chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); This is a spontaneous report from a contactable other health professional (patient).  A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek5760, via an unspecified route of administration in the right arm, on 19Dec2020 17:00 at SINGLE DOSE for covid-19 immunization. The patient's medical history included urticaria and folliculitis: patient was under successful treatment for urticaria and folliculitis with near resolution. Concomitant medication included cefalexin (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC) and triamcinolone. The patient received BNT162B2 on 19Dec2020. Then on 29Dec2020, 12:00, severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); experienced rash and dyspnea requiring steroids and epipen. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. The patient was recovering from all events. Treatment for the events included Prednisone course, epipen, and H2 blockers.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on the temporal relationship and known safety profile of BNT162B2, the reasonable possibility of an association between rash, dyspnea and suspect product cannot be ruled out.  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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chest discomfort, Influenza virus test, Oxygen saturation
Clinical narrative: soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest level); tightness in chest (no productive cough); This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 10Jan2021 09:00 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital and not in a military facility. Medical history included asthma. Concomitant medications included albuterol [salbutamol] from unspecified date for unspecified indication. Historical vaccine included flu shot in Oct2020 for immunization and experienced some soreness in arm and achy. The patient was not given other vaccines given the same day or 4 weeks prior. In Jan2021, the patient had some soreness in arm and achiness (Jan2021) after the Pfizer BioNTech Covid-19 vaccine it didn't last long and she went to work afterwards. The patient was scheduled for work the next day and could tell something was not right. The patient was flushed and thought it was from the Albuterol since it can cause a racing heart beat and checked for a fever and didn't' have one. The patient checked temperature before bed and it was 100.5 degrees and she went straight to (redacted). The patient informed that she went for Covid testing; she went to physician office for Covid testing. The patient was praying for the flu so she could take Tamiflu and the flu test was negative (21Jan2021) and the Covid testing was positive (21Jan2021). The patient was tested positive after first Covid vaccine and ran fever 8 to 9 days and highest temperature was 101 degrees, had a little bit of asthma and kept a close watch, congestion, pulse ox 92 (lowest level), tightness in chest (no productive cough), felt beat up, fatigued and tiredness. The patient was diagnosed with Covid-19. She was told as well not to take pain relievers (ibuprofen, Advil and Aleve) and was advised to take Tylenol instead. The patient informed that she was to get her second dose tomorrow. The patient wanted to know if she can get the second dose if she was tested positive. The patient was supposedly scheduled to have the second dose on 27Jan2021 however it was moved to 04Feb2021 due to tested positive of Covid and was put on quarantined. The outcome of the events was recovering. The patient was unable to provide seriousness criteria when queried and said that this was her luck of the draw. The patient thought the shot actually helped.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest level); tightness in chest (no productive cough); This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 10Jan2021 09:00 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital and not in a military facility. Medical history included asthma. Concomitant medications included albuterol [salbutamol] from unspecified date for unspecified indication. Historical vaccine included flu shot in Oct2020 for immunization and experienced some soreness in arm and achy. The patient was not given other vaccines given the same day or 4 weeks prior. In Jan2021, the patient had some soreness in arm and achiness (Jan2021) after the Pfizer BioNTech Covid-19 vaccine it didn't last long and she went to work afterwards. The patient was scheduled for work the next day and could tell something was not right. The patient was flushed and thought it was from the Albuterol since it can cause a racing heart beat and checked for a fever and didn't' have one. The patient checked temperature before bed and it was 100.5 degrees and she went straight to (redacted). The patient informed that she went for Covid testing; she went to physician office for Covid testing. The patient was praying for the flu so she could take Tamiflu and the flu test was negative (21Jan2021) and the Covid testing was positive (21Jan2021). The patient was tested positive after first Covid vaccine and ran fever 8 to 9 days and highest temperature was 101 degrees, had a little bit of asthma and kept a close watch, congestion, pulse ox 92 (lowest level), tightness in chest (no productive cough), felt beat up, fatigued and tiredness. The patient was diagnosed with Covid-19. She was told as well not to take pain relievers (ibuprofen, Advil and Aleve) and was advised to take Tylenol instead. The patient informed that she was to get her second dose tomorrow. The patient wanted to know if she can get the second dose if she was tested positive. The patient was supposedly scheduled to have the second dose on 27Jan2021 however it was moved to 04Feb2021 due to tested positive of Covid and was put on quarantined. The outcome of the events was recovering. The patient was unable to provide seriousness criteria when queried and said that this was her luck of the draw. The patient thought the shot actually helped.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to arthropod sting, Hyperreflexia, Hypoaesthesia, Miliaria, Nervousness
Clinical narrative: Got nervous feeling; Allergic reaction to bee sting; rash of heat from her neck up to her head; noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow/still having the swallowing; Congested head, head felt congested, not like pressure; Fingertips a little numb and tingling; Fingertips a little numb and tingling; This is a spontaneous report from a contactable consumers (one is the patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269), via an unspecified route of administration on 03Feb2021 at 10:40 at a single dose on the right arm for COVID-19 immunization, ibuprofen (manufactured by other company, strength: 200 mg, lot number: 7AE1784B, expiry date: Nov2018), oral from an unspecified date and ongoing at 400 mg, as needed for an unspecified indication, hydrochlorothiazide (strength: 25 mg), oral from an unspecified date and ongoing at 25 mg, once a day (about 8am) for high blood pressure, and valsartan (strength: 160 mg, expiration date: 11Nov2021), oral from an unspecified date and ongoing at 160 mg, once a day (about 8am) for high blood pressure. Medical history included ongoing high blood pressure. The patient's concomitant medications were not reported. The patient previously took flu shot about 15-20 years ago for immunization and experienced swelling. On 03Feb2021, patient received the vaccine. When going home, she noticed all of a sudden a rash of heat from her neck up to her head. Figured it was not a problem to have a little reaction and thought nothing of it. She had a cup of coffee this morning and not a lot of water, so she started drinking water and had 3 bottles. After the heat passed she noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow. She is still having the swallowing and is continuing to drink water even at home. She also congested head, head felt congested, but not like pressure. She does not get headaches so she guesses she is getting this instead of a headache. She noticed her fingertips feel a little numb and tingling, but overall feels okay. She mentioned that on an unspecified date, she just got this nervous feeling and had allergic reaction to bee sting. Mentioned that her husband and brother in law got the shot and were feeling fine. No further details provided. The action taken in response to the events for ibuprofen was dose not changed , for hydrochlorothiazide was dose not changed, and for valsartan was dose not changed. The outcome of the event rash of heat from her neck up to her head was recovering; event got nervous feeling was unknown, while the other events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Upper respiratory tract congestion
Clinical narrative: Got nervous feeling; Allergic reaction to bee sting; rash of heat from her neck up to her head; noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow/still having the swallowing; Congested head, head felt congested, not like pressure; Fingertips a little numb and tingling; Fingertips a little numb and tingling; This is a spontaneous report from a contactable consumers (one is the patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269), via an unspecified route of administration on 03Feb2021 at 10:40 at a single dose on the right arm for COVID-19 immunization, ibuprofen (manufactured by other company, strength: 200 mg, lot number: 7AE1784B, expiry date: Nov2018), oral from an unspecified date and ongoing at 400 mg, as needed for an unspecified indication, hydrochlorothiazide (strength: 25 mg), oral from an unspecified date and ongoing at 25 mg, once a day (about 8am) for high blood pressure, and valsartan (strength: 160 mg, expiration date: 11Nov2021), oral from an unspecified date and ongoing at 160 mg, once a day (about 8am) for high blood pressure. Medical history included ongoing high blood pressure. The patient's concomitant medications were not reported. The patient previously took flu shot about 15-20 years ago for immunization and experienced swelling. On 03Feb2021, patient received the vaccine. When going home, she noticed all of a sudden a rash of heat from her neck up to her head. Figured it was not a problem to have a little reaction and thought nothing of it. She had a cup of coffee this morning and not a lot of water, so she started drinking water and had 3 bottles. After the heat passed she noticed a feeling of needing to swallow and figured out it was just a knee jerk reaction to make sure she can swallow. She is still having the swallowing and is continuing to drink water even at home. She also congested head, head felt congested, but not like pressure. She does not get headaches so she guesses she is getting this instead of a headache. She noticed her fingertips feel a little numb and tingling, but overall feels okay. She mentioned that on an unspecified date, she just got this nervous feeling and had allergic reaction to bee sting. Mentioned that her husband and brother in law got the shot and were feeling fine. No further details provided. The action taken in response to the events for ibuprofen was dose not changed , for hydrochlorothiazide was dose not changed, and for valsartan was dose not changed. The outcome of the event rash of heat from her neck up to her head was recovering; event got nervous feeling was unknown, while the other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: terrible headache/Her head was pounding; fatigue; injection site soreness; soreness; Her head was pounding, and she was having a hard time concentrating; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient previously took sumatriptan succinate for migraine. She had the first shot of the Pfizer covid vaccine on Saturday since then, she's had soreness. She of course had injection site soreness and fatigue 48 hours after the shot. Today (01Feb2021) she also has a terrible, terrible headache. She was asking if she can take her previous migraine medication called Sumatriptan Succinate tablet. Her head was pounding, and she was having a hard time concentrating. The outcome of events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Rash, Swelling
Clinical narrative: her arm was red; arm swelling; arm warm; he put her on antibiotics just in case because her arm was warm; allergic reaction; she broke out with a rash a little the next day after the vaccination; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received pneumococcal 13-valent conjugate vacccine (dipht crm197 protein) (PREVNAR 13 Solution for injection in pre-filled syringe, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 28Jul2015 14:00, at single dose, for immunization, at the physician's office. There were no medical history, family history and concomitant medications. The patient did not receive other vaccines within 4 weeks. On 29Jul2015, next day after the vaccination, the patient broke out with rash which faded in a few days. Then the rash came back on 03Aug2015. The patient went to the doctor because her rash came back. The patient reported that she had an allergic reaction, nothing serious only rash and on 03Aug2015, her arm was red, warm and swelling. The patient went to the doctor because her rash came back, and her doctor put her on antibiotics just in case because her arm was warm. The events all went away in a few days. The patient reported there was no hospitalization, she only visited the doctor. The outcome of the events was resolved on an unspecified date in 2015.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pruritus, Rash erythematous, Rash papular
Clinical narrative: nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at the injection site; itching going on in my face, my left arm, in the elbow / stomach about 2 inches to the left where they made the incision for the cancer removal; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration into left arm on 06Feb2021 (at the age of 67-years) as a single dose for COVID-19 immunization. Medical history included allergic to peanuts, allergic to Penicillin, cancer and hysterectomy. There were no concomitant medications. The patient previously took vancomycin, cefalexin (KEFLEX) and zelnorm and was allergic. On 06Feb2021, the patient had pain at the injection site, but that was gone now. She also experienced rash, which was elaborated as an itch, like a rash that started since she got the shot. She had the itching rash going on into her face, left arm, the elbow, and also 2 inches from naval on the left side where she had incision from cancer removal, hysterectomy. The rash was started in the area of the hysterectomy. The patient elaborated that the rash was red and she can feel bumps. The patient was taking diphenhydramine hydrochloride (BENADRYL) which usually stop the itching. Last night 06Feb2021, the back of her left elbow and her face started itching as well and at 23:30 the patient experienced nausea and felt tired. The patient is scheduled for second dose on 27Feb2021. The clinical outcome of event rash is red and she can feel bumps was not recovered. The outcome of pain at the injection site was recovered in Feb2021. The clinical outcome of other events was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at the injection site; itching going on in my face, my left arm, in the elbow / stomach about 2 inches to the left where they made the incision for the cancer removal; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration into left arm on 06Feb2021 (at the age of 67-years) as a single dose for COVID-19 immunization. Medical history included allergic to peanuts, allergic to Penicillin, cancer and hysterectomy. There were no concomitant medications. The patient previously took vancomycin, cefalexin (KEFLEX) and zelnorm and was allergic. On 06Feb2021, the patient had pain at the injection site, but that was gone now. She also experienced rash, which was elaborated as an itch, like a rash that started since she got the shot. She had the itching rash going on into her face, left arm, the elbow, and also 2 inches from naval on the left side where she had incision from cancer removal, hysterectomy. The rash was started in the area of the hysterectomy. The patient elaborated that the rash was red and she can feel bumps. The patient was taking diphenhydramine hydrochloride (BENADRYL) which usually stop the itching. Last night 06Feb2021, the back of her left elbow and her face started itching as well and at 23:30 the patient experienced nausea and felt tired. The patient is scheduled for second dose on 27Feb2021. The clinical outcome of event rash is red and she can feel bumps was not recovered. The outcome of pain at the injection site was recovered in Feb2021. The clinical outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: they both have covid; they both have covid; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is first of two reports. A female patient of an unspecified age (reported as 70, unit unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history included pneumonia. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer COVID vaccine on 18Jan2021, and her husband on 20Jan2021. She was diagnosed with COVID last Thursday (04Feb2021). She said she got it from her husband. They both have COVID and received antibodies (from (company name)) as it was mild case. She said she and her husband were congested, had fatigue, and the antibodies made a difference. She had pneumonia before. The patient stated so many people can only take the first dose due to side effects or some other reason. She wanted to know the time they needed to wait to get the second dose of the vaccine and asked if it was 90 days. The outcome of the event was unknown.   Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171730 Same reporter, drug, and events; different patients
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site that started about 3hrs after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247, first dose) solution for injection intramuscular on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced pain at the injection site that started about 3 hours after injection. No treatment was provided for the event pain at the injection site. The outcome of the event pain at the injection site was unknown. The patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eyelid irritation, Glossodynia, Malaise, Palpitations
Clinical narrative: I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin.  Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO).  After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry.  At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not  diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No).   Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Skin burning sensation, Vision blurred
Clinical narrative: I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin.  Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO).  After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry.  At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not  diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No).   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Drug ineffective
Clinical narrative: The vaccine might not have been effective on her; she received 3 different doses of the vaccine, the first one in Jan2014, the second one in Feb2016 and the last one in Sep2019.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13 solution for injection in pre-filled syringe; lot number and expiry date: unknown), via an unspecified route of administration, first dose in Jan2014, second dose in Feb2016, and third dose in Sep2019 , at single doses, for immunization. Relevant medical history included asthma, high blood pressure and allergies. Concomitant medications were not reported. The patient previously received flu vaccine for flu vaccination and experienced allergic reactions. The patient wanted to know if there was a previous version of PREVNAR 13. She wanted to know how often a patient should receive a shot. The patient stated that she received 3 different doses of the vaccine, the first one in Jan2014, the second one in Feb2016 and the last one in Sep2019. She stated during the call that her physician indicated that she should receive an additional dose because the vaccine might not have been effective on her. Outcome of the event "The vaccine might not have been effective on her" was unknown. The patient also wanted to know if she can receive the COVID-19 vaccine manufactured by Pfizer if she has medical history of allergies, asthma and high blood pressure and if she can receive a list of the risks of the vaccine.   No follow up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Kidney infection
Clinical narrative: a mild kidney infection; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 70; unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 08Feb2021 at SINGLE DOSE for covid-19 imunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient received first dose of the Covid vaccine yesterday (08Feb2021). Patient reported that it appears he has a mild kidney infection on an unspecified date in which his urologist has prescribed ciprofloxacin to take. Patient asked if an antibiotic will interfere with his vaccination. Outcome of the event was unknown.   Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: diverticulitis, his condition flares up every once in a while; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunization. Medical history included diverticulitis. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient was concerned about efficiency of the vaccine. He received a second dose of bnt162b2 yesterday morning and today (09Feb2021) he was experiencing bout of diverticulitis and his doctor has given him couple of antibiotics, one of them being Cipro and the other was Flagyl to treat diverticulitis and he was just concerned given he just received a vaccine if those antibiotics would affect the efficiency of the vaccine. He was concerned because he has been given antibiotics by his doctor for when his condition flares up every once in a while. The doctor gave him Cipro and Flagyl. He was wondering if he takes these, if it will have any impact on the efficacy of the vaccine. He thinks the flare up was coming on before the shot so he didn't want to do a report. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Fatigue, Headache, Hypertension
Clinical narrative: Headache; Temperature 99 - 101 F; tiredness; higher blood pressure then usual (140 X 82); administration date=02Feb2021, dose number=2/administration date=20Jan2021, dose number=1; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on her right arm, via an unspecified route of administration on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 (first dose) for covid-19 immunization. The patient experienced Headache, Temperature 99 - 101 F, tiredness, higher blood pressure than usual (140/82); all on 03Feb2021 06:00 AM. Patient received Ibuprofen 200 as treatment for the events. The outcome of the events was recovered on unspecified dates.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Headache; Temperature 99 - 101 F; tiredness; higher blood pressure then usual (140 X 82); administration date=02Feb2021, dose number=2/administration date=20Jan2021, dose number=1; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on her right arm, via an unspecified route of administration on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 (first dose) for covid-19 immunization. The patient experienced Headache, Temperature 99 - 101 F, tiredness, higher blood pressure than usual (140/82); all on 03Feb2021 06:00 AM. Patient received Ibuprofen 200 as treatment for the events. The outcome of the events was recovered on unspecified dates.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: green bile coming out of my behind/ having little green bowel; Bowel like a diarrhea, or bowel movement; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program Pfizer First Connect. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated "I am experiencing green bile coming out of my behind. Can your covid-19 vaccine cause that?" It was clarified as seeing green bile after going to the bathroom and having a stool. It was stated that Sunday she started having little green bowel until today; bowel like a diarrhea or bowel movement. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable physician. A 17-year-old female patient started to received meningococcal group b rlp2086 (TRUMENBA, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, a physician mentioned that she administered the first dose of the Trumenba vaccine to a 17 year old patient last Saturday and the patient was still having fever. She would like to know if there was record of fever lasting this long. The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Meningitis viral
Clinical narrative: viral meningitis, losing function in his legs; viral meningitis, losing function in his legs; headache; dizziness; fatigue; nausea; weak; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient kept having very very bad headaches, dizziness, fatigue, nausea, for several days about a whole week and experienced "viral meningitis, losing function in his legs and he's still weak and having issues". The outcome of the events was unknown.  information on the LOT/Batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Nausea
Clinical narrative: viral meningitis, losing function in his legs; viral meningitis, losing function in his legs; headache; dizziness; fatigue; nausea; weak; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient kept having very very bad headaches, dizziness, fatigue, nausea, for several days about a whole week and experienced "viral meningitis, losing function in his legs and he's still weak and having issues". The outcome of the events was unknown.  information on the LOT/Batch number has been requested
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pain, Pyrexia
Clinical narrative: Cough; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer. A 28-year-old female patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at left arm from an unspecified date at a single dose for COVID-19 immunisation. The patient had no medical history. The patient is not pregnant. There were no concomitant medications.  On an unspecified date, after first vaccine for two weeks, the patient had a cough, couple days of fever, chills and body aches. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and  hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM,  the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose.  The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and  hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM,  the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose.  The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: achiness; low grade fever 100.6; fatigue; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3248), via an unspecified route of administration on the left arm at the age of 55 years, on 09Feb2021 16:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), colecalciferol (VITAMIN D), vitamin c [ascorbic acid] (VITAMIN C) and Multi Vitamin. The patient had the first dose last 20Jan2021. The patient experienced achiness, low grade fever 100.6 and fatigue on 10Feb2021. The patient underwent lab tests and procedures which included body temperature: 100.6 on 10Feb2021. No treatment was received for the adverse events. The outcome of events was recovered on unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Retching
Clinical narrative: bad nose bleed/It's bleeding in the back of my nose; the clots are so big that I gag when I expel them; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 on 01Feb2021 at single dose for covid-19 immunization. Medical history was not reported. Concomitant medications included warfarin sodium (COUMADIN). On 02Feb2021, patient had a bad nose bleed which patient stopped. On 03Feb2021 paitent was ok and on 04Feb2021 patient got a nose bleed that patient could not stop and still have to be careful and not do anything as it starts all over again. It's bleeding in the back of nose also and the clots are so big that patient gag when patient expel them. The outcome of the event was not recovered.   Information on batch/lot number was requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Eye swelling, Fatigue, Headache
Clinical narrative: sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Laboratory test, Myalgia, Nasal oedema, Nausea
Clinical narrative: sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown.   No follow-up attempts are possible. No further information is expected.