an unknown indication and the patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6209), via an unspecified route of administration on an unknown date (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. It  was unknown whether the patient had been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 01:00, the patient experienced joint pains just about everywhere that have not diminished, both wrists had got so sore the patient barely use hands after any major activity, also neck, back, hands fingers, and some previously injured areas were affected too. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event joint pains just about everywhere that have not diminished, both wrists had got so sore the patient barely use hands after any major activity, also neck, back, hands fingers, and some previously injured areas were affected too was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Mild fever; Swollen Lymph node under armpit on the same arm as injection site; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 02May2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included multi vitamins (MANAFACTURER UNKNOWN), birth control (MANAFACTURER UNKNOWN) all from an unknown date. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 06:00 the patient experienced mild fever, swollen lymph node under armpit on the same arm as injection site. The clinical outcome of the events fever, swollen lymph nodes was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, SARS-CoV-2 test
Clinical narrative: Barking cough; Getting sick easier; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism, and obesity. The patient was intolerant to lactose. The patient  received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 01Apr2021, about 12-15 hours after 1st dose, the patient experienced barking cough, was getting sick easier than she ever had before and she got sicker than other people with similar bugs. The patient stated, it was like her immune system didn't work. The event barking cough was still continuing at the time of this report. On 21Apr2021, the patient underwent nasal swab test and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event barking cough which included treatment with cough medicine. The clinical outcomes of barking cough and getting sick easier were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain
Clinical narrative: Bone and joint pain from neck to toes; Bone and joint pain from neck to toes; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021 at 09:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included escitalopram (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 09:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient previously received paracetamol; oxycodone hydrochloride (PERCOCET) for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04May2021 at 21:30, the patient experienced bone and joint pain from neck to toes. The clinical outcome of the events bone and joint pain from neck to toes were resolving at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe Muscle Aches day after second injection; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0170) via an unspecified route of administration in the right arm on 03May2021 15:45 hours (at the age of 50-year-old) as a single dose for COVID-19immunisation. Medical history was not reported. Concomitant medications included  amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate         (ADDERALL), sertraline hydrochloride (ZOLOFT), zolpidem tartrate (AMBIEN) and alprazolam (XANAX) and LOMICTAL all for unknown indication, from an unknown date. The past medication history include sulfadiazine (SULFA) for unknown indication on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158) via an unspecified route of administration in the right arm on 12Apr2021 15:45 hours as a single dose for COVID-19immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four week of vaccination. On 04May2021 at 07:00 the patient experienced severe muscle aches day after second injection. The clinical outcome of the event severe muscle aches day was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Breast tenderness, Burning sensation
Clinical narrative: Burning sensation in neck for 24 hours tapered slowly.; Back pain.; Sore armpits for 1 week; Tender breast for 1 week; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25Apr2021 at 14:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included bell's palsy on left side 2 years ago and the patient was still dealing with synkinesis. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 14:45, the patient experienced burning sensation in neck for 24 hours tapered slowly, back pain, sore armpits and tender breast for 1 week. The clinical outcome of the events burning sensation in neck for 24 hours tapered slowly, back pain, sore armpits and tender breast for 1 week was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Severe abdominal pain; Vomited; I felt kind of yucky; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 11:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic pancreatitis hypoglycemia due to type 1 diabetes mellitus. Concomitant medications included insulin (MANUFACTURER UNKNOWN), pancreatin (CREON), pantoprazole sodium sesquihydrate (PROTONIX) and vitamin d nos (VITAMIN D) all taken on unknown date, for unknown indication. The patient previously took boric acid (MANUFACTURER UNKNOWN), ibandronate sodium (BONIVA), fluconazole (DIFLUCAN) all for unknown indication, from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 Saturday, one day after the vaccination, the patient felt kind of yucky, but ate small meals. On Saturday night at 1900 the  patient started feeling severe abdominal pain and double over. The patient sat down with feet up hoping it would subside but it didn't, it got worsened. On 22:20, the patient was in the bathroom hoping to go but not much would come out, patient did throw up. Since in 19 years, first time the patient brought up mostly flem and specs of food. After that, patient reported that some of the pain went away but it continued on Sunday 28Mar2021, but the patient did not have any vomiting. The clinical outcome of the events felt yucky (nausea) was unknown and severe abdominal pain was recovering at the time of this report. The clinical outcome of the event vomiting was recovered on 28Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Arm pit swollen gland; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Apr2021 at 13:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy. Concomitant medications included topiramate (TOPAMAX), lacosamide (VIMPAT), clonazepam (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN) and buspirone (MANUFACTURER UNKNOWN). The patient previously took shellfish and drugs which included penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 the patient experienced arm pit swollen gland. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event arm pit swollen gland was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: I have had a fever on and off for 8 days since the second shot. It comes and goes but I can't shake being sick.; I have had a fever on and off for 8 days since the second shot. It comes and goes but I cant shake being sick.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient previously had taken apple skins and Debrox from unknown date to unknown date for unknown indication. Concomitant medications taken within two weeks prior to vaccination included cetirizine hydrochloride (ZYRTEC), escitalopram oxalate (LEXAPRO) and montelukast sodium (SINGULAIR) started on unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 22:00, the patient had a fever on and off for 8 days since the second shot. It came and went but he could not shake being sick. The event resulted in doctor or other healthcare professional office/clinic visit. On 05May2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event fever and being sick was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Random red and pink dots appeared around body on face, abdomen, chest, stomach, armpit, nipple; Slight itchy; Slightly itchy, not painful, except for nipple and armpit areas.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 30Apr2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for unknown indications from an unspecified date. The patient's past drug history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 22:00, after 48 hours of receiving the vaccine, the patient developed random red/pink dots around the body, on face, abdomen, chest, stomach, armpit and nipple. It was slightly itchy not painful except for nipple and armpit areas. It was similar to deep pimple in pain and sensitivity. The red spots had slow growth and spread of some spots on abdomen and neck. The clinical outcome of the events rash all over, itchy rash and painful rash were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm left on 04May2021 at 10:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 13Apr2021 at 10:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. 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. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 11:00, the patient experienced mild fatigue relieved by rest. The clinical outcome of the event mild fatigue was recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness/pain in left arm at the injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 26Apr2021(at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021, the patient experienced Soreness/pain in left arm at the injection site. The clinical outcome of the event Soreness/pain in left arm at the injection site was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Chest pain, Heart rate increased
Clinical narrative: Extreme pain in the left stomach and back; Extreme pain in the left stomach and back; Extreme pain in the chest and abdomen area; Extreme pain in the chest and abdomen area; Vaccinated arm got a lot of muscle soreness; Fever; Heart beat so fast; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received unknown dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration in the arm left on 24Apr2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any other medications within two weeks of COVID-19 vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in 2021, the patient experienced heart beat so fast and fever. On 24Apr2021, the patient experienced muscle soreness of vaccinated arm and about 6 days later, arm was no longer have any soreness. On 30Apr2021 (on 6th day) the patient got extreme pain in the chest and abdomen area. It was reported that, it was happened when the patient was sleeping. It was so painful that the patient had to wake up in the middle of the night. The patient cannot  even lie down on the bed. On the 8th day, chest and abdomen pain went away. On an unknown date in May2021, the patient got extreme pain in the left stomach and back and it was still painful. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event muscle soreness was recovered on an unknown date in Apr2021, while that of extreme pain in the chest and abdomen area was recovered on 02 May2021. The clinical outcome of the event extreme pain in the left stomach and back was not recovered while the clinical outcome of the events heart beat so fast and fever were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Extreme pain in the left stomach and back; Extreme pain in the left stomach and back; Extreme pain in the chest and abdomen area; Extreme pain in the chest and abdomen area; Vaccinated arm got a lot of muscle soreness; Fever; Heart beat so fast; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received unknown dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration in the arm left on 24Apr2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any other medications within two weeks of COVID-19 vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in 2021, the patient experienced heart beat so fast and fever. On 24Apr2021, the patient experienced muscle soreness of vaccinated arm and about 6 days later, arm was no longer have any soreness. On 30Apr2021 (on 6th day) the patient got extreme pain in the chest and abdomen area. It was reported that, it was happened when the patient was sleeping. It was so painful that the patient had to wake up in the middle of the night. The patient cannot  even lie down on the bed. On the 8th day, chest and abdomen pain went away. On an unknown date in May2021, the patient got extreme pain in the left stomach and back and it was still painful. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event muscle soreness was recovered on an unknown date in Apr2021, while that of extreme pain in the chest and abdomen area was recovered on 02 May2021. The clinical outcome of the event extreme pain in the left stomach and back was not recovered while the clinical outcome of the events heart beat so fast and fever were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Dizziness, Fall, Gait disturbance
Clinical narrative: He started to feel weak to a point that he felt was going to pass out; He started to feel weak to a point that he felt was going to pass out; Fell three times; His legs were completely numbed; He suffered a cut in one of his knees; Bruises on the shoulders; Limping from his injuries; This is a spontaneous report from a contactable consumer (patient's grand parent). A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 26Apr2021 (at the age of 22-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 26Apr2021, the patient experienced he started to feel weak to a point that he felt was going to pass out, he started to feel weak to a point that he felt was going to pass out, fell three times, his legs were completely numbed, he suffered a cut in one of his knees, bruises on the shoulders and on Apr2021 limping from his injuries. Reportedly, he was not asked to wait for at least 15 minutes. Unaware of any possible reaction, he left the store immediately and drove away. On his way, he started to feel weak to a point that he felt was going to pass out. He doesn't remember how he came to stop the car. At one point, he stepped out of the car on a huge avenue, fell three times as his legs were completely numbed. He suffered a cut in one of his knees, bruises on the shoulders. A couple that was driving by him noticed he was in trouble, stopped and helped him. They gave him water and called the paramedics came in and checked his vitals. Found his vitals ok and released him to get back to our home. I contacted the pharmacy headquarters the day after. They told me they were going to contact him soon, which it has not happened. They made a note of my report as reference. The name of the person I spoke to was I insisted they also contacted the store and let them know of the incident, as in my view didn't follow the expected protocol and put him at risk of a fatal accident. Outcome of the event limping from his injuries was not recovered and for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint injury
Clinical narrative: He started to feel weak to a point that he felt was going to pass out; He started to feel weak to a point that he felt was going to pass out; Fell three times; His legs were completely numbed; He suffered a cut in one of his knees; Bruises on the shoulders; Limping from his injuries; This is a spontaneous report from a contactable consumer (patient's grand parent). A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 26Apr2021 (at the age of 22-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 26Apr2021, the patient experienced he started to feel weak to a point that he felt was going to pass out, he started to feel weak to a point that he felt was going to pass out, fell three times, his legs were completely numbed, he suffered a cut in one of his knees, bruises on the shoulders and on Apr2021 limping from his injuries. Reportedly, he was not asked to wait for at least 15 minutes. Unaware of any possible reaction, he left the store immediately and drove away. On his way, he started to feel weak to a point that he felt was going to pass out. He doesn't remember how he came to stop the car. At one point, he stepped out of the car on a huge avenue, fell three times as his legs were completely numbed. He suffered a cut in one of his knees, bruises on the shoulders. A couple that was driving by him noticed he was in trouble, stopped and helped him. They gave him water and called the paramedics came in and checked his vitals. Found his vitals ok and released him to get back to our home. I contacted the pharmacy headquarters the day after. They told me they were going to contact him soon, which it has not happened. They made a note of my report as reference. The name of the person I spoke to was I insisted they also contacted the store and let them know of the incident, as in my view didn't follow the expected protocol and put him at risk of a fatal accident. Outcome of the event limping from his injuries was not recovered and for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Fatigue
Clinical narrative: Sore throat; Cough; Chills; Headache; Body aches; Joint pain; Arm pain; Swollen lymph node (left under arm), Swollen lymph nodes in neck; Fever; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Ew0172), via an unspecified route of administration in left arm on 29Apr2021 at 16:00 (at the age of 39-year-old) at single dose for COVID-19 immunisation. Medical history included asthma, depression and insomnia/sleep disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), fexofenadine hydrochloride (ALLEGRA ALLERGY), mometasone furoate (FLONASE) and vitamin D. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729) via an unspecified route of administration in left arm on 08Apr2021 at 16:00 (at the age of 39-year-old) at single dose for COVID-19 immunisation; iodine and experienced drug allergy. On 30Apr2021 at 20:00, the patient experienced chills, headache, body ache, joint pain, arm pain, swollen lymph node (left under arm), swollen lymph nodes in neck, fever (99-101 while taking paracetamol (TYLENOL)), severe fatigue. Started on 02May2021, patient experienced sore throat and cough, continued fatigue, continued fever, swollen lymph nodes in neck. As of 05May2021, sore throat, cough, fatigue, swollen lymph nodes in neck and fever were still present. Cough had worsened. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as result of fever included paracetamol (TYLENOL). No treatment was received for the other events. The clinical outcome of the events sore throat, cough, fatigue, swollen lymph nodes in neck and fever was not recovered, outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Sore throat; Cough; Chills; Headache; Body aches; Joint pain; Arm pain; Swollen lymph node (left under arm), Swollen lymph nodes in neck; Fever; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Ew0172), via an unspecified route of administration in left arm on 29Apr2021 at 16:00 (at the age of 39-year-old) at single dose for COVID-19 immunisation. Medical history included asthma, depression and insomnia/sleep disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), fexofenadine hydrochloride (ALLEGRA ALLERGY), mometasone furoate (FLONASE) and vitamin D. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729) via an unspecified route of administration in left arm on 08Apr2021 at 16:00 (at the age of 39-year-old) at single dose for COVID-19 immunisation; iodine and experienced drug allergy. On 30Apr2021 at 20:00, the patient experienced chills, headache, body ache, joint pain, arm pain, swollen lymph node (left under arm), swollen lymph nodes in neck, fever (99-101 while taking paracetamol (TYLENOL)), severe fatigue. Started on 02May2021, patient experienced sore throat and cough, continued fatigue, continued fever, swollen lymph nodes in neck. As of 05May2021, sore throat, cough, fatigue, swollen lymph nodes in neck and fever were still present. Cough had worsened. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as result of fever included paracetamol (TYLENOL). No treatment was received for the other events. The clinical outcome of the events sore throat, cough, fatigue, swollen lymph nodes in neck and fever was not recovered, outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.