chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus; Bodyaches; fever; chills/Night chills; nausea; headache/mild headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient).  A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 07Jan2021 at a SINGLE DOSE for COVID-19 immunization. Medical history included palpitations. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 on 18Dec2020 at 17:00 via intramuscular route of administration in the left arm for COVID-19 immunization.  Concomitant medication included atenolol, vitamin b complex, colecalciferol (VITAMIN D), vitamins (MV), esomeprazole magnesium (NEXIUM), omeprazole (PROTON) and fish oil. The patient previously took morphine and experienced allergies. On 08Jan2021, 1 day post-vaccination after the second dose of vaccine, the patient experienced body aches, fever, chills, nausea, headache and muscle weakness. Then on 18Jan2021, she had night chills and sweating, HR (heart rate) of 130, and mild headache. She also noticed soreness and bumps to anus on 18Jan2021. On 19Jan2021, patient still had chills, HR was 120 and continue to feel muscle weakness Took 100mg atenolol to decrease HR. Usually prn 25 mg atenolol. The soreness and bump increase and was growing. Patient will consult with cardiologist regarding HR. The outcome of events body aches, fever, nausea, headache and was recovered on 13Jan2021. The outcome of event chills, muscle weakness, soreness and bumps to anus was not recovered. The outcome of the other events was unknown. Patient did not receive any treatment for the events body aches, fever, nausea, headache and muscle weakness. Whereas therapeutic measure was taken as a result of "HR of 130/HR was 120".   No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: itchy sensation to arms; redness to chest; This is a spontaneous report from a contactable pharmacist.  A 56-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number EL1284, intramuscular in left arm, on 21Dec2020 at12:30 ( at the age of 56 years old) as a  single dose for COVID-19 immunization.  Medical history included asthma, hyperlipidemia, PTSD, and seasonal allergies. Concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) (rash), ciprofloxacin, codeine (vomiting, rash), escitalopram (dizziness, rapid heart rate). Prior to the vaccination the patient was not diagnosed with COVID-19. The COVID-19 vaccine was administered at a hospital. There were no other vaccines within four weeks prior to the vaccination. On 21Dec2020 at 12:30, the patient experienced itchy sensation to arms, redness to chest. Rapid response was called, patient monitored. No additional intervention, no treatment provided. The outcome of the events was recovered. The patient was not tested for COVID-19 post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Limb discomfort
Clinical narrative: nausea; extreme fatigue/tiredness; left arm very sore and achy, it became very stiff; left arm very sore and achy, it became very stiff; body aches increased; body aches increased; headaches on and off; chills; night sweats really bad for two nights; light fever; nose running; light cough; This is a spontaneous report from a contactable consumer who reported for herself. A 58 (units unknown) non-pregnant adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: E10140) via an unspecified route of administration on 14Jan2021 as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure (High blood pressure-take medication, heart medicine also) from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date and unspecified if ongoing. It was reported that the patient had no known allergies. Concomitant medications were not reported. It was reported that the patient had not taken other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jan2021 at 17:30 (reported as "on Friday after the first dose") the patient experienced nausea, extreme fatigue, left arm very sore and achy, it became very stiff, body aches increased, headaches on and off, chills and night sweats really bad for two nights, tiredness, light fever, nose running and light cough. The clinical outcome of the events nausea, extreme fatigue, left arm very sore and achy, it became very stiff, body aches increased, headaches on and off, chills and night sweats really bad for two nights, tiredness, light fever, nose running and light cough were all recovering/resolving. It was reported that no treatment was received for the adverse events. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Night sweats, Pain, Pain in extremity, Pyrexia
Clinical narrative: nausea; extreme fatigue/tiredness; left arm very sore and achy, it became very stiff; left arm very sore and achy, it became very stiff; body aches increased; body aches increased; headaches on and off; chills; night sweats really bad for two nights; light fever; nose running; light cough; This is a spontaneous report from a contactable consumer who reported for herself. A 58 (units unknown) non-pregnant adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: E10140) via an unspecified route of administration on 14Jan2021 as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure (High blood pressure-take medication, heart medicine also) from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date and unspecified if ongoing. It was reported that the patient had no known allergies. Concomitant medications were not reported. It was reported that the patient had not taken other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jan2021 at 17:30 (reported as "on Friday after the first dose") the patient experienced nausea, extreme fatigue, left arm very sore and achy, it became very stiff, body aches increased, headaches on and off, chills and night sweats really bad for two nights, tiredness, light fever, nose running and light cough. The clinical outcome of the events nausea, extreme fatigue, left arm very sore and achy, it became very stiff, body aches increased, headaches on and off, chills and night sweats really bad for two nights, tiredness, light fever, nose running and light cough were all recovering/resolving. It was reported that no treatment was received for the adverse events. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: nausea; extreme fatigue/tiredness; left arm very sore and achy, it became very stiff; left arm very sore and achy, it became very stiff; body aches increased; body aches increased; headaches on and off; chills; night sweats really bad for two nights; light fever; nose running; light cough; This is a spontaneous report from a contactable consumer who reported for herself. A 58 (units unknown) non-pregnant adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: E10140) via an unspecified route of administration on 14Jan2021 as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure (High blood pressure-take medication, heart medicine also) from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date and unspecified if ongoing. It was reported that the patient had no known allergies. Concomitant medications were not reported. It was reported that the patient had not taken other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jan2021 at 17:30 (reported as "on Friday after the first dose") the patient experienced nausea, extreme fatigue, left arm very sore and achy, it became very stiff, body aches increased, headaches on and off, chills and night sweats really bad for two nights, tiredness, light fever, nose running and light cough. The clinical outcome of the events nausea, extreme fatigue, left arm very sore and achy, it became very stiff, body aches increased, headaches on and off, chills and night sweats really bad for two nights, tiredness, light fever, nose running and light cough were all recovering/resolving. It was reported that no treatment was received for the adverse events. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Oral herpes, Oral mucosal blistering, Pain, Pyrexia
Clinical narrative: blister; fever; chills; body aches; herpes in his mouth; This is a spontaneous report from a contactable consumer (patient himself). A 35-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration at the left arm on 19Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included ongoing Hemophilia A.  There were no concomitant medications. The patient was vaccinated at a hospital. The vaccine was not administered at a military facility. The patient stated that he got his first COVID vaccine, but stated that he has hemophilia A and was worried about getting the second dose. The patient reported that two weeks later after getting the vaccine, on 02Jan2021, he had fever, chills, and body aches. He went to the dentist on 02Jan2021 who told him that he had a herpes in his mouth. The patient stated that it was just a blister. All of these effects have gone away completely now and he has recovered completely. The patient stated that he was able to get the fever under control by 06Jan2021. He was not scheduled to get the second dose yet but stated because he worked at the hospital he can go anytime and get it; he just had not gotten it yet because he wanted to ask about the hemophilia A. Clinical outcome of fever was recovered on 06Jan2021, for chills and body aches was recovered on 04Jan2021, for herpes in mouth was recovered on 15Jan2021, while for the blister was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cold sweat, Hypertension, Nausea, SARS-CoV-2 test
Clinical narrative: Blood pressure sky high; Severe vertigo; Nausea; Vomiting; Cold sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO3249; Expiration date was not reported) on 20Jan2021 (12:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included watermelon allergy. Concomitant medications included celecoxib (CELEBREX), metoprolol tartrate, simvastatin and lisinopril. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Expiration date was not reported) on the right arm on 30Dec2020 (when the patient was 56 years old) for COVID-19 immunization. On 21Jan2021 (03:45), in the morning, the patient's blood pressure was sky high; had severe vertigo; nausea; vomiting; and cold sweats. The patient had resulted in the emergency room/department or urgent case for the reported events. The patient had received unspecified medications as treatment for the nausea and vertigo. The outcome of the events, 'blood pressure was sky high', 'severe vertigo', 'nausea', 'vomiting' and 'cold sweats', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 (nasal swab) post-vaccination which was negative on 21Jan2021.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Blood pressure sky high; Severe vertigo; Nausea; Vomiting; Cold sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO3249; Expiration date was not reported) on 20Jan2021 (12:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included watermelon allergy. Concomitant medications included celecoxib (CELEBREX), metoprolol tartrate, simvastatin and lisinopril. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Expiration date was not reported) on the right arm on 30Dec2020 (when the patient was 56 years old) for COVID-19 immunization. On 21Jan2021 (03:45), in the morning, the patient's blood pressure was sky high; had severe vertigo; nausea; vomiting; and cold sweats. The patient had resulted in the emergency room/department or urgent case for the reported events. The patient had received unspecified medications as treatment for the nausea and vertigo. The outcome of the events, 'blood pressure was sky high', 'severe vertigo', 'nausea', 'vomiting' and 'cold sweats', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 (nasal swab) post-vaccination which was negative on 21Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Flushing, Headache, Paraesthesia
Clinical narrative: "feels like I got run over by a Mac truck"; headache; tingling to left hand; face warm; flushed; This is a spontaneous report from a non-contactable Physician. An adult female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 Intramuscular into left arm as single dose for COVID-19 immunisation.  Medical history and concomitant medication were not reported. The patient was not pregnant at the time of vaccination. Patient did not have Covid prior vaccination. The patient did not have Covid tested post vaccination.  It is not known if patient received other vaccine in last four weeks.  Immediately after injection (18Jan2021), small amount of tingling to left hand, face warm, flushed was experienced and resolved within 30 minutes without intervention.  The patient experienced "feels like I got run over by a Mac truck" on 19Jan2021 and headache on 19Jan2021.  It was unknown if treatment was received.  Outcome of event "feels like I got run over by a Mac truck" was recovered, 'headache' was recovered, 'small amount of tingling to left hand' was recovered, 'face warm' was recovered and 'flushed' was recovered.    The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Movement disorder, Pain in extremity, Peripheral swelling
Clinical narrative: arm pain; itching; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; I feel in my arm, around that shot you know I had the injection, start itchy start feel itchy; my arm feel pink, it's swell up and it's scratch; my arm feel pink, it's swell up and it's scratch; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included bone disorder (reported as bad bone problem). Concomitant medication included denosumab (PROLIA) for bone disorder. The patient received her first injection on 09Jan2021 and had been experiencing arm pain which was mild to moderate but about a week later she developed itching in the same arm.  It's become difficult to move her arm and had worsened since the injection.  She wanted to know if this type of experience had been reported and if she should receive the second vaccination scheduled for the 30th. The patient stated that she had a hard time lift my arm in changing clothes and she can't her shoulder. After one week later about almost 1 week later she felt in her arm, around that shot she had the injection, started itchy started to feel itchy and she was afraid maybe infection, dead skin, maybe infection or something. She showed it to her friend, saying "Look my arm feel pink, it's swell up and it's scratch, it's itchy." Clinical outcome of event "difficulty to move her arm and had worsened since the injection" was not recovered while for the other events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Scratch, Vaccination site pruritus
Clinical narrative: arm pain; itching; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; I feel in my arm, around that shot you know I had the injection, start itchy start feel itchy; my arm feel pink, it's swell up and it's scratch; my arm feel pink, it's swell up and it's scratch; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included bone disorder (reported as bad bone problem). Concomitant medication included denosumab (PROLIA) for bone disorder. The patient received her first injection on 09Jan2021 and had been experiencing arm pain which was mild to moderate but about a week later she developed itching in the same arm.  It's become difficult to move her arm and had worsened since the injection.  She wanted to know if this type of experience had been reported and if she should receive the second vaccination scheduled for the 30th. The patient stated that she had a hard time lift my arm in changing clothes and she can't her shoulder. After one week later about almost 1 week later she felt in her arm, around that shot she had the injection, started itchy started to feel itchy and she was afraid maybe infection, dead skin, maybe infection or something. She showed it to her friend, saying "Look my arm feel pink, it's swell up and it's scratch, it's itchy." Clinical outcome of event "difficulty to move her arm and had worsened since the injection" was not recovered while for the other events was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo starting the evening of vaccination; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on 15Jan2021 13:00 at single dose for COVID-19 immunization.  Medical history included vertigo from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced vertigo starting the evening of vaccination on 15Jan2021 and continues to persist 6 days later with decreasing intensity. The patient further reported they had vertigo that seems to resolve a couple hours after taking the vaccine and has persisted with positional changes. It was further reported that it was diminishing for the past couple of days but they were pretty intense about vertigo in particular. When they were in a laying down position like the whole room is spinning. It was horrible. The day after vaccine like they were spinning for hours at night and with positional changes from laying down to getting out of bed. When they initially lay down they got like a vertigo. The patient was recovering from the event.
Sex: F
Vaccine: COVID19
Symptoms: Ear haemorrhage, Vaccination site bruising
Clinical narrative: bleeding out of her left ear; The injection site feels like bruising; This is a spontaneous report from a contactable consumer (reporting for mother in law). A 90-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1284, expiry date unknown), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. Medical history included patient was diabetic. The patient's concomitant medications included that patient was on blood thinner (unspecified). Reporter's mother-law (patient) received the Pfizer Covid vaccine yesterday (also reported as today), Jan2021. About 5 hours after receipt of the vaccine, patient was bleeding out of her left ear. It's been an ooze, like a capillary bleed. It's intermittent but it has not stopped. This was her first dose. She can hear OK and the ear was not painful. Her respiratory system seemed to doing fine. The injection site felt like bruising (Jan2021). The site looked fine, no bruising around the band aid and no swelling. She has never bled from her ear. There have not been any medication changes and no known damage to the ear. Patient asked if bleeding in the left ear been associated with the Covid vaccine. No treatment was received for the event bleeding out of her left ear. The outcome of the events bleeding out of her left ear and injection site felt like bruising was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Neck pain, Pain in extremity
Clinical narrative: Very sore upper arm and shoulder; Very sore upper arm and shoulder/pain through shoulder and neck throughout the night; pain through shoulder and neck throughout the night; difficulty sleeping; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 14:00 at SINGLE DOSE for COVID-19 immunization.  The patient's medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included birth control (not specified). On 15Jan2021 16:00, the patient experienced a very sore upper arm and shoulder, pain through shoulder and neck throughout the night, caused difficulty sleeping; ibuprofen helped, lasted 1 day.  Therapeutic measures were taken as a result of events. Outcome of events was reported as recovered.  Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever of about 100-101/fever of 101.3/He still has the fever and he just took it and it's now 100.9; slight headache; chills during the night but not now; a stuff neck; This is a spontaneous report from the Medical Team. A contactable consumer (patient) reported that a 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, intramuscular ("in the muscle") in the right arm, on 20Jan2021 14:30 at a SINGLE DOSE for covid-19 immunization. The patient's relevant medical history was not reported.  There were no concomitant medications.  Patient received first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 for covid-19 immunization. The patient experienced 'Fever of about 100-101, chills during the night but not now and a stuff neck'. The patient later reported that he got some chills that evening when he got the second dose of vaccine (20Jan2021). Woke up this morning (21Jan2021) with a fever of 101.3 and slight headache. Patient wanted to know if he could take Tylenol, Ibuprofen, or Aspirin, if it's okay. He wanted to clarify that chills started later that evening (second dose vaccination) but it was not bothering him now. He still has the fever and he just took it and it's now 100.9. Patient was recovering from the events "a stuff neck" and "chills during the night but not now". Whereas he had not recovered from " Fever of about 100-101/fever of 101.3/He still has the fever and he just took it and it's now 100.9" and  headache.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Lymph node pain, Lymphadenopathy
Clinical narrative: swollen left arm pit which is also slightly tender to touch; swollen left arm pit which is also slightly tender to touch; sore arm; low grade temperature (37.8 C); fatigue; chills; Second dose administered on 10Jan2021; first dose was administered on 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9Z61), intramuscular (left arm) on 10Jan2021 15:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL1284) intramuscular (left arm) on 29Dec2020 (02:00 PM) for Covid-19 immunization. The patient's medical history included Covid-19; no known allergies. Concomitant medication included citalopram hydrobromide (CELEXA) taken PO (oral) daily before, during and after vaccination period. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no issues on day zero; on day 1 (11Jan2021) she had sore arm, low grade temperature (37.8 C), fatigue, and chills. All have resolved by 6am on day 2 (12Jan2021). On day 3 (13Jan2021), she noticed swollen left arm pit which is also slightly tender to touch but not bothersome. No other lymph areas are noticeably swollen or tender at this time. There was no treatment received for the adverse event. The outcome of events sore arm, low grade temperature, fatigue, and chills was recovered on 12Jan2021; the outcome of events swollen left arm pit which is also slightly tender to touch was recovering. The patient has not been tested for COVID-19 since the vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: swollen left arm pit which is also slightly tender to touch; swollen left arm pit which is also slightly tender to touch; sore arm; low grade temperature (37.8 C); fatigue; chills; Second dose administered on 10Jan2021; first dose was administered on 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9Z61), intramuscular (left arm) on 10Jan2021 15:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL1284) intramuscular (left arm) on 29Dec2020 (02:00 PM) for Covid-19 immunization. The patient's medical history included Covid-19; no known allergies. Concomitant medication included citalopram hydrobromide (CELEXA) taken PO (oral) daily before, during and after vaccination period. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no issues on day zero; on day 1 (11Jan2021) she had sore arm, low grade temperature (37.8 C), fatigue, and chills. All have resolved by 6am on day 2 (12Jan2021). On day 3 (13Jan2021), she noticed swollen left arm pit which is also slightly tender to touch but not bothersome. No other lymph areas are noticeably swollen or tender at this time. There was no treatment received for the adverse event. The outcome of events sore arm, low grade temperature, fatigue, and chills was recovered on 12Jan2021; the outcome of events swollen left arm pit which is also slightly tender to touch was recovering. The patient has not been tested for COVID-19 since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt a little tender where the shot was; This is a spontaneous report from a contactable consumer (patient). This consumer reported for two patients (herself and her husband). This is the first of two reports.   An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 09Jan2021 at single dose for Covid-19 immunization. Medical history included ongoing cancer cell on eyelid. The patient's concomitant medications were not reported. The patient reported that she received the first dose of Pfizer vaccine on 09Jan2021. The patient reported that she has not had any reaction at all, maybe felt a little tender where the shot was, also reported as felt nothing except maybe a little soreness on the arm in Jan2021. She added that she is due to get her next shot on 30Jan2021 and is also due to have a surgery; she added eye surgery as she have a cancer cell eyelid and she was supposed to have cancer surgery on the 1st, and wanted to know if there would be a complication if she had the vaccine two days before that surgery. She also wanted to know if they will be getting the vaccination on 30Jan2021 and what to do if the facility run out of the vaccine when they are due for the second shot. The outcome of event is unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : same reporter, suspect product, and event, different patient
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Malaise, Vaccination site pain
Clinical narrative: After second dose pain at injection site; chills; diarrhea; GI upset; unwell feeling; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration left arm, on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history reported as none. No reported allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered as at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient is not pregnant at vaccination time. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 on the left arm. The patient experienced after second dose, pain at injection site, chills, diarrhea, GI upset, and unwell feeling on 20Jan2021 21:00. No treatment was given for the events. Outcome of the events was unknown. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Feeling abnormal, Hypersensitivity, Throat irritation, Urticaria
Clinical narrative: her throat feels scratchy; allergic reaction; itchy dermatitis baby hives on the inside of her left elbow; itchy dermatitis baby hives on the inside of her left elbow; felt a strange sensation throughout her body; This is a spontaneous report from a non-contactable nurse (patient herself). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (left deltoid), on 20Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she received the first dose of the COVID vaccine yesterday, 20Jan2021. She experienced an allergic reaction two hours after receiving the vaccine and also experienced itchy dermatitis baby hives on the inside of her left elbow all on 20Jan2021. The vaccine was administered in the left deltoid muscle. Furthermore, when she walked away from the vaccination site, she felt a strange sensation throughout her body on 20Jan2021, but she was able to drive herself home. Her throat feels scratchy today 21Jan2021. With all this, she was concerned about receiving the second dose. She wanted to know if her symptoms have been reported and; if she should receive the second dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Skin disorder
Clinical narrative: 3 day after my vaccine I got a hard bump on the back of my ear; right lymph nodes is swollen from the inside; This is a spontaneous report from a contactable Healthcare Professional, the patient. A 26-year-old female patient started to receive the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via intramuscular route in the right arm on 13Jan2021 12:15 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not have any allergies to medications, food, or other products. On 15Jan2021 12:00 AM, after receiving her vaccine she got a hard bump on the back of her ear and her right lymph nodes was swollen from the inside. No treatment was received for the events. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the event hard bump and lymph node swollen was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Dysphagia, Flushing
Clinical narrative: Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127/90 (usually 90/60); Had difficulty swallowing; Fingers started tingling; Chills (lasted 15-20 minutes); This is a spontaneous report from a contactable consumer.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 15Jan2021, after 2 minutes of the vaccine, patient heart rate went from normal (53-60) to 100 bpm; the patient felt flushing feeling and blood pressure went up to 127/90 (usually 90/60); patient had difficulty swallowing and fingers started tingling, followed by chills (lasted 15-20 minutes, as reported). The patient was ok 90 minutes after the shot. No treatment given. The final outcome of all the events was recovered in Jan2021.Information on the batch/lot number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Paraesthesia
Clinical narrative: Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127/90 (usually 90/60); Had difficulty swallowing; Fingers started tingling; Chills (lasted 15-20 minutes); This is a spontaneous report from a contactable consumer.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 15Jan2021, after 2 minutes of the vaccine, patient heart rate went from normal (53-60) to 100 bpm; the patient felt flushing feeling and blood pressure went up to 127/90 (usually 90/60); patient had difficulty swallowing and fingers started tingling, followed by chills (lasted 15-20 minutes, as reported). The patient was ok 90 minutes after the shot. No treatment given. The final outcome of all the events was recovered in Jan2021.Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: received the entire vial contents (0.45 mL), without dilution/overdose; received the entire vial contents (0.45 mL), without dilution/overdose; This case has been considered invalid since the reporters has no first-hand knowledge of the patients and events.  This is a spontaneous report from contactable two Nurse, two Pharmacist and two Physician. These Nurse, Pharmacist and Physician reported similar events for 8 patients. This report is for 7th of 8 patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose (the entire vial contents 0.45 mL) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that eight healthcare workers in a (facility name) received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine.  Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose.  Information on the Lot/batch number has been requested.  Follow-up (22Jan2021): This is a follow-up spontaneous report received from a contactable Pharmacist in response to the mail trail sent regarding the confirmation of below mentioned query. This Pharmacist reported for a patient that:  Query: (name) from Drug Safety Office phoned yesterday & today. She asked that (name) phone or be in touch with her because (name) wrote the article in the newsletter. (name) is interested in whether (name) had first hand knowledge of the patients mentioned in the article. If so, (name) has questions to ask about them & their reactions.  Response: We are a national reporting program. We do not have any patient data. Just what you already saw. We cannot supply additional information. Reporter is confirming there is no first-hand knowledge of events.  Information on the Lot/batch number has already been requested.; Sender's Comments: Linked Report(s) : Same reporter/drug; different patient/event
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Numbness of my tongue and lips; This is a spontaneous report from a contactable nurse (patient). A 38-year-old non-pregnant female patient started to receive bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL8982; expiration date: unknown), via an unspecified route of administration left arm on 21Jan2021 17:00 at a single dose for covid-19 immunization. Medical history included migraine. The patient was not diagnosed with COVID prior vaccination. The patient has no known allergies. Concomitant medication included allopurinol (ELAVIL), paracetamol (TYLENOL), vitamin c [ascorbic acid] (VITAMIN C) zinc and prenatal vitamins. The patient has not had other vaccine in four weeks. The patient received her vaccine in a hospital. On 22Jan2021 01:00 AM, the patient experienced numbness of her tongue and lips. No treatment was received for the adverse events. The patient has not been COVID tested post vaccination. The outcome of the event was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Injection site quite sore; body aches; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old male patient received bnt162b2 (BNT162B2), lot number Ez9261, via an unspecified route of administration Left arm from 21Jan2021 09:00 to 21Jan2021 09:00 at SINGLE DOSE (first dose) for COVID-19 immunisation.  Medical history included COVID-19 prior vaccination.  The patient's concomitant medications were not reported.  The patient experienced injection site quite sore and body aches on 22Jan2021 03:00. The outcome of the events was not recovered. The patient was not tested for COVID-19 post vaccination. No treatment was received for the events.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Oral discomfort, Paraesthesia, Paraesthesia oral, Throat irritation
Clinical narrative: Itchy throat; left side of face burning; left side of face burning/tingling sensation; burning/tingling sensation left side of lip; burning/tingling sensation and left side of lip; This is a spontaneous report from a contactable other healthcare professional. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose (lot number: EL3302) on 21Jan2021 17:00 at single dose on right arm for COVID-19 immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: E11284, on 29Dec2020 13:30 on right arm. Medical history included asthma and seasonal allergies. The patient did not test for COVID post vaccination. The patient is not pregnant. The patient experienced itchy throat, left side of face burning/tingling sensation and left side of lip on 21Jan2021 17:45. The patient took Benadryl as treatment for the events. The outcome of the events was recovering.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Body height, Body temperature, Chest discomfort
Clinical narrative: tightness on the chest; chest was hurting and felt like it has been compressed; congested; body aches/ his body is still aching/ body was aching/ achy; headaches; fever/ he has a temperature at 100; tired; felt weak; feeling kind of hot and achy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL9261, expiry date unknown) via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. There were no concomitant medications. The patient did not receive medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 29Dec2020, 11:00AM at a single dose on the left arm for COVID-19 immunization. The patient reported he is probably 160 pounds, 5ft 6 inches; he received the second dose of the COVID-19 vaccine on 20Jan2021, while being due for it on 19Jan2021. He explained having body aches, headaches, fever, tired, and felt weak the following morning (21Jan2021, 04:30 AM) and therefore went to the ER. He had blood works and an X-ray done on 21Jan2021 (results unknown) and they said he had no COVID. Today, 22Jan2021, he has a temperature at 100, his body is still aching, the headaches are there along with a tightness on the chest that concerns him. He also described it as his chest was hurting and felt like it has been compressed. Patient asked what to do. He then mentioned that the nearby urgent care had refused to take him because the vaccine is still 'under investigation' and the ER is far away. Patient also reported that he was feeling kind of hot and achy, body was aching on 21Jan2021.Today, 22Jan2021, he was still the same. He got a fever, was congested, and his body is aching. Patient did not received treatment for the events. Outcome of the events 'body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, felt weak, 'feeling kind of hot and achy,' and congested was not recovered. Outcome of the other events was unknown. The events body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, and felt weak required Emergency room visit and were reported as medically significant.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Feeling hot, Headache, Nasal congestion
Clinical narrative: tightness on the chest; chest was hurting and felt like it has been compressed; congested; body aches/ his body is still aching/ body was aching/ achy; headaches; fever/ he has a temperature at 100; tired; felt weak; feeling kind of hot and achy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL9261, expiry date unknown) via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. There were no concomitant medications. The patient did not receive medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 29Dec2020, 11:00AM at a single dose on the left arm for COVID-19 immunization. The patient reported he is probably 160 pounds, 5ft 6 inches; he received the second dose of the COVID-19 vaccine on 20Jan2021, while being due for it on 19Jan2021. He explained having body aches, headaches, fever, tired, and felt weak the following morning (21Jan2021, 04:30 AM) and therefore went to the ER. He had blood works and an X-ray done on 21Jan2021 (results unknown) and they said he had no COVID. Today, 22Jan2021, he has a temperature at 100, his body is still aching, the headaches are there along with a tightness on the chest that concerns him. He also described it as his chest was hurting and felt like it has been compressed. Patient asked what to do. He then mentioned that the nearby urgent care had refused to take him because the vaccine is still 'under investigation' and the ER is far away. Patient also reported that he was feeling kind of hot and achy, body was aching on 21Jan2021.Today, 22Jan2021, he was still the same. He got a fever, was congested, and his body is aching. Patient did not received treatment for the events. Outcome of the events 'body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, felt weak, 'feeling kind of hot and achy,' and congested was not recovered. Outcome of the other events was unknown. The events body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, and felt weak required Emergency room visit and were reported as medically significant.