chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood triglycerides, Blood triglycerides increased, Cardiac disorder
Clinical narrative: She had problems with her heart; lot of stress; Swelling and redness of face; Swelling and redness of face; Triglycerides over 400; Severe vertigo; Blood pressure went high/blood pressure went up to 185/115; 150/95/; Fell; Ocular migraine; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 03Apr2021 08:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure. It started about 20 years ago. It was from stress. Family Medical History included her father had kidney disease, but she did not have any problems with her kidneys. She had a blood test and it was fine. The patient's concomitant medication included usual blood pressure medication. Patient went and had the first shot of the Pfizer Covid-19 Vaccine on 03Apr2021 (also reported as 04Apr2021), and she did okay on it until the following Friday (09Apr2021), 6 days later. She actually had to call her daughter to get her from work. She was suffering from severe vertigo, her blood pressure went high, she fell, and she had ocular migraine on 09Apr2021. Her blood pressure went up to 185/115 which was tested on 12Apr2021. She had problems with her heart at the time (unknown date). She broke out and had swelling of her face and redness on 13Apr2021. She went to the doctor and he had her on steroids. This was with the first dose. She was concerned about the second shot. She was due to do it again in about a week, and she was still not over the one. She had been out of work the whole time. Her blood pressure was still kind of high because she did suffer from volatile blood pressure with stress on her body. Her blood pressure would fluctuate, but it had never been that high. It happened when her body was under a lot of stress. It was still high, but not as high. It was about 150/95. That was normal for her. It was like bam, it all hit her hard. Triglycerides over 400 on 12Apr2021. The migraine had gotten better. It's gone. Her migraine was completely gone. As far as the problems with her heart, her blood pressure was fluctuating and would go up and all of a sudden drop. It was not often, it did it when she was under a lot of stress. She just didn't know if the shot had put her body under stress. The swelling and redness on her face was still there. Outcome of severe vertigo, blood pressure went high was resolving. Outcome of fall, problems with her heart and stress was unknown. Outcome of ocular migraine was recovered on 09Apr2021. Outcome of swelling and redness of face was not recovered.  No Follow-up attempts are needed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fall, Ophthalmic migraine, Stress, Swelling face
Clinical narrative: She had problems with her heart; lot of stress; Swelling and redness of face; Swelling and redness of face; Triglycerides over 400; Severe vertigo; Blood pressure went high/blood pressure went up to 185/115; 150/95/; Fell; Ocular migraine; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 03Apr2021 08:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure. It started about 20 years ago. It was from stress. Family Medical History included her father had kidney disease, but she did not have any problems with her kidneys. She had a blood test and it was fine. The patient's concomitant medication included usual blood pressure medication. Patient went and had the first shot of the Pfizer Covid-19 Vaccine on 03Apr2021 (also reported as 04Apr2021), and she did okay on it until the following Friday (09Apr2021), 6 days later. She actually had to call her daughter to get her from work. She was suffering from severe vertigo, her blood pressure went high, she fell, and she had ocular migraine on 09Apr2021. Her blood pressure went up to 185/115 which was tested on 12Apr2021. She had problems with her heart at the time (unknown date). She broke out and had swelling of her face and redness on 13Apr2021. She went to the doctor and he had her on steroids. This was with the first dose. She was concerned about the second shot. She was due to do it again in about a week, and she was still not over the one. She had been out of work the whole time. Her blood pressure was still kind of high because she did suffer from volatile blood pressure with stress on her body. Her blood pressure would fluctuate, but it had never been that high. It happened when her body was under a lot of stress. It was still high, but not as high. It was about 150/95. That was normal for her. It was like bam, it all hit her hard. Triglycerides over 400 on 12Apr2021. The migraine had gotten better. It's gone. Her migraine was completely gone. As far as the problems with her heart, her blood pressure was fluctuating and would go up and all of a sudden drop. It was not often, it did it when she was under a lot of stress. She just didn't know if the shot had put her body under stress. The swelling and redness on her face was still there. Outcome of severe vertigo, blood pressure went high was resolving. Outcome of fall, problems with her heart and stress was unknown. Outcome of ocular migraine was recovered on 09Apr2021. Outcome of swelling and redness of face was not recovered.  No Follow-up attempts are needed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: She had problems with her heart; lot of stress; Swelling and redness of face; Swelling and redness of face; Triglycerides over 400; Severe vertigo; Blood pressure went high/blood pressure went up to 185/115; 150/95/; Fell; Ocular migraine; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 03Apr2021 08:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure. It started about 20 years ago. It was from stress. Family Medical History included her father had kidney disease, but she did not have any problems with her kidneys. She had a blood test and it was fine. The patient's concomitant medication included usual blood pressure medication. Patient went and had the first shot of the Pfizer Covid-19 Vaccine on 03Apr2021 (also reported as 04Apr2021), and she did okay on it until the following Friday (09Apr2021), 6 days later. She actually had to call her daughter to get her from work. She was suffering from severe vertigo, her blood pressure went high, she fell, and she had ocular migraine on 09Apr2021. Her blood pressure went up to 185/115 which was tested on 12Apr2021. She had problems with her heart at the time (unknown date). She broke out and had swelling of her face and redness on 13Apr2021. She went to the doctor and he had her on steroids. This was with the first dose. She was concerned about the second shot. She was due to do it again in about a week, and she was still not over the one. She had been out of work the whole time. Her blood pressure was still kind of high because she did suffer from volatile blood pressure with stress on her body. Her blood pressure would fluctuate, but it had never been that high. It happened when her body was under a lot of stress. It was still high, but not as high. It was about 150/95. That was normal for her. It was like bam, it all hit her hard. Triglycerides over 400 on 12Apr2021. The migraine had gotten better. It's gone. Her migraine was completely gone. As far as the problems with her heart, her blood pressure was fluctuating and would go up and all of a sudden drop. It was not often, it did it when she was under a lot of stress. She just didn't know if the shot had put her body under stress. The swelling and redness on her face was still there. Outcome of severe vertigo, blood pressure went high was resolving. Outcome of fall, problems with her heart and stress was unknown. Outcome of ocular migraine was recovered on 09Apr2021. Outcome of swelling and redness of face was not recovered.  No Follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Shivering; High fever like spike fever; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported the female patient (wife) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation. Relevant history was none. Relevant concomitant drug was not reported. The patient got the second shot of the Pfizer Vaccine and after couple of hours the patient experienced shivering, high fever may be like spike fever. The patient was trying to figure out may be like she was shivering, so what could be next step. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Development of rash; It is on left and right arm and upper leg; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of bnt162b2 via unspecified route of administration on 10Mar2021 at single dose for COVID-19 immunization. The patient's medical history included Blood pressure (abnormal). The patient's concomitant medications included spironolactone. The patient previously received the first dose of bnt162b2 via unspecified route of administration on 10Feb2021 at single dose for COVID-19 immunization. The patient reported development of rash; It is on left and right arm and upper leg in Apr2021. For a large part of this month, she experienced rash. The patient asked if she was experiencing the latent side effects after that second shot. No Investigation Assessment and no treatment for the event. The patient didn't go by a doctor, just recorded thought the site that they sent her and they kept a record of it. The outcome of the event was not resolved (persisting).   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Tender lymph nodes; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that this 60 years old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6207) single dose in right arm on 17Mar2021 for COVID-19 Immunisation. Medical history and concomitant drugs were not provided. The patient had tender lymph nodes in the morning on 09Apr2021. He clarified side effect experienced initially as swollen lymph nodes, but clarified it was not swollen, but tender lymph nodes. Outcome of the event was not recovered.  No Follow-up attempts are needed. No further information expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Have loud ringing in my ears; This is a spontaneous report from a contactable consumer reported for self. This 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EWO153) at single dose on 13Apr2021 11:30 in left shoulder for COVID-19 immunization. There was no medical history or concomitant medication or investigation assessment. Patient had loud ringing in his ears on 13Apr2021. It just happened 3 hours ago. There was no treatment received. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Nausea
Clinical narrative: stomach hurting; before the vaccine, had a tiny dizzy/ after the vaccine, more dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732) via an unspecified route on left arm single dose for COVID-19 immunization on 27Mar2021 18:00, at 70-year-old. Medical history included: ongoing osteoporosis for a long time maybe 10 years, calcium deficiency, abdominal pain upper, bone density decreased, dyspepsia, rhinorrhoea, dizziness/ tiny dizzy, cerebrovascular accident. Concomitant medications included: Vitamin D from Jan2021 and ongoing; ongoing calcium carbonate (TUMS) twice daily for osteoporosis, bones need the calcium, bone density, heartburn; ongoing loratadine (LORATADINE, 10 mg tablet) oral as needed for runny nose; acetylsalicylic acid (BABY ASPIRIN, 81 mg tablet) oral 1DF a day for dizziness after the meal; famotidine oral 20mg half hour before a meal. The patient experienced very dizzy, nauseous, stomach hurting; all on an unspecified date. The patient was very dizzy, nauseous from Mar2021 and ongoing; ongoing stomach hurting. After the patient had the vaccine for the first 3 days was ok, the fourth day (maybe 30 Mar2021 or 31Mar2021, maybe Tuesday or Wednesday), she started getting very dizzy, she has to hold onto something, she's nauseous. The patient stated before she had the vaccine, she had a tiny dizzy, but after the vaccine, even now, she's more dizzy and sometimes nauseous. Took calcium carbonate sometimes she takes 1 pill, sometimes 2 pills, when her stomach was getting hurt, it would help so she will take more. After the shot, her stomach sometimes it hurt and she took more calcium carbonate because calcium carbonate could be for the treatment of her stomach hurting, so she will take more than 2 pills a day. The patient stated that before the vaccine, her stomach sometimes had problems too. The patient stated when her stomach had problems, then she took the calcium carbonate and she didn't think its because of the vaccine. No emergency room or physician office visited. Outcome of the event was resolving.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The event "stomach hurting" is attributed to an underlying medical condition and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Illness, Pain
Clinical narrative: sick; chill; whole body was achy; This is spontaneous report from a contactable consumer (patient). A patient  of an unknown age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date (reported as Monday) for Covid-19 immunization. Medical history was not provided. Concomitant drug included warfarin sodium (COUMADIN). Patient had shot on "Monday" and was so sick even though "today" (14Apr2021) was chill, really chill, whole body was achy. Patient felt like did not want to take the second shot. Patient was on warfarin sodium, and inquired if that was going to affect anything. Outcome of the events was not resolved.   No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: pain on her arm; bruises on the site; This is a spontaneous report from contactable consumers (patient and patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose 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 patient's concomitant medications were not reported. Patient took the vaccine 13 days ago and she did have pain on her arm and she could not move it and it had bruises on the site where she took the vaccine. The event outcome for events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: had a fever of 104 for four weeks; This is a spontaneous report from a non-contactable consumer via Medical Information Team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller stated her son in law (patient) had a fever of 104 for four weeks. Caller stated she had the second dose of the pfizer covid 19 on 16Mar2021. Caller stated she is still getting symptoms she does not like. Caller stated her symptoms started four days after the vaccine and have continued for four weeks. Caller stated she is sleepy as she could possibly be. Caller stated she has chills, fever, shaking like a leaf and a little cough. Caller stated that her muscles are aching all over. Caller states she aches in her knees but mostly the shoulders and lower arms. Caller stated that she has a headache at the back of her head on the top. Caller stated that she has a pain that goes down the right side of her headache to her shoulder, arm and back Caller stated her eyes are burning all the time noting it is hard to open her right eye. Caller stated she is swallowing phlegm. Caller stated she still feels bad. Caller wanted to know if she should keep resting Caller asked if it is normal to feel this way after four weeks and how long should it be. Caller stated that she has heard of other people that feel worse than her, have severe things and get very sick. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021416802 same reporter/drug, different patient/AE
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swelling face, Throat irritation, Vaccination site mass
Clinical narrative: face swelled; lip tingling; throat was itchy; feverish knot like a lump; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received 1st dose of BNT162B2 (Pfizer vaccine for COVID 19, Lot# EW0151) on 03Apr2021 13:50 pm on left arm for civid-19 immunization. Patient History was ongoing mast cell activation syndrome. She states she has had this condition from birth. Ongoing Ehlers-Danlos syndrome. She said she was just diagnosed with this condition 6 weeks before but it is a condition that is present from birth, that it is one of those zebra diseases. Ongoing POTS. She states she has had this condition for quite while; for 10 years or more. She says she does not know what kind of stuff we are looking for she has a list of precious medical conditions. She says her family has a history of high blood pressure diabetes, and that is probably the only two relevant. She says most of them have high blood pressure, her parents her grandparents her grandfather had diabetes, her dad had high blood pressure, her mom had high blood pressure. Concomitant Products included cetirizine hydrochloride (ZYRTEC ALLERGY) Ongoing (She states she has been on this medication for about a month mast cell activation syndrome), cimetidine (TAGAMENT) Ongoing (She states she has been on this medication for about a month. States they work together for mast cell activation syndrome), duloxetine hydrochloride (CYMBALTA) Ongoing (She started this medication about a month and a half ago to help with chronic pain due to Ehlers-Danlos syndrome). The caller says she got the Pfizer vaccine on 03Apr2021 the first one and had reaction where her face swelled, her lip was a little tingly and her throat was itchy. She says the pharmacist gave her 100mg of Benadryl and that stopped it. She says it has been 2 weeks almost since she got the vaccine and she still had a feverish knot like a lump. She states that she has mast cell activation syndrome and she has heard that the second dose is rougher on the body. She says she is seeking guidance, should get the second vaccine because normally the reaction is worse for the second one since she had a face and lip and throat reaction with first dose. She says she does not have a primary physician now that she lives in(Withheld) she has not had a chance to get a primary care provider. She says she had been taking 100mg Benadryl but does not have bottle available at this time. She says he is taking it every 6 hours. NDC lot number expiration date dosage amount not provided due to caller does not have the bottle with her. No Emergency Room, no Physician Office visit. Outcome of the event for feverish knot like a lump was not recovered, for other events were recovered on 05Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Magnetic resonance imaging, Pre-existing condition improved, Swelling
Clinical narrative: immense pain in my joints and swelling all my body; swelling all my body; all my joint pain, all my inflammation in my body went away; all my joint pain, all my inflammation in my body went away; This is a spontaneous report from a contactable consumer (patient). A 50-year-old patient of unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8727), via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, and osteoarthritis. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6202) for COVID-19 immunisation. The patient reported a pleasant side effect observing after patient got the second dose of BNT162B2. Patient had been from last ten years suffering from joint pain and joint inflammation in various joints of body and had that thing twenty-four hours and three sixty five. So even at nights patient had painful and swelling joints in various parts of body from the last ten years. Patient got the second dose of the Pfizer vaccine on 24Mar2021. The next day, patient suffered immense pain in the joints and swelling all the body. The joints of the body were painful but three days after patient got the vaccine patient woke up with no pain at all in the none of the joints of the body. It was the 20th day on since patient felt like that. So somehow this vaccine fixed the problem that patient had was pain and swelling in the joints. Patient didn't take any medication. Patient didn't do anything different what was doing. Patient didn't take any medication at all. So there was no other explanation that patient felt like that regarding the vaccine. 90 percent improvement. Patient felt like 20 years old at the time of the report. No pain for patient. It was the happiest twenty days of the whole life. Patient's quality of life improved because patient didn't in pain. Patient got sleeping to pain. Patient was up with pain. Patient's life the last 10 years were in pain. So patient got used to be in pain. There was no other, nothing in patient's life changed. The last days but since patient got the 2nd dose of the vaccine. The next day patient was in terrible condition swelling and pain in all been joints of the body but and after 24 hours, Nah. Patient had a magnetic resonance imaging (MRI) for the lower back that was what hurting. Patient had blood test the regular one and in two days the rheumatologist would make specific blood test to figure out why the vaccine helped patient in other problem. Patient had huge improvement in pain. Patient was the quality of life in last twenty days had changed for the better. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: immense pain in my joints and swelling all my body; swelling all my body; all my joint pain, all my inflammation in my body went away; all my joint pain, all my inflammation in my body went away; This is a spontaneous report from a contactable consumer (patient). A 50-year-old patient of unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8727), via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, and osteoarthritis. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6202) for COVID-19 immunisation. The patient reported a pleasant side effect observing after patient got the second dose of BNT162B2. Patient had been from last ten years suffering from joint pain and joint inflammation in various joints of body and had that thing twenty-four hours and three sixty five. So even at nights patient had painful and swelling joints in various parts of body from the last ten years. Patient got the second dose of the Pfizer vaccine on 24Mar2021. The next day, patient suffered immense pain in the joints and swelling all the body. The joints of the body were painful but three days after patient got the vaccine patient woke up with no pain at all in the none of the joints of the body. It was the 20th day on since patient felt like that. So somehow this vaccine fixed the problem that patient had was pain and swelling in the joints. Patient didn't take any medication. Patient didn't do anything different what was doing. Patient didn't take any medication at all. So there was no other explanation that patient felt like that regarding the vaccine. 90 percent improvement. Patient felt like 20 years old at the time of the report. No pain for patient. It was the happiest twenty days of the whole life. Patient's quality of life improved because patient didn't in pain. Patient got sleeping to pain. Patient was up with pain. Patient's life the last 10 years were in pain. So patient got used to be in pain. There was no other, nothing in patient's life changed. The last days but since patient got the 2nd dose of the vaccine. The next day patient was in terrible condition swelling and pain in all been joints of the body but and after 24 hours, Nah. Patient had a magnetic resonance imaging (MRI) for the lower back that was what hurting. Patient had blood test the regular one and in two days the rheumatologist would make specific blood test to figure out why the vaccine helped patient in other problem. Patient had huge improvement in pain. Patient was the quality of life in last twenty days had changed for the better. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: Diarrhea; Muscles are real twist; This is a spontaneous report from a contactable consumer (patient). An 84-year-old patient received 1st dose of BNT162B2 (Age at Vaccination was 83 years old, COVID Vaccine, Batch/lot number: EL1283, Expiry Date Unknown) on 15Jan2021 at single dose on left arm for covid-19 immunization. Relevant medical history was Chronic kidney disease, Blood pressure high. Concomitant drug included Lisinopril at 20mg a day, Felodipine at 10mg a day, Metoprolol 25g twice a day. I don't know what's going on but I think it's diarrhea for a week after took the first one but it's better now, but my stomach got, my muscles are real twist. They really tighten up in my stomach or something because diarrhea was so long. No Treatment. Patient received second Vaccine (Batch/lot number:  EL9264) on 05Feb2021. Outcome of the event diarrhea was recovering, for other event was unknown. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: not a high temperature it is like 100 and half; real pain yesterday night at the injection site; Headache; Muscle pain; Chills; Little feeling of unwell like really tired; Little feeling of unwell like really tired; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient stated, "Well I had the second shot of Covid 19 okay, and I am experiencing some symptoms and I had a temperature, not a high temperature it was like 100 and half so I don't know what the limits are. I had real pain last night at the injection site and I had 5 minutes like headache, some muscle pain, in morning I had chills, a little feeling of unwell like really tired, I had feeling like I had a flu like symptoms." The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: not a high temperature it is like 100 and half; real pain yesterday night at the injection site; Headache; Muscle pain; Chills; Little feeling of unwell like really tired; Little feeling of unwell like really tired; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient stated, "Well I had the second shot of Covid 19 okay, and I am experiencing some symptoms and I had a temperature, not a high temperature it was like 100 and half so I don't know what the limits are. I had real pain last night at the injection site and I had 5 minutes like headache, some muscle pain, in morning I had chills, a little feeling of unwell like really tired, I had feeling like I had a flu like symptoms." The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain in extremity
Clinical narrative: arm that she got the injection in, the left arm, the lymph node swelled/lymph node under her arm in her armpit was swollen; arm was hurting; chills; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8727, Expiration Date: 31Jul2021) at single dose in left arm on 01Apr2021 for COVID-19 immunization. The first dose was on 11Mar2021 (Batch/lot number: EN6206, Expiration Date: 30Jun2021) in left arm. Ongoing medical history included high blood pressure and high cholesterol. Ongoing concomitant medications included blood pressure medication; cholesterol medication; amoxicillin (tablet) from 24Mar2021 for tooth and the filling was painful, 21 tablets were prescribed. She did go to the dentist to have a filling in a tooth and the filling was painful and the doctor prescribed amoxicillin 875mg take one tablet two times daily. She started taking that around the 24Mar2021 she thought. It was 21 tablets. Prior vaccinations (within 4 weeks) was no. Patient experienced chills on 01Apr2021; arm that she got the injection in, the left arm, the lymph node swelled and arm was hurting on 02Apr2021. Patient reported she's been taking her blood pressure and cholesterol medication a long time. She didn't feel they were relevant. The adverse events did not require a visit to emergency room and physician office. Patient got her first vaccine and she didn't have any problems. She got the second Covid 19 vaccine and she had chills and in the arm that she got the injection in, the left arm, the lymph node swelled. Patient clarified that her lymph node under her arm in her armpit was swollen. Her arm started hurting on Friday, 02Apr2021 but she didn't pay attention. She thought it was just where the needle had gone into her skin. It was still hurting underneath her arm and as she went to take a shower she saw that the area under her arm was more even across instead of a dip. Meaning a dip like she had in her armpit. She reported the swelling had gone down some but right now it's staying about the same. The outcome of event chills was recovered on 02Apr2021. The outcome of rest events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Rash
Clinical narrative: I have lower back pain on my left side; I have got a rash that looks like chicken pox; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left (reported as "Firstly on right shoulder then corrected on left shoulder.") on 08Apr2021 (Lot Number: EN6203) (at the age of 50-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported. The patient was suppose to call if he have any reactions to the vaccine, is that correct. So he have a reaction. He received his vaccine on Thursday (08Apr2021) and over the weekend. The patient have lower back pain on his left side and he have got a rash that looks like chicken pox on 10Apr2021. The patient next appointment is 11May2021 for second shot. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Heart rate increased; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received the first 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. Patient just wanted to get medical information because patient had the Pfizer Vaccine (Unspecified vaccine) done on Thursday last week and the next day patient had an increased heart rate and patient wanted to know if it was the side effect that had been happening with or someone could tell about that. Patient wanted to know if patient should take the second shot or it has happened to other people. Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergy; This is a spontaneous report received from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. After the vaccine, like 3 days after she was doing gardening on 29Mar2021, she started having an allergy for some reasons she never had before. Outcome of event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: exhausted; Low grade fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age 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 single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunization. Patient was exhausted after second vaccine and had a low-grade fever. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Blood sodium, Fatigue, Full blood count, Malaise
Clinical narrative: Sick of 5 days; Nauseous; Unstable with balance; very tired; This is a spontaneous report from a contactable consumer (patient). A 76-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 27Jan2021 (at the age of 76-year-old), at single dose, for COVID-19 immunization. Medical history included high blood pressure (taking high blood pressure medication for years, i take 2 blood pressure medicines, take that one in the morning and one in the night); asthma; and glucose tolerance impaired (pre-diabetic). Concomitant medications included amlodipine for hypertension; candesartan for hypertension; cetirizine hydrochloride (ZYRTEC) for asthma; colecalciferol (VITAMIN D); cyanocobalamin (VITAMIN B12); and vitamin B complex (B Complex). The first shot patient was sick for about 5 days, very nauseated, very unstable with balance and very tired. Patient's weight was about 147 pounds. Patient stated first one didn't give patient asthma. Patient stated had pneumonia, shingle shot (unspecified shot) and flu shot. The patient underwent lab tests and procedures, which included sodium was low; and CBC (full blood count) was 4-5. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Weight
Clinical narrative: Sick of 5 days; Nauseous; Unstable with balance; very tired; This is a spontaneous report from a contactable consumer (patient). A 76-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 27Jan2021 (at the age of 76-year-old), at single dose, for COVID-19 immunization. Medical history included high blood pressure (taking high blood pressure medication for years, i take 2 blood pressure medicines, take that one in the morning and one in the night); asthma; and glucose tolerance impaired (pre-diabetic). Concomitant medications included amlodipine for hypertension; candesartan for hypertension; cetirizine hydrochloride (ZYRTEC) for asthma; colecalciferol (VITAMIN D); cyanocobalamin (VITAMIN B12); and vitamin B complex (B Complex). The first shot patient was sick for about 5 days, very nauseated, very unstable with balance and very tired. Patient's weight was about 147 pounds. Patient stated first one didn't give patient asthma. Patient stated had pneumonia, shingle shot (unspecified shot) and flu shot. The patient underwent lab tests and procedures, which included sodium was low; and CBC (full blood count) was 4-5. 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: COVID-19, Drug ineffective
Clinical narrative: getting Covid twice - once after the first shot and again after the second shot; getting Covid twice - once after the first shot and again after the second shot; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (lot number and expiry date unknown) and dose 2 (lot number and expiry date unknown) - both via unspecified routes of administration, on unspecified dates, at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced getting Covid twice - once after the first shot and again after the second shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Illness, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Sick; some looseness in his stomach; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a male patient (reporter's son) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter reported that patient just took shot on Wednesday, he was sick. He took his shot on Wednesday and when he woke up Thursday with severe vomiting and nausea and he did that all night. He was better Friday except he had some looseness in his stomach but he didn't throw up. He woke up this morning and feeling that again. The outcome of the event "Stomach upset" was not recovered. The outcome of other events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Urinary incontinence
Clinical narrative: Caller reported she thinks he said 0.5mL but cannot verify that dose information at time of the call.; Urinary incontinence; This is a spontaneous report from a contactable pharmacist. This 61-year-old female contactable pharmacist(Patient) reported for herself that she received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL3302) at single dose for COVID-19 immunisation on 29Mar2021. Relevant history included Urinary incontinence. Relevant concomitant drug included estradiol (ESTRING) for Urinary incontinence, had been a few years already. The patient (pharmacist) said the dose of vaccine was 0.5mL but cannot verify that dose information at the reporting time. This patient stated the last few days the Estring had not been working; she did not know if they didn't put enough estrogen (1 count 2mg strength) in the ring or if the ring ran out of Estrogen, like at the end of the thing, or if the Estring not working was due to a defect. She clarified that the Estring has not been working because she has had 2 episodes of urinary incontinence, urinary incontinence outcome provided as worsened. First episode happened like 09Apr2021, and the second episode happened last night, 13Apr2021. These episodes were upsetting, annoying and embarrassing. This particular vaginal ring involved in this report was inserted intravaginally on 21Jan2021 and was still in place intravaginally. No change performed as of yet, but she was getting a new Estring today and is going to see if that one works. Because of Covid pandemic she had basically been home but she normally visited friends and may stay over and it would have been really embarrassing if she was staying over and had urinary incontinence episodes; she would probably have to wear a diaper if she stayed over which would be really embarrassing. The event was not considered as life-threatening.  The urinary incontinence outcome was not resolved (worsened). She was scheduled for her second dose of Pfizer-BioNTech COVID-19 Vaccine on 26Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Dysstasia, Fall, Headache
Clinical narrative: equilibrium went out; couldn't stand up; fell; muscle pain; low grade fever, it was like 100; headache that just won't quit; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had first Pfizer shot on the 9th and Sunday (11Apr2021) satin come to visit, patient equilibrium went out. Patient couldn't stand up, fell. Patient had muscle pain and had a very low grade fever, it was like 100. The injection site was fine but patient had a headache that just won't quit. Patient wanted to known what should take to get rid of this headache. The outcome of the event headache was not recovered and the outcome of the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: equilibrium went out; couldn't stand up; fell; muscle pain; low grade fever, it was like 100; headache that just won't quit; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had first Pfizer shot on the 9th and Sunday (11Apr2021) satin come to visit, patient equilibrium went out. Patient couldn't stand up, fell. Patient had muscle pain and had a very low grade fever, it was like 100. The injection site was fine but patient had a headache that just won't quit. Patient wanted to known what should take to get rid of this headache. The outcome of the event headache was not recovered and the outcome of the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT INCORRECTLY RECEIVED THE MODERNA VACCINE AS A MINOR INSTEAD OF THE PFIZER VACCINE.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: I know that it is common for your arm to be sore for a day or two, but my arm was very sore for at least two weeks and it is now 4 weeks and 2 days since the shot and my arm is still somewhat sore.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: lightheaded, nauseous,
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Metamorphopsia, Ophthalmological examination normal, Photopsia, Vision blurred
Clinical narrative: There were incredible headaches like hypertension headaches that lasted for two days after the vaccination (04/27/2021). The headache was throbbing and was mostly around the neck and back of head area. There were not much body ache following the vaccination. Two days after the vaccination on 04/29/2021, I experienced something similar to Visual Migraine. Part of my vision was blurry with lights induced in the blur and the reality was distorted. It lasted around 40 minutes and I spoke to a Telemedicine who advised me to go to ER if I dont feel safe. I rested my eyes for a little bit and the vision disruption finally went away.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pallor, Visual impairment
Clinical narrative: Patient got vaccine and sat down. He felt tired, his vision and hearing was impaired, and his skin turned white.  He was still talking to us and somewhat alert but felt very tired and lightheaded.  After continuing to talk to him for about 5 minutes, he started feeling better and his skin color recovered.  He was able to drink water and his senses came back.  He kept sitting and staff member watched him longer till he was able to get up .
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever 99-100, mild muscle aches, injection site pain. Nausea for about 2 hours beginning approximately 18 hours after injection. Woke up on 04/24/2021 with no lingering symptoms or fever.