chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Skin disorder, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer. A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6206 and Expire Date: unknown), in left arm via unknown route of administration, on 20Mar2021 at 16:00, as single dose for COVID-19 immunization. The patient previously received BNT162B2 (BNT162B2, lot number: EN6200) in arm on 27 Feb 2021 for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Medical history included measles, chicken pox, anemia, bee stings allergy, penicillin allergy. Concomitant medications were none. After 4th day of vaccination, a condition looking very much like flat hives was noticed at midnight. Itchiness was slight. This condition started on the back of her thighs, high up, then spread to the inside and front of the thighs, which she noticed at 5 a.m. There was also redness and a burning sensation. From midnight to 3 a.m. she was itchy on all her areas of skin but the location of the "rash." she checked it out and looked in a mirror and took photos and then looked online and saw that this is a rash that covid19 can once in a while can have with the covid19 virus but not with the vaccination. She then was having some difficulty sleeping all over but put some 1% hydrocortisone anti-itch cream on the area on her thighs and tried to go back to sleep; states she had a very fitful sleep, and her entire body itches every place there was skin except where the rash was where she put the hydrocortisone cream. Caller states she may be an allergic reaction to the ingredients in the Pfizer COVID-19 vaccine. Caller states she wanted to see if the reaction that she had that she is thinking is a reaction or if she is allergic to one of the ingredients for the Pfizer COVID-19 Vaccine. Prior to and since vaccination the patient was not diagnosed with COVID-19. The outcome of the events was not recovered without treatment. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Premature menarche
Clinical narrative: her menstrual period began the day following the second covid vaccination (on 28Mar2021), which was one week early; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 27Mar2021 09:00 (Batch/Lot Number: EN6206) as 2ND DOSE,SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose, of  bnt162b2 (lot number:EN6206) on 06Mar2021 at 09:00 AM in the left arm for covid-19 immunization. The patient stated that her menstrual period began the day following the second covid vaccination (on 28Mar2021), which was one week early. The patient have never started that early before. The outcome of event was unknown. Patient did not receive any treatment for the event  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: Pulmonary Embolism
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Illness, Influenza, Nausea
Clinical narrative: I got really sick; Couldn't get out of bed; Dizzy; Throwing up; I was down all day, I couldn't get my head off the pillow; Nauseous; Achy; I have the flu; This is a spontaneous report from a contactable consumer. A 62-years-old female patient received(PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: ER8737) first dose via an unspecified route of administration on 09Apr2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient got vaccine last Friday and she got really sick on 10Apr2021, she had the flu on Apr2021, she couldn't get out of bed on 10Apr2021 i.e., Saturday, she was dizzy on 10Apr2021 and achy on Apr2021, throwing up on 10Apr2021. This is the first one she got and she had to go back on 04May2021 to get the second one but she got really sick with this. she just wanted to let you guys know, it started on Friday and she was down all day, she couldn't get her head off the pillow, nauseous on 10Apr2021. she had the Pfizer one the first dose. The patient got only sick and experienced all of the above on the day after the covid 19 vaccine. It lasted a week on and off. some days she felt good, others not so good. The out come of the events like illness, fatigue, dizziness, vomiting, Nausea were recovered and the outcome of the events like flu, pain was unknown.  Follow up(11May2021):This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: The event onset dates updated.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence, Vomiting
Clinical narrative: I got really sick; Couldn't get out of bed; Dizzy; Throwing up; I was down all day, I couldn't get my head off the pillow; Nauseous; Achy; I have the flu; This is a spontaneous report from a contactable consumer. A 62-years-old female patient received(PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: ER8737) first dose via an unspecified route of administration on 09Apr2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient got vaccine last Friday and she got really sick on 10Apr2021, she had the flu on Apr2021, she couldn't get out of bed on 10Apr2021 i.e., Saturday, she was dizzy on 10Apr2021 and achy on Apr2021, throwing up on 10Apr2021. This is the first one she got and she had to go back on 04May2021 to get the second one but she got really sick with this. she just wanted to let you guys know, it started on Friday and she was down all day, she couldn't get her head off the pillow, nauseous on 10Apr2021. she had the Pfizer one the first dose. The patient got only sick and experienced all of the above on the day after the covid 19 vaccine. It lasted a week on and off. some days she felt good, others not so good. The out come of the events like illness, fatigue, dizziness, vomiting, Nausea were recovered and the outcome of the events like flu, pain was unknown.  Follow up(11May2021):This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: The event onset dates updated.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: the shingles on the right side of my face, extending from my right ear down to my chin, and up to my right eye.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729, expiration date: unknown) dose 1 via an unspecified route of administration in the left arm on 08Apr2021 at 13:00 (at the age of 59-year-old) as single dose for covid-19 vaccination at Pharmacy or Drug Store. Medical history included penicillin allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination, the patient had not been tested with covid-19. Concomitant medication included VITAMIN D [VITAMIN D NOS]. On 13Apr2021, after five days from vaccination, patient developed the shingles on the right side of my face, extending from my right ear down to my chin, and up to my right eye. He would like to know if it is possible that the Pfizer BioNTech COVID-19 vaccine could have "triggered" the case of shingles of that her husband experienced 5 days after receiving his first dose of the vaccine. Response was that there is no information to suggest that the vaccine causes shingles, shingles was not listed as a commonly reported side effect with the clinical trial participants, this list does not include all possible side effects with the vaccine. Also that they do not have the safety data to speak from since the vaccine has been released to the public. Her wife wanted to know if this was a common thing, Is it from vaccine, if he did get second dose, how soon can he get second dose. she also wanted to know With the Pfizer COVID vaccine, like with the flu vaccine, which has a flu component, does this also have a Covid component in the vaccines. Patient wanted to know wanted to know how soon can he get next COVID shot. Patient's second dose is due on 01May2021. His dermatologist advised he not have second dose. Dermatologist said not to get one on Saturday if the Shingles would clear up. Patient was not sure if he should get it. If so, how soon. Patient also reported that the first vaccine did trigger the shingle's because of whatever in his immune, is he at a higher risk for getting a worse case with second vaccine. Patient received unspecified treatment which was prescribed by dermatologist. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.  No Follow-up attempts are needed. No further information is expected
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Burning sensation, Chest pain, Dyspnoea, Muscle spasms
Clinical narrative: Chest cramping and pain; Chest cramping and pain/cramping between shoulder blades; pain in left arm and left clavicle; pain in left arm and left clavicle; shortness of breath; burning and aching under skin; burning and aching under skin; This is a spontaneous report from a contactable consumer (patient) via COVAES. This non-pregnant 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8731) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 39-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had not received any other vaccines in the four weeks prior to the COVID vaccination. The patient previously received the first dose of BNT162B2 (lot number EW6207) on 13Mar2021 at 15:15 (at the age of 39-years-old) for COVID-19 immunisation. The patient experienced chest cramping and pain, pain in the left arm and left clavicle, cramping between shoulder blades, shortness of breath, and burning and aching under the skin on 16Apr2021. The events required an emergency room visit and physician office visit. No treatment was received for the events. The clinical outcomes of chest cramping and pain, pain in the left arm and left clavicle, cramping between shoulder blades, shortness of breath, and burning and aching under the skin were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain of skin
Clinical narrative: Chest cramping and pain; Chest cramping and pain/cramping between shoulder blades; pain in left arm and left clavicle; pain in left arm and left clavicle; shortness of breath; burning and aching under skin; burning and aching under skin; This is a spontaneous report from a contactable consumer (patient) via COVAES. This non-pregnant 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8731) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 39-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had not received any other vaccines in the four weeks prior to the COVID vaccination. The patient previously received the first dose of BNT162B2 (lot number EW6207) on 13Mar2021 at 15:15 (at the age of 39-years-old) for COVID-19 immunisation. The patient experienced chest cramping and pain, pain in the left arm and left clavicle, cramping between shoulder blades, shortness of breath, and burning and aching under the skin on 16Apr2021. The events required an emergency room visit and physician office visit. No treatment was received for the events. The clinical outcomes of chest cramping and pain, pain in the left arm and left clavicle, cramping between shoulder blades, shortness of breath, and burning and aching under the skin were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip disorder, Lip swelling, Rash
Clinical narrative: a rash on her hand and side of her hand; swelling under her lips with bumpps; swelling under her lips with bumps; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on Tuesday 06Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On Thursday (an unspecified date) the patient experienced a rash on her hand and side of her hand and swelling under her lips with bumps. The patient wanted to know if she should receive the second dose. The outcomes of rash, swelling, and bumps were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Feeling hot, Headache, Induration
Clinical narrative: swelling in the lower part of the arm pits/this side effect of swollen lymph nodes; side effect of swollen lymph nodes/when it gets hot and swollen it really hurts; sometimes it was swollen and hard/it gets hard so fast; it gets hot /the warmth under her arm continues; Fever; Headaches; Chills; can barely move her arm; swelling underarms are painful; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced some considerable swelling in the lower part of the armpits. She had fever, chills, and headaches that had already gone away. The swelling underarms were painful about the size around a baseball, sometimes it was swollen and hard. Pain was always there. The patient asked what recommendations could be made about this side effect of swollen lymph nodes. When it got hot and swollen it really hurt so she might not be able to work tomorrow. The patient was treated with paracetamol (TYLENOL) on Saturday (24Apr2021) around 14:30 because she had a fever and it helped a little. It got swollen so fast and it got so hard and hot that she could barely move her arm and it happened all of a sudden. She also took paracetamol on Sunday (25Apr2021) when the pain was intense and constant. The warmth under her arm continued and the pain was always there and it was intense. The outcomes of hot and pain were not recovered. The outcomes of fever, chills, and headaches were recovered. The outcomes of swollen lymph nodes, hard, and could barely move her arm were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Mobility decreased, Pyrexia
Clinical narrative: swelling in the lower part of the arm pits/this side effect of swollen lymph nodes; side effect of swollen lymph nodes/when it gets hot and swollen it really hurts; sometimes it was swollen and hard/it gets hard so fast; it gets hot /the warmth under her arm continues; Fever; Headaches; Chills; can barely move her arm; swelling underarms are painful; This is a spontaneous report received from a contactable consumer (patient). A 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced some considerable swelling in the lower part of the armpits. She had fever, chills, and headaches that had already gone away. The swelling underarms were painful about the size around a baseball, sometimes it was swollen and hard. Pain was always there. The patient asked what recommendations could be made about this side effect of swollen lymph nodes. When it got hot and swollen it really hurt so she might not be able to work tomorrow. The patient was treated with paracetamol (TYLENOL) on Saturday (24Apr2021) around 14:30 because she had a fever and it helped a little. It got swollen so fast and it got so hard and hot that she could barely move her arm and it happened all of a sudden. She also took paracetamol on Sunday (25Apr2021) when the pain was intense and constant. The warmth under her arm continued and the pain was always there and it was intense. The outcomes of hot and pain were not recovered. The outcomes of fever, chills, and headaches were recovered. The outcomes of swollen lymph nodes, hard, and could barely move her arm were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Nasal congestion
Clinical narrative: a raspy voice/voice changing; congestion; This is a spontaneous report received from a contactable consumer (patient). This female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unknown date for COVID-19 immunisation. The patient initially called to obtain information about vaccination for her brother; during the call she reported she had received both doses of BNT162B2 and was having a raspy voice and congestion; further stating she didn't know why her voice was changing. The clinical outcomes of raspy voice/voice changing, and congestion were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: she was violently throwing up; had severe diarrhea for about 3 days.; This is a spontaneous report from a contactable consumer (patient's parent). A 22-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date ("a few weeks ago on Friday") as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date ("by Sunday afternoon") the patient experienced violently throwing up and severe diarrhea for about 3 days. The patient was not herself for about 6 days before returning to normal. The outcomes of throwing up and diarrhea were recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a non-contactable other health professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: (name) states that "they" got their first dose and then "they" got covid that week; (name) states that "they" got their first dose and then "they" got covid that week; This is a spontaneous report from a contactable consumer. This consumer reported similar events for herself and another one patient (Husband). This is 1st of 2 reports. This female consumer reported that:  A female patient of an unspecified age received BNT162B2 (BNT162B2 solution for injection), dose 1 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number: unknown) as 1st, single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient stated that they got their first dose and then they got covid that week.She called because they are trying to get a second dose but are a little nervous about how its gonna hit us. She states her parents both had moderna and they have been around them and her parents did not catch covid.The patient inquired that someone said it can wait up to six weeks and asked if that was true.The patient thinks they caught covid from her husband work ("they" presumably is referring to her and her husband) and that it has nothing to do with the vaccine.The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 15Apr2021 10:45 (Batch/Lot Number: EP7534) as 2nd dose, single for covid-19 immunisation. Medical history included hypertension, diabetes type 2, and known allergies to any antibiotic with sulfur. The patient was not pregnant. Concomitant medications included lisinopril, metformin hcl and ezetimibe. The patient previously took vancomycin and experienced allergies. The patient received first dose of bnt162b2 for covid-19 immunisation on 25Mar2021, 10:45. On 15Apr2021, at 21:00, the patient experienced neuropathy and had burning pain in legs. The event resulted in doctor or other healthcare professional office/clinic visit. There was no therapy for the event. The patient had no other vaccine in 4 weeks. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Developed a cellulitis in injection arm requiring treatment at an Urgent Care Center with subsequent 10 day course of oral antibiotics.; This is a spontaneous report from a contactable nurse (patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 13Apr2021 at 14:45 (at the age of 59-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included Sjogren's syndrome, arthritis and sleep apnoea syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EP7534), administered in left arm on 23Mar2021 at 05:00 pm (at the age of 59-years-old) for COVID-19 immunisation. On 16Apr2021, the patient developed a cellulitis in injection arm requiring treatment at an Urgent Care Center with subsequent 10-day course of oral antibiotics. Adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event. The outcome of the event was recovered on an unspecified date.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event of Cellulitis and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: headaches; weakness; chills; This is a spontaneous report received from a contactable consumer (the patient). A female patient (Age: 60, Units: unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday (unspecified date). She has been having headaches, weakness, and chills. She asked what she should do. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Vasculitis
Clinical narrative: ANCA Positive Vasculitis; adverse event of vasculitis; This is a spontaneous report from a contactable consumer reported for a male patient received from a Pfizer sponsor program. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and Expiration date: unknown), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. Medical history included vasculitis. The patient concomitant medications were not reported. On an unspecified date, following second dose of vaccination, the patient experienced adverse event of vasculitis and, ANCA positive vasculitis (anti-neutrophil cytoplasmic antibody positive vasculitis). It was reported that the patient had ANCA Positive Vasculitis and ended up getting a recurrence of it after getting the vaccine and they were not sure if it was related or not. The reporter mentioned that she was calling to see if there have been any other examples of this happening. The outcome of the events was unknown.  Information about lot/batch number can be obtained. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling tired; This is a spontaneous report received from a contactable consumer (the patient's grandfather). A 20-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday (unspecified date), and he was feeling tired. Tomorrow he needed to run 2 miles, and the patient's grandfather wanted to know should he run. The outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Coagulopathy, Heavy menstrual bleeding, Hyperhidrosis, Investigation
Clinical narrative: heavy bleeding clot like; heavy bleeding clot like; extreme low back pain; nausea; sweating; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at 33 years old, not pregnant) as unknown, single for covid-19 immunisation. Medical history included allergies: Penicillin, Have not had menstrual cycle in years (Have not had menstrual cycle in years as taking continuous birth control.) all from an unknown date. Concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIN-D); ethinylestradiol, levonorgestrel (LESSINA); sertraline hydrochloride (ZOLOFT). No other vaccine in four weeks. On 15Apr2021, patient experienced heavy bleeding clot like, extreme low back pain, nausea, and sweating. Has been occuring for 3 weeks. Went to doc to rule out serious issues. Everything came back negative.The outcome of the events was not recovered. No treatment for the adverse events. No covid prior vaccination.Not covid tested post vaccination.  Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: heavy bleeding clot like; heavy bleeding clot like; extreme low back pain; nausea; sweating; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at 33 years old, not pregnant) as unknown, single for covid-19 immunisation. Medical history included allergies: Penicillin, Have not had menstrual cycle in years (Have not had menstrual cycle in years as taking continuous birth control.) all from an unknown date. Concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIN-D); ethinylestradiol, levonorgestrel (LESSINA); sertraline hydrochloride (ZOLOFT). No other vaccine in four weeks. On 15Apr2021, patient experienced heavy bleeding clot like, extreme low back pain, nausea, and sweating. Has been occuring for 3 weeks. Went to doc to rule out serious issues. Everything came back negative.The outcome of the events was not recovered. No treatment for the adverse events. No covid prior vaccination.Not covid tested post vaccination.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Dizziness, Influenza, Pain, Pyrexia
Clinical narrative: Flu syndrome; Pain; dizziness; fever; This is a spontaneous report from a non-contactable other healthcare professional. This reporter reported similar events for two patients. This is the first of two reports.  A 7-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose, for COVID-19 immunisation; atorvastatin calcium (manufacturer unknown), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; gabapentin (manufacturer unknown), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; sertraline hcl (ZOLOFT), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. Concomitant medication included daratumumab (DARZALEX) taken for an unspecified indication, start and stop date were not reported. It was reported that patient experienced side effects from COVID vaccine and other drugs (atorvastatin, gabapentin, and ZOLOFT) of flu syndrome, pain, fever, dizziness. Patient couldn't even work. The action taken in response to the events for bnt162b2 was not applicable while for atorvastatin calcium, gabapentin and sertraline hcl was unknown. The outcome of events was unknown.  Pfizer is a marketing authorization holder of atorvastatin calcium, gabapentin in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of atorvastatin calcium, gabapentin has submitted the same report to the regulatory authorities.   No follow up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021494017 Same reporter and product, similar events, different patients
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: A little headache; Low grade fever.; This is a spontaneous report from a non-contactable other healthcare professional. This reporter reported similar events for two patients. This is the second of two reports.  A 6-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that in the second dose, side effects and symptoms are a little bit intense which included a little headache and low grade fever. The 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) : US-PFIZER INC-2021493997 Same reporter and product, similar events, different patients
Sex: U
Vaccine: COVID19
Symptoms: Breast pain, Pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non hcp.  A patient of unspecified age and gender received BNT162B2(solution for injection,Batch/Lot number was not reported)  first dose  via an unspecified route of administration on 28Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 28Apr2021 after the vaccine my arm started hurting from my elbow to my shoulder it started hurting a lot and than this morning I still have the pain in my arm and than my right breast started hurting. I wanted to see if that was normal. The outcome of the events was not recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Incontinence
Clinical narrative: I had lost control of my bladder not completely but enough/incontinence; After the day and half the covid symptoms came back; This is a spontaneous report from a contactable consumer (the patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201) via an unspecified route of administration on 23Feb2021 at age of 77-year-old at single dose for COVID-19 immunisation. Medical history included COVID-19 from 17Dec2020. The patient had no concomitant medications (reported as "no other products"). The patient had COVID, 17Dec2020 her system started and then about 90 days later she had the Pfizer vaccine and then had Pfizer vaccine again and it was been a while since it is been over two weeks what she had COVID. She had lost control of her bladder, not completely but enough so that she had to change her pajamas bottoms quite often. When she had first Pfizer shot about day and half she had the same problem. The patient's doctor often said that incontinence was not symptom of COVID but it might was. it was just after the shot. The patient had COVID symptoms started in 17Dec2020 and lasted for about 2 or 3 weeks. She had experience of COVID. Her experience of COVID was incontinence not all the time but particularly night and when she have first Pfizer shot about 3 months later after the day and half the COVID symptoms came back including the incontinence. No treatment received for the events. No investigation assessment. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: covid like symptoms and tested positive on  22Apr2021; sick; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient's wife) via medical information team. A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 12Apr2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Apr2021, the patient got sick. On22Apr2021, patient had COVID like symptoms and was tested positive for COVID-19. The reporter wanted reassurance that having COVID and getting the vaccine will not affect the vaccine and wants to know if they should wait for a certain period of time before getting the 2nd dose. The outcome of the events was recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Where the caller had her shot there's a little bit of a bump; hurts to the touch; redness at the injection site/red; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 20-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172 and expiry date: unknown), via an unspecified route of administration in arm left on 03May2021 13:15 as second dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737 and expiry date: unknown), via an unspecified route of administration on 12Apr2021, as single dose for COVID-19 immunisation and flu shot. On Monday, 03May2021 (Time the Vaccination Was Given: 1:15 pm), the caller received her second dose of the vaccine. The caller wanted to report that she had a little bit of a reaction. Where the caller had her shot there's a little bit of a bump that is swollen, red, and hurts to the touch. The patient was asking is this common. The patient was asking about any other people that got this reaction. The caller has been taking Ibuprofen and icing her arm and it helps but it is not going away. (Ibuprofen: expiration date Nov2021, unknown NDC, unknown lot number). The patient experienced where the caller had her shot there's a little bit of a bump, swollen red on 05May2021. Vaccination facility type was college. The adverse event did not require a visit to emergency room and physician's office. No prior vaccinations within 4 weeks. The outcome of the events was recovering.  Follow up- # 1 (06May2021): This is follow-up a spontaneous report from contactable consumer. This consumer (patient) reported that: event details updated.  Follow up #2 (06May2021): This is follow-up a spontaneous report from contactable consumer. No new information updated.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Ear discomfort, Feeling abnormal, Head discomfort
Clinical narrative: I had burning from my stomach up to my throat.; I had headache that came from back to neck and ears.; My ears don't feel right.; I feel tired and weak.; My head feels heavy.; I felt very bad; Pain; my hand is so heavy; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 75-year-old female patient received BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot Number: EJ6788, Expiration Date: Unknown), Solution for injection, via an unspecified route of administration on 21Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. In Apr2021 the patient experienced burning sensation from stomach up to my throat and also experienced headache that came from back to neck and ears. Her ears don't feel right and she feel tired and weak. Her head feels heavy and she had pains. Doctor told her to take Pepcid 3 days before and after her 2nd dose. The Patient took Tylenol PM as the treatment for pain so that she can go to sleep. She also stated that she take Synthroid '88 mg' every morning in empty stomach (dose not clarified, hence not captured in tab). The Information included that the patient head is not painful like before but it is so heavy and that comes from her ribs up then neck up and comes all the way in her head. The Patient raised that should she take the second shot. she will feel much better or she will not feel fine because that is not normal how she feel like in her head and her neck and her ribs, she never had this feeling before. Patient hand was so heavy. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb injury, Pain
Clinical narrative: I had burning from my stomach up to my throat.; I had headache that came from back to neck and ears.; My ears don't feel right.; I feel tired and weak.; My head feels heavy.; I felt very bad; Pain; my hand is so heavy; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 75-year-old female patient received BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot Number: EJ6788, Expiration Date: Unknown), Solution for injection, via an unspecified route of administration on 21Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. In Apr2021 the patient experienced burning sensation from stomach up to my throat and also experienced headache that came from back to neck and ears. Her ears don't feel right and she feel tired and weak. Her head feels heavy and she had pains. Doctor told her to take Pepcid 3 days before and after her 2nd dose. The Patient took Tylenol PM as the treatment for pain so that she can go to sleep. She also stated that she take Synthroid '88 mg' every morning in empty stomach (dose not clarified, hence not captured in tab). The Information included that the patient head is not painful like before but it is so heavy and that comes from her ribs up then neck up and comes all the way in her head. The Patient raised that should she take the second shot. she will feel much better or she will not feel fine because that is not normal how she feel like in her head and her neck and her ribs, she never had this feeling before. Patient hand was so heavy. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: loss of taste and smell; loss of taste and smell; fever; congestion (including runny nose); congestion (including runny nose); This is a spontaneous report from a contactable consumer (patient's wife) via medical information team. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number and expiration date: was not reported), via an unspecified route of administration, on an unspecified date as single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced loss of taste and smell; fever; and congestion (including runny nose). The reporter stated that she was calling on behalf of her husband who had the Pfizer Covid vaccine on Monday and reported loss of taste and smell, fever, and congestion (including runny nose); her husband (the patient) was asking as if this was normal. The outcome of all events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : 2021523850 Original Case : 2021513846 (Different patient with same reporter and drug)
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Dizziness, Fatigue, Headache
Clinical narrative: It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown.  Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot.   No follow-up attempts are needed. No further information is expected.