chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Higher than normal blood pressure; This is a spontaneous report from a contactable consumer, the patient. This 89 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1 , single dose via an unspecified route of administration in the right arm on 21Jan2021 at 12:00 PM (at the age of 89 years-old) for COVID-19 vaccination. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history was unknown. Concomitant medications were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced higher than normal blood pressure. The event, higher than normal blood pressure was reported as non-serious. There was no treatment received for the event. The clinical outcome of higher than normal blood pressure was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left axillary lymphadenopathy; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1686/expiration date: not provided), via intramuscular route of administration, on an unknown date as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient previously received the first dose of BNT162B2 (lot number EH9899) on an unknown date for COVID-19 immunization. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021, the patient experienced left axillary lymphadenopathy. The patient did not receive any treatment for the event. The event left axillary lymphadenopathy was assessed as non-serious. The outcome of the event left axillary lymphadenopathy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: severe arm pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 09:45 at single dose for Covid-19 immunization. Medical history included high blood pressure; thyroid disease; high cholesterol; prior stroke; prior to vaccination, the patient was diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced severe arm pain and fever on 20Jan2021 14:30. No treatment received for the adverse events. This is a non-serious report. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: experiencing some mid-axillary pain radiating to my breast on the injection site arm; Low grade fever; This is a spontaneous report from a contactable nurse.  A 44-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EK4176) vaccine  , via an unspecified route of administration  on 19Jan2021 at 0.3 mL, single for covid-19 immunisation .  Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing.  Concomitant medication included omeprazole (OMEPRAZOLE).  On 29Dec2020, the patient received the first dose of BNT162B2 vaccine without any problem. The patient experienced  some mid-axillary pain radiating to the breast on the injection site arm and low grade fever  on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: low grade   on unknown date.   The reported events were considered non serious. The patient received treatment with Tylenol.  Follow up information has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Injection site pain; Tiredness; Mild headache; Chills; Muscle pain; Severe joint pain; Injection site swelling; Feeling unwell; Swollen lymph nodes, specifically left underarm area; Shortness of breath; Fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 16:45 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. No allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site pain, tiredness, mild headache, muscle pain, chills, severe joint pain, injection site swelling, feeling unwell, swollen lymph nodes, specifically left underarm area, shortness of breath and fast heartbeat on 20Jan2021 14:30. Not received treatment for the adverse events. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in Jan2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Injection site pain; Tiredness; Mild headache; Chills; Muscle pain; Severe joint pain; Injection site swelling; Feeling unwell; Swollen lymph nodes, specifically left underarm area; Shortness of breath; Fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 16:45 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. No allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site pain, tiredness, mild headache, muscle pain, chills, severe joint pain, injection site swelling, feeling unwell, swollen lymph nodes, specifically left underarm area, shortness of breath and fast heartbeat on 20Jan2021 14:30. Not received treatment for the adverse events. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in Jan2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain; Tiredness; Mild headache; Chills; Muscle pain; Severe joint pain; Injection site swelling; Feeling unwell; Swollen lymph nodes, specifically left underarm area; Shortness of breath; Fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 16:45 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. No allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site pain, tiredness, mild headache, muscle pain, chills, severe joint pain, injection site swelling, feeling unwell, swollen lymph nodes, specifically left underarm area, shortness of breath and fast heartbeat on 20Jan2021 14:30. Not received treatment for the adverse events. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in Jan2021.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Migraine
Clinical narrative: migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; This is a spontaneous report from a contactable 57-year-old male other health care professional reported for himself. A 57-years-old male patient started to receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration at Left arm on 07Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included pinched nerve in left leg and kidney stones (recovered). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) Intramuscular at Left arm on 17Dec2020 04:00 PM for covid-19 immunization. The patient experienced migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it. it had been going on since second dose and got worse, not sure if can continue work. The event started on 08Jan2021 02:00 AM, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies to medications, food, or other products. The outcome of the event was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Tinnitus; headache; This is a spontaneous report from a contactable other Health Professional (patient). A 37-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 09Jan2021 10:00 at single dose in right arm for covid-19 immunization. Medical history included chronic pain, hypothyroidism and anxiety, allergies to medications, food, or other products included sulfa.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine, eszopiclone (LUNESTA), ibuprofen (MOTRIN), celecoxib (CELEXA). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No treatment was received. The patient experienced tinnitus and headache on 11Jan2021. The outcome of the events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, COVID-19, Chills, Headache
Clinical narrative: extreme chills; awful headache; body aches; severe sweating; low oxygen; 102 degree temperature; 120 pulse rate(abnormal for me); my arm felt like it was broken (9/10), but no other problems. Twelve hours later, the pain was still 9/10".; shoulder still sore; This is a spontaneous report from a contactable 58-year-old female consumer reporting for herself  A 58 years old male patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249) on 16Jan2021 at 23:30  at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient did not have medical history. Concomitant medications were not reported. The patient reported at inoculation, the injection was high on right arm, and his arm felt like it was broken (9/10), but no other problems. On 17Jan2021 twelve hours later, the pain was still 9/10 so the patient put two heating pads on the site of injection. On the same day (17Jan2021) shortly thereafter, patient also experienced extreme chills, low oxygen (94), 102 degree temperature, 120 pulse rate (abnormal for him), awful headache, body aches, then severe sweating. This peaked 8 hours later and it was gone within 24 hours.  No Treatment was given for the events. At the time of rh reporting the patient informed his shoulder was much better, but still sore.  Patient also informed he was positive for SARS-Cov-2 from 07Dec2020 to 28Dec2020.He had mild symptoms.  The patient recovered with sequel from the events on an unspecified date.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: extreme chills; awful headache; body aches; severe sweating; low oxygen; 102 degree temperature; 120 pulse rate(abnormal for me); my arm felt like it was broken (9/10), but no other problems. Twelve hours later, the pain was still 9/10".; shoulder still sore; This is a spontaneous report from a contactable 58-year-old female consumer reporting for herself  A 58 years old male patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249) on 16Jan2021 at 23:30  at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient did not have medical history. Concomitant medications were not reported. The patient reported at inoculation, the injection was high on right arm, and his arm felt like it was broken (9/10), but no other problems. On 17Jan2021 twelve hours later, the pain was still 9/10 so the patient put two heating pads on the site of injection. On the same day (17Jan2021) shortly thereafter, patient also experienced extreme chills, low oxygen (94), 102 degree temperature, 120 pulse rate (abnormal for him), awful headache, body aches, then severe sweating. This peaked 8 hours later and it was gone within 24 hours.  No Treatment was given for the events. At the time of rh reporting the patient informed his shoulder was much better, but still sore.  Patient also informed he was positive for SARS-Cov-2 from 07Dec2020 to 28Dec2020.He had mild symptoms.  The patient recovered with sequel from the events on an unspecified date.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: extreme chills; awful headache; body aches; severe sweating; low oxygen; 102 degree temperature; 120 pulse rate(abnormal for me); my arm felt like it was broken (9/10), but no other problems. Twelve hours later, the pain was still 9/10".; shoulder still sore; This is a spontaneous report from a contactable 58-year-old female consumer reporting for herself  A 58 years old male patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249) on 16Jan2021 at 23:30  at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient did not have medical history. Concomitant medications were not reported. The patient reported at inoculation, the injection was high on right arm, and his arm felt like it was broken (9/10), but no other problems. On 17Jan2021 twelve hours later, the pain was still 9/10 so the patient put two heating pads on the site of injection. On the same day (17Jan2021) shortly thereafter, patient also experienced extreme chills, low oxygen (94), 102 degree temperature, 120 pulse rate (abnormal for him), awful headache, body aches, then severe sweating. This peaked 8 hours later and it was gone within 24 hours.  No Treatment was given for the events. At the time of rh reporting the patient informed his shoulder was much better, but still sore.  Patient also informed he was positive for SARS-Cov-2 from 07Dec2020 to 28Dec2020.He had mild symptoms.  The patient recovered with sequel from the events on an unspecified date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of (most likely) lymph nodes in left armpit (same arm as vaccination); This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 20Jan2021 14:15 at SINGLE DOSE at Left arm for covid-19 immunisation .  Medical history included basal cell carcinoma.  Concomitant medication included l-arginine [arginine].  The patient experienced swelling of (most likely) lymph nodes in left armpit (same arm as vaccination) on 21Jan2021 17:00. No treatment for the event. The outcome of event was not recovered.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a "little bit" of headache; This is a spontaneous report from a Pfizer Sponsored program, received from a non-contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) , via an unspecified route of administration on 21Jan2021 as a SINGLE DOSE for COVID-19 vaccination.  The patient's medical history included migraines from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  On 21Jan2021, the patient experienced a "little bit" of headache, but it is nothing unusual to her since she has always had migraines in the past. She said apart from that, she is not experiencing any side effects as of the moment. If in case she experiences any more headaches, she wants to know if it would be okay to take ibuprofen (ADVIL), Ibuprofen or acetaminophen (TYLENOL) to treat it. The clinical outcome of a "little bit" of headache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dysaesthesia, Paraesthesia, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: dysaesthesia in the right arm (upper arm on the posterior aspect and forearm) and right hip/thigh; the right shoulder, right elbow, and right hip joints are mildly sore; pins and neeles sensation; This is a spontaneous report from a contactable consumer who is the patient.  A 39-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686) intramuscularly in the right arm on 11Jan2021 at 8:30 (at the age of 39-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included hypertension and migraines. The patient does not have allergies to medication, food, or other products. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EK5730) in the right arm on 18Dec2020. Prior to vaccination, the patient had not been diagnosed with COVID-19. The patient was administered the vaccine in a Hospital. The patient's concomitant medications were not reported. Beginning on 14Jan2021 the patient started to experience dysaesthesia in the right arm (upper arm on the posterior aspect and forearm) and right hip/thigh. Discomfort feels like pins/needles sensation anytime skin is touched lightly (such as blankets, clothing etc). As of the reporting date, the symptoms persist. In addition, the right shoulder, right elbow, and right hip joints are mildly sore which also are persistent. No perceived muscle weakness and no associated numbness. Treatment was not received for the events. Lab data included two post vaccination COVID 19 tests. A PCR nasal swab test on 11Jan2021 and a PCR nasal swab test on 17Jan2021 both of which were negative for COVID-19. The clinical outcomes of dysaesthesia, joint soreness and pins and needles were reported as not recovered.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: One week after the second vaccine I developed Bell's Palsy; This is a spontaneous report from a contactable other health professional reported for himself. A 30-year-old male patient received second dose of bnt162b2, via an unspecified route of administration in left arm on 11Jan2021 11:00 at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included terbinafine, cetirizine hydrochloride (ZYRTEC), multivitamin. The patient previous received first dose of bnt162b2, via an unspecified route of administration in right arm on 21Dec2020 11:00 for covid-19 immunization. The patient experienced one week after the second vaccine, he developed bell's palsy on 18Jan2021 with outcome of not recovered. The event was reported as non-serious. The adverse event result in a visit to emergency room/department or urgent care. Treatment Prednisone, valacyclovir was received for the adverse event. Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported event Bell's palsy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: has a very stiff neck; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 (at the age of 82-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on an unspecified date (at an unspecified age). On an unspecified date in Jan2021, the patient had a very stiff neck. The reporter inquired if the patient can take over the counter pain medication for the very stiff neck. The clinical outcome of the very stiff neck was unknown.  Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Frequent bowel movements, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: the arm was very sore all the way down to her elbow; Queasy; pasty frequent stool; pasty frequent stool; the outside of her arm where the vaccine was put hurt that day; This is a spontaneous report from a contactable consumer.  A 81-year-old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1284), at single dose into the left arm on 16Jan2021 at 12:30PM for COVID-19 immunization.  Concomitant drugs included Levothyroxine 0.100mg once daily by mouth taking for years for thyroid and a week and half before the vaccine administration, she had a cortisone shot in her hip for bursitis but it didn't work, it was the first time she has had one in a long time. The patient reported that on 16Jan2021 the outside of her arm where the vaccine was put hurt that day, but then the next day the arm was very sore all the way down to her elbow. But it was bad, she couldn't roll in bed form the pain. Then she woke up on 17Jan2021 queasy like morning sickness that didn't go away until 21Jan2021. Adds she also noticed that day she was having more frequent and pasty stools. Mentions she expected her arm to be sore because with the second shingles vaccine her arm was sore. States this was years ago and she did not have any product or information for the shingles vaccine. The patient is scheduled for the second dose on 06Feb2021. Mentions she lives in a continuous care facility and they will give her the shot. The event arm hurt recoverd on 20Jan2021, the other events resolved on 21Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain
Clinical narrative: Next day after the shot i feel a pain under my left arm. Days later the pain increase and i think is lymphoma; Next day after the shot i feel a pain under my left arm. Days later the pain increase and i think is lymphoma; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1283, expiry: unknown), via an unspecified route of administration in the left arm on 15Jan2021 07:00 at a single dose for COVID-19 immunization. The patient has no medical history and no known allergies. The patient has no Covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient mentioned that the next day after the shot (16Jan2021 at 05:30), the patient feel a pain under her left arm; days later, the pain increased, and she thinks it is lymphoma. The patient was not tested for Covid post vaccination. The outcome of the events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration
Clinical narrative: have two discoloration in my right thumb one black long line and one red line side by side  around 1 and a half inches long and behind it is a circular black and discoloration; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3247), via an unspecified route of administration on the right arm on 19Jan2021 12:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, supraventricular tachycardia and hearing loss from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) and metoprolol tartrate (METOPROLOL TARTRATE). On 22Jan2021 05:00 AM, the patient stated, "I have two discoloration in my right thumb one black long line and one red line side by side around 1 and a half inches long and behind it is a circular black and discoloration." No treatment was received for the events. The outcome of the event was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood count, Computerised tomogram, Dizziness, Dyspnoea, Pulmonary mass
Clinical narrative: have two discoloration in my right thumb one black long line and one red line side by side  around 1 and a half inches long and behind it is a circular black and discoloration; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3247), via an unspecified route of administration on the right arm on 19Jan2021 12:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, supraventricular tachycardia and hearing loss from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) and metoprolol tartrate (METOPROLOL TARTRATE). On 22Jan2021 05:00 AM, the patient stated, "I have two discoloration in my right thumb one black long line and one red line side by side around 1 and a half inches long and behind it is a circular black and discoloration." No treatment was received for the events. The outcome of the event was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration, Weight decreased
Clinical narrative: have two discoloration in my right thumb one black long line and one red line side by side  around 1 and a half inches long and behind it is a circular black and discoloration; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3247), via an unspecified route of administration on the right arm on 19Jan2021 12:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, supraventricular tachycardia and hearing loss from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) and metoprolol tartrate (METOPROLOL TARTRATE). On 22Jan2021 05:00 AM, the patient stated, "I have two discoloration in my right thumb one black long line and one red line side by side around 1 and a half inches long and behind it is a circular black and discoloration." No treatment was received for the events. The outcome of the event was not recovered.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Vaccination site pain
Clinical narrative: Minor soreness at injection site. Lasted about 48 hours; Minor sweats day of vaccination. Lasted 5 hours; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 19Jan2021 09:00 at SINGLE DOSE on Arm Left for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination. No other vaccine in four weeks. Known allergies: No. Had other medications in two weeks. The patient experienced minor soreness at injection site. lasted about 48 hours since on 19Jan2021 with outcome of recovered on 21Jan2021, minor sweats day of vaccination. lasted 5 hours on 19Jan2021 with outcome of recovered in Jan2021. No treatment received. No covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in his arm; This is a spontaneous report from a contactable consumer. An adult male patient received first single dose of BNT162B2 (Pfizer/BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on Jan2021 for COVID-19 immunization. The patient had no relevant medical history. The patient did not have covid prior vaccination. The patient's concomitant medications were not reported. The patient reported after his first shot he had soreness in his arm (onset date: Jan2021). The patient was not covid tested post vaccination. The outcome of the event was unknown.  Information on the lot/Batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration, Vomiting
Clinical narrative: administration date= 04Jan2021/Other vaccine same date vaccine date=21Jan2021; Lightheaded/Dizzy; vomiting; This is a spontaneous report from a contactable other HCP. This 24-year-old female other HCP (no pregnant) received 2nd dose of BNT162B2 (lot number=EL3249) on 21Jan2021 at single dose on Left Arm for covid-19 immunization. Medical history was Total colonic Hirschsprung's disease, POTS, asthma, chronic migraines, recurrent pneumonia, GERD. Historical Vaccine was 1st dose of BNT162B2 (Lot number= EL1284 on 04Jan2021 09:30 AM on Left arm). Known allergies: Erythromycin, azithromycin (Z-PACK), metoclopramide (REGLAND), diphenhydramine hydrochloride (BENADRYL). Concomitant drug included topiramate (TOPAMAX), esomeprazole sodium (NEXIUM), famotidine (PEPCID), ondansetron (ZOFRAN), budesonide/formoterol fumarate (SYMBICORT). No other vaccine in four weeks. Patient experienced Lightheaded, dizzy, vomiting on 21Jan2021 11:15 PM with outcome was recovered. No treatment. No Covid prior vaccination. No covid tested post vaccination.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter was to report a possible side effect. The patient experienced severe diarrhea in Jan2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia
Clinical narrative: chills; muscle ache; joint pain; sweat; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received second single dose of BNT162B2 (Solution for injection, lot number: EL3247, exp date not reported), via an unspecified route of administration  (Anatomical location: Arm Right)on 20Jan2021 15:00 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient previously took first single dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunization. The patient experienced chills, muscle ache, joint pain, and sweat on Jan2021. The events were considered as non-serious. The outcome of events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: developed COVID symptoms/diagnosed positive in Covid19/ tested positive for Covid; developed COVID symptoms/diagnosed positive in Covid19/ tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). This nurse reported same event for two patients (patient and her husband), this is the first of two reports, the report for patient herself.   A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL0142, expiration date unknown), via an unspecified route of administration in arm (reported as deltoid) on 02Jan2021 at single dose for COVID-19 immunization. The patient denied relevant medical history. Concomitant medications were not reported. The patient got her first dose on 02Jan2021, and on 08Jan2021 developed COVID symptoms. On 11Jan2021, she tested positive for COVID-19/diagnosed positive in COVID-19. The reporter nurse think they were exposed sometime at that pharmacy, she mean there was a lot of people in the line. Tomorrow (unspecified) was supposed to be second dose and his family physician didn't know if he should get that second dose. The outcome of events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021064940 Same reporter/drug/event, different patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Rash macular, SARS-CoV-1 test
Clinical narrative: Aching joints; severe headache; blotchy skin on arms; This is a spontaneous report from a contactable other hcp reported for herself. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1282), via an unspecified route of administration on the left arm on 21Jan2021 11:15 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included sertraline (SERTRALINE). The patient previously took the first dose of bnt162b2 (lot number: EL0142) for covid-19 immunization on 31Dec2020 and diflucan and experienced drug hypersensitivity. The patient experienced aching joints, severe headache, blotchy skin on arms on 22Jan2021 04:00 AM . The patient underwent lab tests and procedures which included sars-cov-1 test: negative on 22Jan2021. No treatment was received for the events. The outcome of the events was not recovered.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis
Clinical narrative: Headache; Sweating for approx 12-24 hours; This is a spontaneous report from a contactable healthcare professional (patient himself). A 28-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899, expiry date: Mar2021), intramuscular in the left arm on 15Dec2020 14:45 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included Type II diabetic, irregular heartbeat (Sinus Arrhythmia), and gout. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included atenolol. The patient previously had allergy with lisinopril. On 05Jan2021 23:30, the patient experienced headache and sweating for approximately 12-24 hours. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and Benadryl as treatment. The outcome of the events was recovering. The case was considered non-serious.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Malaise, Nausea
Clinical narrative: side effects he had: nausea; side effects he had: "warm"; side effects he had: "feel lousy"; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if he could take Tylenol or Motrin to treat his side effects after receiving his 1st dose of the vaccine. The side effects he had included: nausea, "warm", and "feel lousy". The reporter said that the vaccination location told him that most people experience the symptoms that he was feeling. The reporter said he already spoke with another nurse. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; fatigue; This is a spontaneous report from a contactable consumer reported for herself. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration on the left arm on 16Jan2021 07:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT), probiotics (PROBIOTICS), lecithin (LECITHIN) and multivitamin. The patient experienced sore arm and fatigue on 16Jan2021 18:00. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Low grade temperature (99.1 degree F); Tiredness; This is a spontaneous report from a contactable healthcare professional (patient himself). A 26-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 15:45 at single dose for covid-19 immunization. The patient was vaccinated in the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 14:15, the patient experienced low grade temperature (99.1 degree F) and tiredness. No treatment was received for the adverse events. The outcome of the events was recovered on 22Jan2021 (time unknown). The case has been considered non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue, Headache, Nausea, Pain
Clinical narrative: nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the left arm on 19Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included osteoarthritis, restless legs syndrome, rubber sensitivity (latex allergies), and COVID-19. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included ropinirole. On 19Jan2021 14:15, the patient experienced nausea, body aches, headache, fatigue, tingling in both hands (and fingers) and crushing depression. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the left arm on 19Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included osteoarthritis, restless legs syndrome, rubber sensitivity (latex allergies), and COVID-19. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included ropinirole. On 19Jan2021 14:15, the patient experienced nausea, body aches, headache, fatigue, tingling in both hands (and fingers) and crushing depression. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Urinary tract infection
Clinical narrative: experienced urinary tract infection; Medical history included multiple sclerosis, immune suppressants a month ago for multiple sclerosis; Medical history included multiple sclerosis, immune suppressants a month ago for multiple sclerosis; This is a spontaneous report from a non-contactable consumer reported for herself. This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 18Jan2021 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. Concomitant medications were not reported. The patient previously took immune suppressants a month ago for multiple sclerosis. The patient reported that she had first dose of the COVID-19 vaccine on 18Jan2021, and she had some reactions similar to those she usually got when she took steroids. The patient experienced urinary tract infection. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Heart rate irregular, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Sharp pain in his heart; Wild palpitations; Extreme erratic heart beat; wiped out; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1248), via an unspecified route of administration on 11Jan2021 at single dose at left arm for covid-19 immunisation. Medical history included Lyme's disease from 09Jun2018 and ongoing, ongoing heart issues, cholesterol lowering and swelling (He was on a water pill for swelling). Concomitant medication included atenolol for heart medication, pitavastatin calcium (LIVALO) for cholesterol lowering. Patient was calling to report a negative reaction with Covid-19 vaccine. Four hours after the injection he laid down in bed and was relaxing on 11Jan2021. He felt a sharp pain in his heart. It was about 1 to 1.5 inches to the right of his nipple. It felt like a knife being jabbed in his chest. This only happened once. His heart was having wild palpitations. He had an extreme erratic heart beat lasting 30-40 seconds. It was terrifying. He had a lot of irregular heart beats for 3-4 days. He was wiped out and unable to get out of bed for 5 days. He had an MRI on 21Jan2021. He was waiting on the results. The erratic heart beats come and go. They were not as pronounced as the first week. He was not getting the second dose. He had not had a flu shot for the last 3 years. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Outcome of event sharp pain in his heart recovered with sequel on 11Jan2021, wild palpitations was recovered in Jan2021, extreme erratic heart beat was recovering, wiped out was recovered with sequel on 16Jan2021. The report was considered as non-serious.