chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal discomfort, Paraesthesia, SARS-CoV-2 test
Clinical narrative: 30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was "asleep").  The sensation moved to shoulder, traps, and face after about 30-45 minutes; 30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was "asleep").  The sensation moved to shoulder, traps, and face after about 30-45 minutes.; numbness/tingling mostly right side (arm, shoulder, face); This is a spontaneous report from a contactable consumer, the patient. A 51 -year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, 0.3 mL, lot number: EL0140), via an unspecified route of administration on 05Jan2021 at 05:30 PM, (at the age of 51 years-old)  as a single dose in the right arm for COVID-19 vaccination. Medical history included Hashimoto's thyroiditis, hypertension and asthma. The patient was allergic to gadolinium MRI contrast, morphine (plus standard environmental allergies). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included allergy shots weekly, vitamin C, vitamin D3 and zinc quercetin. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 06:15 PM, (also reported as 30 min after injection), the patient's right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"). The sensation moved to the shoulder, traps, and face after about 30-45 minutes. The sensation started to subside after about 3-4 hours. There was never ever any weakness or sensation of throat, hives or rash, breathing issues or pain at injection site. Just a numbness/tingling mostly right side (arm, shoulder, face). The lower extremities or left side was not affected. The events were reported as non-serious. Laboratory data included a COVID-19 test (nasal swab) on 15Oct2020 which was negative. The patient was not treated for right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), the sensation moved to the shoulder, traps, and face. right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), sensation moved to the shoulder, traps, and face. The clinical outcome of right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), sensation moved to the shoulder, traps, and face was recovering. It was also reported that since the vaccination, the patient has been tested for COVID-19 (nasal swab) on 15Oct2020 .
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: Developed covid symptoms 21Dec, tested positive 26Dec; Developed covid symptoms 21Dec, tested positive 26Dec; This is a spontaneous report from a contactable physician reporting for a patient.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient developed COVID symptoms 21Dec2020, tested positive 26Dec2020. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. However individuals may not be protected until at least 7 days after their second dose of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: received the first dose of the Pfizer COVID vaccine on 28Dec2020 and tested positive for COVID 03Jan2021 (nasal swab) & symptomatic; received the first dose of the Pfizer COVID vaccine on 28Dec2020 and tested positive for COVID 03Jan2021 (nasal swab) & symptomatic; This is a spontaneous report from a contactable Nurse (patient). A female patient of unspecified age received BNT162B2 (Pfizer, lot number: EL0140) first dose on 28Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was tested positive for COVID 03Jan2021 (nasal swab) & symptomatic, her second dose of the vaccine is scheduled 18Jan2021. She was wondering if she still get the second dose. The outcome of the events was unknown.; Sender's Comments: The reported tested positive for COVID  (nasal swab) & symptomatic after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pain; Overall feeling of unwell; This is a spontaneous report from a non-contactable other HCP (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 31Dec2020 at single dose on arm right for COVID-19 immunisation. Medical history included fibromyalgia and known allergies: Rose hip tea and Diclofenac. No COVID prior vaccination. No pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included zolpidem tartrate (AMBIEN) and duloxetine hydrochloride (CYMBALTA). The patient experienced fatigue, dizziness, light-headed, nausea, diarrhea, swelling of face, muscle pain, chills, joint pain, overall feeling of unwell; all on 01Jan2021. No treatment received for the events. Outcome of events was not recovered. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Swelling face
Clinical narrative: Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pain; Overall feeling of unwell; This is a spontaneous report from a non-contactable other HCP (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 31Dec2020 at single dose on arm right for COVID-19 immunisation. Medical history included fibromyalgia and known allergies: Rose hip tea and Diclofenac. No COVID prior vaccination. No pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included zolpidem tartrate (AMBIEN) and duloxetine hydrochloride (CYMBALTA). The patient experienced fatigue, dizziness, light-headed, nausea, diarrhea, swelling of face, muscle pain, chills, joint pain, overall feeling of unwell; all on 01Jan2021. No treatment received for the events. Outcome of events was not recovered. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Investigation, Lumbar puncture, Magnetic resonance imaging brain, Paraesthesia
Clinical narrative: left V2 and V3 distribution numbness/bilateral foot numbness; bilateral entire lower extremity paraesthesias; This is a spontaneous report from a contactable other hcp. A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. The patient had left V2 and V3 distribution numbness 6 days after vaccine which resolved in 2 days. The patient had bilateral foot numbness 7 days after vaccine which resolved approximately 5 days later. After the foot numbness, the patient had progressively increasing bilateral entire lower extremity paraesthesias since Dec2020 (resolved in 5 days). The patient never had any motor weakness, or delayed tendon reflexes. No other medical conditions. No cause identified on LP, MRI brain, C, T, and L spine, or labs. Presuming vaccine related given relative likelihood of other conditions on differential diagnosis, timing, and resolution. The outcome of the event left V2 and V3 distribution numbness was recovered on 27Dec2020, of the event bilateral foot numbness was recovered on 31Dec2020, of the event bilateral entire lower extremity paraesthesias was recovered on an unspecified date.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Drug interaction, Fatigue
Clinical narrative: Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering if being on Stelera made the symptoms from the COVID Vaccine worse; extreme/ severe fatigue; lightheaded; soreness around injection/Sore arm; felt run down; chills; This is a spontaneous report from a contactable nurse (patient). This 36-years-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via unspecified route at left arm on 21Dec2020 14:00 at single dose for COVID-19 immunization; she also started to receive ustekinumab (STELERA injection), via subcutaneous from 2017 (last injection on 04Nov2020) at unspecified dose every 12 weeks for psoriasis. Medical history was none. Concomitant medications were not reported. No additional vaccines administered on same date of Pfizer vaccine. Historical vaccine included influenza vaccine on Nov2020 for immunization, which was 5 weeks prior to COVID vaccine. Vaccination facility type was hospital. At night of vaccination on 21Dec2020, patient felt run down, thought she had chills. She did not have fever. She woke up next day 22Dec2020 with sore arm/ soreness around injection, was otherwise fine. Day 2, 3, and 4 post vaccine was sick (23Dec2020). She had a sore throat, headache, and extreme/ severe fatigue on 23Dec2020. She was not feeling well/ felt out of sorts on 23Dec2020. She expected to wake up feeling unwell. On 23Dec2020 and 24Dec2020 she felt really bad. Could have been in bed all day. She still did not have fever. She was lightheaded and had a bizarre feeling on 23Dec2020. She woke up 26Dec2020 and felt completely fine. Patient was wondering if being on ustekinumab made the symptoms from the COVID Vaccine worse. Action taken for ustekinumab was unknown. Outcome of events was recovered on 26Dec2020.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering if being on Stelera made the symptoms from the COVID Vaccine worse; extreme/ severe fatigue; lightheaded; soreness around injection/Sore arm; felt run down; chills; This is a spontaneous report from a contactable nurse (patient). This 36-years-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via unspecified route at left arm on 21Dec2020 14:00 at single dose for COVID-19 immunization; she also started to receive ustekinumab (STELERA injection), via subcutaneous from 2017 (last injection on 04Nov2020) at unspecified dose every 12 weeks for psoriasis. Medical history was none. Concomitant medications were not reported. No additional vaccines administered on same date of Pfizer vaccine. Historical vaccine included influenza vaccine on Nov2020 for immunization, which was 5 weeks prior to COVID vaccine. Vaccination facility type was hospital. At night of vaccination on 21Dec2020, patient felt run down, thought she had chills. She did not have fever. She woke up next day 22Dec2020 with sore arm/ soreness around injection, was otherwise fine. Day 2, 3, and 4 post vaccine was sick (23Dec2020). She had a sore throat, headache, and extreme/ severe fatigue on 23Dec2020. She was not feeling well/ felt out of sorts on 23Dec2020. She expected to wake up feeling unwell. On 23Dec2020 and 24Dec2020 she felt really bad. Could have been in bed all day. She still did not have fever. She was lightheaded and had a bizarre feeling on 23Dec2020. She woke up 26Dec2020 and felt completely fine. Patient was wondering if being on ustekinumab made the symptoms from the COVID Vaccine worse. Action taken for ustekinumab was unknown. Outcome of events was recovered on 26Dec2020.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: chills; temp of 100.2; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 05Jan2021 12:00 PM at single dose for covid-19 immunization. Medical history included none.  Known allergies was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient experienced chills, temp of 100.2, and muscle aches on 06Jan2021 12: 00 AM. Treatment received for the adverse event was unknown. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site papule, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Mild rash and itching around injection site; itching around injection site (multiple small red bumps); itching around injection site (multiple small red bumps); This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 14:45 on 29Dec2020 at single dose for COVID-19 immunization. Medical history included celiac disease, Sjogren's syndrome, connective tissue autoimmune disease, allergies to Gluten. Concomitant medication included cetirizine, citalopram, curcuma longa (TURMERIC), ergocalciferol (VIT D), ethinylestradiol, norethisterone acetate (MICROGESTIN), fish oil, hydroxychloroquine, pantoprazole, simethicone, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild rash and itching around injection site (multiple small red bumps) on 31Dec2020, all events were reported as non-serious. The patient did not receive any treatment from events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering. Information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Fever 101.4; Muscle aches; headache; chills; Dose number=1on 17Dec2020/ Dose number=2 on 05Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 09:30 AM on 05Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on left arm at 01:30 P.M on 17Dec2020 at single dose for Covid-19 immunization. The patient had no allergies to any medications, food, or other products. The patient experienced Fever 101.4 approximately 14 hours after getting second dose. Muscle aches, headache and chills at 11:00 PM on 05Jan2021. All events were reported as non-serious. The outcome of events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events fever, muscle aches, headache and chills was not recovered.  Information on the lot/ batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 101.4; Muscle aches; headache; chills; Dose number=1on 17Dec2020/ Dose number=2 on 05Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm at 09:30 AM on 05Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on left arm at 01:30 P.M on 17Dec2020 at single dose for Covid-19 immunization. The patient had no allergies to any medications, food, or other products. The patient experienced Fever 101.4 approximately 14 hours after getting second dose. Muscle aches, headache and chills at 11:00 PM on 05Jan2021. All events were reported as non-serious. The outcome of events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events fever, muscle aches, headache and chills was not recovered.  Information on the lot/ batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Auricular swelling, Dysgeusia, Ear pruritus, Erythema
Clinical narrative: both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; felt tired most of the day; felt soreness at injection site; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), via an unspecified route of administration on left arm at 13:45 on 21Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension, central serous retinopathy, known allergies to penicillin and Nickel. Concomitant medication included losartan, hydrochlorothiazide, cetirizine hydrochloride (ZIRTEC) and multivitamin. The patient previously took clindamycin, Septra and Keflex and experienced drug allergy. Within 30 min on 21Dec2020 started at 02:30 PM, both ears felt hot, mildly itchy, slightly puffy, and bright red in color. The patient's tongue and mouth felt slightly tingly with a metallic taste. She felt tired most of the day. Next day felt soreness at injection site and joint pain. Soreness at injection site lasted several more days. Events resulted in Doctor or other healthcare professional office/clinic visit, events were reported as non-serious. The patient received Benadryl 50 mg & additional dose of Zyrtec as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date.   No follow up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Paraesthesia oral, Vaccination site pain
Clinical narrative: both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; felt tired most of the day; felt soreness at injection site; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), via an unspecified route of administration on left arm at 13:45 on 21Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension, central serous retinopathy, known allergies to penicillin and Nickel. Concomitant medication included losartan, hydrochlorothiazide, cetirizine hydrochloride (ZIRTEC) and multivitamin. The patient previously took clindamycin, Septra and Keflex and experienced drug allergy. Within 30 min on 21Dec2020 started at 02:30 PM, both ears felt hot, mildly itchy, slightly puffy, and bright red in color. The patient's tongue and mouth felt slightly tingly with a metallic taste. She felt tired most of the day. Next day felt soreness at injection site and joint pain. Soreness at injection site lasted several more days. Events resulted in Doctor or other healthcare professional office/clinic visit, events were reported as non-serious. The patient received Benadryl 50 mg & additional dose of Zyrtec as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date.   No follow up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pain
Clinical narrative: Light headed; weakness; body aches; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 10:00 at single dose in her left arm for covid-19 immunization. The patient medical history was not reported. The patient concomitant that the patient received within 2 weeks of vaccination included "blood pressure" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The patient experienced light headed, weakness, body aches on 05Jan2021 10:00. No treatment received for the adverse event. The outcome of the events was recovered in Jan2021.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Nausea; Chills; sweats; vomit; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration on 02Jan2021 14:15 at SINGLE DOSE in the left arm for COVID-19 immunization. Medical history included depression from an unknown date. Concomitant medication included marijuana, depression meds and sleep meds. 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. On 06Jan2021 04:00, the patient experienced nausea, chills, sweats and vomit. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Lethargy, Nausea, Pain
Clinical narrative: diarrhea; vomiting; body aches; fever; nausea; lethargy; sob (Shortness of breath); This is a spontaneous report from a contactable nurse. A 58-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EJ1686, from 04Jan2021 10:45 to 04Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included heart disorder and prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included prasugrel hydrochloride (EFFIENT), metoprolol, ASA, lisinopril and atorvastatin. The patient experienced diarrhea, vomiting, body aches, fever, nausea, lethargy and shortness of breath (SOB) on 04Jan2021. The patient did not receive any treatment for the adverse events. The outcome of the evet was not recovered.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: diarrhea; vomiting; body aches; fever; nausea; lethargy; sob (Shortness of breath); This is a spontaneous report from a contactable nurse. A 58-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EJ1686, from 04Jan2021 10:45 to 04Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included heart disorder and prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included prasugrel hydrochloride (EFFIENT), metoprolol, ASA, lisinopril and atorvastatin. The patient experienced diarrhea, vomiting, body aches, fever, nausea, lethargy and shortness of breath (SOB) on 04Jan2021. The patient did not receive any treatment for the adverse events. The outcome of the evet was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Feeling hot, Headache, Muscle tightness
Clinical narrative: body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle groups sore/tense; mild chills; arm hurts so bad, like deep in her arm pit bad; Shooting headache; Vivid stressful dreams; Nauseous; This is a spontaneous report from a non-contactable pharmacist.  A 29-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the right arm on 05Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital.  The patient's medical history and  concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 16:45, at the right arm  for COVID-19 immunization. On 05Jan2021, the patient experienced mild chills at 19:00 and took acetaminophen (TYLENOL) and went to bed, at 23:30, patient reported shaking from her core and all main muscle groups sore/tense. In addition, patient stated her arm hurts so bad, like deep in her arm pit bad, had shooting headache, vivid stressful dreams, & was nauseous on the same day of 05Jan2021. On 06Jan2021 04:00, the patient also stated her body feels like a furnace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for it since the vaccination. The patient was recovering from the events.  No follow up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Tremor
Clinical narrative: body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle groups sore/tense; mild chills; arm hurts so bad, like deep in her arm pit bad; Shooting headache; Vivid stressful dreams; Nauseous; This is a spontaneous report from a non-contactable pharmacist.  A 29-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the right arm on 05Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital.  The patient's medical history and  concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 16:45, at the right arm  for COVID-19 immunization. On 05Jan2021, the patient experienced mild chills at 19:00 and took acetaminophen (TYLENOL) and went to bed, at 23:30, patient reported shaking from her core and all main muscle groups sore/tense. In addition, patient stated her arm hurts so bad, like deep in her arm pit bad, had shooting headache, vivid stressful dreams, & was nauseous on the same day of 05Jan2021. On 06Jan2021 04:00, the patient also stated her body feels like a furnace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for it since the vaccination. The patient was recovering from the events.  No follow up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscle fatigue, SARS-CoV-2 test
Clinical narrative: Muscle fatigue; Chills; Headache; Fatigue; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date at a single dose then intramuscularly (left arm) on 05Jan2021 18:30 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no relevant medical history. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Jan2021 19:00, the patient experienced Muscle fatigue, chills, headache and fatigue. No treatment was provided in response to the events. The patient assessed the events as non-serious. The patient underwent COVID test post vaccination via nasal swab (PCR) on 21Dec2020 and was negative.  The outcome of the events was recovering.   No follow-up attempts are possible, information about lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over; This is a spontaneous report from a non-contactable Nurse. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration on 21Dec2020 at single dose (dose 1) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received her first dose of the COVID vaccine on 21Dec2020; she woke up on 04Jan2021 (2 weeks later) with hives all over. Patient stated that she know this can happen right after injection, but it has been 2 weeks. Patient stated that she is due for the 2nd dose soon and was concerned. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Discomfort, Inflammation, Pain, Rash maculo-papular
Clinical narrative: erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round areas on the left side of neck; feel more inflamed; burning feeling to the touch; Is getting slightly painful; Discomfort; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 05:30 at a single dose for COVID-19 immunization. Medical history included atopic dermatitis. Patient previously took DUPIXENT, last dose was 18Dec2020 (due to a lack of knowledge about DUPIXENT) and the COVID vaccine, patient have not taken next due dose of DUPIXANT on 01Jan2021). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported.  The patient previously took amoxicillin and experienced allergies. On 31Dec2020 02:00 (reported as day 4 after the injection), patient developed 2 swollen erythematous maculopapular round areas on the left side of neck that were sore and slightly have a burning sensation (not pins/needle) to the touch also described as 2 very large erythematous swollen thick raised sores with vesicles on the left side of neck. Patient showed photos to internist a couple days later when they did not go away. As of this reported, it was now day 10 and they are not bigger but they feel more inflamed and have more of a burning feeling to the touch. The small vesicle on each sore had disappeared. Patient stated she had a history of atopic dermatitis but looked and felt nothing like it. Initially had little vesicular areas in the center but the vesicles aren't there today. Discomfort remains. No associated fever or headache. Patient had read of zoster developing with COVID-19 infection, but not associated with the actual vaccine.  She was asking if this might be a weird varicella zoster reaction to the vaccine and any data about this. This did not seem to be going away and was getting slightly painful (though so far tolerable) though does not seem to be spreading at this point. Outcome of the events was not recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round areas on the left side of neck; feel more inflamed; burning feeling to the touch; Is getting slightly painful; Discomfort; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 05:30 at a single dose for COVID-19 immunization. Medical history included atopic dermatitis. Patient previously took DUPIXENT, last dose was 18Dec2020 (due to a lack of knowledge about DUPIXENT) and the COVID vaccine, patient have not taken next due dose of DUPIXANT on 01Jan2021). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported.  The patient previously took amoxicillin and experienced allergies. On 31Dec2020 02:00 (reported as day 4 after the injection), patient developed 2 swollen erythematous maculopapular round areas on the left side of neck that were sore and slightly have a burning sensation (not pins/needle) to the touch also described as 2 very large erythematous swollen thick raised sores with vesicles on the left side of neck. Patient showed photos to internist a couple days later when they did not go away. As of this reported, it was now day 10 and they are not bigger but they feel more inflamed and have more of a burning feeling to the touch. The small vesicle on each sore had disappeared. Patient stated she had a history of atopic dermatitis but looked and felt nothing like it. Initially had little vesicular areas in the center but the vesicles aren't there today. Discomfort remains. No associated fever or headache. Patient had read of zoster developing with COVID-19 infection, but not associated with the actual vaccine.  She was asking if this might be a weird varicella zoster reaction to the vaccine and any data about this. This did not seem to be going away and was getting slightly painful (though so far tolerable) though does not seem to be spreading at this point. Outcome of the events was not recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: within 6 hours experienced severe chills and covid-like symptoms, she also tested positive for COVID-19; within 6 hours experienced severe chills and covid-like symptoms, she also tested positive for COVID-19; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left arm on 04Jan2021 11:30 at a single dose for COVID-19 vaccination. Medical history included allergies to Sulfa diagnosed in 2008, Allergies to Strawberries diagnosed when she was very young, Diamox allergy diagnosed in 2008, dyslexic, and Obesity but never been treated. Concomitant medication included levothyroxine (LEVOTHYROXINE), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), zinc (ZINC), nd cetirizine hydrochloride (ZYRTEC). The patient previously took diamox [acetazolamide] and experienced drug hypersensitivity.  Patient received first dose Monday, 04Jan2021, then she experienced severe chills and Covid like symptoms. Apparently, she tested positive for COVID 19. She ws not sure if it was a false positive or if she actually has COVID, but was concerned because her husband has cancer and was immunocompromised. Literally, she got the vaccine because her OB/GYN told her she needs to get it as soon as possible. She did blood work and she tested negative for pregnancy. There was no prescriber as it was given as part of her work. Fifteen minutes after receiving the vaccine, she had the worst headache she has ever had in her life. Six hours after that, she had such bad chills. That night, it worsened and it got better every hour when she took something. She said her congestion was still present. She stated she took Tylenol and hour later and it subsided. The outcome of the events was not recovered. The patient underwent laboratory date including negative antibodies on an unknown date, blood work on Mar2020 with unknown result, then on 05Jan2020 tested positive to COVID 19 by saliva test at 09:15 and nasal test at 11:30  Information about 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
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Hot flush
Clinical narrative: swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch; swollen and stiff neck; swollen and stiff neck; chills; hot flashes; radiating pain of arms; numb fingers; blue hands and feet; joint pain; muscle aches; weakness; tirednes; lethargic; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EL0140, via an unspecified route of administration in the left arm on 04Jan2021 16:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, ADHD, overweight, asthma and known allergies to milk, cat, roach mix, dust mites and bermuda grass. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), trazodone and montelukast. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced swollen lymph nodes at neck and sore to the touch, swollen and stiff neck, chills, hot flashes, radiating pain of arms, numb fingers, blue hands and feet, joint paint, muscle aches, weakness, tiredness, and was lethargic, all on 04Jan2021 at 17:30 PM with outcome of recovering. The events were reported as non-serious with no treatment received.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lethargy, Lymph node pain, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch; swollen and stiff neck; swollen and stiff neck; chills; hot flashes; radiating pain of arms; numb fingers; blue hands and feet; joint pain; muscle aches; weakness; tirednes; lethargic; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EL0140, via an unspecified route of administration in the left arm on 04Jan2021 16:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, ADHD, overweight, asthma and known allergies to milk, cat, roach mix, dust mites and bermuda grass. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), trazodone and montelukast. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced swollen lymph nodes at neck and sore to the touch, swollen and stiff neck, chills, hot flashes, radiating pain of arms, numb fingers, blue hands and feet, joint paint, muscle aches, weakness, tiredness, and was lethargic, all on 04Jan2021 at 17:30 PM with outcome of recovering. The events were reported as non-serious with no treatment received.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Skin discolouration, Swelling
Clinical narrative: swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch; swollen and stiff neck; swollen and stiff neck; chills; hot flashes; radiating pain of arms; numb fingers; blue hands and feet; joint pain; muscle aches; weakness; tirednes; lethargic; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EL0140, via an unspecified route of administration in the left arm on 04Jan2021 16:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, ADHD, overweight, asthma and known allergies to milk, cat, roach mix, dust mites and bermuda grass. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), trazodone and montelukast. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced swollen lymph nodes at neck and sore to the touch, swollen and stiff neck, chills, hot flashes, radiating pain of arms, numb fingers, blue hands and feet, joint paint, muscle aches, weakness, tiredness, and was lethargic, all on 04Jan2021 at 17:30 PM with outcome of recovering. The events were reported as non-serious with no treatment received.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vision blurred
Clinical narrative: numbness in right fingers along with tingling.  moved to back of neck and side of face.  right side of face was completely numb.  began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling.  moved to back of neck and side of face.  right side of face was completely numb.  began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling.  moved to back of neck and side of face.  right side of face was completely numb.  began with tingling and then moved to numbness. right eye was blurred; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL01284, expiry date not reported), via an unspecified route of administration in the right arm on 31Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included pituitary tumor/prolactinoma. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Concomitant medications were none. On 31Dec2020 at 10:45, the patient experienced numbness in right fingers along with tingling. The patient moved to back of neck and side of face. The right side of face was completely numb. It began with tingling and then moved to numbness. Her right eye was blurred for short period. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Began itching about 1/2 hour afterwards; Woke up next morning with hives on left forearm and up left arm; This is a spontaneous report from a contactable nurse (patient). A non-pregnant 36-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration on 05Jan2021 12:15 at a single dose on right arm for COVID-19 immunization at workplace clinic. Medical history included anxiety, attention deficit hyperactivity disorder (ADHD), and seasonal allergy from unknown dates. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. The patient reported that she began itching about 1/2 hour afterwards on 05Jan2021 13:00 and she woke up next morning with hives on left forearm and up left arm. The events were non-serious. Antihistamine was given as treatment for the events. Outcome of the events was recovering. Since the vaccination, the patient has not been tested for COVID-19.