chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Lethargy, Neck pain, Renal pain
Clinical narrative: Headache; lethargic; Headache/lethargic, continued and progressively got worse; neck pain; kidney pain; This is a spontaneous report from a contactable nurse reported for herself. A 34-year-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 34 years of age, via an unspecified route of administration on 22Jan2021 14:00 at single dose, for COVID-19 immunization. The patient medical included PCOS (Polycystic ovarian syndrome). Patient had sulfa allergy. Concomitant medication included Levothyroxine, metformin, spironolactone and vitamin. On 23Jan2021, the patient experienced Headache, lethargic, continued and progressively got worse over the past 2 weeks, neck pain, kidney pain that comes and goes. The events were considered as non-serious. Events were treated with Compazine, fioricet, flexerol and Tylenol. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19 and COVID-19 test shows negative results. The outcome of the events was not recovered.    Information on batch/lot number was requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Headache; lethargic; Headache/lethargic, continued and progressively got worse; neck pain; kidney pain; This is a spontaneous report from a contactable nurse reported for herself. A 34-year-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 34 years of age, via an unspecified route of administration on 22Jan2021 14:00 at single dose, for COVID-19 immunization. The patient medical included PCOS (Polycystic ovarian syndrome). Patient had sulfa allergy. Concomitant medication included Levothyroxine, metformin, spironolactone and vitamin. On 23Jan2021, the patient experienced Headache, lethargic, continued and progressively got worse over the past 2 weeks, neck pain, kidney pain that comes and goes. The events were considered as non-serious. Events were treated with Compazine, fioricet, flexerol and Tylenol. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19 and COVID-19 test shows negative results. The outcome of the events was not recovered.    Information on batch/lot number was requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Seroconversion test, Vaccination failure
Clinical narrative: As a post-vaccination test of seroconversion, tested on 2 separate occasions, the first 21 days after first dose and the second 25 days...Both tests were negative for the presence of anti-sars-cov-2; As a post-vaccination test of seroconversion, tested on 2 separate occasions, the first 21 days after first dose and the second 25 days...Both tests were negative for the presence of anti-sars-cov-2; This is a spontaneous report from a contactable physician (patient). A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wanted to make aware of a potential issue with the Pfizer Covid vaccine received. As a post-vaccination test of seroconversion, the patient was tested on two separate occasions, the first 21 days after first vaccine dose and the second 25 days after second vaccine dose. The first test was a proprietary assay through a research study conducted at School. The second test was commercial assay. Both tests were negative for the presence of anti-SARS-COV-2 IgG. The patient could provide the vaccine lot numbers and administration times/locations if needed. Outcome of the events was unknown.  Information of lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lymphadenopathy, Vaccination site swelling
Clinical narrative: She had an allergic reaction; swelling underneath her arm in the lymph node; Injection site swelling; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old female patient received the second dose Pfizer BioNtech COVID 19 vaccine (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number EN6201), Injected in left arm unsure if given in muscle, on 09Feb2021 15:17 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. First dose of Pfizer COVID 19 vaccine given on 19Jan2021, Lot EL3247, injected on left arm and unable to confirm if intramuscular. Patient reported that after COVID 19 vaccine second shot she had an allergic reaction and got it done late afternoon on Tuesday. The lymph node under he left arm pit is completely swollen and has been since yesterday early Wednesday (10Feb2021) morning around 04:30. The injection site also swelled up immediately (09Feb2021 15:17). She had all the other stuff too, but she is only concerned about these two. The outcome of the event swelling underneath her arm in the lymph node was not recovered, event Injection site swelling was recovering. and the outcome of the event hypersensitivity was recovered.  No further details provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient who was administered the first dose of the Pfizer covid vaccine and 2 weeks later tested positive for covid; patient who was administered the first dose of the Pfizer covid vaccine and 2 weeks later tested positive for covid; This is a spontaneous report from a contactable other health care professional. A 57-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jan2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. It was reported that, the patient who was administered the first dose of the pfizer covid vaccine and tested positive for covid, two weeks later . Caller questioned about the guidance for administering second dose,  as it was 28 days post the first dose as of now. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome for the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2  vaccine in this patient cannot be completely excluded
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: He was just congested for 24 hours; Tested positive for COVID post vaccination; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 23-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration in deltoid left on 20Jan2021 at 09:20 am as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. No family history. On 01Feb2021 after 10 days the patient was tested positive for covid post vaccination, and he was just congested for 24 hours on an unspecified date. She was tested positive for COVID post vaccination. He wants to know if he can get the second dose of the vaccine. Patient was barely symptomatic, he was just congested for 24 hours. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 01Feb2021. No prior vaccinations within 4 weeks. Patient did not any AE(s) require a visit to Emergency Room and Physician Office. No treatment received. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: Pressure built up in his lungs; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after 11 days the patient experienced pressure built up in his lungs when started exercise and it decreased when stopped, but continued to happen every time during exercise. The outcome of the event was unknown.  Information about batch/lot number requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Calling for his father. Father received 1st dose of Covid vaccine January 21st and then developed Covid; This is a spontaneous report from a contactable consumer (Son) received from a Pfizer Sponsored Program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer calling for his father. father received 1st dose of covid vaccine january 21st and then developed covid on an unspecified date. They are wondering what his father should do about his 2nd dose. The action taken in response to the event(s) for BNT162B2 was not applicable. The outcome of event was unknown. Information on the Batch/Lot has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Influenza, Pyrexia
Clinical narrative: fever of 102 was reported as worsened; fever of 101- 102 , 102.6 now; feeling like the flu; This is a spontaneous report from a contactable consumer. This consumer reported for an 80-year-old male patient (reporter's husband) patient received first dose of BNT162B2 (Solution for injection, lot number: EL9262, Expiration date; unknown), via an unspecified route of administration in left arm on 08Feb2021 11:15AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had temperature (fever), of 102 was reported as worsened. and feeling like the flu worsened on 08Feb2021 at 08:00PM or 09:00PM. Patient temperature 102.6 higher than 07Feb2021. Patient taken vaccination facility in mall. Mentions patient got the two-tear shingle shot in Sep2020 and had fever for that and didn't feel well. They had no product or information to provide NDC, lot or expiration date for the shingles vaccine. Mentioned he does have an appointment with his primary care doctor today at 4:15 PM. He was scheduled to received the second dose on 04Mar2021. The outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Lymphadenopathy, Nausea
Clinical narrative: got really tired'; chills; diarrhea; she threw up; had swollen lymph nodes; nausea; pain in her arm; This is a spontaneous report from a Pfizer-sponsored program. A 81-years-old contactable female consumer(patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. On 28jan2021, patient experienced some reactions like chills, nausea and diarrhea so was asking if she really needs to take the second dose.  Follow-up information was received on 12Feb2021 from a contactable consumer reported that patient experienced pain in her arm, got really tired', chills, diarrhea, vomiting, and swollen lymph nodes for a little bit. Caller stated that her husband only experienced a sore arm.   Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: got really tired'; chills; diarrhea; she threw up; had swollen lymph nodes; nausea; pain in her arm; This is a spontaneous report from a Pfizer-sponsored program. A 81-years-old contactable female consumer(patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. On 28jan2021, patient experienced some reactions like chills, nausea and diarrhea so was asking if she really needs to take the second dose.  Follow-up information was received on 12Feb2021 from a contactable consumer reported that patient experienced pain in her arm, got really tired', chills, diarrhea, vomiting, and swollen lymph nodes for a little bit. Caller stated that her husband only experienced a sore arm.   Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal pain
Clinical narrative: runny stool - started one day after injection - has continued for two days --  pain in bowels prior to bowel movement.; runny stool - started one day after injection - has continued for two days --  pain in bowels prior to bowel movement.; This is a spontaneous report from a contactable consumer (patient). A 71-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, in Arm Left on 06Feb2021 as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient experienced runny stool-started one day after injection has continued for two days, pain in bowels prior to bowel movement on 08Feb2021. The patient received any treatment for the events. The patient did not received prior vaccination and Covid tested post vaccination. The patient known allergies as no. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, COVID-19, Cough, Dysphonia
Clinical narrative: I have been sick all night; I got 101 fever; Chilliness; Hoarseness; Ache all over; Joints are aching; Coughing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (Solution for injection, Batch/lot number: unknown) via an unspecified route of administration administered in left arm on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included alprazolam. The patient got first Covid shot yesterday as her doctor told her to go ahead and get it. She asked what kind of side effects it has and he said you would probably get sore arm and I was okay. So, she went and got it yesterday and about 8 o'clock. She have been sick all night. She had a fever, chilliness, little hoarseness and ache all over. She didn't have before the Covid-19 shot. She went in there and now got 101 fever, coughing, joints were aching. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Illness, Pyrexia, Weight
Clinical narrative: I have been sick all night; I got 101 fever; Chilliness; Hoarseness; Ache all over; Joints are aching; Coughing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (Solution for injection, Batch/lot number: unknown) via an unspecified route of administration administered in left arm on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included alprazolam. The patient got first Covid shot yesterday as her doctor told her to go ahead and get it. She asked what kind of side effects it has and he said you would probably get sore arm and I was okay. So, she went and got it yesterday and about 8 o'clock. She have been sick all night. She had a fever, chilliness, little hoarseness and ache all over. She didn't have before the Covid-19 shot. She went in there and now got 101 fever, coughing, joints were aching. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ultrasound scan, X-ray
Clinical narrative: Pain in left knee. I cannot put my weight on it.; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 16Mar2021 15:00 (Lot Number: En620A) as SINGLE DOSE for covid-19 immunisation, at 69 years old at Pharmacy or Drug Store. Medical history included allergies: food from an unknown date. Patient is not pregnant. No COVID prior vaccination.  No other vaccines in four weeks. No other medications in two weeks. Patient received the first dose of BNT162B2, (Lot number: En198) on 23Feb2021 15:00 at right arm for Covid-19 immunization, at 69 years old. The patient's concomitant medications were not reported. The patient experienced pain in left knee. She cannot put my weight on it on 16Mar2021 16:00. Treatment was received for the event (reported as ultra sound and X ray). Lab tests included ultra sound and x ray with unknown results on Mar2021. Event required emergency room and physician office visit. Patient was not tested for COVID post vaccination. Outcome of the event was not recovered. Seriousness criteria was reported as disability.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Cough, Dyspnoea
Clinical narrative: Chills; got a temp 99.9 used his temperature about and he had a fever; Vomiting; Coughing; Shortness of breath; Tightness in chest; This is a spontaneous report from a contactable consumer (patient himself). A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207), via an unspecified route of administration, on 18Mar2021 10:00, at a single dose, for covid-19 immunization. Medical history included blood pressure. Concomitant medications included unspecified blood pressure medicine and blood thinner. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205) on 25Feb2021 for covid-19 immunization. The patient stated he had the second shot of the Pfizer vaccine and he had a reaction. He got the shot on Thursday, 18Mar2021 at 10:00 and about 21:00 (also reported as 6 hours after the shot), he was getting chills, got a temp 99.9 used his temperature about and he had a fever, vomiting, and coughing, kind of shortness of breath, and tightness in chest and that was about it. The patient was still experiencing shortness of breath, tightness in chest, vomiting, fever and coughed a lot too. No treatment was received for the adverse events reported. The patient stated he was feeling better today than he was yesterday. The patient was recovering from the adverse events at the time of the report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Chills; got a temp 99.9 used his temperature about and he had a fever; Vomiting; Coughing; Shortness of breath; Tightness in chest; This is a spontaneous report from a contactable consumer (patient himself). A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207), via an unspecified route of administration, on 18Mar2021 10:00, at a single dose, for covid-19 immunization. Medical history included blood pressure. Concomitant medications included unspecified blood pressure medicine and blood thinner. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205) on 25Feb2021 for covid-19 immunization. The patient stated he had the second shot of the Pfizer vaccine and he had a reaction. He got the shot on Thursday, 18Mar2021 at 10:00 and about 21:00 (also reported as 6 hours after the shot), he was getting chills, got a temp 99.9 used his temperature about and he had a fever, vomiting, and coughing, kind of shortness of breath, and tightness in chest and that was about it. The patient was still experiencing shortness of breath, tightness in chest, vomiting, fever and coughed a lot too. No treatment was received for the adverse events reported. The patient stated he was feeling better today than he was yesterday. The patient was recovering from the adverse events at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: but thinking that she is a covid positive.; but thinking that she is a covid positive.; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 25Feb2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After 1st dose she was thinking that she was a covid positive on an unspecified date in 2021. The patient 2nd dose vaccine was scheduled on 19Mar2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: feels tired; muscle ache; joint ache; fever (up to 100F).; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 61-years, at single dose on 22Mar2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received first dose of pfizer covid vaccine yesterday (on 22Mar2021). Today (on 23Mar2021), she felt tired, muscle ache, joint ache and fever (up to 100F). The patient underwent lab tests and procedures which included body temperature was up to 100F on 23Mar2021. Events outcome was unknown.  Information on the lot/ batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: migraine for the past few days; Headache is going away but she wants to make sure that it is safe for her to take the vaccine; This is a spontaneous report received from a contactable consumer (patient reported herself). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "patient would get the second dose of the PFIZER-BIONTECH COVID-19 VACCINE today 23Mar2021 and asked if she could get the vaccine even if she had been experiencing migraine for the past few days. Headache was going away but she wanted to make sure that it was safe for her to take the vaccine. She mentioned that she already spoke to another agency to report the symptoms". Outcome of the event migraine was unknown whereas another event was recovering. No present.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hot flush, Palpitations, Paraesthesia
Clinical narrative: The next morning she experienced hot flashes; Heart palpitations reaching 124-127 beats per minute; Tingling in the arms and back; Felt weird but not flu like; This is a spontaneous report from a contactable consumer (Patient). A 54-years-old female patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection Batch/Lot number was not reported) at an unspecified route of administration on 21Mar2021 03:30 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Mar2021 (next morning) she experienced hot flashes (hot flush), heart palpitations reaching 124-127 beats per minute (palpitations), tingling in the arms and back (paraesthesia), felt weird but not flu like (feeling abnormal). The patient underwent lab tests and procedures which included palpitations: heart palpitations reaching 124-127 beats per min on heart palpitations reaching 124-127 beats per minute. The outcome of the events was recovered.  No follow-up attempts are possible, no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Pain in extremity, Pyrexia
Clinical narrative: dizziness; chills; temperature of up to 101.9*F.; sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 15Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced initially nothing but a sore arm which went away within 24 hours. On 22Mar2021, mid evening, she experienced dizziness, chills and had a temperature of up to 101.9 degree F. On 23Mar2021 at 07:45, the temperature became normal. The outcome of the event temperature of up to 101.9*F was recovered on 23Mar2021 and rest of the events recovered in Mar2021. The reporter considered the event to be non-serious.  Response: Referenced PI Section 6 LAB-1457-6.0 Revised: 25 February 2021.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: Dizziness; Pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that his dizziness had gone down now 24Mar2021 and his second dose was due Friday, 26Mar2021. It was also stated that the pain had also completely stopped. Outcome of the event dizziness was recovering, pain was recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fear, Hyperhidrosis
Clinical narrative: dizzy; scared to get out of bed; sweaty hands; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), via an unspecified route of administration on 17Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that I woke up this morning feeling dizzy and scared to get out of bed. I have sweaty hands on 24Mar2021. The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: burning sensation; itching feeling; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot no was not reported), dose 1st via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, patient developed a burning sensation, itching feeling in the left part of her face but no rash. She called her doctor today and they told her to take Benadryl. Patient asked should she take second dose of the vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: bump with a rash around it on her Lt cheek; redness; itching; This is a spontaneous report received from a 60-year-old female contactable consumer (patient). This patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 18Mar2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Mar2021, the patient experienced a bump with a rash around it on her left cheek. It started with redness and itching. The outcome of the vents was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she said she was not able to receive the 2nd dose because she has Covid; she said she was not able to receive the 2nd dose because she has Covid; This is a spontaneous report received from a contactable consumer (patient) 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206 and expiry date was not provided), via an unspecified route of administration, in Arm Left on 03Mar2021 15:00 (Age at time of Vaccination; 60-year-old) as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient's mother-in-law had COVID 19. Patient reported that she received the first dose of the COVID-19 vaccine on 03MAR2021 at 15: 00PM in the left arm. She had no side effects from the vaccination. Patient was exposed to her mother-in-law who had COVID-19 and had to get tested. Patient had Covid-19 PCR test and positive for COVID 19 on 17MAR2021 although she might have it before then. Patient didn't have any symptoms with the COVID 19 infection either. She supposed to get her second shot today (24Mar2021) but she couldn't get it because she is still in quarantine. She was asking when can she get the second dose of the vaccine after having COVID 19 infection?. Patient was not admitted to Emergency Room and not visited physician office for the event. However, she said that she was not able to receive the 2nd dose because she had COVID, and tomorrow (25Mar2021) is her last day of isolation. She wanted to know when she can get her 2nd dose. The outcome of the events was unknown.    Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: Very cold fingers/cold ears, right leg and then entire body; Numbness; Tingling fingers; cold ears, right leg and then entire body; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for inection), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:00 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. The patient's medical and concomitant medications were not reported. The patient experienced Very cold fingers, numbness, cold ears, right leg and then entire body and tingling fingers on 24Mar2021 11:00. No treatment was given for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Fever; chills; body ache; Swollen lymph nodes in face, back, underarm, collarbone; counting- lymph nodes have swollen knots that are very painful to the touch; burning sensation in arm of injection; This is a spontaneous report received from a contactable consumer (patient). A 35-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 20Mar2021 09:00 AM, at the age of 35 years old, as single dose for Covid-19 immunisation. Medical history included allergies to Food Dyes. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on 27Feb2021 01:00 PM in Left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received other medications within 2 weeks of vaccination. The patient experienced fever, chills, body ache approximately 48 hours. Extremely Swollen lymph nodes in face, back, underarm, collarbone 4 days and counting- lymph nodes have swollen knots that are very painful to the touch, burning sensation in arm of injection, 3 days after injection. All symptoms occurred on 20Mar2021 07:00 PM after 2nd dose. No treatment received. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. Events outcome were recovering.  The information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; body ache; Swollen lymph nodes in face, back, underarm, collarbone; counting- lymph nodes have swollen knots that are very painful to the touch; burning sensation in arm of injection; This is a spontaneous report received from a contactable consumer (patient). A 35-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 20Mar2021 09:00 AM, at the age of 35 years old, as single dose for Covid-19 immunisation. Medical history included allergies to Food Dyes. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on 27Feb2021 01:00 PM in Left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received other medications within 2 weeks of vaccination. The patient experienced fever, chills, body ache approximately 48 hours. Extremely Swollen lymph nodes in face, back, underarm, collarbone 4 days and counting- lymph nodes have swollen knots that are very painful to the touch, burning sensation in arm of injection, 3 days after injection. All symptoms occurred on 20Mar2021 07:00 PM after 2nd dose. No treatment received. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. Events outcome were recovering.  The information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 2 RNs I work with got their 2nd dose and tested positive for COVID the same week.; 2 RNs I work with got their 2nd dose and tested positive for COVID the same week.; This is a spontaneous report from a contactable nurse. This was the second of two reports. This patient of unspecified age and gender received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), with the first dose and second dose; both doses via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not provided. The reporting nurse posted that 2 RNs the nurse worked with got their 2nd dose and tested positive for COVID the same week. Event took place after use of product. Lab data included COVID-19 test was positive on unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The causal association cannot be excluded between the reported events and BNT162B2 use.,Linked Report(s) : US-PFIZER INC-2021328440 same reporter, drug and AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: very infected with covid-19 after receiving the first dose; very infected with covid-19 after receiving the first dose; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received first dose of BNT162B2(Solution for injection, Lot Number and Expiration date were not reported), via an unspecified route of administration on 04Mar2021 as SINGLE DOSE for COVID-19 immunization . The patient's medical history and concomitant medications were not reported. It was reported that Patient received the first dose of COVID-19 vaccine on 04 Mar 2021, at a hospital . He was due to get the second dose today and want to know what to do, since he was very infected with COVID-19 after receiving the first dose. He did not get too infected, he has been protected partly by the first dose. He would not provide his mailing address. Seriousness of the events were considered as Non-serious by the reporter. On an unspecified date in Mar2021 the patient underwent SARS-CoV-2 test and resulted as very infected with COVID-19. Outcome of the events was unknown.  Information related to lot/batch no. has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021333615 same reporter/drug, different patients.;US-PFIZER INC-2021333614 same reporter/drug, different patients.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; low grade fever; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 24Mar2021 10:45 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient received dose 1 via, administered in left arm on 02Mar2021 18:00 for covid-19 immunisation. The patient concomitant medication included Depo shot received within 2 weeks of vaccination. The patient experienced chills and low grade fever on 25Mar2021 11:15. There is no other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Therapeutic measures paracetamol (TYLENOL) were taken as a result of chills and low grade fever. The outcome was not recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever, 100-101 F; chills; general body soreness; injection site pain; This is a spontaneous report from a non-contactable consumer (patient). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm Right on 24Mar2021 09:00 as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient previously received first dose of BNT162B2 administered in arm right on 03Mar2021 17:30 for COVID-19 Immunization. The patient experienced fever (100-101 F, onset 12 h post-second dose, duration of 12 h), chills, general body soreness, injection site pain on 24Mar2021 21:00. Tylenol treatment was received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive list of any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. The patient did not Allergy to medications, food, or other products. The patient underwent lab tests and procedures which included body temperature was 100-101 fahrenheit on 24Mar2021. The outcome of the events was resolving.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Arm pain; chills; This is a spontaneous report from contactable consumer. An adult female patient (No Pregnant at the time of vaccination) received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm pain and chills on 24Mar2021. No treatment received for the adverse event. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling cold, Hyperhidrosis, Myalgia
Clinical narrative: arm pain/somewhat sore/very sore arms; Body aches; Sweating/woke up sweating wet; fever; Chills; muscle aches; tiny cough; froze/cold all day; This is a spontaneous report received from a contactable consumer (patient) in response to Non-HCP letter sent to consumer. This 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03FEB2021 11:00 AM (24 hour clock) at single dose (lot: EL9262) at Arm Left for COVID-19 immunisation. Medical history was not reported. Concomitant medications were none. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot: EJ1685) on 30Dec2020 for COVID-19 immunisation and experienced got covid from 07Jan2021, No reaction. The patient experienced arm pain/very sore arms, 2nd shot Some what sore, Body aches, Sweating/woke up sweating wet, Tiny cough from 03FEB2021, no treatment received. The patient also experienced Chills/2nd shot froze 48 hours treated with Tylenol, Fever treated with Tylenol and Advil, Cold all day from 03FEB2021 and treatment with Tylenol and Advil. No admission to the hospital due to the events. The patient experienced some muscle aches as well. The reported issue occurred after use of Pfizer product. The patient and her husband both got covid dalp after shot as many of their friend have, husband was hospitalized. The outcomes of the events was recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: arm pain/somewhat sore/very sore arms; Body aches; Sweating/woke up sweating wet; fever; Chills; muscle aches; tiny cough; froze/cold all day; This is a spontaneous report received from a contactable consumer (patient) in response to Non-HCP letter sent to consumer. This 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03FEB2021 11:00 AM (24 hour clock) at single dose (lot: EL9262) at Arm Left for COVID-19 immunisation. Medical history was not reported. Concomitant medications were none. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot: EJ1685) on 30Dec2020 for COVID-19 immunisation and experienced got covid from 07Jan2021, No reaction. The patient experienced arm pain/very sore arms, 2nd shot Some what sore, Body aches, Sweating/woke up sweating wet, Tiny cough from 03FEB2021, no treatment received. The patient also experienced Chills/2nd shot froze 48 hours treated with Tylenol, Fever treated with Tylenol and Advil, Cold all day from 03FEB2021 and treatment with Tylenol and Advil. No admission to the hospital due to the events. The patient experienced some muscle aches as well. The reported issue occurred after use of Pfizer product. The patient and her husband both got covid dalp after shot as many of their friend have, husband was hospitalized. The outcomes of the events was recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested Positive for Covid after first Dose; Tested Positive for Covid after first Dose; This is a spontaneous report received from a contactable consumer (patient).  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for covid after first dose on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included covid-19: positive on unknown date.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: very infected with COVID-19 after receiving the first dose; very infected with COVID-19 after receiving the first dose; This is a spontaneous report received from a contactable consumer (patient's husband), reporting same events under the same suspect product for three patients.  A female patient of an unspecified age, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were unknown), via an unspecified route of administration, on 04Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that, his wife received the first dose of COVID-19 vaccine on 04Mar2021, at hospital. She was due for second dose today and wanted to know what to do, since she was "very infected" with COVID-19, after receiving the first dose. It was also reported that his wife was delicate and COVID put her on bed, but she was partially protected by the vaccine and she was recovering. On an unspecified date in Mar2021 the patient underwent SARS-CoV-2 test and resulted as very infected with COVID-19. The outcome of the event was recovering.  Information regarding batch/lot number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329502 same reporter/drug, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: High temperature; Cough; Body aches; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced high temperature, cough and body aches on an unspecified date after vaccination. The outcome with events was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: 1301.  Patient noted numbness in front and back of hand, and down L arm.  Thin patient - whose IM injection was given by 1" needle. No focal neurological findings.  1303: BP 121/85; 85 HR; Sate 98% on RA;  1307: 126/87; 73-98% Sat.  Benadryl 25 mg po@ 1312.  Cold pack applied to injection site.  1337.  Patient reports symptoms have improved.  discharged from clinic to home. Advised to follow up with PCP should symptoms return, worsen or has SOB.