chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.   A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration (right arm shoulder-pending clarification) on 17Jan2021 at singe dose for Covid-19 immunization. The patient's medical history included high blood pressure. There were no concomitant medications. It was reported that the patient got the shot on Sunday (17Jan2021) along with her husband. All of the sudden she was getting dizzy, otherwise they had no problem. She even made a second appointment. The dizziness started today (19Jan2021), a couple hours ago. It concerned the patient. She thought maybe because she didn't eat breakfast, but she ate and that hasn't helped. She would like to know if dizziness is a side effect because she really doesn't want to go to the hospital. The outcome of event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021061667 same reporter/drug/event and different patients.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: fatigue; Dizzy; Unstable; arm pain; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the 2nd of two patients. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient initially had no reaction however he experienced similar reaction as his wife did on 19Jan2021. The patient experienced fatigue, was dizzy, unstable and has arm pain on 19Jan2021. The reporter was inquiring if it was normal to have these effects 4 days after the vaccination. Outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044678 Same reporter/drug, similar events, different patients
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Injection site pain; chills; headache; body aches; nausea; swollen lymph nodes; fatigue; swollen, tender lymph nodes in the neck and armpits; This is a spontaneous report from a non-contactable other health professional. A 23-year-old female  patient reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 20Jan2021 at 08:00 AM for COVID-19 immunization. The patient medical history was unknown. Concomitant drug  was Sertraline and Mili tablets. Within 4 weeks prior to the COVID vaccine the patient received the vaccine TDAP on 08Jan2021 in the right arm. On 20Jan2021 at 09:00 PM the patient experienced injection site pain, chills, headache, body aches, nausea, swollen lymph nodes, fatigue. These started about 12-14 hours after getting the vaccine and worsened over the next several hours. Most symptoms resolved, but she still had swollen, tender lymph nodes in the neck and armpits as well as some mild body aches and headache (at the 48 hour mark). No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site pain
Clinical narrative: Injection site pain; chills; headache; body aches; nausea; swollen lymph nodes; fatigue; swollen, tender lymph nodes in the neck and armpits; This is a spontaneous report from a non-contactable other health professional. A 23-year-old female  patient reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 20Jan2021 at 08:00 AM for COVID-19 immunization. The patient medical history was unknown. Concomitant drug  was Sertraline and Mili tablets. Within 4 weeks prior to the COVID vaccine the patient received the vaccine TDAP on 08Jan2021 in the right arm. On 20Jan2021 at 09:00 PM the patient experienced injection site pain, chills, headache, body aches, nausea, swollen lymph nodes, fatigue. These started about 12-14 hours after getting the vaccine and worsened over the next several hours. Most symptoms resolved, but she still had swollen, tender lymph nodes in the neck and armpits as well as some mild body aches and headache (at the 48 hour mark). No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Vaccination site pain
Clinical narrative: intense itching/ itching on his hips and on his back; gets red whenever he scratches it; after the injection his arm got a little sore; Feels like it is hot; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246, expiry: 30Apr2021) intramuscularly into the left arm on 06Jan2021 at a single dose for covid-19 immunisation. Medical history included nerve damage, brain damage, disability from 1997, anxiety, major severe depression, occupational exposure to heavy metal uranium, chronic obstructive pulmonary disease (COPD), early stage emphysema and diabetes. Concomitant medication includes unspecified medications for brain damage, anxiety and major severe depression. It was reported that after the injection, his arm got a little sore on 06Jan2021. On 13Jan2021, patient experienced intense itching; further reported as itching on his hips and on his back which gets red whenever he scratches it. It was also reported that the more he would scratch it, the more intense the itching would get. On an unspecified date in Jan2021, the patient also feels like it is hot. The patient applied EUCERIN cream and CORTISONE 10 for the events "intense itching/ itching on his hips and on his back" and "gets red whenever he scratches it". The patient was scheduled for his second dose on 27Jan2021. Outcome of event "intense itching/ itching on his hips and on his back" was not recovered while for the events "after the injection, his arm got a little sore", "gets red whenever he scratches it" and "feels like it is hot" was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: severe rash on abdomen, sides and back, itchy red bumps; severe rash on abdomen, sides and back, itchy red bumps; severe rash on abdomen, sides and back, itchy red bumps; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3249), via an unspecified route of administration on 17Jan2021 12:45 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 73 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included congestive heart failure and atrial fibrillation. The patient had no allergies to medications, food, or other products. Concomitant medications included acetylsalicylic acid (ASPIRIN), atorvastatin, duloxetine, apixaban (ELIQUIS), hydralazine hydrochloride (HYDRALAZIN). On 21Jan2021 the patient had a severe rash on abdomen, sides and back; itchy, red bumps. The events were reported as non serious. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia, Vaccination site pain
Clinical narrative: pain/soreness in arm where shot was administered; feeling of pain extending beyond arm to back of shoulder; low grade fever; This is a spontaneous report from a non contactable  consumer. A non pregnant female patient of an unspecified age received the first dose of  bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration in the left arm  on 21Jan2021 at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced pain/soreness in arm where shot was administered  on 21Jan2021 with outcome of recovering , feeling of pain extending beyond arm to back of shoulder  on 21Jan2021 with outcome of recovering , low grade fever  on 21Jan2021 with outcome of recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: redness, itchiness, bump on injection site; redness, itchiness, bump on injection site; redness, itchiness, bump on injection site; This is a spontaneous report from a contactable other Health Professional (patient). A 50-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration on 18Jan2021 11:15 at single dose on right arm for covid-19 immunisation. Medical history included hypertension, hyperlipidemia, history of brain tumor. Concomitant medication included levetiracetam, hydrochlorothiazide, valsartan (VALSARTAN HCTZ), atorvastatin and K [potassium]. Historical vaccine included 1st dose of bnt162b2 (Lot: EK5730) on 29Dec2020 at 11:00 on right arm for covid-19 immunisation. The patient experienced redness, itchiness, bump on injection site on 19Jan2021 at 19:30 with outcome of unknown. No treatment was received for the events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Presyncope
Clinical narrative: Lightheaded; intermittent palpitations; felt like passing out; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported COVID-19 VACCINE; lot number: EL3246; expiration date: unknown), intramuscular right arm on 10Jan2021 at a single dose for covid-19 immunization. Medical history allergies to seafood, milk and peanuts. The patient was not diagnosed with covid prior to vaccination. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient previously took tetracycline but had allergies. The patient experienced lightheaded, felt like passing out and had intermittent palpitations on 10Jan2021. No treatment was received for the adverse event. The patient did not covid tested post vaccination. The outcome of the events was recovered on Jan2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: STOMACH STARTED BURNING; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at 14:00 at single dose in left arm for covid-19 immunisation at 51-year-old. Lot number was EL1283. Medical history and concomitant medications were unknown. The patient was not pregnant at the time of vaccination. Past drug history included allergy to Benadril and Vicodin. On 21Jan2021 at 14:00, as soon as the patient got the shot stomach started burning and was still burning. The patient was not treated for the event. The patient did not recover from the event.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Paraesthesia, Vaccination site pain
Clinical narrative: Tingling; site of injection was swollen and red; site of injection was swollen and red; Ache; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) solution for injection, via an unspecified route of administration on left arm on 17Jan2021 07:00 at a single dose for Covid-19 immunization. Medical history included diabetes, cholesterol, and blood pressure. There were no concomitant medications. Patient received the first dose of the Pfizer COVID 19 vaccine on 17Jan2021 at 07:00AM in the left arm. She noticed she had aches and chills midday on Monday 18Jan2021 and also a headache all of which went away as of this morning 19Jan2021. Today (19Jan2021), this morning she woke up and her arm at the site of the injection was swollen and red. Later, she noticed she had tingling (19Jan2021) throughout the lower part of her arm and hand. The tingling was on and off and wasn't there right away. She was scheduled to receive the second dose of the vaccine 06Feb2021. Patient was looking for recommendation on second dose. Outcome of the event ache, chills, headache was recovered on 19Jan2021; tingling was not recovered; while injection was swollen and red was unknown.  No follow-up activities are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Tingling; site of injection was swollen and red; site of injection was swollen and red; Ache; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) solution for injection, via an unspecified route of administration on left arm on 17Jan2021 07:00 at a single dose for Covid-19 immunization. Medical history included diabetes, cholesterol, and blood pressure. There were no concomitant medications. Patient received the first dose of the Pfizer COVID 19 vaccine on 17Jan2021 at 07:00AM in the left arm. She noticed she had aches and chills midday on Monday 18Jan2021 and also a headache all of which went away as of this morning 19Jan2021. Today (19Jan2021), this morning she woke up and her arm at the site of the injection was swollen and red. Later, she noticed she had tingling (19Jan2021) throughout the lower part of her arm and hand. The tingling was on and off and wasn't there right away. She was scheduled to receive the second dose of the vaccine 06Feb2021. Patient was looking for recommendation on second dose. Outcome of the event ache, chills, headache was recovered on 19Jan2021; tingling was not recovered; while injection was swollen and red was unknown.  No follow-up activities are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: severe diarrhea; stomach cramping; vomiting; nausea; fatigue; headaches; This is a spontaneous report from a contactable consumer reporting for herself.  A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142) on 12Jan2021 at 12:00  pm at single dose via an unspecified route of administration on arm left  for COVID-19 immunization. Relevant medical history included high blood pressure and celiac disease. Concomitant medications included unspecified high blood pressure medicine. On 12Jan2021 at 20:00 patient experienced severe diarrhea, stomach cramping, nausea, vomiting, fatigue and headaches. This lasted 10 days so far (as reported). The events were reported as non serious. Treatment received includes Antacid, anti-nausea medication and immodiome. At the time of the reporting the patient had not yet recovered from the events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe diarrhea; stomach cramping; vomiting; nausea; fatigue; headaches; This is a spontaneous report from a contactable consumer reporting for herself.  A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142) on 12Jan2021 at 12:00  pm at single dose via an unspecified route of administration on arm left  for COVID-19 immunization. Relevant medical history included high blood pressure and celiac disease. Concomitant medications included unspecified high blood pressure medicine. On 12Jan2021 at 20:00 patient experienced severe diarrhea, stomach cramping, nausea, vomiting, fatigue and headaches. This lasted 10 days so far (as reported). The events were reported as non serious. Treatment received includes Antacid, anti-nausea medication and immodiome. At the time of the reporting the patient had not yet recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: sore arm and chills; sore arm and chills; This is a spontaneous report from a non-contactable female consumer (patient herself).  A female patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient presented sore arm and chills x 2 days post vaccination. Therapeutic measures taken as result of the events included paracetamol (TYLENOL).  The patient recovered from the events on unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Duodenogastric reflux, Dyspepsia
Clinical narrative: arm soreness for 36hrs; oral temp of 99.7 deg F.; malaise; chills; nausea; indigestion leading to small amounts bile rising into mouth when burping; indigestion leading to small amounts bile rising into mouth when burping; short of breath on usual activities; headache; sore throat; frequent dry cough; This is a spontaneous report from a non-contactable nurse (patient).  A 35-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) in the hospital, via intramuscular route on 15Jan2021 at a single dose for COVID-19 immunization. Medical history includes allergy to sulfa. The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. The patient had a COVID PCR nasal swab in 15Apr2020, 29Sep2020 and in 04Dec2020 all with a negative result. The patient had a COVID antibodies blood test on 09Dec2020 with a negative result. The patient had a COVID test saliva on 23Dec2020 with a negative result. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) via intramuscular route on 28Dec2020 for COVID-19 immunization. The patient did not have other vaccines in four weeks. The patient experienced arm soreness for 36hrs, obtained oral temp of 99.7 deg F, malaise, chills, nausea, indigestion leading to small amounts bile rising into mouth when burping, short of breath on usual activities, headache,  sore throat and frequent dry cough all on 16Jan2021. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: arm soreness for 36hrs; oral temp of 99.7 deg F.; malaise; chills; nausea; indigestion leading to small amounts bile rising into mouth when burping; indigestion leading to small amounts bile rising into mouth when burping; short of breath on usual activities; headache; sore throat; frequent dry cough; This is a spontaneous report from a non-contactable nurse (patient).  A 35-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) in the hospital, via intramuscular route on 15Jan2021 at a single dose for COVID-19 immunization. Medical history includes allergy to sulfa. The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. The patient had a COVID PCR nasal swab in 15Apr2020, 29Sep2020 and in 04Dec2020 all with a negative result. The patient had a COVID antibodies blood test on 09Dec2020 with a negative result. The patient had a COVID test saliva on 23Dec2020 with a negative result. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) via intramuscular route on 28Dec2020 for COVID-19 immunization. The patient did not have other vaccines in four weeks. The patient experienced arm soreness for 36hrs, obtained oral temp of 99.7 deg F, malaise, chills, nausea, indigestion leading to small amounts bile rising into mouth when burping, short of breath on usual activities, headache,  sore throat and frequent dry cough all on 16Jan2021. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: arm soreness for 36hrs; oral temp of 99.7 deg F.; malaise; chills; nausea; indigestion leading to small amounts bile rising into mouth when burping; indigestion leading to small amounts bile rising into mouth when burping; short of breath on usual activities; headache; sore throat; frequent dry cough; This is a spontaneous report from a non-contactable nurse (patient).  A 35-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) in the hospital, via intramuscular route on 15Jan2021 at a single dose for COVID-19 immunization. Medical history includes allergy to sulfa. The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. The patient had a COVID PCR nasal swab in 15Apr2020, 29Sep2020 and in 04Dec2020 all with a negative result. The patient had a COVID antibodies blood test on 09Dec2020 with a negative result. The patient had a COVID test saliva on 23Dec2020 with a negative result. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) via intramuscular route on 28Dec2020 for COVID-19 immunization. The patient did not have other vaccines in four weeks. The patient experienced arm soreness for 36hrs, obtained oral temp of 99.7 deg F, malaise, chills, nausea, indigestion leading to small amounts bile rising into mouth when burping, short of breath on usual activities, headache,  sore throat and frequent dry cough all on 16Jan2021. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Vomiting
Clinical narrative: diarrhea; vomiting; Upset stomach; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: ELO142), via an unspecified route of administration on 15Jan2021 13:00 at a single dose in left arm for COVID-19 immunization. Medical history included Hodgkin lymphoma, thyroid cancer, breast cancer and hypothyroidism, known allergies: allopurinol. There was no other vaccine in four weeks. Concomitant medications: There was other medications in two weeks, but unspecified. The patient experienced upset stomach about 2 hours after vaccination was administered (15Jan2021 15:00), then diarrhea and vomiting both on 16Jan2021 15:00 (as reported) (about 14 hours after vaccine was given). No treatment received. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No COVID prior vaccination and no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Lymph node pain, Lymphadenopathy
Clinical narrative: Bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes - Onset: 12 hours post-vaccination Duration: >40 hours; Bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes - Onset: 12 hours post-vaccination Duration: >40 hours; Fever - Onset: 6 hours post-vaccination Duration: >40 hours; Generalized muscle soreness - Onset: 6 hours post-vaccination Duration - 30 hours; Headache - Onset: 6 hours post-vaccination Duration: >40 hours; Tiredness - Onset: 4 hours post-vaccination Duration: >40 hours; Injection site soreness - Onset: 2 hours post-vaccination; Start Date/Time:17Jan2021 03:00 PM; Start Date/Time: 31Dec2020 01:00 PM; This is a spontaneous report from a non-contactable healthcare professional (patient). A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on left arm on 17Jan2021 15:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. The patient previously took first dose of BNT162B2 (lot number: EL0142) on 31Dec2020 13:00 on left arm for COVID-19 immunization. On 17Jan2021, 2 hours post-vaccination (17:00) patient had injection site soreness; 4 hours post vaccination patient had tiredness for more than 40 hours; and 6 hours post vaccination (21:00) patient had fever for more than more than 40 hours, generalized muscle soreness for 30 hours, and headache for 40 hours. On 18Jan2021, 12 hours post vaccination (03:00), patient had bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes for more than 40 hours. There was no treatment for the events. Patient was not COVID tested post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes - Onset: 12 hours post-vaccination Duration: >40 hours; Bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes - Onset: 12 hours post-vaccination Duration: >40 hours; Fever - Onset: 6 hours post-vaccination Duration: >40 hours; Generalized muscle soreness - Onset: 6 hours post-vaccination Duration - 30 hours; Headache - Onset: 6 hours post-vaccination Duration: >40 hours; Tiredness - Onset: 4 hours post-vaccination Duration: >40 hours; Injection site soreness - Onset: 2 hours post-vaccination; Start Date/Time:17Jan2021 03:00 PM; Start Date/Time: 31Dec2020 01:00 PM; This is a spontaneous report from a non-contactable healthcare professional (patient). A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on left arm on 17Jan2021 15:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. The patient previously took first dose of BNT162B2 (lot number: EL0142) on 31Dec2020 13:00 on left arm for COVID-19 immunization. On 17Jan2021, 2 hours post-vaccination (17:00) patient had injection site soreness; 4 hours post vaccination patient had tiredness for more than 40 hours; and 6 hours post vaccination (21:00) patient had fever for more than more than 40 hours, generalized muscle soreness for 30 hours, and headache for 40 hours. On 18Jan2021, 12 hours post vaccination (03:00), patient had bilateral painful and enlarged cervical, supra-clavicular, and axillary lymph nodes for more than 40 hours. There was no treatment for the events. Patient was not COVID tested post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling hot, SARS-CoV-2 test, Tremor
Clinical narrative: both legs became hot and shaky; both legs became hot and shaky; Elevated blood pressure for 3 days following vaccine; This is a spontaneous report from a contactable other HCP.  A 36-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1283), intramuscular on arm left from 16Jan2021 10:30 to 16Jan2021 10:30 at SINGLE DOSE for covid-19 immunisation.  Medical history included birth control implant. Concomitant medication included etonogestrel (NEXPLANON) for birth control implant. The patient previously took zithromax and experienced Known allergies: Zithromax. On 16Jan2021 10:30, within 2 minutes of vaccine, both legs became hot and shaky. Elevated blood pressure for 3 days following vaccine. Will continue to track bp (blood pressure). The patient underwent lab tests and procedures which Nasal Swab: unknown results (pending results) on 19Jan2021. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Myalgia, Pain in extremity
Clinical narrative: tingling/numbness in face and lips; tingling/numbness in face and lips; tingling/numbness in face and lips; tingling/numbness in face and lips; Muscle aches; slight fever; arm  soreness/sore arm; slight headache; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included shellfish allergy from an unknown date and unknown if ongoing. Concomitant medication included colecalciferol (VIT D3 gummies). The patient was not pregnant. 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 has not been tested for COVID-19. The patient experienced some tingling/numbness in face and lips about 1 1/2 hours after injection, muscle aches, slight fever and arm soreness evening of injection on an unspecified date. The next day on an unspecified date, the patient experienced sore arm and slight heads he for 24 hours after injection. No treatment was given to the patient for the events. The outcome of the events was recovered on unspecified date.  Information on batch/lot number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pyrexia
Clinical narrative: tingling/numbness in face and lips; tingling/numbness in face and lips; tingling/numbness in face and lips; tingling/numbness in face and lips; Muscle aches; slight fever; arm  soreness/sore arm; slight headache; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included shellfish allergy from an unknown date and unknown if ongoing. Concomitant medication included colecalciferol (VIT D3 gummies). The patient was not pregnant. 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 has not been tested for COVID-19. The patient experienced some tingling/numbness in face and lips about 1 1/2 hours after injection, muscle aches, slight fever and arm soreness evening of injection on an unspecified date. The next day on an unspecified date, the patient experienced sore arm and slight heads he for 24 hours after injection. No treatment was given to the patient for the events. The outcome of the events was recovered on unspecified date.  Information on batch/lot number was requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: slight inflammation where I had facial filler injections/inflammation in the same locations around my lips; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3246), via an unspecified route of administration in the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included low potassium but in general good health. The patient has no known allergies. Concomitant medications included metoprolol, progesterone, estradiol, and potassium chloride (K CHLOR). On 12Jan2021 06:00, the day after the shot, the patient noticed slight inflammation where she had facial filler injections. Eight days later she woke up with slightly more inflammation in the same locations around her lips. The patient was not sure if this was a side effect, but seems coincidental. No treatment was given for the event. The patient was not diagnosed with COVID-19 prior vaccination and has not been tested for COVID-19 post vaccination. The last outcome of the event was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: severe body aches; chills; low grade fever; diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 15Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included hypertension, endometrial cancer and radiation therapy from an unknown date and unknown if ongoing. Concomitant medication included lisinopril. The facility where the most recent COVID-19 vaccine was administered was in the hospital. 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 has not been tested for COVID-19. On 17Jan2021 10:00 AM, the patient stated, "the second day I began having severe body aches, chills, low grade fever, diarrhea, and vomiting. I received radiation therapy three days prior to getting Pfizer vaccine". The outcome of the events was recovering. No treatment for the events was given to the patient.  Information on the batch/lot number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Nasal congestion, Nasal pruritus
Clinical narrative: extremely fatigued; congested; ended up losing her sense of smell over the weekend; ended up losing her sense of taste over the weekend; headache and terrible sinuses/sinus headaches; felt the scratchiness in her nose; felt the scratchiness in her throat; This is a spontaneous report from a non-contactable healthcare professional. A 30-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), intramuscular left arm on 07Jan2021 14:00 at a single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took benzoyl peroxide and clindamycin (BENZACLIN) but had allergies. The patient reported that within 4 hours (07Jan2021 06:00 PM), she felt the scratchiness in her throat in and nose. The next morning (08Jan2021), she was extremely fatigued, congested, and ended up losing her sense of taste and smell over the weekend, for the next week. She also had headache and terrible sinuses. Treatment was received for the adverse events. The patient received acetaminophen (TYLENOL) as treatment for sinus headaches. The patient was not diagnosed with Covid prior to vaccination and was not covid tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache, Throat irritation
Clinical narrative: extremely fatigued; congested; ended up losing her sense of smell over the weekend; ended up losing her sense of taste over the weekend; headache and terrible sinuses/sinus headaches; felt the scratchiness in her nose; felt the scratchiness in her throat; This is a spontaneous report from a non-contactable healthcare professional. A 30-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), intramuscular left arm on 07Jan2021 14:00 at a single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took benzoyl peroxide and clindamycin (BENZACLIN) but had allergies. The patient reported that within 4 hours (07Jan2021 06:00 PM), she felt the scratchiness in her throat in and nose. The next morning (08Jan2021), she was extremely fatigued, congested, and ended up losing her sense of taste and smell over the weekend, for the next week. She also had headache and terrible sinuses. Treatment was received for the adverse events. The patient received acetaminophen (TYLENOL) as treatment for sinus headaches. The patient was not diagnosed with Covid prior to vaccination and was not covid tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Epistaxis, Nasal congestion, Pyrexia
Clinical narrative: Fever of 103-104 degrees for 10-12 hours; chills; congestion with bloody mucous; congestion with bloody mucous; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Jan2021 at 08:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included GERD and sleep apnea, both from unspecified dates and unspecified if ongoing. It was reported that the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported; however, it was reported that there were no other medications taken in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 27Dec2020 at 08:15 (at the age of 45-years-old) in the left arm for COVID-19 vaccination. On 16Jan2021 at 03:00 the patient experienced fever of 103-104 degrees for 10-12 hours, chills and congestion with bloody mucous. It was reported that the patient did not receive treatment for the events. The clinical outcomes of the events fever of 103-104 degrees for 10-12 hours, chills and congestion with bloody mucous were all recovered/resolved on unspecified dates in Jan2021. 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Malaise
Clinical narrative: diarrhea; weakness; fatigue; malaise; This is a spontaneous report from a contactable nurse reported for herself. A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 24Dec2020 08:00 AM at SINGLE DOSE for covid-19 immunisation. Medical history included childhood asthma, pancreatitis acute, allergies: sulfa and peanuts, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took ceclor and experienced drug allergy. On 24Dec2020 03:00 PM, the patient experienced diarrhea, weakness, fatigue and malaise for 2 days, all with outcome recovered. No treatment for these events. The patient has no covid prior vaccination. The patient has no covid tested post vaccination. The patient is not pregnant.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Herpes simplex test, Nausea
Clinical narrative: multiple sores/lesions on her labia minora, red/purple in color; Fever; Aches; Chills; Headache; Fatigue; Nausea; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), intramuscular on the right arm, on 11Jan2021 18:00 at a single dose for COVID-19 immunization. The first dose was received on 21Dec2020 16:00 in which the patient experienced a small sore on the vagina. Medical history included birth control. Patient was not pregnant at the time of vaccination. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC).  After the 2nd vaccine a few days later, on 12Jan2021 18:00, patient had multiple sores/lesions on her labia minora, red/purple in color. She also had fever, aches, chills, headache, fatigue, and nausea. Patient went to gyno and she tested her, and swabbed the sores for everything you could think of and everything came back negative. Treatment was received for the event and antiviral (ValAcyclovir) in case HSV1/HSV2 swab came back positive - but they did not. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vulval disorder
Clinical narrative: multiple sores/lesions on her labia minora, red/purple in color; Fever; Aches; Chills; Headache; Fatigue; Nausea; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), intramuscular on the right arm, on 11Jan2021 18:00 at a single dose for COVID-19 immunization. The first dose was received on 21Dec2020 16:00 in which the patient experienced a small sore on the vagina. Medical history included birth control. Patient was not pregnant at the time of vaccination. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC).  After the 2nd vaccine a few days later, on 12Jan2021 18:00, patient had multiple sores/lesions on her labia minora, red/purple in color. She also had fever, aches, chills, headache, fatigue, and nausea. Patient went to gyno and she tested her, and swabbed the sores for everything you could think of and everything came back negative. Treatment was received for the event and antiviral (ValAcyclovir) in case HSV1/HSV2 swab came back positive - but they did not. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain
Clinical narrative: Headache; Pain at site of injection; Chills; This is a spontaneous report from a non-contactable healthcare professional (HCP) (Patient). A 43-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 15Jan2021 19:45 at a single dose in left arm for COVID-19 immunization. There were no medical history or concomitant medications. No known allergies. No other vaccine in four weeks and no other medications in two weeks. On 16Jan2021, the patient experienced headache, pain at site of injection, chills. No treatment received for events. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No COVID prior vaccination and no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021.   No follow-up attempts are possible. Information about batch/ lot number cannot be obtained. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Illness, Pain in extremity
Clinical narrative: painful arm; fatigue/body fatigue/she felt fatigued; sick; abdominal cramping; diarrhea; This is a spontaneous report from a contactable nurse, the patient. This 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3246),  dose 1, single dose via an unspecified route of administration in the left upper deltoid on 18Jan2021 at 18:00 (at the age of 52 years-old) for COVID-19 vaccination. Relevant medical history included ongoing diabetes type 2  in 2011. Concomitant medications were unknown. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 18Jan2021, the patient experienced a painful arm, more painful than other vaccines and then she had body fatigue about 2 hours after the injection. illness, diarrhea 3 times and abdominal cramping that was painful. Seriousness was not provided. It was unknown if any  treatment was given. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of events, painful arm and fatigue/body fatigue was not recovered. The clinical outcome of events sick, abdominal cramping and diarrhea was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Inappropriate schedule of product administration, Nausea
Clinical narrative: read around the site and more swollen; fever of 101 or less; chills; injection site pain; Headache; body aches; nausea; read around the site and more swollen; administration date 15Jan2021; This is a spontaneous report from a contactable nurse (patient herself). A 33-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), intramuscular in the left arm on 15Jan2021 16:00 at single dose for COVID-19 immunisation.  Medical history included ulcerative colitis, depression, and incomplete lupus. 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. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included vedolizumab (ENTYVIO), and fluoxetine hydrochloride (PROZAC). The patient previously took first dose of bnt162b2 (lot number: EK9231, expiry date not reported), intramuscular in the right arm on 29Dec2020 at 12:00 PM at single dose for COVID-19 immunisation. The patient verbalized, "The day after the second vaccine I had a fever of 101 or less, chills, injection site pain, headache, body aches especially in my lower back and neck ,and some nausea. I took Tylenol which helped with the fever, but the headache continued that day. On the second to hear from vaccine I continued to have a fever and chills with some body aches but improving. On the second day I noticed the injection site was not only painful but read around the site and more swollen. Currently it is Tuesday and I no longer have a fever but continue to have injection site pain, redness, swelling. I have an appointment to follow up with my doctor for any further recommendations." Clinical outcome of fever was recovered on an unspecified date; for pyrexia, chills, and body aches was resolving; while for the other events was unknown.