chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pulmonary pain
Clinical narrative: chest is extremely heavy; right lung hurts more than the left lung/her right lung hurts more when she breathes deep; This is a spontaneous report from a contactable consumer.   This female consumer (Patient) reported that a female patient of an unspecified age received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 2 via an unspecified route of administration in right arm on 05Feb2021 12:30 as single for covid-19 immunisation from pharmacy. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. the patient was diagnosed with Covid on 20Dec2020. The patient reported that, her chest is extremely heavy and the right lung hurts more than the left lung. Patient reported that it was definitely different than the first vaccine. Patient reported that she was alone and was freaked out a little. The patient reported that her right lung hurts more when she breathes deep. It was a tight, heavy hurt. She said that she feels constricted a little bit. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his arm is much more sore than her arm; This is a spontaneous report from a contactable consumer (patient) via medical information team reported similar events for two patients. This report is for 2nd of 2 patient. This report is reported by consumer (wife) for a male patient (husband). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 07Feb2021 as single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm. The reporter stated that she and her husband received their first dose of the Pfizer COVID-19 vaccine on Sunday, 07Feb2021, and his arm is much more sore than her arm. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore/Injection site pain; This is Spontaneous report from a non-contactable Pharmacist. This Pharmacist reported similar events for herself and 1 patient. This is a 2nd of Two reports. This report included that a 68-year-old male patient who received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date was unknown), via an unspecified route of administration first dose on 17Jan2021 and second dose on 05Feb2021(Age at vaccination was 68-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On an unknown date patient experienced sore/Injection site pain. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130209 Same reporter/drug/similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood, Pain, Rhinorrhoea, Sinusitis
Clinical narrative: Other than normal body aches and pains, but the next day was high as a kite; Other than normal body aches and pains; Clearned up her runny nose and sinus problem; Clearned up her runny nose and sinus problem; This is a spontaneous report from a contactable other health care professional (Nurse). A 92-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 23Jan2021 as dose1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced other than normal body aches and pains, but the next day was high as a kite followed by cleaned up her runny nose and sinus problem. It was reported that patient(her friend) got high after the vaccine and didn't want to talk to anybody, stated it was her first dose. Stated her friend is going to be 93 in March, exact date of birth is unknown, stated with the first vaccine her friend said she felt no other symptoms except it cleared up her runny nose and sinus problem she had, no more than the normal pains that she had. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: "wiped out" for 3 days following the second dose. He also described it as being "exhausted"; This is a spontaneous report from a contactable other hcp. This contactable consumer reported for 2nd Dose administered.   A 64-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for an COVID-19 immunization. The patient medical history was not reported. Concomitant medications included metformin and meloxicam taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (COMIRNATY) and had he headache for 1.5 days and sore arm for a week. The patient stated that he experienced "wiped out" for 3 days following the second dose and described it as being "exhausted" on an unspecified date. The patient expressed that they should make it a standard protocol not to take anti-inflammatory drugs prior to the COVID-19 vaccination series and were there any test to assess the immunity after the receipt of the COVID-19 vaccine. The patient asked could COVID-19 vaccination series be repeated? Has it been done? If so, what are the consequences. Caller stated he received both doses of the COVID-19 vaccine while being on Meloxicam and Metformin. He explained yesterday, he read on news that taking anti-inflammatory drugs interferes with the body's immune response to the COVID-19 vaccine. The patient asked was there a potential interaction between Meloxicam, being an non-steroidal anti-inflammatory drug and the COVID-19 vaccine and Would these anti-inflammatory drugs inhibit an optimal immune response to the vaccine and was there a potential interaction between Metformin and this vaccine and how many of the clinical trial participants were on anti-inflammatory drugs during the study, how does it correlate with the 95 percent effectiveness for the vaccine and what percentage of participants who responded to the vaccine were on anti-inflammatory drugs. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: only our shoulders was hurting a little but we had not fever; This is a spontaneous report from a contactable consumer. This consumer reported for 5 patients. This is 2nd of 5 reports.   A patient of unspecified age and gender received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as unknown dose number, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. It was reported that, there was 5 of us and none of us had reactions, only our shoulders were hurting a little, but we had not fever" with outcome of unknown.   Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171049 same drug/AE, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulders was hurting a little; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is 3rd of 5th reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported on an unspecified date that if Consumer didn't get a reaction that means the shot was not effective and was not working, was that true? As per consumer there was 5 of us and none of us had reactions, only our shoulders were hurting a little but we had not fever. The outcome of event was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171051 same drug/AE, different patient.;US-PFIZER INC-2021171050 same drug/AE, different patient.;US-PFIZER INC-2021171048 same drug/AE, different patient.;US-PFIZER INC-2021130494 same drug/AE, different patient.;US-PFIZER INC-2021171050 same drug/AE, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: there was 5 of us and none of us had reactions, only our shoulders was hurting a little but we had not fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for five patients. This is fourth of five reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that, there was 5 of them and none of them had reactions, only their shoulders were hurting a little, but they had not fever. The reporter wanted know that the patient didn't get a reaction that means the shot was not effective and was not working, was that true. The outcome of the event was unknown.  Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171051 same drug/AE, different patient.;US-PFIZER INC-2021130494 same drug/AE, different patient.;US-PFIZER INC-2021171048 same drug/AE, different patient.;US-PFIZER INC-2021171049 same drug/AE, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulders was hurting a little; This is a spontaneous report received from a contactable consumer. This consumer reported similar events for 5 patients. This is 5th of 5 reports. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date, as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reported stated that "there was 5 of them had reactions and their shoulders was hurting a little but they did not have fever." The outcome of the event was unknown.  Information on Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171049 same drug/AE, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Influenza like illness, Nasal discomfort
Clinical narrative: Feeling very bad still/ I feel like crap; the flu symptoms and stuff but that will only last 24-48 hours but they did go on and off; It's been a low grade fever and highest is 100.4; Cold; Sneezing; Terrible headache; some kind of sore inside my nostril, my left nostril; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date (on Wednesday), as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, patient had experienced really feeling very bad still. I have had you know, I mean I was fine, a couple of hours after the injection I was expecting to get some kind of side effects like the flu symptoms and stuff but that will only last 24-48 hours but they did go on and off. I have had fever, the cold, the sneezing, the terrible headache and I have also developed some kind of sore inside my nostril, my left nostril. So I am starting to get a little concerned, the fever hasn't been that high, it's been a low grade fever, the highest it's been is 100.4 and it goes back and for so, it goes down and then it goes up a little and so far today so far I haven't had any fever, it's been 99.0 so that's alright but I was really starting to get concerned because I did not know how long this thing is supposed to last and I am not usually prone to get headaches or cold, I haven't had a cold or flu in years so I will like to have some information and the place where I got it was "Covid" (not clarified) Hospital. They did not have any contact number for this, so I want to know if I should be concerned, if I should go in to the emergency or see a doctor, I don't have a primary care doctor right now. I really did not have my primary doctor, retired back in July and I have always seen one doctor since 10 and it's hard getting to be ill (not clarified), getting through the doctors, to the clinic and appointment and stuff so I don't know if I should be concerned or how long this is going to last or whatever because I really feel like crap. Lab test fever: result: 99.0, 100.4 (unit not reported). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia, Sneezing
Clinical narrative: Feeling very bad still/ I feel like crap; the flu symptoms and stuff but that will only last 24-48 hours but they did go on and off; It's been a low grade fever and highest is 100.4; Cold; Sneezing; Terrible headache; some kind of sore inside my nostril, my left nostril; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date (on Wednesday), as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, patient had experienced really feeling very bad still. I have had you know, I mean I was fine, a couple of hours after the injection I was expecting to get some kind of side effects like the flu symptoms and stuff but that will only last 24-48 hours but they did go on and off. I have had fever, the cold, the sneezing, the terrible headache and I have also developed some kind of sore inside my nostril, my left nostril. So I am starting to get a little concerned, the fever hasn't been that high, it's been a low grade fever, the highest it's been is 100.4 and it goes back and for so, it goes down and then it goes up a little and so far today so far I haven't had any fever, it's been 99.0 so that's alright but I was really starting to get concerned because I did not know how long this thing is supposed to last and I am not usually prone to get headaches or cold, I haven't had a cold or flu in years so I will like to have some information and the place where I got it was "Covid" (not clarified) Hospital. They did not have any contact number for this, so I want to know if I should be concerned, if I should go in to the emergency or see a doctor, I don't have a primary care doctor right now. I really did not have my primary doctor, retired back in July and I have always seen one doctor since 10 and it's hard getting to be ill (not clarified), getting through the doctors, to the clinic and appointment and stuff so I don't know if I should be concerned or how long this is going to last or whatever because I really feel like crap. Lab test fever: result: 99.0, 100.4 (unit not reported). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a little soreness in arm where the vaccine was injected; This is a spontaneous report from a contactable consumer or other non-healthcare professional. An elderly non pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, 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. Other medications in two weeks were unknown. On 07Feb2021, the patient experienced a little soreness in arm where the vaccine was injected. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, SARS-CoV-2 test, Vertigo
Clinical narrative: 4 days after 2nd dose I had vertigo/dizzy. I could not walk for about 30 minutes without holding on to something; 4 days after 2nd dose I had vertigo/dizzy. I could not walk for about 30 minutes without holding on to something; 4 days after 2nd dose I had vertigo/dizzy. I could not walk for about 30 minutes without holding on to something; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264), via an unspecified route in the left arm on 02Feb2021 at 15:00 (at the age of 57-years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient had known allergic to amoxicillin. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3302), via an unspecified route in the left arm on 12Jan2021 at 15:30 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not use other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 06Feb2021 at 08:00, the patient experienced vertigo/dizzy. She could not walk for about 30 minutes without holding on to something. The patient did not receive treatment for events. The patient underwent lab tests and procedures which included COVID test nasal swab was negative on unspecified date of 2021. The outcome of events was recovered on unspecified date of Feb2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, SARS-CoV-2 test, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 70-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration on 03Feb2021 at 11:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history not reported. Concomitant medication included antihistamine. patient had allergies to sulfa and latex. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient was tested COVID post vaccination. On 06Feb2021 (on the 3rd day) at 16:00, patient experienced that her throat felt like it was closing and could not swallow. The swallow reflex would not work. This went on for around an hour. No treatment was received. Patient wants to know if this happens again with the 2nd dose or should not take the 2nd dose. Lab test covid test: unknown. The outcome of all events was recovered. Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Joint swelling, Nausea
Clinical narrative: Bilateral lower extremity pain; pain 9/10 ankle swelling w pain; pain 9/10 ankle swelling w pain/Knee pain; Unable to difficulty to ambulate; Night sweats; Chills w/o fever; Nausea; This is a spontaneous report from a contactable other hcp. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 19Jan2021 14:30 (at the age of 45-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included none. The patient concomitant medications were not reported. AE treatment was given at physicians office visit. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 the patient experienced bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate. Night sweats, chills w/o fever and nausea. On 24Jan2021 the patient underwent lab tests and procedures which included pain assessment: 9/10. Therapeutic measures were taken as a result of bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate, night sweats, chills w/o fever and nausea. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pain assessment, Pain in extremity
Clinical narrative: Bilateral lower extremity pain; pain 9/10 ankle swelling w pain; pain 9/10 ankle swelling w pain/Knee pain; Unable to difficulty to ambulate; Night sweats; Chills w/o fever; Nausea; This is a spontaneous report from a contactable other hcp. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 19Jan2021 14:30 (at the age of 45-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included none. The patient concomitant medications were not reported. AE treatment was given at physicians office visit. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 the patient experienced bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate. Night sweats, chills w/o fever and nausea. On 24Jan2021 the patient underwent lab tests and procedures which included pain assessment: 9/10. Therapeutic measures were taken as a result of bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate, night sweats, chills w/o fever and nausea. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dizziness, Malaise, Nausea
Clinical narrative: Nausea; no appetite; felt woozy; Low grade fever; felt crummy and spent the day in bed /She is not feeling too good; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 04Feb2021 14:00 (at the age of 62-years-old) (Batch/Lot Number: EL9269) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from 2015 and ongoing, hyperthyroidism, cholesterol, bipolar ii disorder. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hyperthyroidism from 2012 and ongoing; simvastatin (SIMVASTATIN) taken for blood cholesterol abnormal from 2010 and ongoing; lamotrigine (LAMICTAL) taken for bipolar ii disorder from 2003 and ongoing; venlafaxine (VENLAFAXINE) taken for bipolar ii disorder from 2000 and ongoing. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The patient no Prior Vaccinations (within 4 weeks). The patient previously first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Jan2021 (at the age of 62-years-old) (Batch/Lot Number: EL3246) for COVID-19 immunisation. Since 05Feb2021, the patient experienced low grade fever, no appetite and felt woozy. Since 06Feb2021, the patient had nausea. That was day four since she received the second dose of the Covid-19 vaccine. She was not feeling too good. She has had a low grade fever and nausea. She has not had anything weird or unusual. She was still drinking liquids but had no appetite. She still felt woozy. still felt woozy. Her temperature was 100.2 degrees. She felt crummy and spent the day in bed. When asked about concomitant medications, patient asked if there would be a difference in taking these medications verses not taking the vaccination. She had a medical background and didn't go seek treatment. She wanted to know when she would feel better, there was anything that anyone could do. This had knocked her for a loop. The event did not require visit to Emergency Room/ Physician Office. The patient had no relevant tests done. Outcome of the events low grade fever was recovered on 06Feb2021; nausea, felt woozy was recovering; no appetite was not recovered; felt crummy and spent the day in bed /she is not feeling too good was unknown.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea; no appetite; felt woozy; Low grade fever; felt crummy and spent the day in bed /She is not feeling too good; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 04Feb2021 14:00 (at the age of 62-years-old) (Batch/Lot Number: EL9269) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from 2015 and ongoing, hyperthyroidism, cholesterol, bipolar ii disorder. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hyperthyroidism from 2012 and ongoing; simvastatin (SIMVASTATIN) taken for blood cholesterol abnormal from 2010 and ongoing; lamotrigine (LAMICTAL) taken for bipolar ii disorder from 2003 and ongoing; venlafaxine (VENLAFAXINE) taken for bipolar ii disorder from 2000 and ongoing. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The patient no Prior Vaccinations (within 4 weeks). The patient previously first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Jan2021 (at the age of 62-years-old) (Batch/Lot Number: EL3246) for COVID-19 immunisation. Since 05Feb2021, the patient experienced low grade fever, no appetite and felt woozy. Since 06Feb2021, the patient had nausea. That was day four since she received the second dose of the Covid-19 vaccine. She was not feeling too good. She has had a low grade fever and nausea. She has not had anything weird or unusual. She was still drinking liquids but had no appetite. She still felt woozy. still felt woozy. Her temperature was 100.2 degrees. She felt crummy and spent the day in bed. When asked about concomitant medications, patient asked if there would be a difference in taking these medications verses not taking the vaccination. She had a medical background and didn't go seek treatment. She wanted to know when she would feel better, there was anything that anyone could do. This had knocked her for a loop. The event did not require visit to Emergency Room/ Physician Office. The patient had no relevant tests done. Outcome of the events low grade fever was recovered on 06Feb2021; nausea, felt woozy was recovering; no appetite was not recovered; felt crummy and spent the day in bed /she is not feeling too good was unknown.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-year-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in the right arm on 04Feb2021 09:00 (age at the time 73-year-old) as single dose for covid-19 immunization at pharmacy. The patient's medical history and no concomitant medications was not reported. The patient did not receive any other vaccine within 4 weeks. The patient previously received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in the right arm on 15Jan2021 16:00 (age at the time 73-year-old) as single dose for covid-19 immunization. On 04Feb2021, the patient had a sore arm which she noticed pretty soon after the second shot. It went away three days later. She had fully recovered from the sore arm. Patient did not required visit to physician or ER. No investigation assessment was reported. The outcome for the event was resolved on 07Feb2021.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: left knee is really swollen; Knee pain; This is a spontaneous report from a contactable consumer or other non health care professional (Patient's daughter). A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9269) via intramuscularly, administered in Arm Left on 05Feb2021 around noon (at the age of 89 years old) as dose 1, single for COVID-19 immunization at Church. No Patient's Medical History and no other products reported. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations were N/A. Caller explained she took her mom to get the vaccine on Friday, 05Feb2021 and explained her mother was fine on Friday when she received the vaccine. Probably the next day, Saturday, 06Feb2021, she stared experiencing really bad knee pains. Her left knee was really swollen. Caller was asking if patient could take an Advil or something to help with pain. Patient did not visit Emergency Room and Physician Office. The caller explains her mother was waiting it out because she knows she would have side effects. If the knee pains persist and goes on until tomorrow, maybe they will go somewhere. Relevant Tests were None. Investigation Assessment was reported as No. The clinical outcome of the event knee pain was not resolved, and left knee is really swollen was unknown.  Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Very tired/tiredness; This is a spontaneous report from two contactable consumers (patient's husband and patient). A 77-years-old female patient received first dose of BNT162B2 (FPFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot Number: EM9810) via intramuscular administered in left arm on 06Feb2021 at 10:00 as dose 1, single (at the age of 77-years-old) for COVID-19 immunization at Clinic. No additional vaccines administered on the same date of Pfizer vaccine. Medical history included ongoing Chronic obstructive pulmonary disease (COPD) diagnosed probably 4 or 5 years ago; and also developed a blood clot 4 or 5 years ago; both from an unknown date. Concomitant medication included WARFARIN 3.5 tablet, by mouth, daily taken as blood thinner for blood clot. The patient not received any other vaccine within 4 weeks prior Vaccination. On 07Feb2021 (Yesterday), patient was very tired and on 08Feb2021, she experienced diarrhea which started early the morning. No Investigation Assessment. No Emergency Room or Physician Office visit and no relevant tests. It was reported reporter did call the physician's office to let her know he was experiencing these side effects. She did too and had the same thing happen. He clarifies further her, and her husband had the whole thing. The caller declined to compete a report on either the physician or the physician's husband. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure abnormal, Blood pressure measurement, Body temperature, Body temperature fluctuation
Clinical narrative: Diarrhea; Very tired/tiredness; This is a spontaneous report from two contactable consumers (patient's husband and patient). A 77-years-old female patient received first dose of BNT162B2 (FPFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot Number: EM9810) via intramuscular administered in left arm on 06Feb2021 at 10:00 as dose 1, single (at the age of 77-years-old) for COVID-19 immunization at Clinic. No additional vaccines administered on the same date of Pfizer vaccine. Medical history included ongoing Chronic obstructive pulmonary disease (COPD) diagnosed probably 4 or 5 years ago; and also developed a blood clot 4 or 5 years ago; both from an unknown date. Concomitant medication included WARFARIN 3.5 tablet, by mouth, daily taken as blood thinner for blood clot. The patient not received any other vaccine within 4 weeks prior Vaccination. On 07Feb2021 (Yesterday), patient was very tired and on 08Feb2021, she experienced diarrhea which started early the morning. No Investigation Assessment. No Emergency Room or Physician Office visit and no relevant tests. It was reported reporter did call the physician's office to let her know he was experiencing these side effects. She did too and had the same thing happen. He clarifies further her, and her husband had the whole thing. The caller declined to compete a report on either the physician or the physician's husband. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nasal congestion, Nausea
Clinical narrative: Diarrhea; Very tired/tiredness; This is a spontaneous report from two contactable consumers (patient's husband and patient). A 77-years-old female patient received first dose of BNT162B2 (FPFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot Number: EM9810) via intramuscular administered in left arm on 06Feb2021 at 10:00 as dose 1, single (at the age of 77-years-old) for COVID-19 immunization at Clinic. No additional vaccines administered on the same date of Pfizer vaccine. Medical history included ongoing Chronic obstructive pulmonary disease (COPD) diagnosed probably 4 or 5 years ago; and also developed a blood clot 4 or 5 years ago; both from an unknown date. Concomitant medication included WARFARIN 3.5 tablet, by mouth, daily taken as blood thinner for blood clot. The patient not received any other vaccine within 4 weeks prior Vaccination. On 07Feb2021 (Yesterday), patient was very tired and on 08Feb2021, she experienced diarrhea which started early the morning. No Investigation Assessment. No Emergency Room or Physician Office visit and no relevant tests. It was reported reporter did call the physician's office to let her know he was experiencing these side effects. She did too and had the same thing happen. He clarifies further her, and her husband had the whole thing. The caller declined to compete a report on either the physician or the physician's husband. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, Vaccination site pain
Clinical narrative: Diarrhea; Very tired/tiredness; This is a spontaneous report from two contactable consumers (patient's husband and patient). A 77-years-old female patient received first dose of BNT162B2 (FPFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot Number: EM9810) via intramuscular administered in left arm on 06Feb2021 at 10:00 as dose 1, single (at the age of 77-years-old) for COVID-19 immunization at Clinic. No additional vaccines administered on the same date of Pfizer vaccine. Medical history included ongoing Chronic obstructive pulmonary disease (COPD) diagnosed probably 4 or 5 years ago; and also developed a blood clot 4 or 5 years ago; both from an unknown date. Concomitant medication included WARFARIN 3.5 tablet, by mouth, daily taken as blood thinner for blood clot. The patient not received any other vaccine within 4 weeks prior Vaccination. On 07Feb2021 (Yesterday), patient was very tired and on 08Feb2021, she experienced diarrhea which started early the morning. No Investigation Assessment. No Emergency Room or Physician Office visit and no relevant tests. It was reported reporter did call the physician's office to let her know he was experiencing these side effects. She did too and had the same thing happen. He clarifies further her, and her husband had the whole thing. The caller declined to compete a report on either the physician or the physician's husband. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Headache; Tiredness; The caller states he has some pain at the injection site; aller verifies he took the following at 9:25 am today, 08Feb2021: Blood pressure: 151/100; blood pressure was usually 140-145 somewhere in ther; emperature: it was low grade at 96.7 degrees, his temperature normally runs about 98.5, 98.7; Nausea; Diarrhea; Joint pain in hands; Congestion; This is Spontaneous report from a contactable consumer. This is report 1 of 4. This report is in regards to the husband. The husband completes the report on behalf of himself. A 68-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM9810), via intramuscular, administered in right arm on 06Feb2021 10:00 (at the age of 68-years-old) as a dose 1,single for covid-19 immunization. Medical history included ongoing diabetes mellitus, surgery (He also had a surgery a year ago on his right foot for his grand toe. He had three surgeries on that toe, and one surgery on his second toe. He was been working with a podiatrist because his toes do not want to heal right because of his diabetes. He was on antibiotics). He was tired and weary yesterday in the afternoon. He had some breathing problems yesterday afternoon that occurred. He became a little congested yesterday afternoon. He confirms the congestion started yesterday afternoon, on 07Feb2021. He was working with some stuff that was dusty and was doing some stuff around the house. So, he initially thought the symptoms he was experiencing were due to that. However, the symptoms are persisting. On 08Feb2021, at around 1am this morning, the nausea and diarrhea kicked in. He took Imodium for the diarrhea and kind of helped stem it but it hasn't stopped it. The joint pain in his hands started yesterday evening and its staying the same. He had some pain at the injection site, it was some pain that popped up later on. He states it doesn't hurt but if he touches it, he knows where the injection was given. Caller verifies he took the following at 9:25 am today, 08Feb2021: Blood pressure: 151/100; blood pressure was usually 140-145 somewhere in there, O2 oxygenation was 95%, temperature: it was low grade at 96.7 degrees, temperature normally runs about 98.5, 98.7. The Outcome of the event congestion and joint pain in hands was not recovered, while for other events was unknown. Description of Product Complaint: The caller explains him and his wife went Saturday and had the Pfizer COVID-19 vaccine at 10am. At around 1am this morning, the caller started to experience nausea and diarrhea. He took Imodium for the diarrhea and kind of helped stem it but it hasn't stopped it. Caller verifies he has no UPC Lot number or expiry date for the Imodium he took. He clarifies he believes it was the last one and he discarded of it. No further details were provided or obtained.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure abnormal, Blood pressure measurement, Body temperature, Body temperature fluctuation
Clinical narrative: Headache; Tiredness; The caller states he has some pain at the injection site; aller verifies he took the following at 9:25 am today, 08Feb2021: Blood pressure: 151/100; blood pressure was usually 140-145 somewhere in ther; emperature: it was low grade at 96.7 degrees, his temperature normally runs about 98.5, 98.7; Nausea; Diarrhea; Joint pain in hands; Congestion; This is Spontaneous report from a contactable consumer. This is report 1 of 4. This report is in regards to the husband. The husband completes the report on behalf of himself. A 68-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM9810), via intramuscular, administered in right arm on 06Feb2021 10:00 (at the age of 68-years-old) as a dose 1,single for covid-19 immunization. Medical history included ongoing diabetes mellitus, surgery (He also had a surgery a year ago on his right foot for his grand toe. He had three surgeries on that toe, and one surgery on his second toe. He was been working with a podiatrist because his toes do not want to heal right because of his diabetes. He was on antibiotics). He was tired and weary yesterday in the afternoon. He had some breathing problems yesterday afternoon that occurred. He became a little congested yesterday afternoon. He confirms the congestion started yesterday afternoon, on 07Feb2021. He was working with some stuff that was dusty and was doing some stuff around the house. So, he initially thought the symptoms he was experiencing were due to that. However, the symptoms are persisting. On 08Feb2021, at around 1am this morning, the nausea and diarrhea kicked in. He took Imodium for the diarrhea and kind of helped stem it but it hasn't stopped it. The joint pain in his hands started yesterday evening and its staying the same. He had some pain at the injection site, it was some pain that popped up later on. He states it doesn't hurt but if he touches it, he knows where the injection was given. Caller verifies he took the following at 9:25 am today, 08Feb2021: Blood pressure: 151/100; blood pressure was usually 140-145 somewhere in there, O2 oxygenation was 95%, temperature: it was low grade at 96.7 degrees, temperature normally runs about 98.5, 98.7. The Outcome of the event congestion and joint pain in hands was not recovered, while for other events was unknown. Description of Product Complaint: The caller explains him and his wife went Saturday and had the Pfizer COVID-19 vaccine at 10am. At around 1am this morning, the caller started to experience nausea and diarrhea. He took Imodium for the diarrhea and kind of helped stem it but it hasn't stopped it. Caller verifies he has no UPC Lot number or expiry date for the Imodium he took. He clarifies he believes it was the last one and he discarded of it. No further details were provided or obtained.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nasal congestion, Nausea
Clinical narrative: Headache; Tiredness; The caller states he has some pain at the injection site; aller verifies he took the following at 9:25 am today, 08Feb2021: Blood pressure: 151/100; blood pressure was usually 140-145 somewhere in ther; emperature: it was low grade at 96.7 degrees, his temperature normally runs about 98.5, 98.7; Nausea; Diarrhea; Joint pain in hands; Congestion; This is Spontaneous report from a contactable consumer. This is report 1 of 4. This report is in regards to the husband. The husband completes the report on behalf of himself. A 68-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM9810), via intramuscular, administered in right arm on 06Feb2021 10:00 (at the age of 68-years-old) as a dose 1,single for covid-19 immunization. Medical history included ongoing diabetes mellitus, surgery (He also had a surgery a year ago on his right foot for his grand toe. He had three surgeries on that toe, and one surgery on his second toe. He was been working with a podiatrist because his toes do not want to heal right because of his diabetes. He was on antibiotics). He was tired and weary yesterday in the afternoon. He had some breathing problems yesterday afternoon that occurred. He became a little congested yesterday afternoon. He confirms the congestion started yesterday afternoon, on 07Feb2021. He was working with some stuff that was dusty and was doing some stuff around the house. So, he initially thought the symptoms he was experiencing were due to that. However, the symptoms are persisting. On 08Feb2021, at around 1am this morning, the nausea and diarrhea kicked in. He took Imodium for the diarrhea and kind of helped stem it but it hasn't stopped it. The joint pain in his hands started yesterday evening and its staying the same. He had some pain at the injection site, it was some pain that popped up later on. He states it doesn't hurt but if he touches it, he knows where the injection was given. Caller verifies he took the following at 9:25 am today, 08Feb2021: Blood pressure: 151/100; blood pressure was usually 140-145 somewhere in there, O2 oxygenation was 95%, temperature: it was low grade at 96.7 degrees, temperature normally runs about 98.5, 98.7. The Outcome of the event congestion and joint pain in hands was not recovered, while for other events was unknown. Description of Product Complaint: The caller explains him and his wife went Saturday and had the Pfizer COVID-19 vaccine at 10am. At around 1am this morning, the caller started to experience nausea and diarrhea. He took Imodium for the diarrhea and kind of helped stem it but it hasn't stopped it. Caller verifies he has no UPC Lot number or expiry date for the Imodium he took. He clarifies he believes it was the last one and he discarded of it. No further details were provided or obtained.