chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pyrexia
Clinical narrative: aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive rapid test and PCR test after 1st vaccination; Positive rapid test and PCR test after 1st vaccination; This is a spontaneous report from a contactable nurse reporting for her/himself. A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 15Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive on 27Dec2020 on a rapid test and on 28Dec2020 on a respiratory panel by PCR. Next dose was scheduled  on 05Jan2021.  The information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Positive rapid test and PCR test based on the known safety profile. However the short duration of 12 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Fatigue, Pain in extremity, Taste disorder
Clinical narrative: Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. There was no medical history. Concomitant medication in two weeks included vitamin d3, cyanocobalamin (B12).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain and tiredness on 17Dec2020 at time of 09:00 AM. No treatment received for these events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test positive, Illness, Occupational exposure to SARS-CoV-2
Clinical narrative: tested positive for coronavirus; tested positive for coronavirus; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for coronavirus on 24Dec2020. The patient worked in a hospital. She got the first dose of Pfizer coronavirus vaccine on Tuesday, 22Dec2020. She tested positive for coronavirus on Thursday 24Dec2020 after exposure to patients and staff. She had mild symptoms. Her 2nd dose was scheduled for 12Jan2021. The patient was inquiry whether she should receive it, or should she take an antibody test first, but it would be less than 3 weeks from the onset of illness. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive for coronavirus based on the known safety profile. However the short duration of 2 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Tenderness
Clinical narrative: I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination.; I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination.; feeling like prodromal shingles pain though she never personally had shingles; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 35-year-old female patient received first dose of BNT162B2, intramuscular (right arm), on 18Dec2020 at 11:00, at a single dose, for COVID-19 vaccination. Medical history included allergies to penicillin. The patient's concomitant medications were not reported. On 20Dec2020, the patient had mild tenderness and would describe as a burning sensation around the T1-T3 dermatome area, on the same side of her injection, beginning approximately 1-2 days post vaccination. She was feeling like prodromal shingles pain though she never had shingles. Patient is currently on 10th day post vaccination and continues to have this sensation and mild tenderness but have yet to develop any shingles rash. The patient did not receive treatment for events "I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination." Outcome of the event pain was unknown, while for the remaining events was recovering.  Information about lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever 101.5; body aches; chills; headache; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on 27Dec2020 08:45 at single dose at right arm for COVID-19 immunization. Medical history reported as none, no Allergies to medications, food, or other products. Concomitant medication was none, the patient did not receive any medications within 2 weeks of vaccination. 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. On 27Dec2020 21: 30 (09:30 PM), the patient experienced fever 101.5, body aches, chills, headache. Treatment received for the adverse events included Tylenol. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Spinal pain
Clinical narrative: pain between her right scapula and spine; pain between her right scapula and spine; This is a spontaneous report from a contactable nurse (patient herself). A 22-year-old female patient started to receive BNT162B2 (lot number: EJ1685; expiry date unknown) intramuscular (right arm), on 28Dec2020, at a single dose, for COVID-19 vaccine injection/ vaccination. The patient's medical history and concomitant medications were not reported. This nurse was administered her first dose of Pfizer COVID-19 Vaccine on 28Dec2020, in the morning. Her first concern was that the nurse put the COVID-19 Vaccine injection really low into her right arm, but believes it did go into the muscle. She was concerned that it did not really go into her muscle but the more she has been lifting her arm and seeing where the shot was administered and where her muscle in her arm ends she believes it did go into the muscle. She contacted her primary care provider today because about 30 minutes to 1 hour after she was administered the COVID-19 vaccine injection on 28Dec2020 she had a pain in between her right scapula and spine, which is the side she got her vaccine on. She also reported that her right arm does not hurt at all, she has no pain at injection site for COVID-19 Vaccine which she finds really weird. She also felt the pain if she hunches her shoulders backwards, sits up really straight, crosses her arms or hunches forward; she does not really feel it if she takes a deep breath. She was wondering if these events are normal or expected or serious. Outcome of the events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash, Scab, Urticaria
Clinical narrative: Left with nasty scab; Hand was wet from where she had scratched/busted open water blisters on her hand; A rash and hives on that hand/rash unilaterally from the vaccination-side armpit to her breast and collar bone; A rash and hives on that hand; 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), via an unspecified route of administration on 22Dec2020 at 14:00 at single dose for COVID-19 immunization. The patient medical history included breast cancer survivor, radiotherapy, psoriasis, pre-diabetic, hypertension, hypercholesterolemia and chronic obstructive pulmonary disease (COPD), all from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient reported that: " on 23Dec2020 at 6:00, she woke up and her hand was wet from where she had scratched/busted open water blisters on her hand (same arm that she received the vaccine in).  She also reported a rash and hives on that hand, and a rash unilaterally from the vaccination-side armpit to her breast and collar bone but nothing at injection site.  She stated she took BENADRYL, symptoms subsided until BENADRYL wore off, then resurfaced, took more BENADRYL, then symptoms resolved. Symptoms lasted about 24 hours post injection, patient was left with a "nasty scab" on her hand from where she scratched the water blisters". The patient outcome of the events was recovered except for the "nasty scab" whose outcome was not recovered.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable Pharmacist reported similar events for 2 patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller is a pharmacist asked if there is a contraindication for administering antibody therapy to a person after they have received the first dose of the covid vaccine. He reported that there are 2 patients that received the covid vaccine the week of 14Dec and subsequently tested positive for covid on the 23rd and 24th of December. He was trying to determine the safety of administering antibody therapy for those patients even though they already got the first vaccine dose. He reported this question has some urgency and needed the information within 48 hours. Attempted to warm transfer but caller reported that he does not have any patient specific information or identifiers at this time. Escalating Urgently for additional research. Outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the event "tested positive for COVID" and vaccination with BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2020516661 same reporter/ drug/ AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test abnormal, Headache, Influenza virus test negative, Pyrexia
Clinical narrative: meningitis; headache; fever; weakness; rash; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on 16Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the Pfizer-BioNTech COVID-19 Vaccine on 16Dec2020, he experienced headache, fever, weakness and rash; went to the ER and after testing blood work and suspecting of meningitis. They did a spinal tap. Test came out negative for Flu and COVID; was told the rash could be due to a drug reaction and they attributed side effects to a generic bactrim, so he stopped taking all medications. If he continues to have issues the primary concern is whether he should get the second dose of the COVID-19 vaccine or not. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: meningitis; headache; fever; weakness; rash; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on 16Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the Pfizer-BioNTech COVID-19 Vaccine on 16Dec2020, he experienced headache, fever, weakness and rash; went to the ER and after testing blood work and suspecting of meningitis. They did a spinal tap. Test came out negative for Flu and COVID; was told the rash could be due to a drug reaction and they attributed side effects to a generic bactrim, so he stopped taking all medications. If he continues to have issues the primary concern is whether he should get the second dose of the COVID-19 vaccine or not. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: soreness in left arm the following day along with fatigue and body aches; soreness in left arm the following day along with fatigue and body aches; soreness in left arm the following day along with fatigue and body aches; This is a spontaneous report from contactable other healthcare professional. A 33-year-old male patient received first dose of BNT162B2 (lot number: EH9899; expiry date: unknown) intramuscular (left arm), on 23Dec2020 at 14:00, at a single dose, for COVID-19 vaccination. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced soreness in left arm the following day (24Dec2020) at 8:00 a.m. along with fatigue and body aches. The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date in Dec2020.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Pharyngeal swelling
Clinical narrative: Tingling in throat; throat swelling; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient received first dose of BNT162B2 (lot number: EH9899; expiry date: 31Mar2021), via an unspecified route of administration, on 28Dec2020 10:00 am (left arm), at a single dose, for COVID-19 vaccination. Relevant medical history included hypertension and seasonal allergies. Concomitant medication included levocetirizine dihydrochloride (XYZAL). The patient previously took losartan, sulfa, ultram, morphine, codiene, and lisinopril and experienced allergies. On 28Dec2020, at 10:15 a.m., the patient experienced tingling in throat and throat swelling. The patient received Benadryl as treatment for the events. Outcome of the events was recovering.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: Body aches; chills; redness and pain in injection site; redness and pain in injection site; headache; This is a spontaneous report from a contactable other hcp (patient). A 28-year-old female patient received bnt162b2 (lot number: EL0140), intramuscularly at arm right, first dose on 27Dec2020 10:15, at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS) and hypertension from an unknown date. The patient was not pregnant. No known drug allergies. Concomitant medication included losartan, and metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced body aches, chills, redness and pain in injection site, headache on 27Dec2020 12:00. Therapeutic measures were taken as a result of body aches, chills, redness and pain in injection site, headache, treatment included Tylenol. The events were reported as non-serious. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: High fevers (103/104 degree F) with chills for five days followed by low fevers ( upto 101) for another six days and still ongoing; High fevers (103/104 degree F) with chills for five days followed by low fevers ( upto 101) for another six days and still ongoing; headaches; fatigue; This is a spontaneous report from a contactable physician, the patient.  A 49-year-old non-pregnant 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 left arm on 18Dec2020 at 15:15 (at 49-years-old) as a single dose for COVID-19 immunization. Medical history included severe iron deficiency, hypothyroidism, osteoporosis, and low baseline IgM antibodies levels (unknown cause). The patient did not have any allergies to medications, food, or other products.  Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), and biotin (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Dec2020 at 18:00, the patient experienced high fevers (103/104 degrees Fahrenheit) with chills for five days followed by low fevers (up to 101 degrees Fahrenheit) for another six days, headaches, and fatigue; all reported as non-serious. On 24Dec2020, the patient had a post vaccination nasal swab rapid antigen test and SARS-CoV-2 PCR test with negative results. The patient took paracetamol (TYLENOL) and ibuprofen (ADVIL) for treatment for the events. The clinical outcomes of the fever, chills, headaches, and fatigue were recovering.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of high fevers with chills. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: mild fever; body and joint aches; body and joint aches; This is a spontaneous report from a non-contactable physician. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, an unspecified route of administration, from 26Dec2020 at a single dose, for COVID-19 immunization. Medical history included penicillin allergies. The patient's concomitant medications were not reported. On 26Dec2020 20:00, the patient experienced mild fever and "body and joint aches", lasted for 24 hours. Therapeutic measures were taken as a result of the events included tylenol and advil. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable other healthcare provider.  A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 21Dec2020 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient said that she received the Pfizer-BioNTech Covid-19 Vaccine last Tuesday, 21Dec2020, then tested positive for Covid on 26Dec2020. She said the symptoms started on 24Dec2020. Now, she wants to know if it is still okay to get the 2nd dose of the vaccine on the scheduled date. The outcome of events was unknown.    Information about Lot/Batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the event "tested positive for COVID" and vaccination with BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: had an inflamed lymph node after the vaccine; This is a spontaneous report from a contactable consumer (Pfizer colleague). A female patient of an unspecified age received bnt162b2 (BNT162B2; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The reporter stated that her family friend reported that she had an inflamed lymph node after the vaccine. She said that she already did the vsafe but didn't say anything about the reaction to the vaccine. The patient inquired if there was another website that she needs to report to which the reporter replied that VAERS is the correct place to report. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Myalgia, Tachycardia, Vaccination site discomfort
Clinical narrative: tachycardia(HR-90's to 130) for 3 days; injection site discomfort; myalgias; fatigue; This is a spontaneous report from a non-contactable physician (patient).  A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular at right arm on 21Dec2020 09:30 at single dose for COVID-19 immunization at a hospital. The patient's relevant medical history was reported as none, other medical history was none. No allergies to medications, food, or other products. Concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. It was reported that the patient got the vaccine on Monday (21Dec2020). On 21Dec2020 13:00, the main symptom that he was having was tachycardia (HR-90's to 130) for 3 days. Only other symptoms were injection site discomfort, myalgias and fatigue. The above events resulted in doctor or other healthcare professional office/clinic visit. No treatment was taken for the above events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Maternal exposure during pregnancy, Off label use, Product use issue, Rhinorrhoea
Clinical narrative: runny nose that had bloody discharge; runny nose that had bloody discharge; The mother was 23 weeks pregnant at the onset of the event; pregnancy; pregnancy; This is a spontaneous report from a non-contactable physician (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Not available/provided to reporter at the time of report completion) via an unspecified route of administration on 26Dec2020 13:30 on right arm at a single dose for COVID-19 immunization. The patient was allergies for adhesives. The patient is pregnant at the time of vaccination. The mother was 23 weeks pregnant at the onset of the event. The mother was due to deliver on 23Apr2021. 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 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) at 81mg. The patient experienced runny nose that had bloody discharge on 27Dec2020. No treatment received for the event. The outcome of the event was recovered in Dec2020.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma.  Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR).  The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering.  Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hepatic pain, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma.  Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR).  The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering.  Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mental impairment, Myalgia, Nausea, Pain of skin
Clinical narrative: difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma.  Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR).  The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering.  Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma.  Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR).  The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering.  Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Rash
Clinical narrative: itchy flushed skin with a rash; itchy flushed skin with a rash; itchy flushed skin with a rash; This is a spontaneous report from a contactable healthcare professional. A 45-year-old female patient received bnt162b2 (BNT162B2; reported as Pfizer-Bio-Tech COVID-19 Vaccine; lot number: EH9899; expiration date: unknown), intramuscular left arm on 16Dec2020 10:45 (also reported as 10:50 AM) at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. It was unknown if the patient has allergies to medications, food, or other products. It was reported that the patient was given vaccine at 10:50 am and 10 minutes after receiving the vaccine individual developed itchy flushed skin with a rash. She was given Benadryl 50 mg IM (intramuscular) in Right arm at 11:00 am. 11:37 am the itchy skin was less intensified, and vitals were stable. The patient went home with her husband. The event was considered as non-serious, was not life-threatening, did not caused/prolonged hospitalization, did not cause congenital anomaly/birth defect and did not resulted to death. The patient received the COVID-19 vaccine in the Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patent had any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination and if the patient been tested for COVID-19 since the vaccination. The outcome of the event itchy skin was recovering while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Nausea
Clinical narrative: nausea; diarrhea; upset stomach; This is a spontaneous report from a contactable nurse (patient herself). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EH9899, expiration date: unknown), intramuscularly on the right arm on 21Dec2020 at 07:15 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included asthma. The patient had no known allergies; no allergies to medications, food, or other products. Concomitant medications included montelukast sodium (SINGULAIR) and budesonide, formoterol fumarate (SYMBICORT). 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 was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Dec2020 at 06:00, the patient experienced nausea, diarrhea, and upset stomach, which were assessed as non-serious. The patient did not receive treatment for the adverse events. The patient was recovering from the events "nausea, diarrhea, and upset stomach."
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lip pain, Nausea, Stomatitis
Clinical narrative: developed 2 more of the same type of sores on inside of my cheek, in mouth; sore under top lip; headache; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 12:00 PM, at left arm, at single dose for covid-19 immunization. Medical history included hepatitis c from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient was not pregnant at the time of vaccination. First day on 24Dec2020 the patient had headache and fatigue, some nausea. Day 3 (26Dec2020) and 4 (27Dec2020) headaches all day, mild. Day 5 (28Dec2020) developed sore under top lip and day 6 (29Dec2020) developed 2 more of the same type of sores on inside of my cheek, in mouth. No treatment was received for all events. The outcome of the events was not recovered. 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 about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: right side axillary lymph node swollen; This is a spontaneous report from a contactable other healthcare professional (HCP). A 27-year-old male patient (a registered nurse) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number: EK5730, expiration date: unknown), via an unspecified route of administration via injection to the right deltoid on 22Dec2020 at a single dose for COVID-19 immunization as he was working in a high risk patient population in the intensive care unit (ICU). The patient had no medical history. There were no concomitant medications. On 27Dec2020, the patient experienced right side axillary lymph node swollen, which was assessed as non-serious. It was further reported that the patient developed symptoms and stated at the injection site, he had a swollen lymph node, and he called his primary care physician; they did a telehealth visit, and he also reported to the hospital where he received the vaccine and he wanted to fulfill his reporting responsibilities and report to Pfizer, since he had received the vaccine. The patient further clarified the location and stated that the injection site was in the shoulder, but the lymph node was the same side, the axillary lymph node; it was not at the site, it was the axillary lymph node on the right side. The patient had no investigation assessment. The patient was not recovered from the event "right side axillary lymph node swollen." The causal relationship of the drug to the event "right side axillary lymph node swollen" was assessed by the reporting HCP as related; method of assessment: Global Introspection.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: tongue swell; This is a spontaneous report from a contactable consumer (patient herself; a therapist, but was not clarified). A 35-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number: EK5730, expiration date: unknown), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization administered at the workplace. Relevant medical history included bipolar II disorder, hand tremors, and sleep (disorder). Concomitant medications included lithium and lamotrigine (LAMICTAL), both for bipolar II disorder; carbidopa, levodopa for hand tremors; and trazodone for her sleep. The patient had the vaccination and her tongue swelled on 26Dec2020, probably about 15 minutes after she had the shot. The patient had no investigation assessment. In response to the event, the patient had taken diphenhydramine (BENADRYL) at 25 mg, once; just one time. The outcome of the event was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Urticaria
Clinical narrative: hivers on lower back to side and left leg; joint stiffness over entire body; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: ett9899, expiration date: unknown), intramuscularly on the left arm on 17Dec2020 at 10:45 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included hypertension, diabetes, tachycardia, diverticulitis, and known allergies to pimentos. Concomitant medications included metformin and metoprolol tartrate (LOPRESSOR). The patient previously took valaciclovir hydrochloride (VALTREX) and experienced allergies to it. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 hivers on lower back to side and left leg and joint stiffness over entire body on an unspecified date in Dec2020 with hive improvement several days later. The patient received diphenhydramine (BENADRYL) and paracetamol (TYLENOL) orally from the emergency room as treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were assessed as non-serious. The patient recovered from the events "hivers on lower back to side and left leg and joint stiffness over entire body" on an unspecified date in Dec2020.