chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Last period was March 14th; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included none and received concomitant medication (not specified). The patient received unspecified allergy and anxiety medications within two weeks of vaccination. The patient's last menstrual period was 14Mar2021. 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 an unknown date in Apr2021, the patient experienced delayed period since it was reported that her last period was on 14Mar2021. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had no allergies to medications, food, or other products. The clinical outcome of the event delayed period was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache
Clinical narrative: Constant headaches; Chest Pain; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 03:00, the patient had constant headaches daily and recently chest pain. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient didn't receive treatment for events. The clinical outcome of the events constant headaches and chest pain was not resolved at the time of this report.   No follow-up attempts are possible, information about batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: added information that patient didn't receive treatment for events.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeding disorder, Malaise, Nausea, Pain in extremity
Clinical narrative: her arm was sore/sore arm; feeling a little queasy; it took her appetite away; the nausea she didn't eat; the nausea she didn't eat; feeling unwell (queasiness); This is a spontaneous report from a contactable consumer or other non HCP (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced her arm was sore/sore arm, feeling a little queasy, it took her appetite away, the nausea she didn't eat, feeling unwell (queasiness). Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on Wednesday. On Thursday and Friday her arm was sore, then patient felt alright. On Sunday patient started feeling a little queasy, this sensation comes for 2 or 3 minutes and the goes away, in the middle of the night patient woke up and felt queasy, it took her appetite away, patient laid down and fall asleep (Patient stated that she didn't lose her appetite but because of the nausea she didn't eat). Patient felt the same way yesterday and today. Patient read in the paper the list of side-effects, patient describes her symptoms as nausea and feeling unwell (queasiness), patient would like to know if this could be related to the vaccine. Patient would like to know if someone can have side-effects from the vaccine after 3 or 4 days or if they come right after. Patient stated that she went and took the Pfizer vaccine shot on Wednesday and her arm was sore the next couple of days. Stated that she was alright. Stated that this is the third day. Stated that for the past couple of days that she was queasy. Stated that she that she decided to read the side effects and one was feeling unwell and nausea. Stated that it was like she was feeling unwell and a little queasy but patient did not put the two together with the shot. Stated that she still does not know if it is connected to shot. Stated that yesterday was the second day and she felt like that last night. Wanted to know if this is a side effect of the shot. Stated that she got shot on Wednesday and wanted to know if she can have side effects four days later. Is Pfizer Covid 19 vaccination shot. Stated that she was in the hospital prior to the shot. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dry mouth, Dysgeusia, Dyspnoea
Clinical narrative: Right side partial facial numbness; Right arm pins and needles (whole arm); Severe dry mouth; Metallic taste; Nausea; Diarrhea; Headache; Chest pain; Difficulty breathing; ear pressure in right ear; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER 8763), via an unspecified route of administration in left arm on 22Apr2021 at 13:15 (at the age of 29-year-old) at single dose for COVID-19 immunisation. Medical history included endometriosis and prior to the vaccination, the patient was diagnosed with COVID-19. Patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC), acetylsalicylic acid (BABY ASPIRIN) and pseudoephedrine hydrochloride (SUDAFED). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 13:45, the patient experienced right side partial facial numbness, right arm pins and needles (whole arm), severe dry mouth, metallic taste, nausea, diarrhea, headache, chest pain, difficulty breathing, ear pressure in right ear. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events included prednisone 40 mg for five days. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: lab data was removed as no relevant information reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Right side partial facial numbness; Right arm pins and needles (whole arm); Severe dry mouth; Metallic taste; Nausea; Diarrhea; Headache; Chest pain; Difficulty breathing; ear pressure in right ear; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER 8763), via an unspecified route of administration in left arm on 22Apr2021 at 13:15 (at the age of 29-year-old) at single dose for COVID-19 immunisation. Medical history included endometriosis and prior to the vaccination, the patient was diagnosed with COVID-19. Patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC), acetylsalicylic acid (BABY ASPIRIN) and pseudoephedrine hydrochloride (SUDAFED). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 13:45, the patient experienced right side partial facial numbness, right arm pins and needles (whole arm), severe dry mouth, metallic taste, nausea, diarrhea, headache, chest pain, difficulty breathing, ear pressure in right ear. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events included prednisone 40 mg for five days. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: lab data was removed as no relevant information reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; chills; achiness; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EN6206), dose 2 intramuscular, administered in left arm on 16Mar2021 (at the age of 50-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL8982) as dose 1, single intramuscular, administered in left arm on 23Feb2021 at 11:00AM for COVID-19 immunization. Patient experienced wheezy. The patient medical and concomitant medication history were reported. No prior vaccination within 4 weeks. Patient had an allergic reaction to both doses-with 2 hours of vaccine. Vaccine facility type at hospital. On 06Mar2021, the patient experienced fever, chills and achiness on an unspecified date for 36 hours. Seriousness criteria-not serious. Patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 08Feb2021. The event require the initiation of new medication/other treatment/procedure reported as no. The outcome of the events were recovered on 2021.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Oral herpes, Pain
Clinical narrative: Cold sore formed on lip; Body ache; Developed chills; Fever (up to 102.8 degrees F); A very bad headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164), via an unspecified route of administration in the left arm on 25Apr2021 at 15:15 (at the age of 45-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient had no medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in left arm on 04Apr2021 at 15:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. 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. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 at 04:00, about 12 hours after the second vaccination, the patient experienced chills, followed by fever (up to 102.8 Fahrenheit), a very bad headache and body ache which lasted for about 30 hours. On 27Apr2021, the patient experienced a cold sore formed on her lip which was almost healed by 04May2021, and later another cold sore appeared. Therapeutic measure was taken as the result of chills, fever, headache, general body pain and cold sore lip which included paracetamol (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of chills, fever, headache, general body pain were recovered on 27Apr2021 at 10:00 and cold sore lip was recovering.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information included: Fahrenheit captured as unite for Body temperature. The patient experienced cold sores lip updated to the patient experienced a cold sore formed on her lip in narrative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care added in narrative.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Cold sore formed on lip; Body ache; Developed chills; Fever (up to 102.8 degrees F); A very bad headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164), via an unspecified route of administration in the left arm on 25Apr2021 at 15:15 (at the age of 45-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient had no medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in left arm on 04Apr2021 at 15:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. 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. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 at 04:00, about 12 hours after the second vaccination, the patient experienced chills, followed by fever (up to 102.8 Fahrenheit), a very bad headache and body ache which lasted for about 30 hours. On 27Apr2021, the patient experienced a cold sore formed on her lip which was almost healed by 04May2021, and later another cold sore appeared. Therapeutic measure was taken as the result of chills, fever, headache, general body pain and cold sore lip which included paracetamol (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of chills, fever, headache, general body pain were recovered on 27Apr2021 at 10:00 and cold sore lip was recovering.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information included: Fahrenheit captured as unite for Body temperature. The patient experienced cold sores lip updated to the patient experienced a cold sore formed on her lip in narrative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care added in narrative.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Very sore arm; Fatigue; This is a spontaneous report from a contactable pharmacist. This report was received via a company representative. A 25-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), intramuscularly on 26Mar2021 (at the age of 25-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 26Mar2021, the patient experienced very sore arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The clinical outcome of the events very sore arm and fatigue was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: events details added (no treatment was received).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore on top lip of mouth; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Apr2021 at 14:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Patient had no known allergies. Patient did not take any concomitant medications. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, at 09:00 the patient experienced cold sore on top lip of mouth. Patient has not had a cold sore in over 15 or more years. That was continuing to worsen hence patient was applying NEXCARE. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included applying NEXCARE. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold sore on top lip of mouth was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Large itchy rash covering torso, chest; Arm and legs hives; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female 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 15Apr2021 at 12:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 23Apr2021 at 19:00, the patient experienced large itchy rash covering torso, chest and some hives on arms and legs. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with antihistamines (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large itchy rash covering torso, chest and some hives on arms and legs was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: On 04/29, 9 days after shot, my left arm suddenly swelled.; Experiencing light pain, itching and swelling around the injection site.; Experiencing light pain, itching and swelling around the injection site.; Experiencing light pain, itching and swelling around the injection site.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 13:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included ascorbic acid (VITAMIN C) taken from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 08:00, nine days after shot, the patients left arm suddenly swelled. The patient was also experiencing light pain, itching and swelling around the injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events on 29Apr2021 at 08:00, nine days after shot, left arm suddenly swelled; experiencing light pain, itching and swelling around the injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Paraesthesia, Pruritus, Skin burning sensation
Clinical narrative: Burning skin; Itchy skin; Crawly feelings like bugs crawling all over; Sometimes pins and needles; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm right on 05Apr2021 at 11:45(at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's antibodies (no medications) and blood pressure. Concomitant medications included methrochlorize (MANUFACTURER UNKNOWN) started on an unknown date for blood pressure. The patient was known allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 10:00, the patient had burning skin, itchy skin, crawly feelings like bugs crawling all over, sometimes pins and needles. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of burning skin, itchy skin, crawly feelings like bugs crawling all over, sometimes pins and needles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia, Pain in extremity
Clinical narrative: Terrible arm pain 9 days after the vaccine.; I could move, it was very painful like arm nerves were squeezing; "I wet to the doctor a diagnostic shingles"; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 14Apr2021 at 09:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks of the COVID-19 vaccination. On 24Apr2021 at 03:00, the patient experienced a terrible arm pain 9 days after the vaccine. The patient "could move, it was very painful and like arm nerves were squeezing". The patient "wet to the doctor a diagnostic shingles". The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events terrible arm pain 9 days after the vaccine, "could move, it was very painful and like arm nerves were squeezing" and "wet to the doctor a diagnostic shingles" was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is excepted.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: I am feeling a little bit of numbness; This is a spontaneous report from a contactable consumer, the patient. An adult (20s) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0172), via an unspecified route of administration in upper arm left on 29Apr2021 as dose number unknown, single for covid-19 immunization. The patient had no medical history. The concomitant medications were not reported. The patient experienced a little bit of numbness on 29Apr2021. The patient did not receive any treatment for the event. The outcome of the event was unknown.  No follow-up attempts were needed. No further information was expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash, Rash erythematous, Swelling
Clinical narrative: Red rash between breasts, on the left side of my left breast; Red rash around the sides of my neck; Painful large swelling in area of underarm; Painful large swelling in area left breast; Not just slightly enlarged lymph node; But the tissue of my underarm is swollen; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 14:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic rash and swelling (got tested but they couldn't determine the cause) from 2015 and unknown if ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Ibuprofen (ADVIL), taken for an unknown indication from an unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 14:45 (at the age of 50-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 vaccine. On 28Apr2021 the patient experienced red rash between breasts, around the sides of the neck, on the left side of the left breast, painful large swelling in area of underarm and left breast. Not just slightly enlarged lymph node, but the tissue of the underarm was swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red rash between breasts, around the sides of the neck, on the left side of the left breast, painful large swelling in area of underarm and left breast, slightly enlarged lymph node and swollen tissue of the underarm was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; Slight chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 26Apr2021 at 17:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included calcium citrate (CALCIUM), iron (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 12:30, the patient experienced headache, slight chills and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, slight chills and fever was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: started spotting two days after the second shot; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0164) via an unspecified route of administration in the left arm on 26Apr2021 at 11:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 11:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 01:00, two days after the second shot, the patient experienced spotting. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event spotting was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Pregnancy test, Weight increased
Clinical narrative: it feels numb to her on the inside but she has pain at the same time; it feels numb to her on the inside but she has pain at the same time; she gained 20 pounds/usually stays at 135 pounds and got her Pfizer COVID Vaccine 1st dose on 25Mar2021 and 2nd dose on 16Apr2021 and she is now 153; This is a spontaneous report from a contactable consumer. A 31-year-old female consumer(patient) reported for herself.  A 31-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW1051, Expiration date: unknown), via unspecified route, administered in left arm on 16Apr2021 between 11:00am-11:30am (at the age of 31-year-old) as dose 2, single for COVID-19 immunization. Patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: ER8733, Expiration date: unknown), via unspecified route, administered in left arm on 25Mar2021 (at the age of 31-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  No vaccinations prior 4 weeks of vaccinations. On an unspecified date in Apr2021, after the vaccination, the patient experienced her right leg was felt like it is going to sleep and that happened about 4 days after the 2nd dose. Patient states she can stomp her leg and it kind of feels like painful but almost numb and she can feel it at the same time, and it feels numb to her on the inside, but she was in pain at the same time, and she can feel it when she pushes on her leg and her leg is almost asleep and it is a numbing pain of not waking up. states she has never had back or orthopaedic problems before this and takes no medications and does not go to the doctor unless she is sick or for her yearly check-up and is on no medicine. Patient was asking if this is normal and states she doesn't feel like her leg is going limp or she is losing control of her leg and it was going to sleep and won't wake up good. Caller states she gained 20 pounds and does not know why and usually stays at 135 pounds and got her Pfizer COVID Vaccine 1st dose on 25Mar2021 and 2nd dose on 16Apr2021 and she is now 153 pounds. Patient lab data includes pregnancy tests which was negative for three pregnancy tests she has done at morning noon and night and was not pregnant. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, Blood pressure abnormal, Blood pressure measurement, Body temperature
Clinical narrative: deep red bruise directly behind my left lower rib/ the bruise was mildly painful to the touch; 3days after the second injection I developed a fever of 101.; blood pressure and blood sugars are not as well controlled; blood pressure and blood sugars are not as well controlled; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 26Mar2021 at 15:45 (at the age of 58-years-old) in left arm as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, covid-19, hypertension, allergy to Tamiflu and mushrooms all from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included metformin hydrochloride (METFORMIN ER); glimepiride (GLIMEPIRIDE) and Irbursar all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Batch/Lot number: unknown) on 05Mar2021 at 16:15 (at the age of 58-years-old) in left arm for covid-19 immunization. On 29Mar2021, 3days after the second injection the patient developed fever of 101. He took a dose of Tylenol and it went away. One week after the second dose on 05Apr2021 at 13:30, she noticed a deep red bruise directly behind her left lower rib, it was about 5 cm. She called her doctor and went in the following week to see the MD. She was told to watch the bruise and call back if it did not subside. The following week the bruise began to dissipate. The bruise was mildly painful to the touch and she had not suffered any injuries causing the bruise. Since the vaccination, her blood pressure and blood sugar were not as well controlled. She had been switched to amlodipine 7.5mg. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood glucose and blood pressure measurement: not as well controlled on an unknown date in 2021, body temperature: 101 on 29Mar2021. The outcome of the event bruise was recovered in Apr2021 and all other events were resolved in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pyrexia
Clinical narrative: deep red bruise directly behind my left lower rib/ the bruise was mildly painful to the touch; 3days after the second injection I developed a fever of 101.; blood pressure and blood sugars are not as well controlled; blood pressure and blood sugars are not as well controlled; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 26Mar2021 at 15:45 (at the age of 58-years-old) in left arm as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, covid-19, hypertension, allergy to Tamiflu and mushrooms all from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included metformin hydrochloride (METFORMIN ER); glimepiride (GLIMEPIRIDE) and Irbursar all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Batch/Lot number: unknown) on 05Mar2021 at 16:15 (at the age of 58-years-old) in left arm for covid-19 immunization. On 29Mar2021, 3days after the second injection the patient developed fever of 101. He took a dose of Tylenol and it went away. One week after the second dose on 05Apr2021 at 13:30, she noticed a deep red bruise directly behind her left lower rib, it was about 5 cm. She called her doctor and went in the following week to see the MD. She was told to watch the bruise and call back if it did not subside. The following week the bruise began to dissipate. The bruise was mildly painful to the touch and she had not suffered any injuries causing the bruise. Since the vaccination, her blood pressure and blood sugar were not as well controlled. She had been switched to amlodipine 7.5mg. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood glucose and blood pressure measurement: not as well controlled on an unknown date in 2021, body temperature: 101 on 29Mar2021. The outcome of the event bruise was recovered in Apr2021 and all other events were resolved in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever; Body ache; Fatigue; Nausea; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 16:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Apr2021, the patient experienced fever, body ache, fatigue, nausea and vomiting. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events fever, body ache, fatigue, nausea and vomiting were unknown at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspepsia, Pain
Clinical narrative: uncomfortable; heart stinging/dull stinging sensation; Now a few hours later it feels like I have heart burn; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0169 and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 28Apr2021 13:30 (at the age of 23-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0158 and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:30 (at the age of 23-years-old) as dose 1, single dose for covid-19 immunization. The patient had known allergies with augmentin. Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination, has the patient has not been tested for COVID-19. On 28Apr2021 13:30, on the day of vaccination, when injected patient started to feel heart stinging for around a minute after shot. It was a dull stinging sensation so she wasn't in severe pain, it felt more uncomfortable but it went away shortly after. Now a few hours later it feels like she has heart burn. She wasn't sure if it was related to something she ate with first shot and being anxious, but realize these side effect were definitely caused from shot after receiving second dose. AE not resulted in Physician visit/ER visit. No treatment taken for reported events. The outcome of all the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: felt fatigued on the day after dosing; Moderate pain at the injection site; mild headache several hours after vaccine administration; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0165) via an unspecified route of administration in the left arm on 28Apr2021 at 12:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and asthma. The patient had known allergies to environmental, pet dander, and wasp. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), budesonide, formoterol fumarate (SYMBICORT), salbutamol (ALBUTEROL), fexofenadine hydrochloride (ALLEGRA), fish oil (MANUFACTURER UNKNOWN) and unspecified multivitamin; all taken for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the right arm on 07Apr2021 at 12:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 28Apr2021 at 20:00, the patient experienced moderate pain at the injection site on the day of dosing increasing towards the evening, still sore in the morning (24 hr after dosing) but improved throughout the day after dosing. Also developed a mild headache several hours after vaccine administration, but gone by the next morning. On 29Apr2021, the patient felt fatigued on the day after dosing, but started to improve towards the evening. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with EXCEDRIN and ALEVE. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events moderate pain at the injection site and felt fatigued on the day after dosing were recovering at the time of this report while the clinical outcome of the event mild headache several hours after vaccine administration was recovered on 29Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Vertigo; numb and tingling lips; numb and tingling lips; headache; chills; fever 101; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 64 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injec-tion; Lot Number: ER8732) via an unspecified route of administration, administered in Left Arm on 27Mar2021 at 15:00 (64-year-old at vaccination) as dose 2, single for COVID-19 immunization. The patient was non-pregnant at vaccination. The patient's medical history included hypothyroidism, eczema, psoriasis, shellfish allergy, known allergies to IV contrast. Past drug included Celclor, Doxycycline, patient was allergic to both the past drugs. The patient's concomitant medication(s) included levothyroxine sodium; amitriptyline; ALLEGRA; ADVIL. Facility where the most recent COVID-19 vaccine was administered was reported at facility. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Left Arm on 06Mar2021 at 15:00 (64-year-old at vaccination) as dose 1, single for covid-19 immunization. On 27Mar2021, the patient experienced numb and tingling lips, headache, chills, fever 101, and all resolved after 1 day, vertigo lasted 5 days and had returned on 28Apr2021. The patient underwent lab tests and procedures which included body temperature of 101 on 27Mar2021. The patient had not received any treatment medication for the resulted events. Device date was reported as 28Apr2021. The outcome 2nd occurrence of vertigo was unknown, while outcome of other events was recovered on 28Apr2021.  No follow-up attempts are needed. No further information was expected.