chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Rash pruritic, Vaccination site pain
Clinical narrative: palpitations; 3 days straight skin rash with itching on her left leg; muscle soreness on arm of injection site; muscle soreness on arm of injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received the first dose of bnt162b2 (Covid 19 vaccine, brand: Pfizer) via an unspecified route of administration in right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization in a hospital. Medical history included GERD and Strep throat, both from unknown dates.  Concomitant medication included benzylpenicillin (PENICILLIN). The patient did not receive other vaccine in four weeks. The patient experienced palpitations - 3 days straight skin rash with itching on her left leg, muscle soreness on arm of injection site, all on 31Dec2020 11:00.  The events were reported as non-serious. The patient did not receive treatment for the events. The patient had not recovered from the events.   Information on the lot number/Batch number was requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Rash papular, Rash pruritic, SARS-CoV-1 test, SARS-CoV-2 test
Clinical narrative: Some skin rashes as reaction when there is an allergen; Rash/They red bumps and itches; Rash/They red bumps and itches; This is a spontaneous report from a contactable other hcp.  A 49-years-old female patient started to receive  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140), intramuscular (arm left) on 28Dec2020 12:00 at single dose (dose 1) for COVID-19 immunization. Medical history included psoriasis from an unknown date and allergies to medications, food, or other products (unspecified). The patient was taking unspecified concomitant medications including a vaccine within 2 weeks. Patient did not receive other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 with unknown results. On 29Dec2020 04:00, the patient had some skin rashes as a reaction when there is an allergen. After the vaccines, she has been having occasional rashes that pops at different places. They were red bumps and itches. She stated she needed to keep antihistamines CLARITIN/BENADRYL on the clock. Event outcome was not recovered. The patient underwent lab tests and procedures which included COVID test (Nasal swab): negative on 24Nov2020. Event outcome was not recovered. Patient considered the events as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo, Vomiting
Clinical narrative: nausea; vomiting/Severe bout of vomiting this morning; vertigo; This is a spontaneous report from a contactable consumer, the patient.  A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right deltoid on 30Dec2020 at 15:00 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 02Jan2021 at 05:00, the patient experienced nausea, vomiting/severe bout of vomiting, and vertigo. The patient experienced these same symptoms again on 02Jan2021 at 20:00.  The clinical outcomes of nausea, vomiting, and vertigo were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Mild soreness left arm for one day post vaccination; This is a spontaneous report from a contactable physician (patient). A 55-year-old male patient received bnt162b2 (BNT162B2 also reported as Covid-19 vaccine; lot number: EJ1685; expiration date: unknown), via an unspecified route of administration left arm on 19Dec2020 05:00 PM at a single dose for covid-19 vaccination. The patient has no medical history. The patient has no known allergies. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications the patient received within 2 weeks of vaccination. It was reported that the patient received the COVID-19 vaccine in a hospital on 19Dec2020 05:00 PM. On 20Dec2020, the patient had mild soreness left arm for one day post vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient considered the events as non-serious. No treatment received for the adverse event. The outcome of the event was recovered on an unspecified date.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza virus test, SARS-CoV-2 test positive
Clinical narrative: was diagnosis with COVID-19 through nasopharyngeal swab today, 02Jan2021; was diagnosis with COVID-19 through nasopharyngeal swab today, 02Jan2021; This is a spontaneous report from a contactable pharmacist (patient himself).  A 34-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EJ1685, expiry date not reported), via an unspecified route of administration in his right arm on 23Dec2020 15:30 at single dose, for Covid-19 vaccination. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included bupropion. The patient informed that he was diagnosed with Covid-19 through nasopharyngeal swab (COVID-19 Nucleic Acid Amplification test) on 02Jan2021 01:00 and Influenza virus test was unknown results (02Jan2021). It was unknown if there was a treatment used. The outcome of event was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: redness at injection site; Mildly tender injection site; slight swelling at injection site; This is a spontaneous report from a contactable nurse. A 64-year-old non-pregnant female patient received bnt162b2 (BNT162B2 also reported as COVID-19 vaccine; lot number: EL 3246; expiration date: unknown), via an unspecified route of administration left arm on 02Jan2021 15:45 at a single dose for covid-19 vaccination. Medical history included HTN (hypertension) and controlled PAT (paroxysmal atrial tachycardia). Concomitant medication included unspecified medication. The patient previously took cephalexin [reported as Cephlexin]. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID-19 vaccine in a public health clinic/facility. It was reported that the patient had mildly tender injection site, slight swelling and redness at injection site on 02Jan2021 08:00 PM. The reporter did not consider the event serious. The patient was not tested for COVID-19 since the vaccination. The patient did not received treatment for the adverse event. The outcome of the events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache and nausea with vomiting; Headache and nausea with vomiting; Headache and nausea with vomiting; This is a spontaneous report from a contactable Other HCP (patient). A 29-year-old female patient received the first dose of BNT162B2 (Lot number and expiry date not reported), intramuscular on 30Dec2020 07:15 at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 01Jan2021, the patient experienced headache and nausea with vomiting. No treatment received for all the events. The outcome of the events was recovered on an unspecified date.    The following information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days after vaccine; Body aches, low grade fever, chills 4 days after vaccine; This is a spontaneous report from a contactable other HCP (patient).  A 32-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration on 28Dec2020 09:45 at single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism from an unknown date. Concomitant medication included levothyroxine and topiramate. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced body aches, low grade fever, chills 4 days after vaccine on 01Jan2021 15:30. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 02Jan2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: herpes zoster on the left and mid back in the L1 distribution; This is a spontaneous report from a contactable physician (patient). A 34-year-old non pregnant female patient received bnt162b2 (lot number: EK9231), via an unspecified route of administration on 22Dec2020 in left arm at single dose for Covid-19 immunization. Medical history was none. There were no other medications the patient received within 2 weeks of vaccination. The most recent COVID-19 vaccine was administered 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 unspecified date, the patient experienced herpes zoster on the left and mid back in the L1 distribution. She was not otherwise immunosuppressed and never had zoster before. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered with sequel (reported as Recovered with lasting effects). Therapeutic measures were taken as a result of the event which included Valacyclovir. The event was considered as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Middle insomnia, Pain
Clinical narrative: fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhausted; sore arm; woke her up briefly; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included spending 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. The patient has no known allergies. The patient has no covid prior vaccination, and she was not tested for covid post vaccination. The patient's concomitant medication included multivitamin. The patient did not receive other vaccine in last four weeks. The patient was vaccinated on 31Dec2020 at 10am for her 1st Pfizer vaccine. No symptoms for 6-8 hrs. By bedtime at 06:00 PM, she experienced headache, achey, tired, and sleeping on her sore arm woke her up briefly. Next day on 01Jan2021, more achey, exhausted, fever of 2-3 degrees, slept most of the day and didn't feel well at all. She could tell that her body was fighting something, but she is much better 48 hours out. The patient did not receive any treatment for the reported adverse events. She stated she had no regrets. She stated that she loves Pfizer, because it has given hope. She just wasn't expecting any side effects after the 1st vaccine, only for the 2nd. Anecdotally, it seemed her hospital coworkers who have had Covid react more to the 1st vaccine, possibly for them, 1st vaccine is like the 2nd. She doesn't know if she has had Covid, but as an Acute Care PT on Covid units, she spends 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. She stated that possible her immune system already recognizes Covid. She is curious. No complaints, only curious. Again, she said thank you. She stated that she has seen too many good people die this year, thus, she didn't hesitate on the vaccine. The outcome of the events was recovered in Jan2021. The report was considered non-serious.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence
Clinical narrative: fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhausted; sore arm; woke her up briefly; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included spending 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. The patient has no known allergies. The patient has no covid prior vaccination, and she was not tested for covid post vaccination. The patient's concomitant medication included multivitamin. The patient did not receive other vaccine in last four weeks. The patient was vaccinated on 31Dec2020 at 10am for her 1st Pfizer vaccine. No symptoms for 6-8 hrs. By bedtime at 06:00 PM, she experienced headache, achey, tired, and sleeping on her sore arm woke her up briefly. Next day on 01Jan2021, more achey, exhausted, fever of 2-3 degrees, slept most of the day and didn't feel well at all. She could tell that her body was fighting something, but she is much better 48 hours out. The patient did not receive any treatment for the reported adverse events. She stated she had no regrets. She stated that she loves Pfizer, because it has given hope. She just wasn't expecting any side effects after the 1st vaccine, only for the 2nd. Anecdotally, it seemed her hospital coworkers who have had Covid react more to the 1st vaccine, possibly for them, 1st vaccine is like the 2nd. She doesn't know if she has had Covid, but as an Acute Care PT on Covid units, she spends 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. She stated that possible her immune system already recognizes Covid. She is curious. No complaints, only curious. Again, she said thank you. She stated that she has seen too many good people die this year, thus, she didn't hesitate on the vaccine. The outcome of the events was recovered in Jan2021. The report was considered non-serious.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: Joint pain; Pain at injection site; Fever of 100.4; This is a spontaneous report from a contactable healthcare professional. A 55-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 17Dec2020 14:00 in right arm at single dose for COVID-19 immunization. Medical history included allergies to Ovaltine from an unknown date and unknown if ongoing. Concomitant medication included atorvastatin calcium (LIPITOR). On 25Dec2020, the patient experienced pain at injection site x 2 days, fever of 100.4 and joint pain at day 7. The facility where the most recent COVID-19 vaccine was administered was in a military base. 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 outcome of event pain at injection site was recovered in Dec2020 and the outcome of the remaining events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Fatigue, Headache, Nausea
Clinical narrative: fever; chills; nausea; headache; fatigue; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; This is a spontaneous report from a contactable physician (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 19Dec2020 at a single dose for Covid-19 immunization. Medical history included pneumonia from 03Aug2020 to 08Aug2020. Concomitant medications were not reported. Patient had the first COVID-19 vaccine dose on 19Dec2020. Patient said he had a "pretty strong reaction" of fever, chills, nausea, headache, fatigue in Dec2020. Felt ill until day 2, started feeling better on day 3. Patient also had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn" in Dec2020. Patient also mentioned he had his blood work last 30Dec2020 and confirmed he has IgG antibodies. Patient then asked "I want to get the second dose, is it okay to get the vaccine?" The outcome of the events 'fever, chills, nausea, headache, fatigue' was recovering while unknown for the other events.  Information about Lot/Batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain
Clinical narrative: fever; chills; nausea; headache; fatigue; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; This is a spontaneous report from a contactable physician (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 19Dec2020 at a single dose for Covid-19 immunization. Medical history included pneumonia from 03Aug2020 to 08Aug2020. Concomitant medications were not reported. Patient had the first COVID-19 vaccine dose on 19Dec2020. Patient said he had a "pretty strong reaction" of fever, chills, nausea, headache, fatigue in Dec2020. Felt ill until day 2, started feeling better on day 3. Patient also had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn" in Dec2020. Patient also mentioned he had his blood work last 30Dec2020 and confirmed he has IgG antibodies. Patient then asked "I want to get the second dose, is it okay to get the vaccine?" The outcome of the events 'fever, chills, nausea, headache, fatigue' was recovering while unknown for the other events.  Information about Lot/Batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Lymph node pain, Lymphadenopathy
Clinical narrative: swollen/sore lymph node in left neck/clavicle area after about several days; swollen/sore lymph node in left neck/clavicle area after about several days; This is a spontaneous report from a contactable nurse (patient herself). A 53-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number: EL0140; expiration date: not known), via an unspecified route of administration on 24Dec2020 08:00 (left arm) at single dose for covid-19 immunisation. Medical history included depression, hypertension (HTN), and high cholesterol. The patient had allergies with sulfa and beta blockers. The patient's concomitant medications were not reported. The patient previously took pravastatin sodium (PRAVACHOL) and experienced allergies. The patient was vaccinated at a hospital and was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2 vaccine and received other medications within 2 weeks of vaccination but were unspecified. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced swollen/sore lymph node in left neck/clavicle area after about several days on an unspecified date (reported as "01Dec2020", pending clarification). The reported events were non-serious. The patient did not receive treatment for these reported events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: small rash that has been getting larger; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age (reported as age: 30, unit: unknown) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Laboratory employee received her first dose of vaccine on 19Dec2020. On 01Jan2021, she developed a small rash that has been getting larger that she has been treating with Benadryl. She is calling to see if she can receive the second dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Off label use, Product use issue, Urticaria
Clinical narrative: mild hives on the chest a few hours after receiving the vaccine; her asthma kept flaring up with shortness of breath; her asthma kept flaring up with shortness of breath; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported for both herself and baby. This is a mother report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a breastfeeding mother. The patient experienced mild hives on the chest a few hours after receiving the vaccine and her asthma kept flaring up with shortness of breath. She took Benadryl and everything went away. Outcome of the events was recovered. The patient asked if she had side effects to the vaccine is it ok for her to get the second dose.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003624 mother/baby
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Pain, Pain in extremity
Clinical narrative: whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was excruciating/the vaccine amplified the pain; sore arm; progressed to Flu like symptoms; Arthritis in her knee/vaccine amplified the pain; This is a spontaneous report from a contactable healthcare professional. A 42-year-old female patient received bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; lot number: EH 9899; expiration date: unknown), intramuscular left arm on 30Dec2020 20:30 at a single dose for covid-19 vaccination. Medical history included arthritis in my knee, labrum hip tear, HSV2 (herpes simplex virus type 2), haven't had an OB [pending clarification] in over 2 years and herpes. Concomitant medication included omeprazole (PRILOSEC), ondansetron (ZOFRAN MELT), alprazolam (XANAX; reported as Xanax ER), lamotrigine (LAMICTAL), famotidine (PEPCID AC) , colecalciferol (VITAMINS D3; reported as vitamin D), ascorbic acid (VIT-C) and zinc. The reporter stated that after the vaccine (31Dec2020 12:00), the patient had a sore arm and it progressed to Flu like symptoms and pain in her joints. Her whole body ached. The patient mentioned that she has arthritis in her knee and a labrum hip tear, and the vaccine amplified the pain. She also has HSV2 and she haven't had an OB in over 2 years, and she had a bad OB and shingles like pain in her butt/legs/groin to where her skin hurt to touch it. The pain was excruciating. The patient did not received treatment for the adverse event. The patient considered the event as non-serious. She received the COVID-19 vaccine in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Investigation, Throat tightness
Clinical narrative: also had a very hoarse voice; throat starting feeling a little tight; This is a spontaneous report from a contactable Other HCP (patient). A 24-year-old female patient received first dose of BNT162B2 (Lot number: EK9231), intramuscular on 31Dec2020 15:45 at single dose in the left arm for COVID-19 immunization. Medical history included chronic sinusitis from an unknown date and seasonal allergies from an unknown date. Concomitant medication included azithromycin. The patient previously took penicillin and experienced allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that within 10 minutes of receiving the vaccine on 31Dec2020, the patient's throat started feeling a little tight. However, she did not have trouble breathing. The feeling continued for the next 3 hours. She also had a very hoarse voice. The ER suggested that she will be seen. They did an exam and gave her Benadryl which completely resolved her symptoms. The events resulted in emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: she received the Pfizer vaccine on 29Dec2020. She tested positive for coronavirus on 01Jan2021. Is the efficacy of the vaccine after the second dose?; tested positive for coronavirus; This is a spontaneous report from a contactable nurse reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. VA nurse calling stating that she received the Pfizer vaccine on 29Dec2020. She tested positive for coronavirus on 01Jan2021. She wanted to know how to proceed with getting her second vaccine, and if the efficacy of the vaccine is after the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and Coronavirus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Nausea
Clinical narrative: had intermittent abdominal pain that hit at 72 hours (late last night, early this morning); began with nausea and it comes in waves/continues in waves along with the nausea, it comes and goes from moderate severe to low grade; headache; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID 19 vaccine on Wednesday close to noon and reported that, "I didn't notice any symptoms until yesterday morning (02Jan2021), I began with nausea and it comes in waves. I did have headache that began Friday evening (01Jan2021) and continues in waves along with the nausea, it comes and goes from moderate severe to low grade. I then had intermittent abdominal pain that hit at 72 hours (late last night, early this morning, 03Jan2021). No diarrhea associated with it. I can't find abdominal pain on the paperwork that was provided to me. is this also one of the expected or reported side effects?" The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: received vaccine on 17Dec2020, then tested positive for coronavirus on 25Dec2020; received vaccine on 17Dec2020, then tested positive for coronavirus on 25Dec2020; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received vaccine on 17Dec2020, then tested positive for coronavirus on 25Dec2020. The patient was calling to inquire if she can get second vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Malaise, Nasopharyngitis
Clinical narrative: headache; sore throat; pulse stayed up from 120 - 140 bpm; didn't sleep other than that first night except for about 2 hours at a time.; felt like I was about to get a cold, but then it went away; immediately felt sleepy; couldn't function and wasn't feeling well; tired /fatigue; This is a spontaneous report from a non-contactable Nurse.   A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 22Dec2020 at single dose for COVID-19 immunization. Relevant medical history included high blood pressure. Concomitant medications included vitamin B. Patient informed that since an unspecified date in Dec2020 after receiving vaccine she immediately felt sleepy, she asked other's that I work with if they felt sleepy. (None reported feeling sleepy). Patient went back to work and took Vitamin B and Coca Cola. She went to sleep 8 pm that evening and stayed asleep all night, and woke up at 6:-6:30 am. On 23Dec2020 she called out of work because so tired. I went to work the next day (Thursday, 24Dec2020) and couldn't function, she wasn't feeling well but stayed for her entire shift.  She woke up the next day with a sore throat. From Wednesday (23Dec2020) her pulse stayed up from 120-140 bpm. The pulse went back to normal on the following Wednesday, it took a week for it to get back to normal. She didn't sleep other than that first night except for about 2 hours at a time. Patient felt like she was about to get a cold, but then it went away. She took her soup and didn't go to work for a week. Patient returned to work on Monday the 28Dec2020. All of her symptoms (fatigue, headache, sore throat) subsided on Wednesday 30Dec2020.  Patient also reported  that a  Co-worker told her that the day after the vaccine said she had chills, not feeling well. Her friend said she will call to report and did not want to provide any demographic information on her behalf. Another Nurse - felt congested and worried. (Yesterday), also no demographic information provided. The Provider (he participated in the clinical trial and had the placebo) received the vaccine the same day as she and he will be calling also. He had body aches and headache.  No follow up attempts are possible; Information on lot/batch cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pulse abnormal, Sleep disorder, Somnolence
Clinical narrative: headache; sore throat; pulse stayed up from 120 - 140 bpm; didn't sleep other than that first night except for about 2 hours at a time.; felt like I was about to get a cold, but then it went away; immediately felt sleepy; couldn't function and wasn't feeling well; tired /fatigue; This is a spontaneous report from a non-contactable Nurse.   A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 22Dec2020 at single dose for COVID-19 immunization. Relevant medical history included high blood pressure. Concomitant medications included vitamin B. Patient informed that since an unspecified date in Dec2020 after receiving vaccine she immediately felt sleepy, she asked other's that I work with if they felt sleepy. (None reported feeling sleepy). Patient went back to work and took Vitamin B and Coca Cola. She went to sleep 8 pm that evening and stayed asleep all night, and woke up at 6:-6:30 am. On 23Dec2020 she called out of work because so tired. I went to work the next day (Thursday, 24Dec2020) and couldn't function, she wasn't feeling well but stayed for her entire shift.  She woke up the next day with a sore throat. From Wednesday (23Dec2020) her pulse stayed up from 120-140 bpm. The pulse went back to normal on the following Wednesday, it took a week for it to get back to normal. She didn't sleep other than that first night except for about 2 hours at a time. Patient felt like she was about to get a cold, but then it went away. She took her soup and didn't go to work for a week. Patient returned to work on Monday the 28Dec2020. All of her symptoms (fatigue, headache, sore throat) subsided on Wednesday 30Dec2020.  Patient also reported  that a  Co-worker told her that the day after the vaccine said she had chills, not feeling well. Her friend said she will call to report and did not want to provide any demographic information on her behalf. Another Nurse - felt congested and worried. (Yesterday), also no demographic information provided. The Provider (he participated in the clinical trial and had the placebo) received the vaccine the same day as she and he will be calling also. He had body aches and headache.  No follow up attempts are possible; Information on lot/batch cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: chills; headache; body ache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 41; unit: unknown) received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number and expiration date: not known), on 24Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got vaccinated on 24Dec2020 and after 1 week, which was exactly last Friday afternoon (01Jan2021), she started to experienced chills, headache and body ache. The patient wanted to know if this is normal and how long before it goes away. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Tension headache, Vaccination site pain
Clinical narrative: Mild to moderate pain at injection site.; Severe tension headache that started approximately 24 hours after injection and lasted approximately 18 hours; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received the first dose of bnt162b2 (COVID 19 vaccine, brand: Pfizer) lot no: EH9899, via an unspecified route of administration in left arm on 27Dec2020 12:30 at a single for COVID-19 immunization in workplace clinic. There were no relevant medical history and concomitant medications. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. No known allergies. The patient did not receive other vaccines in four weeks or other medications in two weeks. On 28Dec2020 at 12:00 pm, the patient experienced mild to moderate pain at injection site. Severe tension headache that started approximately 24 hours after injection and lasted approximately 18 hours. The events were alleviated by single acetaminophen (TYLENOL) and sleep. The events were reported as non-serious. The patient recovered from the events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a contactable healthcare professional.  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at the left arm on 31Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital.  The patient's medical history and concomitant medications were not reported.  The patient experienced dizziness, diarrhea, sore arm, headache, fatigued, and chills on 01Jan2021. The patient did not received any treatment for the evets. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19 via a blood test in Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient recovered from the events on an unknown date in Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a contactable healthcare professional.  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at the left arm on 31Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital.  The patient's medical history and concomitant medications were not reported.  The patient experienced dizziness, diarrhea, sore arm, headache, fatigued, and chills on 01Jan2021. The patient did not received any treatment for the evets. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19 via a blood test in Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient recovered from the events on an unknown date in Jan2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Nervousness
Clinical narrative: feeling very shaky and dizzy when I stand up.; feeling very shaky and dizzy when I stand up.; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19, lot number and expiry date not reported), intramuscular on 03Jan2021 13:15 at a single dose on right arm for COVID-19 immunisation. Medical history included none. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient reported, "I'm feeling very shaky and dizzy when I stand up on 03Jan2021 14:30. No treatment was given for the events. The outcome of the events was unknown. The events were considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was in Nursing Home/Senior Living Facility. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19.  Information about lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Injection site soreness only first 24hrs.; fatigue; chills; fever of 99.8 F; body aches; headache; vomiting; Diarrhea; This is a spontaneous report from a contactable other health professional (patient). A 44-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 22Dec2020 14:00 at single dose at right arm for COVID-19 immunization. Medical history included Asthma, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), omeprazole. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that injection site soreness only first 24hrs. At 30 hrs, fatigue, chills, fever of 99.8 Fahrenheit (F), body aches, headache, vomiting and diarrhea. These lasted for 24hrs. Diarrhea persisted for 48 hrs. To the best of his knowledge he had not ever been exposed to Covid. The events onset date reported as 23Dec2020 23:00 (pending clarification). Treatment received for the adverse event reported as "Called nurse line". The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Injection site soreness only first 24hrs.; fatigue; chills; fever of 99.8 F; body aches; headache; vomiting; Diarrhea; This is a spontaneous report from a contactable other health professional (patient). A 44-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 22Dec2020 14:00 at single dose at right arm for COVID-19 immunization. Medical history included Asthma, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), omeprazole. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that injection site soreness only first 24hrs. At 30 hrs, fatigue, chills, fever of 99.8 Fahrenheit (F), body aches, headache, vomiting and diarrhea. These lasted for 24hrs. Diarrhea persisted for 48 hrs. To the best of his knowledge he had not ever been exposed to Covid. The events onset date reported as 23Dec2020 23:00 (pending clarification). Treatment received for the adverse event reported as "Called nurse line". The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: became positive for covid 19; became positive for covid 19; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration on 22Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient she received covid vaccine on 22Dec2020 and on 30Dec2020 became positive for covid 19. The patient wanted to know when she can schedule her 2nd dose. Outcome of the event was unknown.  Information about Batch/Lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Cough, Diarrhoea, Dyspnoea
Clinical narrative: slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positive for covid 19 virus; feel tired; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was Diagnosed with covid 19 virus on the 31Dec2020, she was set to have the second vaccine on the 10Jan2021. She wanted to know if she can get the second dose and if so, when. Also asked if she should get tested before taking the 2nd dose of the covid 19 vaccine. Her Adverse effects are sore arm on vaccination day (20Dec2020), and she began to feel tired on 27Dec2020 and thought that was normal. She went to a Christmas eve party 24Dec2020 and no one was masked, friend had several people from work tested positive. was tested and was positive for covid 19 virus on 31Dec2020. She also was experiencing slight cough, diarrhea (which is normal for her), shortness of breath is improving and she had no sense of smell but she was able to taste. The outcome of event shortness of breath is recovering. The outcome of other events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.