chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she only had injection site pain after vaccine first dose; This is a spontaneous report received from a non-contactable other 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 in left arm on 14Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose on 14Mar2021. She only had injection site pain after vaccine first dose. Event outcome was unknown.  No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Presyncope
Clinical narrative: Instant pain through whole arm/Hurts to hold any weight in hand of injected arm; Lightheaded and dizzy within a few minutes of injection; Felt like she was going to pass out; This is a spontaneous report from a non-contactable consumer (the patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150), via an unspecified route of administration, administered in left arm on 05Apr2021 15:30 as single dose for COVID-19 immunization. Medical history included allergy to nickel from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 05Apr2021, the patient experienced instant pain through whole arm, she was lightheaded and dizzy within a few minutes of injection, she felt like she was going to pass out and had to sit down, she stated it hurts to hold any weight in hand of injected arm. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: checked his antibodies 2 weeks later and it was negative/ 2 weeks later on 10Feb2021 took an antibody test and he was negative for his IgG and IgM; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration on 22Dec2020 at single dose and the second dose via an unspecified route of administration on 22Jan2021 at single dose, both for COVID-19 immunization. Medical history included CAD coronary Artery Disease and pulmonary hypertension. Concomitant medications were not reported. Patient received the Pfizer vaccine in Dec (22Dec2020) and he checked his antibodies 2 weeks later and it was negative. Patient received the 2nd dose on 22Jan2021 and 2 weeks later on 10Feb2021 took an antibody test and he was negative for his IgG and IgM. Patient used for both antibody test. Patient was concerned about his health and his family and the patients he worked with. Patient may be a non-responder. Patient was in a hospital and operating room. Patient spoke with his pharmacist and they were all very confused and what to make out of it. Any recommendation regarding if patient should get his doses again. Or about using other companies Covid vaccines. Physician asked what other markers were used to determine efficacy. Outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 23Mar2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Approximately six days later caller was diagnosed with Covid. The patient has appointment to receive her second Pfizer Covid vaccine on 13Apr2021 in which she will be completed her isolation. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip blister, Swollen tongue, Tongue blistering
Clinical narrative: tongue swollen so bad; blisters on tongue and lips; blisters on tongue and lips; This is a spontaneous report from a contactable consumer reported for herself. A 54-year-old female patient received first dose of bnt162b2 via an unspecified route of administration on 20Mar2021 15:00 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer COVID vaccine on 20Mar2021 around 3 pm. The next morning around 6 am her tongue swollen so bad she couldn't close her mouth and she had blisters on tongue and lips. She was still dealing with the blisters. Her doctor wanted her to go to the emergency room but she decided to stay home and took Benadryl for a day and a half, the swelling went down but the blisters remains. Patient would like to know if she should receive the second dose. The outcome of tongue swollen was recovered, blisters on tongue and lips was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip blister, Oral mucosal blistering, Swollen tongue, Tongue blistering
Clinical narrative: tongue swollen so bad; blisters on tongue and lips; blisters on tongue and lips; This is a spontaneous report from a contactable consumer reported for herself. A 54-year-old female patient received first dose of bnt162b2 via an unspecified route of administration on 20Mar2021 15:00 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer COVID vaccine on 20Mar2021 around 3 pm. The next morning around 6 am her tongue swollen so bad she couldn't close her mouth and she had blisters on tongue and lips. She was still dealing with the blisters. Her doctor wanted her to go to the emergency room but she decided to stay home and took Benadryl for a day and a half, the swelling went down but the blisters remains. Patient would like to know if she should receive the second dose. The outcome of tongue swollen was recovered, blisters on tongue and lips was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Tinnitus
Clinical narrative: muscle fatigue; ears were ringing; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729) administered in upper left arm on 01Apr2021 as single dose for covid-19 immunisation. Medical history included heart murmur diagnosed when she was quite young as a child by pediatrician, overweight, and allergic to Penicillin. The patient's concomitant medications were not reported. None other vaccines administered on same date. On 01Apr2021 mid afternoon after patient got the shot, her ears were ringing and was worse the next day and was more pronounced, it is not going away. On the second day 02Apr2021, she started to notice the muscle fatigue, her strength back until 04Apr2021. The outcome of ear ringing was not recovered, of muscle fatigue was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lymphadenopathy, Skin mass, Swelling face
Clinical narrative: a big old puffy bag under his right eye; face was swelling; left eye is a little bit swollen; lymph nodes are swollen coming down to his nose and down on his cheek; This is a spontaneous report from a contactable consumer reported self. A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955) on 18Mar2021 as single dose for covid-19 immunisation. Medical history included blocked artery that can't put a stent. None family medical history. None other vaccines administered on same date. Last vaccines were 50 years ago as a child and there were no issues. After his first dose, patient was asked to sit for 15 minutes and he was fine and got in the car and drove home which takes 5-7 minutes and by the time he got home, he had a big old puffy bag under his right eye which drew his attention to look in the mirror and he saw his face was swelling. It started under his right eye and his left eye is a little bit swollen and then on the side coming down to his nose and all the way down on his cheek, lymph nodes are swollen on both sides as well. He went to the pharmacist and they told him they don't recommend him taking anything so he left it alone thinking it would be gone when he woke up. His daughter asked him called an ambulance, so he did that at 2:00-3:00a.m. When they came they said that there is no swelling any other place, they could recommend to take Benadryl, following morning he got the tablets and has taken all 24 and it is still there. No emergency room or physician office visit. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Hyperhidrosis, Renal pain
Clinical narrative: can't eat; patient woke in a pool of sweat that was so ubiquitous; extreme chills; massive kidney pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Apr2021 09:30 AM in left arm as single dose for covid-19 immunisation. Medical history included Seronegative RA and glomular nephritis. Patient not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Apr2021 05:30 PM, 32 hours after the vaccine, patient could feel kidneys working overtime. He went into extreme chills and massive kidney pain, heat and clothes did not help. 38 hours after injection he couldn't stand the chill or the kidney pain so he took 800 mg ibuprofen and slept for 2 hours. 40 hours after injection patient woke in a pool of sweat that was so ubiquitous it went to the mattress. Since then (51 hours after injection) patient had bedridden with massive kidney pain. He can drink water but can't eat. Patient had not been tested for covid-19 since the vaccination. The events outcome was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Pharyngeal swelling
Clinical narrative: difficulty swallowing; difficulty breathing; a little swelling in the throat; This is a spontaneous report from a contactable consumer (patient). An 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 16:30 as SINGLE DOSE in Arm Right for covid-19 immunisation.  Medical history included He has seasonal allergies and sneezes. He does not take medication for it.  It has been diagnosed 3-4 years ago.  It is not real bad. Concomitant medications included atenolol taken 10-15 years, amlodipine taken for 10 years, both for high blood pressure. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was None.  Vaccination facility type was Clinic. After 5-6 hours after the first injection he developed difficulty swallowing, a little difficulty breathing and a little swelling in the throat on 11Mar2021. When he took first shot, there was no reaction until 5-6 hours later.  He had trouble swallowing at 21:30-22:00. He was concerned about these side effects and whether he should receive the second shot.  NO ER or physician's office required. The outcome of a little swelling in the throat was recovering, of other events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Adrenal disorder, Blood corticotrophin, Urine analysis abnormal, Urine output
Clinical narrative: she had a 24 hour urine test (performed 5 days ago) that "showed a lot of stuff in my urine and that I have an adrenal gland problem and now I need to have an MRI; had a 24 hour urine test that "showed a lot of stuff in my urine"; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Mar2021 (Lot Number: EN6204) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received her first vaccine dose on 16Mar2021 and afterwards (Facility name) scheduled her second dose for 28 days later. She reports that her understanding it that the doses should be 21 days apart and asks if this changes the effectiveness. Before she got her first vaccine dose she had a blood test showing that her "Plasma acth" went up. After having the covid vaccine she had a 24 hour urine test (performed 5 days ago) that "showed a lot of stuff in my urine and that I have an adrenal gland problem and now I need to have an MRI". She was asking if its ok to have the second dose if she has an adrenal gland disorder? She had difficulty explaining the tests and condition she was currently being worked up for.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Euphoric mood
Clinical narrative: lightheadedness; Feels "like he's high" or "like he's on a roller coaster" everyday since receiving his second dose vaccine; This is a spontaneous report from a contactable consumer (Patient mother).  A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Mar2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient has been experiencing lightheadedness, and feels "like he's high" or "like he's on a roller coaster" everyday since receiving his second dose vaccine. The outcome was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he received Pfizer's COVID vaccine on Friday, 02Apr2021, and got tested for COVID today (Apr2021) with a positive test. He is asking if the vaccine may cause a positive test. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Apr2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller states her aunt received the first dose of the Pfizer COVID vaccine on 18 FEB 2021. Caller states on 06 MAR 2021 aunt was diagnosed with COVID-19. Caller states on 19 MAR 2021 her aunt tested negative for COVID-19; Caller states her aunt received the first dose of the Pfizer COVID vaccine on 18 FEB 2021. Caller states on 06 MAR 2021 aunt was diagnosed with COVID-19.; This is a spontaneous report from a contactable other hcp.  An 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on 18Feb2021 as single dose for covid-19 immunisation.  The patient medical history concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test on 06Mar2021 and sars-cov-2 test was negative on 19Mar2021. On 06mar2021 patient was diagnosed with covid-19. Caller states on 19Mar2021 patient tested negative for covid-19. The outcome of 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, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity with only 1st dose of the vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Joint swelling, Swelling
Clinical narrative: Joints that were swollen became red, hot and more swollen including third toe on left foot, right ankle and foot, left hip, right wrist and right thumb.; hot and more swollen including third, toe on left foot, right ankle and foot, left hip, right wrist and right thumb; hot and more swollen including third, toe on left foot, right ankle and foot, left hip, right wrist and right thumb; Joints that were swollen became red, hot; This is a spontaneous report from a contactable other hcp. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 14:30 (Batch/Lot Number: ER8730) as SINGLE DOSE for covid-19 immunisation.  Medical history included Small fiber peripheral neuropathy, Enteropathic  Arthritis Associated With Inflammatory Bowel Disease , vulvodynia, frequent PVCs, allergy with pollen, mold, fungi, dander and dust.  food sensitivities but no true allergies. Patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Mar2021, for covid-19 immunization and experienced fatigue and joint swelling.  The patient's concomitant medications were not reported.  The patient experienced joints that were swollen became red, hot and more swollen including third toe on left foot, right ankle and foot, left hip, right wrist and right thumb on 25Mar2021 20:00.  Therapeutic measures were taken as a result of all events. Outcome of all events was not recovered. Case was reported as non-serious.  No Follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : same patient different vaccine dose
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: pretty deep pain in my neck, shoulder and arm opposite of the side I got the injection; pretty deep pain in my neck, shoulder and arm opposite of the side I got the injection; pretty deep pain in my neck, shoulder and arm opposite of the side I got the injection; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (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 received the first dose of the Pfizer BioNTech covid vaccine a week ago.  She was due back in 2 more weeks.  Just today she woke up with some of the side effects.  In particular, she had a pretty deep pain in my neck, shoulder and arm opposite of the side she got the injection.  Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Herpes zoster, Pain
Clinical narrative: shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; Chills; Fatigue; Shingles; This is a spontaneous report from a contactable consumer.A 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Medical history included Mitral valve prolapse, thyroid surgery, sleep apnoea. The patient's concomitant medications were not reported.  On February 26th she got her first dose of the  vaccine, and she is scheduled to get the second April 8th. She says on March 8th she was diagnosed with shingles. Her shingles rash she really didn't have long, it has almost faded now, it is almost nothing as far as scabs. She says she still has the burning, itching, and pain, but today it is not so bad. She says she sometimes has chills, which is one of the things that goes along with it, and fatigue. She says her concern was about this too, because even though the rash is gone she still has symptoms, does this mean her shingles are still active. She says she asked her pharmacist and they said it could still be active. her first dose of the vaccine was given in the afternoon, probably 02:30PM. She says she was diagnoses with shingles on March 8th after a visual diagnosis. Pfizer COVID-19 vaccine NDC/EXP: Not provided on handwritten vaccine card. AE Treatment:  Caller says for the shingles her doctor hasn't said anything, she did get a prescription which she took, of 3 tablets a day for a week, so 21 tablets. She says she was also prescribed an ointment that she was putting on. She says that the tablets were Valacyclovir 1 gram, and she took one tablet by mouth three times daily for 7 days. She says this medication was dispensed in a pharmacy bottle from pharmacy, NDC/LOT/EXP were not provided on pharmacy label. Caller says the ointment was Triamcinolone Acetonide ointment USP 0.025%, which was applied usually before bed around 10:00PM-10:30PM. She says the label on that says apply externally to affected area twice daily for 15 days, but she applied it only once a day. Caller says that the EXP on the tube is little, it is July 2022, LOT: Unknown, unable to see on the tube. NDC: Caller says this is very, very little, she needs her magnifying glass, it looks like it is 45802-054-35. She says that the NDC is almost not on there, it is so little. Outcome of  shingles, rash,burning, itching, and pain was recovering, of  chills and fatigue was unknown.Therapeutic measures were taken as a result of shingles.  No follow-up attempts possible. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; Chills; Fatigue; Shingles; This is a spontaneous report from a contactable consumer.A 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Medical history included Mitral valve prolapse, thyroid surgery, sleep apnoea. The patient's concomitant medications were not reported.  On February 26th she got her first dose of the  vaccine, and she is scheduled to get the second April 8th. She says on March 8th she was diagnosed with shingles. Her shingles rash she really didn't have long, it has almost faded now, it is almost nothing as far as scabs. She says she still has the burning, itching, and pain, but today it is not so bad. She says she sometimes has chills, which is one of the things that goes along with it, and fatigue. She says her concern was about this too, because even though the rash is gone she still has symptoms, does this mean her shingles are still active. She says she asked her pharmacist and they said it could still be active. her first dose of the vaccine was given in the afternoon, probably 02:30PM. She says she was diagnoses with shingles on March 8th after a visual diagnosis. Pfizer COVID-19 vaccine NDC/EXP: Not provided on handwritten vaccine card. AE Treatment:  Caller says for the shingles her doctor hasn't said anything, she did get a prescription which she took, of 3 tablets a day for a week, so 21 tablets. She says she was also prescribed an ointment that she was putting on. She says that the tablets were Valacyclovir 1 gram, and she took one tablet by mouth three times daily for 7 days. She says this medication was dispensed in a pharmacy bottle from pharmacy, NDC/LOT/EXP were not provided on pharmacy label. Caller says the ointment was Triamcinolone Acetonide ointment USP 0.025%, which was applied usually before bed around 10:00PM-10:30PM. She says the label on that says apply externally to affected area twice daily for 15 days, but she applied it only once a day. Caller says that the EXP on the tube is little, it is July 2022, LOT: Unknown, unable to see on the tube. NDC: Caller says this is very, very little, she needs her magnifying glass, it looks like it is 45802-054-35. She says that the NDC is almost not on there, it is so little. Outcome of  shingles, rash,burning, itching, and pain was recovering, of  chills and fatigue was unknown.Therapeutic measures were taken as a result of shingles.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer(patient). A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Consumer stated he was scheduled to receive the second dose on 21 MAR 2021. Consumer states he was diagnosed with shingles a couple days before his scheduled appointment for the second dose. Outcome of event was unknown.Therapeutic measures were taken as a result of shingles.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 24 hours after shot was administered, got an elevated temp (99.5) and muscle soreness which lasted for a week, went to urgent care where was tested positive for covid; This is a spontaneous report received from a contactable consumer (patient). A 47-years-old male patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021 at 12:15 (at the age of 47-year-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included ascorbic acid, rosa canina fruit (VITAMIN C & ROSEHIP), vitamin b complex (B COMPLEX (B50)), krill oil (KRILL OIL), Beet Capsule and D. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 30Mar2021 at 20:00, 24 hours after the shot of vaccine, the patient experienced elevated temp (99.5) and muscle soreness which lasted for a week. The patient went to urgent care, where he was tested positive for COVID-19. The patient did not receive any treatment for the events. Due to event the patient visited doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Apr2021. The outcome of the event was not recovered.  Additional information has requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: left shoulder joint pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 09Mar2021 23:30 (Batch/Lot Number: EN6198) as single dose for covid-19 immunization at a public health department. Medical history included diabetic and blood pressure. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the first dose, the patient had left shoulder joint pain for about 10 days. The event resulted in emergency room/department or urgent care visit and hospitalization. The event was not treated. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis; This is a spontaneous report received from a contactable Other HCP reported for himself. This 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 23Mar2021 13:00 (Batch/Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included have been recovering from reactive arthritis since very late 2016, had Still's disease in 1989 and had allergy to lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen; losartan; alfuzosin; lansoprazole. A couple of days after the vaccination on 26Mar2021, his arthritis (primarily, but not entirely joints related to the reactive arthritis rather than the Still's) started becoming much more painful. This grew quite intense about 10 days after the vaccination. At that time he increased hgis daily intake of ibuprofen from two 200 mg pills per day to four 200 mg pills (two pills twice per day). This has stabilized the condition. When the reactive arthritis began several years ago, he was taking eight pills per day and had gradually brought it down to two pills, and he had no real discomfort at the time of vaccination and was planning to drop the dose again. The patient have never had to increase the dosage in the past except for cases when he was slowly reducing the dose, would try a new lower dose and would decide he was not quite ready. The patient have never before had to increase the dose from a stable level. The event result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea
Clinical narrative: feeling Dizzy; she felt like "garbage" and felt like she was going to throw up; she felt like "garbage" and felt like she was going to throw up; This is spontaneous report from a contactable nurse reported for slef. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose (lot: ER8732) in left arm on 01Apr2021 09:30 AM for COVID-19 immunisation. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included allergies to dairy and eggs. Concomitant medications were not reported. The patient got her first vaccine on 01Apr2021 (Thursday morning). About an hour and a half after she got her vaccine, she started feeling "super dizzy" that got worse throughout the day because she was driving. She felt like "garbage" and felt like she was going to throw up. By the time she got home that day it was a little better, but she had to lay down, and any time she got up or moved too fast she experienced the dizziness. The next day she felt it again when she was in the car and then reported that by that night she felt better. She started feeling dizzy and it didn't go away until Friday evening, no treatment received for the adverse event. The patient wanted to know if she should get the second vaccine. She is due to get her second dose next week on Thursday and is concerned if it is safe for her to do so. She is worried how bad her reaction is going to be after the second dose. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Muscle aches; arm soreness/calf pain; Ankle pain; This is a spontaneous report received from a non-contactable consumer reported for herself. This 34-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced muscle aches and arm soreness after 2nd shot of covid19 vaccine, ankle and calf pain within 30 min of shot. Treatment was received for events. Muscle ache remained 2 days after shot when required ibuprofen (ADVIL) as paracetamol (TYLENOL) did not help. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Fever; body aches/general soreness; his head hurts; This is a spontaneous report received from a Pfizer sponsored program from a male contactable consumer(patient) reported for himself. A male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of Covid-19 vaccine on 11Mar2021 at single dose for Covid-19 immunization. Patient stated he got his first dose of the Pfizer vaccine 11Mar2021 and he got the second dose yesterday 01Apr2021. Patient relays that he didn't think to ask the pharmacy when got the vaccine and he called them this morning to ask about taking an anti-inflammatory afterwards. Stated he was told it was ok. Stated he talked to his primary care provider before he got the 2nd dose and they mentioned that for 72 hours before and 72 hours after not to take an anti-inflammatory. Patient stated he thought he would contact Pfizer to get an exact answer. Stated he has a fever over 100 now and is trying to combat that. Stated he had been on hold for an hour and a half. Patient declined to make a report at this time. Stated to be honest what he was seeing is fever and body aches and he wanted to know if he can take paracetamol (TYLENOL). Reporter seriousness was unspecified. Patient stated he was a pharmacist intern but he didn't finish school though. Patient clarified that he did not make a report with the previous agent, that they just got contact information. Patient called because he wanted to know if he could take Tylenol after getting his second dose of the covid-19 vaccine yesterday (01APR2021). Patient asked his medical provider and was advised to take Tylenol 72 hours before and after the covid-19 vaccine and the Pharmacy where he was administered with the vaccine told him it was okay to take Tylenol. According to patient, he wanted to take Tylenol because he was feeling general soreness, body aches and his head hurts, his first dose was given on 11Mar2021. Outcome of events was unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Presyncope
Clinical narrative: felt like if I was going to pass out; whole body started feeling warm all over from my legs up to my head; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration administered in the Left Arm on 25Mar2021 12:45 as a single dose for COVID-19 immunization. Medical history included gastritis. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 25Mar2021, within minutes after the vaccine, the patient's whole body started feeling warm all over from her legs up to her head and she felt like as if she was going to pass out. After 15 minutes it went away completely. No treatment was given in response to the events. The outcome of the events was recovered on 25Mar2021. The patient has not been tested for COVID-19 since vaccination. The reporter assessed the events as non-serious.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: Stated that a week later that he had a temperature and tested positive for Covid/stated that he felt bad; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's wife) reported for a male patient (reporter's husband) of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, at an unknown anatomical location on 31Mar2021 (age at vaccination was unknown) at a single dose for covid-19 immunisation. Patient's medical history included dialysis. Concomitant medications were not reported. After the vaccination, the patient felt bad that evening. The patient is on dialysis. The patient went to dialysis and told them how he felt. They told him it was probably from the vaccine. Reporter stated he got better. A week later that he had a temperature and tested positive for Covid. They wanted to know that since they got the vaccine on 31Mar2021 and are scheduled for the second one on 11Apr2021 when they will get the second vaccine. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) via an unspecified route of administration at left arm on 03Apr2021 at 16:30 (47-year-old and not pregnant at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included bronchitis, elevated blood pressure, seasonal allergies (dust and pollen allergies), muscle pain, and back pain. Prior to vaccination, the was not patient diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ALLER TEC, lot number: 9BE2641B, expiry date: Dec2020, patient says this is a Zyrtec generic) for seasonal allergies; naproxen sodium (ALEVE LIQUID GELS, lot number: 87167925, expiry date: May2022) for a couple years for her muscle pain and back pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 05Apr2021 at 12:00. The adverse event did not result in emergency room visit or physician office visit. Patient said she took both of cetirizine hydrochloride and naproxen sodium after getting her first dose of the vaccine since that was her normal night routine, and it didn't occur to her that it might interfere with the vaccine. She said she would like to know if she needs to stop taking these medications before her second dose on 24Apr2021. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ecchymosis, Rash
Clinical narrative: rash on the buttocks or upper thigh; ecchymotic appearance; This is a spontaneous report from a contactable Other Health Professional (nurse practitioner). This Other Health Professional reported similar events for four patients (4 workers). This is the second of four reports.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (unknown age at time of vaccination) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed a rash on the buttocks or upper thigh within a few days to a week after getting a Pfizer COVID-19 vaccine. The rash begins with an appearance similar to shingles. After about a week the lesions are flat with an ecchymotic appearance. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021375425 same drug, event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac disorder, Incorrect route of product administration, Investigation
Clinical narrative: had a "protein thing" around her heart; BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) subcutaneously; blood pressure to go "sky high"; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) subcutaneously on 01Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient would like to know the percentage of BNT162b2 that was in her system after one dose. She spoke with one physician who told her that she was 50% covered and another who told her it was 80%. The first dose of the vaccine caused her blood pressure to go "sky high" in Apr2021 and reported she almost passed out. She was taken to the emergency room where it was found that she had a "protein thing" around her heart that the doctors were not sure came from the vaccine or not. Due to this reaction, the patient was unsure if she would be able to get the second dose and would like to know how protected she was with just the first dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid on 05Apr, after being exposed at 8pm on 31Mar.; Tested positive for Covid on 05Apr, after being exposed at 8pm on 31Mar.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number Unknown and expiry date was not provided), dose 2, via an unspecified route of administration, in the Arm Left, on 28Mar2021 at 10:00 AM as a single dose, for covid-19 immunisation. Medical history included BNT162B2 dose 1, via an unspecified route of administration, in the Arm Right, on Mar2021 at 01:30 PM (Batch/ Lot Number Unknown and expiry date was not provided), as a single dose and penicillin allergy. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Lab test includes Nasal Swab (SARS-CoV-2 test) on 05Apr2021, result Positive. On 04Apr2021, patient Tested positive for Covid on 05Apr2021, after being exposed at 8pm on 31Mar 2021, in emergency room, no treatment received for adverse events. Outcome of the events was recovering.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea
Clinical narrative: feeling dizzy when he went to bed/dizziness occasionally throughout the day; feeling weak; a little bit out of breath; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 55 years old on 02Apr2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced feeling dizzy when he went to bed/dizziness occasionally throughout the day on 02Apr2021, feeling weak in Apr2021, a little bit out of breath in Apr2021. The patient was calling on behalf of her husband, the patient had first dose on 02Apr2021 and started feeling dizzy when he went to bed that night, he's dizzy when laying down in bed sometimes it woke him up, he had dizziness occasionally throughout the day and he was also feeling weak and a little bit out of breath. The patient was concerned on getting second. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cholecystitis infective, Tooth infection
Clinical narrative: gall bladder infection; tooth infection; This is a spontaneous report received from a contactable consumer (patient's friend). A 60-year-old female patient (no pregnant) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter was calling for her friend who took BNT162b2 and the day after the report was the last day for her to get the second dose of vaccine. The patient had tooth and gallbladder infection and wanted to know if she could still go ahead and get the second shot. The reporter heard many friends had problems with the vaccine and stated she had two also. The reporter wanted to know what organ processed the vaccine, if it was spleen and pancreases. The patient  got one vaccine and she was really nervous about getting her 2nd vaccine because she had a tooth infection and she believed she had a gall bladder infection and she was due to get her 2nd vaccine no later than the day of the report; the reporter asked if she could go ahead and get that 2nd vaccine even though she had a tooth infection and possibly a gall bladder infection. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.