chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Tremor
Clinical narrative: Chills; Shaking; Cough; Weakness; This is a spontaneous report received from a contactable Pharmacist.   A 24-year-old male received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ELO140 and Expiration date was unspecified) on 19Jan2021 07:15 as single dose, (at 24 years of age), intramuscular left arm and dose 1 Lot number ELO140 and Expiration date was unspecified) on 29Dec2020 09:00 as single dose, (at 24 years of age), intramuscular left arm for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not have Covid prior to vaccination.  The patient was not tested post vaccination for Covid.  No other vaccine was taken within four weeks. Treatment included Acetaminophen ES. Chills on 19Jan2021 19:00, Shaking on 19Jan2021 19:00, Cough on 19Jan2021 19:00, and Weakness on 19Jan2021 19:00.  Outcome of event chills, shaking, cough and weakness was recovered.   No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Breast pain, Menstrual disorder
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  Consumer stated, patient just received Covid-19 vaccine, patient took it just today (15Jan2021) and patient didn't get (word not clear) but patient was supposed to have patient's menstruation. Patient had Covid vaccine, patient worked with a (City name) (state name) (not clarified). After 15 minutes, it is a time that patient was supposed to see patient's menstruation and patient's menstruation came out in one hour time. After that patient didn't take up anything and when patient woke up this morning on 15Jan2021 patient felt that patient had lumps on patient's right breast and very painful and big. Patient had lumps (sentence incomplete). When probed to clarify if consumer wants some information, consumer stated, "Yes, because I developed lump immediately, so I want to find the issue. I want to know what would be the next step to do.".  Consumer stated, "I don't know if vaccine has expiration date. I saw something written as Pfizer Covid L and then they wrote a number and the number is 3302. Then they wrote Healthcare professionals at (Pharmacy name)." The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Headache, Malaise, Nausea
Clinical narrative: nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tired, very tired and just wanted to sleep; nausea, some nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140 and expiry date unknown) via unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization on her job (nursing home). Medical history included blood pressure high. Concomitant medications vitamins. The patient took that COVID-19 vaccine shot yesterday (later clarified the date as 14Jan2021) on her job. The patient informed that she was okay the first day, but yesterday (15Jan2021) last night she had some new problems and she wanted to talk about and see it's a clinical sign. The patient informed that it was headache, tired, very tired and just wanted to sleep. The patient had no swelling/no swelling in arm, nausea, some nausea and even she has been just feeling unwell. The patient informed that today (16Jan2021) this morning, she was having nosebleed until the last time she felt like congestion in her throat and she kind of "blew like a quarter size of blood clot". The patient blew her nose and it bled a while, but then a quarter size blood clot come out and since then it wasn't bleeding, her nose was not bleeding. The patient did not receive treatment due to the events. The patient underwent lab tests and procedures which included COVID testing; swab the nose: negative on 13th or maybe 14th (Jan2021). The outcome of the events headache, tired, very tired and just wanted to sleep, nausea, some nausea, feeling unwell, nose bleed/kind of "blew like a quarter size of blood clot", congestion in her throat was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Upper respiratory tract congestion
Clinical narrative: nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tired, very tired and just wanted to sleep; nausea, some nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140 and expiry date unknown) via unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization on her job (nursing home). Medical history included blood pressure high. Concomitant medications vitamins. The patient took that COVID-19 vaccine shot yesterday (later clarified the date as 14Jan2021) on her job. The patient informed that she was okay the first day, but yesterday (15Jan2021) last night she had some new problems and she wanted to talk about and see it's a clinical sign. The patient informed that it was headache, tired, very tired and just wanted to sleep. The patient had no swelling/no swelling in arm, nausea, some nausea and even she has been just feeling unwell. The patient informed that today (16Jan2021) this morning, she was having nosebleed until the last time she felt like congestion in her throat and she kind of "blew like a quarter size of blood clot". The patient blew her nose and it bled a while, but then a quarter size blood clot come out and since then it wasn't bleeding, her nose was not bleeding. The patient did not receive treatment due to the events. The patient underwent lab tests and procedures which included COVID testing; swab the nose: negative on 13th or maybe 14th (Jan2021). The outcome of the events headache, tired, very tired and just wanted to sleep, nausea, some nausea, feeling unwell, nose bleed/kind of "blew like a quarter size of blood clot", congestion in her throat was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fear, Illness, Impaired driving ability
Clinical narrative: so sick; can't possibly drive herself to anywhere as she would be too afraid; can't possibly drive herself to anywhere as she would be too afraid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 18Jan2021 a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced so sick and can't possibly drive herself to anywhere as she would be too afraid in on Jan2021. The clinical outcome of so sick and can't possibly drive herself to anywhere as she would be too afraid was unknown.  The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Infrequent bowel movements
Clinical narrative: This is spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in Jan2021 at single dose for COVID-19 Immunization. Patient took the Pfizer Vaccine. Patient was a senior citizen and a lot of time patient gets diarrhea normally. It was a normal thing if patient eat certain things. So, patient took the vaccine 2 days ago (Jan2021). Now diarrhea was that it pops out. patient did not have that. patient just have a loose bowl movement. So, patient was thinking may be when sometimes patient get diarrhea, patient only eat like bananas and things like that. So, patient definitely want to take the second dose and patient took the first dose 2 days ago and it may not be the diarrhea from the product. So, patient just wanted to know, what foods patient should eat to go over. What should patient eat so that patient do not get the diarrhea. patient think it may be if patient eat the right food, everything will be okay. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypersensitivity, Pharyngeal swelling, Throat tightness
Clinical narrative: Allergic reaction; Throat swelling; tightness; difficulty swallowing; This is a spontaneous report from a contactable Other Health Professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient medical history reported no current heath issue like no "acute" (not clarified) current she got but she had got "bulging" (not clarified) disc and "effects" in the past, no "aplasia" (not clarified) nothing, no and she was "marina" (not clarified)." There were no concomitant medications. The reporter reported a patient that had an allergic reaction to the Pfizer Covid vaccine. Nurse stated that when she was "admitted" (not clarified) she was in the ER being monitored she got "admitted" (not clarified) first day today 7:45 not clarified (15Jan2021). The patient experienced allergic reaction, included "Throat swelling, tightness, difficulty swallowing." The reporter gave the patient "Api" (not clarified) 0.3 milligram and then also she had "Dimedrol" (not clarified) 125 and then she had CAPCID 20mg IV "piggy back" (not clarified). She had Benadryl 50 milligrams." The outcome of the events was unknown.  Information on the batch number and lot number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the product. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pain in extremity
Clinical narrative: Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a spontaneous report from a contactable consumer reporting for herself. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration, on 11Jan2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient reported that she received her COVID Vaccine on Monday afternoon 11Jan2021. The patient experienced events doesn't feel good and her arm is sore on an unspecified date in Jan2021. On 11Jan2021, after she got the shot, an hour after she started getting nauseous. On Tuesday, 12Jan2021, she experienced headache that went away the next day. On 13Jan2021, her muscles started to ache. That lasted on Wednesday (13Jan2021), Thursday (14Jan2021). On Friday (15Jan2021) afternoon, when she got home from work, she started running a fever and at the time of report she was still running a fever. She stated, "as of right now starting yesterday afternoon, I've got my fever, I don't feel good, I ache, my arm is sore but that's okay. It started Monday afternoon after I got the shot, an hour after I started getting nauseous that was Monday afternoon. Tuesday, I got headache that went away on Wednesday. On Wednesday my muscles started to ache. And that was Wednesday, Thursday and Friday afternoon when I got home from work, I started running a fever and I am still running a fever." When confirmed if the consumer wanted to report the same or looking for some information, consumer stated, "I want to report this and I just want information, what do I do? I test twice a week, rapid test and saliva test for COVID. And I have tested negative for months. And I tested negative before I got the vaccination, I tested on Thursday (14Jan2021), I am still negative. That was the rapid test." The patient took ibuprofen as a corrective treatment for the reported adverse events. Outcome of the event headache was recovered on 13Jan2021, outcome of fever was not recovered, while outcome of the other events was unknown.   Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a spontaneous report from a contactable consumer reporting for herself. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration, on 11Jan2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient reported that she received her COVID Vaccine on Monday afternoon 11Jan2021. The patient experienced events doesn't feel good and her arm is sore on an unspecified date in Jan2021. On 11Jan2021, after she got the shot, an hour after she started getting nauseous. On Tuesday, 12Jan2021, she experienced headache that went away the next day. On 13Jan2021, her muscles started to ache. That lasted on Wednesday (13Jan2021), Thursday (14Jan2021). On Friday (15Jan2021) afternoon, when she got home from work, she started running a fever and at the time of report she was still running a fever. She stated, "as of right now starting yesterday afternoon, I've got my fever, I don't feel good, I ache, my arm is sore but that's okay. It started Monday afternoon after I got the shot, an hour after I started getting nauseous that was Monday afternoon. Tuesday, I got headache that went away on Wednesday. On Wednesday my muscles started to ache. And that was Wednesday, Thursday and Friday afternoon when I got home from work, I started running a fever and I am still running a fever." When confirmed if the consumer wanted to report the same or looking for some information, consumer stated, "I want to report this and I just want information, what do I do? I test twice a week, rapid test and saliva test for COVID. And I have tested negative for months. And I tested negative before I got the vaccination, I tested on Thursday (14Jan2021), I am still negative. That was the rapid test." The patient took ibuprofen as a corrective treatment for the reported adverse events. Outcome of the event headache was recovered on 13Jan2021, outcome of fever was not recovered, while outcome of the other events was unknown.   Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nasal congestion, Tonsillar hypertrophy
Clinical narrative: Swollen tonsils; Neck stiffness; Congestion; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced swollen tonsils, neck stiffness, and congestion on 15Jan2021. Event details: The patient got the shot yesterday and when she woke up this morning her tonsils were swollen. She had neck stiffness, her neck was stiff, forearms, a lot of congestion. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: I had a bloodshot eye; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 15Jan2021, the patient experienced a bloodshot eye. The outcome of the event was unknown.  Information about lot and batch number was requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: behind my ear I feel like it's like the gland is swollen; behind my ear I feel like it's like the gland is swollen/saw the swelling and it's painful, pain a little bit, painful; This is a spontaneous report from a contactable consumer (reported for herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration in the left arm on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had the first dose of vaccine and it was on Tuesday afternoon (12Jan2021) and this morning (16Jan2021), she woke up and felt behind her ear, she felt like it's like the gland was swollen, so she wanted to know if anything to concern about it or she should wait few days or asked if is this normal for the gland could be swollen from an infection but. The further stated she didn't take anything as treatment but stated, its just this morning she woke up and she saw the swelling and its painful, pain a little bit, painful. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Gait inability, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Back of my legs are very sore, stiff, I mean I am crippled and difficult to walk; I couldn't walk I couldn't walk but it's very it's pain and it is sore; Back of my legs are very sore, stiff, I mean I am crippled and difficult to walk; I couldn't walk; Back of my legs are very sore, stiff, I mean I am crippled and difficult to walk; I couldn't walk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142; expiry date: unknown) via an unspecified route of administration, on 08Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated, "I took the vaccine a week ago from yesterday on Friday and it didn't appear right away but now back of my legs are very sore and it's very stiff and it's very difficult to walk. I mean I am crippled; I mean I couldn't walk but it's very it's pain and it is sore. I don't know if it does vaccine or not?" Patient is a healthcare worker, a speech therapist but works with high risk patients. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Everyone was very sore in their arm; everyone felt off; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 03 patients. This is 1st of 03 reports. This consumer (Girlfriend) reported for a (Boyfriend). A 72-years-old male patient received  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 18Jan2021 as a single dose, for COVID-19 vaccination. The patient medical history and  concomitant medications were not reported. On an unspecified date, the patient experienced everyone was very sore in their arm and everyone felt off. The clinical outcome of very sore in their arm and everyone felt off was unknown.    Information on the lot number has been requested.; Sender's Comments: Linked Report(s) : Same reporter/products/events, different patients; Same reporter/products/events, different patients
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Hypertension, Hypoacusis
Clinical narrative: I am very "hard of hearing"; My blood pressure went up, very high/high blood pressure/my BP was 186/113/my Blood pressure was like 214/87 to 205/99; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a shot on Wednesday (13Jan2021) and on Thursday (14Jan2021) morning, the patient's blood pressure went up, very high. The patient had high blood pressure. That is when the patient took blood pressure tablets (unspecified medication). The patient's BP was 186/113 and pulse was 62. The patient was taking BP (measurement or medication?) all the time. Anyways, the patient was just wondering yesterday (15Jan2021), the patient's blood pressure was like 214/87 to 205/99 which was really high, and the patient went to the emergency care, they gave the patient some pills to bring it down anyways. The patient was just wondering because it just could be coincident. From the patient's sheets, it looked like the patient's blood pressure was going up a little bit. The patient wanted to see if it's some sort of reaction or (incomplete sentence). The patient also stated very "hard of hearing (further not clarified)". The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Arm is still weak; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Feeling unwell; Little bit of pain from the injection site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration, on 13Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included diabetes (controlled by food not by injection), coronary artery spasm (blood vessels that occasionally collapsed), glaucoma, and asthma. The patient's concomitant medications included albuterol for asthma, atorvastatin (LIPITOR), glyceryl trinitrate (NITROGLYCERIN) for coronary artery spasm, and numbers of eye drops (unspecified) for glaucoma. The patient had taken the COVID-19 vaccine just not too long ago and had good number of non-serious side effects. The patient was not really concerned with these side effects that she had. On 13Jan2021, the patient had the little bit of pain from the injection site but that's common with any injection, so he did not count it, but next day the events started, and he still had some, but they were subsiding. The next events happened the next day after administration (14Jan2021). The patient had the injection site pain and the arm is still weak, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, and feeling unwell on 14Jan2021. The patient was recovering from the events.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Arm is still weak; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Feeling unwell; Little bit of pain from the injection site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration, on 13Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included diabetes (controlled by food not by injection), coronary artery spasm (blood vessels that occasionally collapsed), glaucoma, and asthma. The patient's concomitant medications included albuterol for asthma, atorvastatin (LIPITOR), glyceryl trinitrate (NITROGLYCERIN) for coronary artery spasm, and numbers of eye drops (unspecified) for glaucoma. The patient had taken the COVID-19 vaccine just not too long ago and had good number of non-serious side effects. The patient was not really concerned with these side effects that she had. On 13Jan2021, the patient had the little bit of pain from the injection site but that's common with any injection, so he did not count it, but next day the events started, and he still had some, but they were subsiding. The next events happened the next day after administration (14Jan2021). The patient had the injection site pain and the arm is still weak, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, and feeling unwell on 14Jan2021. The patient was recovering from the events.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Muscle spasms, Paraesthesia
Clinical narrative: Had a lot of cramps and pain in my chest; I really feel difficulty in breathing; I just feel like electrical shocks in my entire chest left and right; Had a lot of cramps and pain in my chest; This is a spontaneous report from a contactable physician. A 44-year-old patient of an unspecified gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) , via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history included sleep apnea. There were no concomitant medications.  The patient experienced a lot of cramps and pain in chest and really felt difficulty in breathing but just felt like 'electrogram' and electrical shocks in entire chest, left and right and that last for the whole night. The outcome of the events was unknown. No treatment was used for the events.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased
Clinical narrative: Blood sugar drop immediately after first dose; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the second dose of two reports. A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blood sugar drop immediately after first dose in Dec2020 with outcome of unknown. This report is considered as non-serious.   No follow-up attempts are possible. Information on lot/batch number could not be obtained.; Sender's Comments: Linked Report(s) :  same reporter/drug, similar event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Swelling face
Clinical narrative: my face is swollen, specifically in cheeks and nasolabial fold; can feel kind of protruding out; Temperature was 100.9 / fever; Chills; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) solution for injection, via an unspecified route of administration on 14Jan2021 15:45 at a single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medications included vitamin C [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), and zinc. Patient reported she got the vaccine on Thursday (14Jan2021) around "15:45" (not clarified) and she came home yesterday, and on 15Jan2021 had just like fever, chills and like "slightly high" (not clarified) temperature it was 100.9, so she took some Tylenol, took some Benadryl last night, went to bed, and then woke up this morning (16Jan2021) and her face was very swollen. Specifically, in her cheeks and then kind of her nasolabial fold, she do have a history of  fillers but the last time she got fillers done with, probably 7 months ago. She was not having any difficulty breathing or shortness of breath, but it was just really swollen and like she can feel it like it was kind of protruding out. Right now she doesn't have any fever or chills, that was just yesterday. Right now, her temperature was normal 98.4. The last time she took the Tylenol and Benadryl was last night. She has not taken anything this morning. Outcome of the event face is swollen was unknown while the outcome of the other events was recovered.  No follow-up activities are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Light-headed; Pulse rate is higher than what normally was/ from maybe 55 to 65, now, it's running into the 70's; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included being on long time care facility, has hearing problem, and pulse rate abnormal. Concomitant medications included metoprolol tartrate for pulse rate abnormal. Patient got first dose yesterday. Patient felt very good all day long; got the dose in morning and had a good night sleep. But when patient woke up, patient felt so light-headed. Patient took blood pressure several times and it was normal. The other thing that was different a little bit was the pulse rate, which is higher than what normally was with the medication that patient takes for it. Patient takes metoprolol and usually, when patient takes it, pulse rate is anywhere from maybe 55 to 65, now, its running into the 70's. It is not great difference but patient just reporting experience when blood pressure was checked. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia, SARS-CoV-2 test positive
Clinical narrative: Went to go get a Covid test and it came back positive; Went to go get a Covid test and it came back positive; had a bitter taste in her mouth; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse(patient) reported that a female patient of an unspecified age received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization.  The patient medical history was none. The concomitant medications were none. The patient got the vaccine on the 02Jan2021. After getting the vaccine she started losing taste. After getting vaccine in Jan2021 she had a bitter taste in her mouth. She went to go get a Covid test and it came back positive in Jan2021 and she had additional questions. The patient stated it was the Pfizer vaccine but she did not think it gave her the Covid because she had symptoms before that period then they just came back. If it feels with adverse reaction or anything just wanted to know if it was associated with the vaccine or not.The patient stated she did not lose taste, she just had a bitter taste. She could taste everything. She just had bitter taste in her mouth. She did not think bitter taste in her mouth was related to product. The patient just find anybody who can explain to her if it was okay for her to go for the second dose because there was no more information about the Pfizer because she had Covid. She just needed to know it was ok for her to get the second dose or stop the vaccine. The patient was informed to contact Medical information. The outcome of the events was unknown.  Information on the batch number/lot number has been requested.; Sender's Comments: Based on the available information and time association, the possible contribution of suspect BNT162B2 administration to the COVID-19 infection and bitter teste cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Left side of her face is swollen; This is a spontaneous report from a contactable consumer reported for grandmother. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. Medical history included root canal from 04Jan2021. Concomitant medications were unknown. The patient got the vaccine on 15Jan2021 and 'this morning' the left side of her face was swollen on Jan2021. The patient was taking Benadryl as treatment. Outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Nausea
Clinical narrative: My arm just bothered me; Nausea; Chills; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated "I got the Covid vaccine on Friday afternoon. Yesterday morning my arm just bothered me. Today 4 O'clock in the morning I started getting nausea and chills." Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pain in extremity, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Got the flu like body aches; Got 100 temperature; Had a sore arm but it was mild; Started hurting a little bit more; This is a spontaneous report from a contactable nurse, the patient.  A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248; Expiration Date: Apr2021), intramuscular in the right upper arm on 15Jan2021 at 12:30 (at the age of 69-years-old) as a 0.3 ml single dose for COVID-19 immunization.   Medical history included atrial septal defect, palpitations, and COVID-19 from Aug2020 to an unknown date.  The patient had COVID antibody titers done in Aug2020 and Dec2020 and they were "270." Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), cyanocobalamin (B12-VITAMIIN), estrogens conjugated (PREMARIN), pravastatin (MANUFACTURER UNKNOWN), and escitalopram oxalate (LEXAPRO). On 15Jan2021 after getting the vaccine, the patient had a sore arm but it was mild. Then as the night went on, it started to hurt a little bit more. On 16Jan2021, the patient had flu like body aches, and had a temperature of 100.  The patient did not receive any treatment for the events. The clinical outcome of the sore arm that hurt a little bit more was not recovered; while that of the flu like body aches and a temperature of 100, were unknown. The nurse thought the events were related to the vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Localised infection, Lymphadenopathy, Neck mass
Clinical narrative: Lump in neck/it might be infected or a lymph node; Lump in neck/it might be infected or a lymph node; Lump in neck/it might be infected or a lymph node; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (lot number: EK9231), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. This morning (17Jan2021) patient woke up and there is a lump in neck. And patient looked at some information, patient thought it might be infected or a lymph node. The outcome of the events was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Lip dry, Lymphadenopathy, Neck pain
Clinical narrative: touched the back of her ear, it was tender and very sore; feeling very tender on the gland; Lymphatic glands, those were the ones that got swollen; Headache; Neck was hurting; swollen; Neck was hurting; swollen; dryness, felt it on lips; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on14Jan2021 at a single dose for COVID-19 immunization. Medical history included arthritis on clavicle, thorax and lumbar. The patient had concomitant medications (unspecified). The patient wanted to report the reactions occurred on 14Jan2021 for the vaccine she got; she got a headache, couple of hours later, her neck was hurting. So, she asked somebody that was with her to check and told her that it was swollen. She also had dryness, felt it on lips. The patient touched her neck and it hurts. It did hurt and it was swollen, the neck. They gave her Tylenol and Benadryl. So, it does help her sleep but the next day, she was not so much hurting. Just had headache. On 17Jan2021, when she touched the back of her ear, it was tender and very sore. It was not as bad as it was. The first day (14Jan2021), she was feeling very tender on the gland. Those were not swollen. Lymphatic glands, those were the ones that got swollen on 14Jan2021. She would like you to know the main cause, they looked and told her it is normal for the lymphatic glands to get swollen after the vaccine. So, the patient guessed that is what she got but she still had a lot of soreness in the back of her neck. Outcome of the event events headache and neck pain was not recovered while unknown for other events.  Information on the Lot/Batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: touched the back of her ear, it was tender and very sore; feeling very tender on the gland; Lymphatic glands, those were the ones that got swollen; Headache; Neck was hurting; swollen; Neck was hurting; swollen; dryness, felt it on lips; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on14Jan2021 at a single dose for COVID-19 immunization. Medical history included arthritis on clavicle, thorax and lumbar. The patient had concomitant medications (unspecified). The patient wanted to report the reactions occurred on 14Jan2021 for the vaccine she got; she got a headache, couple of hours later, her neck was hurting. So, she asked somebody that was with her to check and told her that it was swollen. She also had dryness, felt it on lips. The patient touched her neck and it hurts. It did hurt and it was swollen, the neck. They gave her Tylenol and Benadryl. So, it does help her sleep but the next day, she was not so much hurting. Just had headache. On 17Jan2021, when she touched the back of her ear, it was tender and very sore. It was not as bad as it was. The first day (14Jan2021), she was feeling very tender on the gland. Those were not swollen. Lymphatic glands, those were the ones that got swollen on 14Jan2021. She would like you to know the main cause, they looked and told her it is normal for the lymphatic glands to get swollen after the vaccine. So, the patient guessed that is what she got but she still had a lot of soreness in the back of her neck. Outcome of the event events headache and neck pain was not recovered while unknown for other events.  Information on the Lot/Batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; She didn't know what but it is itchy, it hurts or a combination of both; She didn't know what but it is itchy, it hurts or a combination of both; My arm hurts/her arm felt like a little sore; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) via an unspecified route of administration, on 06Jan2021 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medications included metoprolol and lisinopril, both for high blood pressure. Patient stated that she got the Pfizer vaccine on 06Jan2021. The regular reaction to it like her arm hurts and that was it, it lasted like for three days and it went away. Not yesterday, but the day before (15Jan2021), her arm felt like a little sore. Yesterday (16Jan2021), when she was in the showering, she noticed that the around the site of injection, it was like a red circle like a size of an inch that was (sentence incomplete). She felt like a little warm to her. She didn't know what but it was itchy, it hurt or a combination of both, it didn't bother her unless she touched it or rubbed against it but it was there. So, she just wanted to know whether that was a reaction to the injection or what that was, is that common or is that not common. Patient said she still felt it. As treatment, patient took a paracetamol (TYLENOL). She took one paracetamol this morning (17Jan2021) and one yesterday (16Jan2021). Outcome of arm hurts/arm felt like a little sore was recovered, outcome of other events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: She got the vaccine and now she has Covid, she is tested positive; She got the vaccine and now she has Covid, she is tested positive; This is a spontaneous report from a contactable nurse (patient's husband). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142, expiry date not reported) on 07Jan2021 intramuscularly in left deltoid muscle at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID), amlodipine besilate/ atorvastatin calcium (CADUET). The patient received the vaccine and then had COVID. On 07Jan2021 Thursday, the patient received the vaccine, and on Tuesday (12Jan2021) she said she was not feeling good. On Thursday (14Jan2021) she went to work and because she was not feeling good, she was tested and she was tested positive. The patient worked in a nursing home where she had been tested almost everyday. She was tested negative before she got the vaccine. She was at home, not receiving treatment for COVID. The reporter didn't understand why the patient (reporter's wife) got the vaccine and then had COVID. The outcome of the event was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive based on the known safety profile. However the short duration of 7 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: it is probably more sore than when the patient got the injection; Started to get a little bit of a rash at the injection; it is spreading; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 07Jan2021 15:40 at SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had first dose on 07Jan2021 at 3:40 pm and everything seemed to be fine and then yesterday (17Jan2021), the patient started to get a little bit of a rash at the injection point and today (18Jan2021) it was spreading and it was probably more sore than when the patient got the injection. The outcome of the events was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Laboratory test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: FL3302) via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 Immunization. There was no medical history. There were no concomitant medications. The patient reported a side effecting occurrence with COVID-19 Vaccination he received about a week ago. He experienced two days after the vaccination has been given to him, on 14Jan2021, that was on day three or two days later of the vaccination; and then again second yesterday (17Jan2021), that was on day five, some pain in the stomach and it was kind of a (Incomplete sentence), it appeared heavily and then he needed to go to the toilet and the first time it was only once and the second time there was two reactions like the other. No treatment received for event. He did lab test some months ago. Event outcome was recovering, it was very slightly not anymore.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Flatulence, Head injury
Clinical narrative: Gas; Aches and pains; Passed out; Fell; did get hurt when he fell; Hit his head on the counter and cut open his head; Dizzy; Nausea; Weakness/He is very weak; This is a spontaneous report from a contactable consumer (caregiver). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunisation, lot number: unknown. Medical history included Blood pressure high. Concomitant medications included some blood pressure medicine (no names reported). It was reported that patient got up in the morning the following day (on 16Jan2021), so dizzy, weak, nauseous, and he fell (did get hurt when he fell), passed out. On the way down, he hit his head on the counter and cut open his head, not a pretty sight when he got up. On unknown date patient experienced gas, aches and pains. Patient was very weak. Patient was not going to pass out, but he was very weak, and reporter thought some of it was from fall, he fell. When you pass out, you fall like a ton of bricks. He fell on a tile floor. So, he had gas, he had some aches and pains now too. Patient was going to take him to the doctor because he did get hurt when he fell. No treatment received for the events, patient had not seen a doctor yet, he will be seeing one the day of the report. Patient had not recovered from weakness, while outcome of the other reported events was unknown. Information about Batch/Lot number has been requested.