chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Pyrexia
Clinical narrative: Strong metallic taste; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02May2021 at 17:00 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to salmon. 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 included unspecified anti-depressants and  Attention Deficit Hyperactive Disorder (ADHD) medications from unknown dates for unknown indications. The patient previously received lamotrigine (LAMICTAL) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Apr2021 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. On 03May2021, the patient experienced fever. On 04May2021, the patient had strong metallic taste (also reported as since as of today 11 days) which did not go away with tooth brushing or gum. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever and strong metallic taste was unknown at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vaccination site dryness, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchy skin around the site; dry skin around the site; Itchy with dry skin around the site with a bit of redness; Warm to touch; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0128) via an unspecified route of administration in the left arm on 11May2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumothorax on both lungs at different times about 28-years ago and pollen allergy. 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 COVID vaccine. Concomitant medications included lysine hydrochloride (L-LYSINE), cetirizine hydrochloride (WAL ZYR) and multivitamins; all for unspecified indication and start date. On 11May2021 at 15:30, the patient experienced itchy with dry skin around the site with a bit of redness and warm to touch. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and 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 itchy with dry skin around the site with a bit of redness and warm to touch was not resolved at the time of this report.  No follow-up attempts are needed; No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Mild muscle and joint aches; Mild muscle and joint aches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received the second 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 14:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included celiac disease. The patient did not have any allergies to food, medications, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified birth control medication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 25Mar2021 at 14:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. On 16Apr2021 at 08:00, the patient experienced mild muscle and joint aches starting the morning after receiving the vaccine, which lasted until mid-day. 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 visit. Therapeutic measures were taken as a result of events mild muscle and joint aches which included treatment with ibuprofen. The clinical outcome of the events mild muscle and joint aches was recovered on 16Apr2021, until mid-day.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on entire back, which I noticed around 6 p.m the next day; Rash on upper left arm within two hours of vaccine; Slightly itchy but not too uncomfortable.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 11May2021 at 12:00(at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. 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: EW0162) via an unspecified route of administration in the left arm on 20Apr2021 at 11:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 14:00, within two hours of vaccine, the patient experienced rash on upper left arm and on 12May2021 around 18:00, patient noticed rash on entire back. The rash was slightly itchy but not too uncomfortable. 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 event rash on upper left arm within two hours of vaccine and rash on entire back and slightly itchy but not too uncomfortable were recovering 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: Fatigue, Feeling cold, Irritability, Menstruation normal
Clinical narrative: Extreme exhaustion; irritability; menstrual bleeding; cold body that I am unable to warm up; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 44-years-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 04Mar2021 17:30 (at the age of 44 years) as single followed by patient took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported) second dose via an unspecified route of administration, administered in Arm Left on 25Mar2021 17:30 single for covid-19 immunization. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin aspart (NOVOLOG), atorvastatin calcium, sertraline hydrochloride (ZOLOFT), aspirin [acetylsalicylic acid] taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 02Apr2021 18:00 the patient experienced extreme exhaustion, irritability, menstrual bleeding, cold body that patient was unable to warm up. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Adverse treatment included Increase of Zoloft until symptoms resolve. The outcome of the events was Not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is slightly sore; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO183) via an unspecified route of administration in the right arm on 13May2021 at 09:30 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 09:45 the patient experienced slightly sore arm, but that was it. 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, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event slightly sore arm was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: I had vaginal bleeding after a week of vaccination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 24-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07May2021 10:30 (at the age of 24 years), (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at clinic. Medical history included no from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no known allergies. 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 13May2021 16:00 the patient experienced, had vaginal bleeding after a week of vaccination. The patient did not receive any treatment for the adverse event. The clinical outcome of the event was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Limb discomfort
Clinical narrative: Chills (no fever); feeling so cold; cant lift arm at all; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13May2021 at 10:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 16:00, the patient experienced chills (no fever), feeling so cold and can't lift arm at all. 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 events and included treatment with ibuprofen. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event chills (no fever), feeling so cold and can't lift arm at all was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Slight numbness in left ear/slight numbness of left eyebrow area; Numbness in neck along left side; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 12May2021 at 11:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. 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. Concomitant medication included tramadol (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 21Apr2021 at 11:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. On 12May2021 at 12:00, within 30 minutes of vaccination, the patient experienced a slight numbness in left ear which was similar to the feeling of procaine hydrochloride (NOVOCAINE) injection but only very slight numbness. Later that day, the patient felt a similar numbness in neck along left side and later still felt a slight numbness of left eyebrow area. It dissipated by evening and did not return. 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. Therapeutic measures were not taken as a result of the events.  The clinical outcome of the events slight numbness in left ear/slight numbness of left eyebrow area and numbness in neck along left side were resolved on 12May2021.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 09:30 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Allergies to medications, food or other products was reported as not that the patient knows of. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 09:30 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 07:00, the patient experienced innumerable petechiae on torso, arms and legs. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event innumerable petichiae on torso, arms and legs was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, SARS-CoV-2 test
Clinical narrative: Feel fatigued; Bit hot; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0161) via an unspecified route of administration in the left arm on 13May2021 at 08:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. It was reported that patient did not know if he had any medical history or known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 (reported as no). On 03Dec2020, the patient underwent test COVID-19 test and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0153) via an unspecified route of administration in the left arm on 22Apr2021 at 08:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 13May2021 at 22:00, (reported as 15 hours) after the second dose of vaccine the patient felt fatigued and a bit hot. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19 (reported as yes). Therapeutic measures were not taken as a result of the events. The clinical outcome of the event felt fatigued and a bit hot was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Euphoric mood
Clinical narrative: A  state of calm euphoria, roughly comparable to having a raised level of Serotonin. Felt wonderful and relaxful.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Evel82) via an unspecified route of administration in the left arm on 12May2021 at 18:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history and known allergies were reported as NA. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 12May2021 at 20:30, the patient experienced ''a state of calm euphoria, roughly comparable to having a raised level of serotonin felt wonderful and relaxful.'' This was an unusual reaction so patient wanted to note this formally. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event '' a state of calm euphoria, roughly comparable to having a raised level of serotonin felt wonderful and relaxful'' was recovered with sequelae on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Heart rate, Heart rate decreased, Migraine
Clinical narrative: After 30hrs severe migraine; chest rash; vomiting; diarrhea; low-heart rate; dizziness; blurry vision; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 41-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration, administered in Arm Left on 11May2021 17:15 (Batch/Lot number and Expiry date was not reported) (at the age of 41-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient previously took tramadol and experienced allergy. The patient did not receive any other vaccine within 4 weeks of covid vaccine. The patient did not receive any medication within 2 weeks of covid vaccine. The patient did not have covid prior vaccination and was not tested for covid post vaccination. On 12May2021 18:00, the patient experienced after 30hrs severe migraine, chest rash, vomiting, diarrhea, dizziness and blurry vision. Laboratory tests on 12May2021 included heart rate: low. The events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if any treatment was received for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vision blurred, Vomiting
Clinical narrative: After 30hrs severe migraine; chest rash; vomiting; diarrhea; low-heart rate; dizziness; blurry vision; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 41-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration, administered in Arm Left on 11May2021 17:15 (Batch/Lot number and Expiry date was not reported) (at the age of 41-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient previously took tramadol and experienced allergy. The patient did not receive any other vaccine within 4 weeks of covid vaccine. The patient did not receive any medication within 2 weeks of covid vaccine. The patient did not have covid prior vaccination and was not tested for covid post vaccination. On 12May2021 18:00, the patient experienced after 30hrs severe migraine, chest rash, vomiting, diarrhea, dizziness and blurry vision. Laboratory tests on 12May2021 included heart rate: low. The events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if any treatment was received for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia
Clinical narrative: Excessive joint pain; Overall weakness; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 01Apr2021 at 17:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant past medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 11Mar2021 at 17:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced excessive joint pain and overall weakness. 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 excessive joint pain and overall weakness 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 expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Right arm sore; mild flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 13May2021 at 09:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On 13May2021 at 13:00, the patient experienced right arm sore and mild flu like symptoms. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events right arm sore and mild flu like symptoms was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Vaginal haemorrhage
Clinical narrative: I am breastfeeding and am postpartum; I am breastfeeding and am postpartum; I had vaginal bleeding, otherwise known as my period.  It lasted for four days and has not returned since April 10th.; This is a spontaneous report from a contactable consumer, the patient. A 35-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 left arm on 31Mar2021 at 19:30 (at the age of 35-years-old) as DOSE 2, SINGLE and also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 10Mar2021 at 12:30 as DOSE1, SINGLE for COVID-19 immunisation. Medical history reported as none. Concomitant medications included post-natal vitamins (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021, at 12:00 after receiving the second dose of vaccine the patient had vaginal bleeding, otherwise known as period, strange thing about this was that patient was breastfeeding and postpartum as of January 1, 2021. It lasted for four days and has not returned since April 10th. No therapeutic measures were taken as a result of reported 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 for the events were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021547027 Mother/Baby case
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling in arm, shoulder, and neck.; This is a spontaneous report from a contactable consumer. An elderly, non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient's medical history and allergies were unknown. It was unknown if prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any medication within two weeks of vaccination. It was unknown if the patient received any other vaccine within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced swelling in arm, shoulder and neck. It was unknown if since the vaccination, the patient had been tested for COVID-19. It was unknown if patient received any treatment for the events. The clinical outcome of the event swelling in arm, pain in neck and pain in shoulder was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Asthenia, Dyspnoea, Headache
Clinical narrative: Felt progressively weaker; Disturbing dreams; Neck pain; Shoulder pain; Intermittent cramps; Spotting; Terrible headache; Trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EW0164) via an unspecified route of administration, administered in Arm Left on 21Apr2021 08:15 (age at vaccination 38-years-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included melatonin (MANFACTURER UNKNOWN); ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 21:30, after the first vaccine, the patient felt progressively weaker over the course of 2 weeks which ended with terrible headache and trouble breathing on an unknown date in 2021. On an unknown date in Apr2021, the patient had disturbing dreams, neck and shoulder pain for approx. 1 week after first shot. On an unknown date in 2021, the patient also had intermittent cramps not part of menstrual cycle and spotting which the patient doesn't normally had since the patient had been on birth control. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0179) via an unspecified route of administration in the left arm on12May2021 at 09:00 (at the age of 38-years-old) as a single dose for COVID-19 immunization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05May2021. The clinical outcome of the events was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neck pain, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Felt progressively weaker; Disturbing dreams; Neck pain; Shoulder pain; Intermittent cramps; Spotting; Terrible headache; Trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EW0164) via an unspecified route of administration, administered in Arm Left on 21Apr2021 08:15 (age at vaccination 38-years-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included melatonin (MANFACTURER UNKNOWN); ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 21:30, after the first vaccine, the patient felt progressively weaker over the course of 2 weeks which ended with terrible headache and trouble breathing on an unknown date in 2021. On an unknown date in Apr2021, the patient had disturbing dreams, neck and shoulder pain for approx. 1 week after first shot. On an unknown date in 2021, the patient also had intermittent cramps not part of menstrual cycle and spotting which the patient doesn't normally had since the patient had been on birth control. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0179) via an unspecified route of administration in the left arm on12May2021 at 09:00 (at the age of 38-years-old) as a single dose for COVID-19 immunization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05May2021. The clinical outcome of the events was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Breast mass, Breast pain, Breast swelling, Breast tenderness
Clinical narrative: lump developed in my left breast/abnormal breast tissue forming.; left breast became very swollen and painful; left breast became very swollen and painful; felt very weak; tired; tenderness in my left breast; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: el 9266), via an unspecified route of administration in arm left on 16Mar2021 at 08:30 (at the age of 69-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included COPD and irregular heart rate. The patient's concomitant medications received within 2 weeks of vaccination included Tadalafil, simvastatin (ZOCOR), carvedilol (COREG), amlodipine, mirabegron (MYRBETRIQ) and spiq. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: el9266), via unspecified route of administration in arm left on 23Feb2021 at 08:30 (at the age of 69-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, 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, has the patient been tested for COVID-19 was reported as no. About 3 weeks after second shot felt very weak and tired. Then started to have tenderness in her left breast. Around 01May2021, left breast became very swollen and painful, then a lump developed in her left breast. The doctor had a mammogram and ultrasound done. It was determined that, it was abnormal breast tissue forming. She scheduled a preop with a surgeon in the next few weeks. On 14May2021, the tenderness and lump started to reside, today Sunday on 16May2021, the lump was 95% smaller that last week, the swelling was gone and only have a very small amount of tenderness. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events was not reported. On an unspecified date in Apr2021, the patient underwent lab tests and procedures which included mammogram, resulted as abnormal breast tissue forming and Ultrasound, resulted as abnormal breast tissue forming. The device date was on 16May2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Mammogram, Ultrasound Doppler
Clinical narrative: lump developed in my left breast/abnormal breast tissue forming.; left breast became very swollen and painful; left breast became very swollen and painful; felt very weak; tired; tenderness in my left breast; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: el 9266), via an unspecified route of administration in arm left on 16Mar2021 at 08:30 (at the age of 69-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included COPD and irregular heart rate. The patient's concomitant medications received within 2 weeks of vaccination included Tadalafil, simvastatin (ZOCOR), carvedilol (COREG), amlodipine, mirabegron (MYRBETRIQ) and spiq. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: el9266), via unspecified route of administration in arm left on 23Feb2021 at 08:30 (at the age of 69-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, 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, has the patient been tested for COVID-19 was reported as no. About 3 weeks after second shot felt very weak and tired. Then started to have tenderness in her left breast. Around 01May2021, left breast became very swollen and painful, then a lump developed in her left breast. The doctor had a mammogram and ultrasound done. It was determined that, it was abnormal breast tissue forming. She scheduled a preop with a surgeon in the next few weeks. On 14May2021, the tenderness and lump started to reside, today Sunday on 16May2021, the lump was 95% smaller that last week, the swelling was gone and only have a very small amount of tenderness. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events was not reported. On an unspecified date in Apr2021, the patient underwent lab tests and procedures which included mammogram, resulted as abnormal breast tissue forming and Ultrasound, resulted as abnormal breast tissue forming. The device date was on 16May2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pain in extremity
Clinical narrative: Arm redness; Arm redness/pain; Arm redness/pain/burning; This is a spontaneous report from a contactable other healthcare professional (Nurse). A 41-year-old male patient received 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 (at the age of 41-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm redness/pain/burning on an unspecified date. Seriousness of the events was reported as non-serious. The outcome of events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Information about lot/batch number cannot be obtained. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Abdominal pain upper, Headache
Clinical narrative: lower stomach pain; lower intestinal pain; a slight headache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on the right arm on 27Feb2021 at 11:30 (Lot Number: 6203) at the age of 74-year-old as single dose for COVID-19 immunization. Medical history included iliac artery blockage, partial arterial blockages and excess salt, salt craving, high cholesterol, blood pressure, diabetes 2, diverticulitis and chronic obstructive pulmonary disease (COPD), all from an unknown duration. The patient not had any known allergies. 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. Concomitant medications included clopidogrel (manufacturer unknown), Irbesartan (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), metformin (manufacturer unknown), fluvastatin (manufacturer unknown), ezetimibe (manufacturer unknown), Tamsulosin (manufacturer unknown), ibuprofen (manufacturer unknown), acetylsalicylic acid (ASPIRIN BAYER), vitamin d nos (manufacturer unknown) and fluticasone (manufacturer unknown), all were taken for an unknown indication and within two weeks of the vaccination. On 27Feb2021 probably around 11:30, after the first shot on the ride home, the patient developed a slight headache, that disappeared the next day. The patient was not sure when but prior to the second shot, in Mar2021, the patient experienced lower stomach and lower intestinal pain for about 2 days, and then it disappeared. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The outcome of headache was recovered on 28Feb2021. The outcome of Pain stomach was recovered in 2021. The outcome of Lower abdominal pain was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Pain, Pruritus
Clinical narrative: Fever 102 F; chills; body aches; joint pain; morbilliform rash on abdomen, chest and neck; generalized pruritus; This is a spontaneous report from a non-contactable female consumer (patient). A 49-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8737, Expiration date: Not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 10:00 (at the age of 49-years-old) as a DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included arthritis. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6204), dose 1 via an unspecified route of administration, administered in Arm Left 15Mar2021 at 10:00 AM, (at the age of 49-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 06Apr2021 14:00, The patient experienced fever 102 f, chills, body aches, joint pain, morbilliform rash on abdomen, chest and neck, generalized pruritus. The patient had Fever 102 F lasted from 2 am to 7 pm and would not subside with ibuprofen or acetaminophen, chills, body aches, joint pain (specially ankles), morbilliform rash on abdomen, chest and neck, generalized pruritus. All symptoms subsided at day 3 post vaccination. The patient underwent lab tests and procedures which included body temperature that was 102 Fahrenheit on 06Apr2021. The report was Non-serious. Device Date was reported as 22May2021. No treatment was received for the event. Outcome of the events were recovered.  No follow up attempts are possible. No further information is expected. Since non contactable reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Fever 102 F; chills; body aches; joint pain; morbilliform rash on abdomen, chest and neck; generalized pruritus; This is a spontaneous report from a non-contactable female consumer (patient). A 49-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8737, Expiration date: Not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 10:00 (at the age of 49-years-old) as a DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included arthritis. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6204), dose 1 via an unspecified route of administration, administered in Arm Left 15Mar2021 at 10:00 AM, (at the age of 49-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 06Apr2021 14:00, The patient experienced fever 102 f, chills, body aches, joint pain, morbilliform rash on abdomen, chest and neck, generalized pruritus. The patient had Fever 102 F lasted from 2 am to 7 pm and would not subside with ibuprofen or acetaminophen, chills, body aches, joint pain (specially ankles), morbilliform rash on abdomen, chest and neck, generalized pruritus. All symptoms subsided at day 3 post vaccination. The patient underwent lab tests and procedures which included body temperature that was 102 Fahrenheit on 06Apr2021. The report was Non-serious. Device Date was reported as 22May2021. No treatment was received for the event. Outcome of the events were recovered.  No follow up attempts are possible. No further information is expected. Since non contactable reporter.