chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Iron binding capacity total, Malaise, Nausea
Clinical narrative: Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; A sore arm at site of injection on the first dose; The first dose is "compromised (may not have been kept at the proper temperature); The first dose is "compromised (may not have been kept at the proper temperature); This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; manufacturer: Unspecified; NDC number, UPC number and Expiry Date: Unknown; Lot Number: EL9269), dose 1 via an unspecified route of administration on 15Feb2021 (at the age of 74 years) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus, NASH cirrhosis and hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient reported that she received the Pfizer-BioNTech COVID-19 Vaccine first dose a week ago on 15Feb2021. Patient stated that she received a call this morning from the Hospital, told her that the first dose is "compromised (may not have been kept at the proper temperature)" and that is the reason she is scheduled for another dose this Thursday 24th. Just 10 days later. She also mentioned that she had a sore arm at site of injection on the first dose. They said it was compromised because it was not properly handled or refrigerated. If she get another number 1 vaccine, that will be 2 first vaccines she will have had. She reported receiving a "compromised" Pfizer vaccine dose, along with 81 other people who received the same "compromised" doses. She stated the vaccine was not kept at proper temperatures and the CDC advised them to get another dose of the vaccine. She received her second Pfizer Covid vaccine dose on 25Feb2021 (10 days later) and had been experiencing side effects since 28Feb2021. She reported "severe headache, back and neck pain, nausea, diarrhea, weak, tired, on 9th day of this and still not feeling well. Her MD had a feeling there was too much vaccine given in a short period of time, which could cause antibodies to be high. Her MD gave her a Covid antibody spike test, results back today showed that the spike was 9.3 and normal is 1.0 on an unknown date. She wanted to know how serious this could be because she was concerned that the first dose still had some efficacy and now she had received another dose too soon. She wanted to know if she was in any danger with her antibody number being so high. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, SARS-CoV-2 antibody test
Clinical narrative: Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; A sore arm at site of injection on the first dose; The first dose is "compromised (may not have been kept at the proper temperature); The first dose is "compromised (may not have been kept at the proper temperature); This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; manufacturer: Unspecified; NDC number, UPC number and Expiry Date: Unknown; Lot Number: EL9269), dose 1 via an unspecified route of administration on 15Feb2021 (at the age of 74 years) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus, NASH cirrhosis and hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient reported that she received the Pfizer-BioNTech COVID-19 Vaccine first dose a week ago on 15Feb2021. Patient stated that she received a call this morning from the Hospital, told her that the first dose is "compromised (may not have been kept at the proper temperature)" and that is the reason she is scheduled for another dose this Thursday 24th. Just 10 days later. She also mentioned that she had a sore arm at site of injection on the first dose. They said it was compromised because it was not properly handled or refrigerated. If she get another number 1 vaccine, that will be 2 first vaccines she will have had. She reported receiving a "compromised" Pfizer vaccine dose, along with 81 other people who received the same "compromised" doses. She stated the vaccine was not kept at proper temperatures and the CDC advised them to get another dose of the vaccine. She received her second Pfizer Covid vaccine dose on 25Feb2021 (10 days later) and had been experiencing side effects since 28Feb2021. She reported "severe headache, back and neck pain, nausea, diarrhea, weak, tired, on 9th day of this and still not feeling well. Her MD had a feeling there was too much vaccine given in a short period of time, which could cause antibodies to be high. Her MD gave her a Covid antibody spike test, results back today showed that the spike was 9.3 and normal is 1.0 on an unknown date. She wanted to know how serious this could be because she was concerned that the first dose still had some efficacy and now she had received another dose too soon. She wanted to know if she was in any danger with her antibody number being so high. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Headache, Lethargy, Pyrexia
Clinical narrative: Cough; Shortness of breath (SOB); lethargy; Head ache; 8 hours after vaccine. high fever 101-102 x 2 days.; This is a spontaneous report from a contactable nurse. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EI.8982) via an unspecified route of administration in the right arm on 12Mar2021 at 12:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications was not reported. The patient previously took bromocriptine mesylate(PARLODEL) and erythromycin(MANUFACTURER UNKNOWN) ointment from unknown date. 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-19 vaccination. On 12Mar2021 at 20:00, 8 hours after vaccination, the patient experienced high fever of 101-102 for 2 days, cough, head ache, shortness of breath (SOB), lethargy for 7 days. The patient underwent lab test which included body temperature on 12Mar2021 and resulted with a temperature of 101-102(unspecified unit). On 14Mar2021, the patient underwent SARS-CoV-2 test(nasal swab) and the result was negative. The clinical outcome of the event high fever, cough, head ache, shortness of breath (SOB), lethargy  were recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cough, Dyspnoea, Headache, Lethargy
Clinical narrative: Cough; Shortness of breath (SOB); lethargy; Head ache; 8 hours after vaccine. high fever 101-102 x 2 days.; This is a spontaneous report from a contactable nurse. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EI.8982) via an unspecified route of administration in the right arm on 12Mar2021 at 12:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications was not reported. The patient previously took bromocriptine mesylate(PARLODEL) and erythromycin(MANUFACTURER UNKNOWN) ointment from unknown date. 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-19 vaccination. On 12Mar2021 at 20:00, 8 hours after vaccination, the patient experienced high fever of 101-102 for 2 days, cough, head ache, shortness of breath (SOB), lethargy for 7 days. The patient underwent lab test which included body temperature on 12Mar2021 and resulted with a temperature of 101-102(unspecified unit). On 14Mar2021, the patient underwent SARS-CoV-2 test(nasal swab) and the result was negative. The clinical outcome of the event high fever, cough, head ache, shortness of breath (SOB), lethargy  were recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Cough; Shortness of breath (SOB); lethargy; Head ache; 8 hours after vaccine. high fever 101-102 x 2 days.; This is a spontaneous report from a contactable nurse. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EI.8982) via an unspecified route of administration in the right arm on 12Mar2021 at 12:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications was not reported. The patient previously took bromocriptine mesylate(PARLODEL) and erythromycin(MANUFACTURER UNKNOWN) ointment from unknown date. 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-19 vaccination. On 12Mar2021 at 20:00, 8 hours after vaccination, the patient experienced high fever of 101-102 for 2 days, cough, head ache, shortness of breath (SOB), lethargy for 7 days. The patient underwent lab test which included body temperature on 12Mar2021 and resulted with a temperature of 101-102(unspecified unit). On 14Mar2021, the patient underwent SARS-CoV-2 test(nasal swab) and the result was negative. The clinical outcome of the event high fever, cough, head ache, shortness of breath (SOB), lethargy  were recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness, Ear discomfort, Musculoskeletal discomfort, Tinnitus
Clinical narrative: Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm right on 08Mar2021, at 15:15 (at the age of 71-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 19Apr2021 at 09:00, the patient experienced tinnitus in right ear and pressure surrounding the ear. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events tinnitus in right ear and pressure surrounding the ear were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm right on 08Mar2021, at 15:15 (at the age of 71-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 19Apr2021 at 09:00, the patient experienced tinnitus in right ear and pressure surrounding the ear. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events tinnitus in right ear and pressure surrounding the ear were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Full blood count abnormal, Metabolic function test, Urine analysis
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the arm left on 31Mar2021 at 13:00 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy (sulfa drugs). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the arm left on 10Mar2021 (at the age of 68-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 01Apr2021, the patient experienced flu-like symptoms and sore arm (reported as starting day 2 and ending on day 3). On 04Apr2021 at 12:00, the patient experienced feel very, very itchy on the skin behind ears, on neck, stomach and thighs, too itchy to sleep at night. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm, flu-like symptoms and feel very, very itchy on the skin behind ears, on neck, stomach and thighs was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the arm left on 31Mar2021 at 13:00 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy (sulfa drugs). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the arm left on 10Mar2021 (at the age of 68-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 01Apr2021, the patient experienced flu-like symptoms and sore arm (reported as starting day 2 and ending on day 3). On 04Apr2021 at 12:00, the patient experienced feel very, very itchy on the skin behind ears, on neck, stomach and thighs, too itchy to sleep at night. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm, flu-like symptoms and feel very, very itchy on the skin behind ears, on neck, stomach and thighs was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain in extremity, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the arm left on 31Mar2021 at 13:00 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy (sulfa drugs). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the arm left on 10Mar2021 (at the age of 68-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 01Apr2021, the patient experienced flu-like symptoms and sore arm (reported as starting day 2 and ending on day 3). On 04Apr2021 at 12:00, the patient experienced feel very, very itchy on the skin behind ears, on neck, stomach and thighs, too itchy to sleep at night. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm, flu-like symptoms and feel very, very itchy on the skin behind ears, on neck, stomach and thighs was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia
Clinical narrative: Ongoing continuous metallic pasty taste; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262), via an unspecified route of administration in the left arm on 11Feb2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), guaifenesin (MUCINEX), montelukast sodium (SINGULAIR) and budesonide (RHINOCORT AQUA NS); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1384), via an unspecified route of administration in the left arm on 21Jan2021 at 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation and hydrocodone (MANUFACTURER UNKNOWN) on an unknown date for an unspecified indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 since the vaccination. On 25Feb2021, the patient experienced continuous metallic pasty taste. No therapeutic measures were taken as the result of adverse event. The clinical outcome of continuous metallic pasty taste was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Lymph node pain, Lymphadenopathy
Clinical narrative: Shingles; Lymph node was painfully swollen; Lymph node was painfully swollen; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old patient with unspecified gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ew0153), in right arm on 08Apr2021 at 08:30 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included shingles. Concomitant medications were not included. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number En6204), in right arm on 18Mar2021 at 16:00, as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 15:00, the patient experienced shingles (which is three days after the vaccination) on right side behind neck and lymph node was painfully swollen. It was also reported that the patient got shingles a few times in life and doctor said it is unrelated and stress. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with antiviral medication. The clinical outcome of the events shingles and lymph node was painfully swollen recovered in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Raised red bumps across upper body. Started 12 days after shot. Spread from center of chest across entire front/side of torso. Also spread to neck, shoulders, arms. Concentrated around armpits.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 12Apr2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, occasional smoker, slightly elevated cholesterol and blood pressure. The patient's past drug was reported as no. Concomitant medications taken within two weeks included colecalciferol 50 microgram (VITAMIN D3) for unknown indication from unknown date. Prior to the vaccination, it was unknown if the patient was 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 24Apr2021 at 20:00 the patient experienced raised red bumps across upper body. Started 12 days after shot, spread from center of chest across entire front/side of torso, also spread to neck, shoulders, arms and concentrated around armpits. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the adverse event which included treatment with diphenhydramine. The patient underwent lab test which included Polymerase Chain Reaction (PCR) on 29Apr2021, and the result was negative. The clinical outcome of the event raised red bumps across upper body, spread from center of chest across entire front/side of torso, neck, shoulders, arms and concentrated around armpits was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Skin disorder
Clinical narrative: Raised red bumps across upper body. Started 12 days after shot. Spread from center of chest across entire front/side of torso. Also spread to neck, shoulders, arms. Concentrated around armpits.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 12Apr2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, occasional smoker, slightly elevated cholesterol and blood pressure. The patient's past drug was reported as no. Concomitant medications taken within two weeks included colecalciferol 50 microgram (VITAMIN D3) for unknown indication from unknown date. Prior to the vaccination, it was unknown if the patient was 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 24Apr2021 at 20:00 the patient experienced raised red bumps across upper body. Started 12 days after shot, spread from center of chest across entire front/side of torso, also spread to neck, shoulders, arms and concentrated around armpits. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the adverse event which included treatment with diphenhydramine. The patient underwent lab test which included Polymerase Chain Reaction (PCR) on 29Apr2021, and the result was negative. The clinical outcome of the event raised red bumps across upper body, spread from center of chest across entire front/side of torso, neck, shoulders, arms and concentrated around armpits was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: Arm sore at injection site; Flu like symptoms for two days after injection; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 13Apr2021 at 15:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included seizures. Concomitant medications included lamotrigine (LAMICTAL) for unspecified indication from an unknown date. The patient's past drug was reported as no.  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 14Apr2021 at 01:00, the patient experienced arm sore at injection site and flu like symptoms. The clinical outcome of the event vaccination site pain was recovered on an unknown date in 2021. The clinical outcome of flu like symptoms was recovered on 16Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Vaccination site pain
Clinical narrative: Arm sore at injection site; Flu like symptoms for two days after injection; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 13Apr2021 at 15:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included seizures. Concomitant medications included lamotrigine (LAMICTAL) for unspecified indication from an unknown date. The patient's past drug was reported as no.  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 14Apr2021 at 01:00, the patient experienced arm sore at injection site and flu like symptoms. The clinical outcome of the event vaccination site pain was recovered on an unknown date in 2021. The clinical outcome of flu like symptoms was recovered on 16Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fever of 104.4; Chills; Headache; Body aches; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 30Apr2021 at 11:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included testosterone (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 11:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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 30Apr021 at 11:30, the patient experienced fever of 104.4, chills, headache, body aches, nausea and fatigue. The patient has taken ibuprofen (MANUFACTURER UNKNOWN) as a treatment for the reported events. The clinical outcome of the events fever of 104.4, chills, headache, body aches, nausea and fatigue were recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 104.4; Chills; Headache; Body aches; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 30Apr2021 at 11:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included testosterone (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 11:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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 30Apr021 at 11:30, the patient experienced fever of 104.4, chills, headache, body aches, nausea and fatigue. The patient has taken ibuprofen (MANUFACTURER UNKNOWN) as a treatment for the reported events. The clinical outcome of the events fever of 104.4, chills, headache, body aches, nausea and fatigue were recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: Fever of 104.4; Chills; Headache; Body aches; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 30Apr2021 at 11:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included testosterone (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 11:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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 30Apr021 at 11:30, the patient experienced fever of 104.4, chills, headache, body aches, nausea and fatigue. The patient has taken ibuprofen (MANUFACTURER UNKNOWN) as a treatment for the reported events. The clinical outcome of the events fever of 104.4, chills, headache, body aches, nausea and fatigue were recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever of 104.4; Chills; Headache; Body aches; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 30Apr2021 at 11:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included testosterone (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 11:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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 30Apr021 at 11:30, the patient experienced fever of 104.4, chills, headache, body aches, nausea and fatigue. The patient has taken ibuprofen (MANUFACTURER UNKNOWN) as a treatment for the reported events. The clinical outcome of the events fever of 104.4, chills, headache, body aches, nausea and fatigue were recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Erythema, Feeling hot, Flushing, Pain
Clinical narrative: Hives on my cheeks; Flushing within 10 minutes; Flushing within 10 minutes where my face and neck became really hot feeling to me and to touch.; This is a spontaneous report from a contactable consumer (patient). This consumer reported 2 reports for same patient and different dose, this is the first of 2 reports. A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05May2021 at 15:30 (Batch/Lot Number: EW0179) at age of 27 years old as DOSE 1, SINGLE for covid-19 immunisation. Known allergies included patient was allergic to Tylenol and environmental allergies like dust, dogs, mold, trees and weeds. Other medical history included patient had Irritable bowel syndrome (IBS-D), anxiety, and Obsessive-compulsive disorder (OCD). Patient had had a colonoscopy, and laparoscopy to break apart an abdominal adhesion she had. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The first time patient got the vaccine she had flushing within 10 minutes (as reported) where her face and neck became really hot feeling to she and to touch. Patient thought she was just warm in her mask but when she got to her car, patient could see it all and there were hives on her cheeks. Patient ended up taking BENADRYL which cleared it up. Patient saw an allergist between vaccines who told she to take ALLEGRA and PEPCID one hour prior to the second vaccine (and patient also retested miralax). Adverse event started on 05May2021 at 15:45 PM (as reported). The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included BENADRYL. The outcome of event flushing within 10 minutes was recovered in 2021, of other events was recovering.  Follow-up attempts completed. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021627027 same patient/reporter/drug, different dose and different AE in separated time
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Sensation of foreign body, Thirst
Clinical narrative: Hives on my cheeks; Flushing within 10 minutes; Flushing within 10 minutes where my face and neck became really hot feeling to me and to touch.; This is a spontaneous report from a contactable consumer (patient). This consumer reported 2 reports for same patient and different dose, this is the first of 2 reports. A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05May2021 at 15:30 (Batch/Lot Number: EW0179) at age of 27 years old as DOSE 1, SINGLE for covid-19 immunisation. Known allergies included patient was allergic to Tylenol and environmental allergies like dust, dogs, mold, trees and weeds. Other medical history included patient had Irritable bowel syndrome (IBS-D), anxiety, and Obsessive-compulsive disorder (OCD). Patient had had a colonoscopy, and laparoscopy to break apart an abdominal adhesion she had. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The first time patient got the vaccine she had flushing within 10 minutes (as reported) where her face and neck became really hot feeling to she and to touch. Patient thought she was just warm in her mask but when she got to her car, patient could see it all and there were hives on her cheeks. Patient ended up taking BENADRYL which cleared it up. Patient saw an allergist between vaccines who told she to take ALLEGRA and PEPCID one hour prior to the second vaccine (and patient also retested miralax). Adverse event started on 05May2021 at 15:45 PM (as reported). The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included BENADRYL. The outcome of event flushing within 10 minutes was recovered in 2021, of other events was recovering.  Follow-up attempts completed. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021627027 same patient/reporter/drug, different dose and different AE in separated time
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing, Urticaria
Clinical narrative: Hives on my cheeks; Flushing within 10 minutes; Flushing within 10 minutes where my face and neck became really hot feeling to me and to touch.; This is a spontaneous report from a contactable consumer (patient). This consumer reported 2 reports for same patient and different dose, this is the first of 2 reports. A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05May2021 at 15:30 (Batch/Lot Number: EW0179) at age of 27 years old as DOSE 1, SINGLE for covid-19 immunisation. Known allergies included patient was allergic to Tylenol and environmental allergies like dust, dogs, mold, trees and weeds. Other medical history included patient had Irritable bowel syndrome (IBS-D), anxiety, and Obsessive-compulsive disorder (OCD). Patient had had a colonoscopy, and laparoscopy to break apart an abdominal adhesion she had. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The first time patient got the vaccine she had flushing within 10 minutes (as reported) where her face and neck became really hot feeling to she and to touch. Patient thought she was just warm in her mask but when she got to her car, patient could see it all and there were hives on her cheeks. Patient ended up taking BENADRYL which cleared it up. Patient saw an allergist between vaccines who told she to take ALLEGRA and PEPCID one hour prior to the second vaccine (and patient also retested miralax). Adverse event started on 05May2021 at 15:45 PM (as reported). The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included BENADRYL. The outcome of event flushing within 10 minutes was recovered in 2021, of other events was recovering.  Follow-up attempts completed. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021627027 same patient/reporter/drug, different dose and different AE in separated time
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Menstruation irregular, Muscle spasms
Clinical narrative: Headache; Fatigue / Tiredness; nausea; feet cramp; no longer get periods since before 2021; The period lasted 09May2021 to 17May2021; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0173), via an unspecified route of administration in left arm on 29Apr2021 at 13:15 (age at vaccination 49-years-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history was none and not had any known allergies. Concomitant medication(s) included acetylsalicylic acid (ASPRIN) child asprin, cetirizine hydrochloride (ZYRTEC ALLERGY), caffeine, paracetamol (EXCEDRIN ASPIRIN FREE) and diphenhydramine hydrochloride, paracetamol (TYLENOL PM). Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09May2021, patient had a period lasted from 09May2021 to 17May2021. It was reported that the patient did not have a period since December 2020 and was always two days, and no longer get periods since before 2021 and have had twice blood flow, and on 10May2021, patient experienced headache, fatigue or tiredness, nausea, and feet cramp. Nausea and tiredness have kept patient away from being able to do my usual workout or other activities. There was no redness/swelling, muscle pain/pain, chills/fever. Patient had a doctor or other healthcare professional office/clinic visit because of event period lasted from 09May2021 to 17May2021. The doctor scheduled an ultrasound but not until 21Jun2021. Patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0187), via an unspecified route of administration, administered in left arm on 24May2021 at 13:15 as dose 2, single for COVID-19 immunization. Patient did not receive any treatment for the events headache, fatigue / tiredness, nausea and feet cramp and it was unknown if received treatment for event period lasted from 09May2021 to 17May2021. Since the vaccination, the patient had not been tested for Covid-19. The outcome of event period lasted from 09May2021 to 17May2021 was unknown, while all the other events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Headache; Fatigue / Tiredness; nausea; feet cramp; no longer get periods since before 2021; The period lasted 09May2021 to 17May2021; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0173), via an unspecified route of administration in left arm on 29Apr2021 at 13:15 (age at vaccination 49-years-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history was none and not had any known allergies. Concomitant medication(s) included acetylsalicylic acid (ASPRIN) child asprin, cetirizine hydrochloride (ZYRTEC ALLERGY), caffeine, paracetamol (EXCEDRIN ASPIRIN FREE) and diphenhydramine hydrochloride, paracetamol (TYLENOL PM). Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09May2021, patient had a period lasted from 09May2021 to 17May2021. It was reported that the patient did not have a period since December 2020 and was always two days, and no longer get periods since before 2021 and have had twice blood flow, and on 10May2021, patient experienced headache, fatigue or tiredness, nausea, and feet cramp. Nausea and tiredness have kept patient away from being able to do my usual workout or other activities. There was no redness/swelling, muscle pain/pain, chills/fever. Patient had a doctor or other healthcare professional office/clinic visit because of event period lasted from 09May2021 to 17May2021. The doctor scheduled an ultrasound but not until 21Jun2021. Patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0187), via an unspecified route of administration, administered in left arm on 24May2021 at 13:15 as dose 2, single for COVID-19 immunization. Patient did not receive any treatment for the events headache, fatigue / tiredness, nausea and feet cramp and it was unknown if received treatment for event period lasted from 09May2021 to 17May2021. Since the vaccination, the patient had not been tested for Covid-19. The outcome of event period lasted from 09May2021 to 17May2021 was unknown, while all the other events were not recovered.  Follow-up attempts completed. No further information expected.