chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Nausea; Headache; Dizziness; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 11Jan2021 (19:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included sulfa allergy and penicillin (PCN) allergy. The patient's concomitant medications were not reported. The patient had previously received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) for COVID-19 immunization. On 12Jan2021 (11:00), the patient had nausea, headache and dizziness. The patient did not receive any treatment for the reported events. The outcome of the events, 'nausea', 'headache' and 'dizziness', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; sore arm; This is a spontaneous report from a Pfizer . A non-contactable consumer reported that a male patient (dad) of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced fever and a sore arm, which was normal. Events outcome was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Six hours later, i woke up with a terrible headache and took more Tylenol; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age (age: 72 ; unit: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included headache prior to vaccination. The patient's concomitant medications were not reported. The patient was experiencing a headache prior to vaccination. Patient received her first dose on 12Jan2021 and then took 2 TYLENOL five minutes later after vaccination. Patient wanted to know if that would lower her immune response to vaccine. Patient had headache before she got the vaccine, she did not take anything for her headache before the vaccine. She did take TYLENOL 5 minutes after getting the vaccine for her headache and is asking if that will interfere with the vaccine. Patient stated that six hours later in Jan2021, she woke up with a terrible headache and took more TYLENOL. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache on front lobe of head; This is a spontaneous report from a contactable consumer (reporting for herself).  A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  Medical history included high blood pressure and breathing problem.  Concomitant medication included salbutamol (ALBUTEROL) taken for breathing problem and unspecified high blood pressure medications and blood thinners.  The patient experienced headache on front lobe of head on 09Jan2021. The outcome of headache on front lobe of head was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Headache, Neck pain, Pain
Clinical narrative: Body ache; Headache; Light fever; Sore arm; neck pain; It's swollen under my right arm; This is a spontaneous report from a contactable (patient).  A 56-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm, on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide for hypertension. Patient reported that on Friday (Jan2021), she took her first dose of vaccine.  She didn't have any reaction right away but after like 8 to 9 hours in Jan2021 she had body ache and headache, light fever. She knew this sore arm would be, it always will be there, she knew it's now under her arm, it's swollen under her right arm that she took the vaccine, was swollen. Patient took ibuprofen (MOTRIN, Expiry Date: Jun2023) 200 mg orally two times a day for treatment. Her body does not as hurt as it used to after taking it, but she still has neck pain and her arms still hurting and right now under her right arm that she took the shot that was swollen, patient said she still has 'this band' (not clarified further) in her neck right now. Patient works in the healthcare. She does cut skin. She took it at her work. Patient did blood test three months ago (Oct2020) at her doctor's office. Outcome of sore arm was not recovered, outcome of body ache was recovering, outcome of other events was unknown.    Information on lot number/batch number was requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Body ache; Headache; Light fever; Sore arm; neck pain; It's swollen under my right arm; This is a spontaneous report from a contactable (patient).  A 56-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm, on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide for hypertension. Patient reported that on Friday (Jan2021), she took her first dose of vaccine.  She didn't have any reaction right away but after like 8 to 9 hours in Jan2021 she had body ache and headache, light fever. She knew this sore arm would be, it always will be there, she knew it's now under her arm, it's swollen under her right arm that she took the vaccine, was swollen. Patient took ibuprofen (MOTRIN, Expiry Date: Jun2023) 200 mg orally two times a day for treatment. Her body does not as hurt as it used to after taking it, but she still has neck pain and her arms still hurting and right now under her right arm that she took the shot that was swollen, patient said she still has 'this band' (not clarified further) in her neck right now. Patient works in the healthcare. She does cut skin. She took it at her work. Patient did blood test three months ago (Oct2020) at her doctor's office. Outcome of sore arm was not recovered, outcome of body ache was recovering, outcome of other events was unknown.    Information on lot number/batch number was requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, International normalised ratio, Nausea, Pain
Clinical narrative: Severe headache; Nausea; Throwing up; I got so sick; Body ache; I was in pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK5730), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunisation. Medical history included migraine, depression, AFib, COVID-19 in Jun2020, and sleep disorder. Concomitant medications included prednisolone, ciprofloxacin, warfarin, timolol, sleep medications (unspecified), and eye drop (unspecified). The patient experienced body ache; stated that she was in pain everywhere on ; severe headache, nausea, throwing up, The patient stated that she felt like she had COVID all over again. She got so sick. It was reported that she worked for a clinic (also reported as a hospital) and on Friday (08Jan2021), she got the COVID shot. By Friday evening, she had body ache, and by Saturday, she was in pain everywhere. She also had severe headache, nausea, and was throwing up on 09Jan2021. According to her, the whole thing felt like she had COVID all over again and this went on through yesterday, she still had the headache today and some nausea. She stated that they were supposed to report this. When further clarified, the patient stated that she was tested yesterday again, just because it felt like COVID and because she had COVID way back in June last year. Stated that it felt like that all over again. She went to the [unclear statement], after hours to urgent care yesterday, they tested her again for COVID. She did not have COVID, she was clear, she was negative for COVID. Stated that she now knows that's what she has was just a result to the shot. When probed to clarify if it was the first dose or the second dose, the patient stated that she was just calling to ask. According to her, she was due to have it, the 29 (not clarified). She doesn't know if she should do it, she got so sick, she had been throwing up and everything. The patient was inquiring if she should do the second dose. The patient stated that she was about 150 lbs. and she does get her INR checked. As treatment, the patient took Tylenol and then took Zofran for the nausea. Outcome of the events 'Severe headache' and 'Nausea' was not recovered, while for the other events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting, Weight
Clinical narrative: Severe headache; Nausea; Throwing up; I got so sick; Body ache; I was in pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK5730), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunisation. Medical history included migraine, depression, AFib, COVID-19 in Jun2020, and sleep disorder. Concomitant medications included prednisolone, ciprofloxacin, warfarin, timolol, sleep medications (unspecified), and eye drop (unspecified). The patient experienced body ache; stated that she was in pain everywhere on ; severe headache, nausea, throwing up, The patient stated that she felt like she had COVID all over again. She got so sick. It was reported that she worked for a clinic (also reported as a hospital) and on Friday (08Jan2021), she got the COVID shot. By Friday evening, she had body ache, and by Saturday, she was in pain everywhere. She also had severe headache, nausea, and was throwing up on 09Jan2021. According to her, the whole thing felt like she had COVID all over again and this went on through yesterday, she still had the headache today and some nausea. She stated that they were supposed to report this. When further clarified, the patient stated that she was tested yesterday again, just because it felt like COVID and because she had COVID way back in June last year. Stated that it felt like that all over again. She went to the [unclear statement], after hours to urgent care yesterday, they tested her again for COVID. She did not have COVID, she was clear, she was negative for COVID. Stated that she now knows that's what she has was just a result to the shot. When probed to clarify if it was the first dose or the second dose, the patient stated that she was just calling to ask. According to her, she was due to have it, the 29 (not clarified). She doesn't know if she should do it, she got so sick, she had been throwing up and everything. The patient was inquiring if she should do the second dose. The patient stated that she was about 150 lbs. and she does get her INR checked. As treatment, the patient took Tylenol and then took Zofran for the nausea. Outcome of the events 'Severe headache' and 'Nausea' was not recovered, while for the other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm is really great, it was just sore for a day; 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 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his/her vaccine on Friday. The patient stated he/she had no effects, his/her arm was really great, it was just sore for a day. The outcome of the event was recovered.  Information about lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Fatigue, Feeling abnormal, Nausea
Clinical narrative: felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient).  A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date.  The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour.  The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient).  A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date.  The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour.  The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Nausea; Vertigo; Dizzy; This is a spontaneous report from a contactable Nurse (patient). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot#: EJ1685, Expiry Date: Mar2021), via an unspecified route of administration on 07Jan2021 04:30 at single dose for COVID-19 immunization. Medical history included GERD (Gastrooesophageal reflux disease).  Concomitant medication included montelukast sodium (SINGULAIR), pantoprazole sodium sesquihydrate (PROTONIX) for GERD, omeprazole for GERD. The patient experienced nausea on 08Jan2021, vertigo and dizzy in Jan2021.  Investigation Assessment: No. The patient received the second dose of Pfizer COVID Vaccine (later confirmed) on 07Jan2021 around 4:30. And since 08Jan2021 night till now, the patient was feeling, it started out with nausea and now it's just vertigo. The patient had been in bed since 08Jan2021 night, pretty much except to get something to eat or drink. The patient just very dizzy. When probed if the product was prescribed by a doctor, consumer stated, "The hospital, the patient worked there." Treatment: the patient had some Meclizine, took it once it didn't do anything, 12.5 mg. The outcome of all the events was unknown. Causality: the patient thought yes.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Investigation, Nausea
Clinical narrative: Body shaking; Chills; Tingling; Nauseous; Body ache; Tiredness; having like little sweat; This is a spontaneous report from a contactable nurse (reporting for herself). A 59-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration from 08Jan2021 07:40 at single dose for COVID-19 immunization. Medical history included hypertension, high cholesterol and COVID-19  survivor from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had historical vaccine of first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient stated, "I am calling to report a side effect from the vaccine (Clarified COVID-19 vaccine). I am a health care worker, I got the first dose I was fine but I got the second dose last Friday and I woke up hour later with terrible chills, tingling, my body shaking. It was not half an hour later, it was hours later. I took it at 07:40 in the morning at work and then I came home, I was fine but then chills woke me up in mid night Friday it was Saturday, let's say Saturday morning 12 am. I woke up with chills like, I am in refrigerator and I felt like I wanted to warm it but I did not, I felt nauseous, it happened like two different times and after that I took like Motrin (treatment) I did not have any temperature but I have like body ache and after that I started having like little sweat and tiredness. I just call my job now. Having the same symptoms now." The patient took Motrin and Tylenol and underwent lab work at the hospital with unknown result. The patient think that the events were related to COVID as the patient stated, "I think so because I woke up with the chills extreme chills. I never felt that way, it's like the last time when I felt it, when I had COVID, I woke up with extreme chills the only difference between this one was that I didn't have a temperature with these chills but with COVID I have temperature but this one was extreme chills." The outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Tremor
Clinical narrative: Body shaking; Chills; Tingling; Nauseous; Body ache; Tiredness; having like little sweat; This is a spontaneous report from a contactable nurse (reporting for herself). A 59-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration from 08Jan2021 07:40 at single dose for COVID-19 immunization. Medical history included hypertension, high cholesterol and COVID-19  survivor from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had historical vaccine of first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient stated, "I am calling to report a side effect from the vaccine (Clarified COVID-19 vaccine). I am a health care worker, I got the first dose I was fine but I got the second dose last Friday and I woke up hour later with terrible chills, tingling, my body shaking. It was not half an hour later, it was hours later. I took it at 07:40 in the morning at work and then I came home, I was fine but then chills woke me up in mid night Friday it was Saturday, let's say Saturday morning 12 am. I woke up with chills like, I am in refrigerator and I felt like I wanted to warm it but I did not, I felt nauseous, it happened like two different times and after that I took like Motrin (treatment) I did not have any temperature but I have like body ache and after that I started having like little sweat and tiredness. I just call my job now. Having the same symptoms now." The patient took Motrin and Tylenol and underwent lab work at the hospital with unknown result. The patient think that the events were related to COVID as the patient stated, "I think so because I woke up with the chills extreme chills. I never felt that way, it's like the last time when I felt it, when I had COVID, I woke up with extreme chills the only difference between this one was that I didn't have a temperature with these chills but with COVID I have temperature but this one was extreme chills." The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Weakness; Joint pain; Dizziness; Tiredness; Headache; Swollen lymph nodes; Feeling unwell; Muscle pain; A bad rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The consumer reported the side effects included dizziness and weakness, a bad rash on the patient's "right leg where it was given in his/her right arm" (not clarified further), tiredness, headache, muscle pain, joint pain, feeling unwell and swollen lymph nodes. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Myalgia, Rash
Clinical narrative: Weakness; Joint pain; Dizziness; Tiredness; Headache; Swollen lymph nodes; Feeling unwell; Muscle pain; A bad rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The consumer reported the side effects included dizziness and weakness, a bad rash on the patient's "right leg where it was given in his/her right arm" (not clarified further), tiredness, headache, muscle pain, joint pain, feeling unwell and swollen lymph nodes. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Pain, Pyrexia
Clinical narrative: I got a fever of 101.5; Chills; Body ache; This is a spontaneous report from a contactable healthcare professional (patient). A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included Graves' disease, hypothyroidism, cholesterol, thyroid problems, hyperthyroidism, and had COVID in July (year unspecified). Concomitant medications included atorvastatin (generic) and atorvastatin calcium (LIPITOR) for cholesterol, and levothyroxine sodium (SYNTHROID). The patient had first vaccine and then next evening on an unknown date she got a fever of 101.5 and then had the chills and body ache and everything and she was scheduled to have her next one on 25 (not clarified). Patient had blood test before the end of the year 2020 but nothing new now. Patient took TYLENOL as treatment for the events. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: feeling extremely nauseous; My arm was sore; Headache; Slightly tired; Little dizzy; 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, Reason for no lot number: of Covid-19 Vaccine: It just say Pfizer INC it's hard to read it, this is 0 crossed out EN0142. The patient didn't know what looking at, thought it says E and O or E21042 Pfizer INC.), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced feeling extremely nauseous, arm was sore, headache, slightly tired, little dizzy, all in Jan2021. The patient received this first dose of the Covid-19 Vaccine on 05Jan2021, the patient had been feeling extremely nauseous yesterday and today but after the vaccination the arm was sore, the patient had a headache and slightly tired but did not feel nauseous at all but the patient was feeling extremely nauseous yesterday and today and a little dizzy was that the common side effect and should have subside. The outcome of all the events was unknown.  Information about Lot/Batch has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Contusion, Investigation, Weight, Weight decreased
Clinical narrative: Bruise in arm; I lost some weight; This is a spontaneous report from a contactable Consumer. This consumer reported for herself that the 62-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on unknown date at a single dose for covid-19 immunisation. Medical history included "I went to the doctor because I wasn't feeling well just little congestion inside my lungs." Concomitant medications included "Yes, Antibiotics, I was worried I didn't think about it since I think about it yesterday, wow is this going to effect the vaccine (further not clarified)." Consumer stated, "I have a question I received the First shot (clarified as Covid 19 vaccine) here 20th of this month I get my second but 7th of this month I didn't even think about it I went to the doctors even though I was negative and they put me on antibiotics is that going to interfere with the vaccine. Consumer stated, "I guess no, I had no side effects, I got a bruise in my arm and that was all." Consumer stated, "120 pounds, I lost some weight." Consumer stated, "I just had my blood count checked that's all." The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Liver injury, SARS-CoV-2 test negative
Clinical narrative: Acute liver injury; This is a spontaneous report from a contactable physician.   A 35-year-old female non-pregnant patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) intramuscularly, in the right arm, at single dose, on 04Jan2021 at 11:00 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included hypertension and drug hypersensitivity to amoxicillin; clavulanic acid (AUGMENTIN). Concomitant medications included labetalol; ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and cetirizine hydrochloride (ZYRTEC). On 10Jan2021, at 12:00 AM, the patient experienced acute liver injury and hospitalization was required (duration of hospitalization: 1 day). Treatment was received (supportive care for acute liver injury). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 17Jan2021. Covid test result: negative. The adverse event was assessed as serious (Hospitalization, Life threatening illness). Clinical outcome of the adverse event was unknown at time of this report.  Information on Lot/Batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Malaise
Clinical narrative: Shivering/Chills; Diarrhea; Not feeling well; This is a spontaneous report from a contactable physician (patient self). A patient of unspecified age and gender received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via an unspecified route of administration on 10Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and shivering and then diarrhea. Patient was not feeling well. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Breaking out rash; This is a spontaneous report from a contactable consumer reported for himself. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 09:00 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient experienced breaking out rash on an unspecified date with outcome of unknown.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Headache, Nausea
Clinical narrative: Headache; Loss of taste and smell; Loss of taste and smell; Nausea; Dizziness; General body aches; This is a spontaneous report from a contactable nurse reported for herself. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced Headache, loss of taste and smell, nausea, dizziness, general body aches. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache; Loss of taste and smell; Loss of taste and smell; Nausea; Dizziness; General body aches; This is a spontaneous report from a contactable nurse reported for herself. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced Headache, loss of taste and smell, nausea, dizziness, general body aches. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I developed the rash on the inside of my elbow about an inch and half in circular; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL1284), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient's concomitant medications included lisinopril for blood pressure high. Patient stated she was keeping that under control with lisinopril. Patient stated she took bnt162b2 because she didn't want to die. Patient stated she got the vaccine shot on and 08Jan2021 and just this evening she developed the rash on the inside of my elbow about an inch and half in circular. Patient was fine, she meant it's just a skin rash nothing itchy. No treatment received in response to event. Outcome of the event was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vaccination site pain
Clinical narrative: Migraine; Mild pain at injection site; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 53-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 4178) Intramuscular on 08Jan2021 09:15 AM at left arm at single dose for COVID -19 immunization in Hospital. Medical history was none. No Known allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. Patient receive the first dose of bnt162b2 (lot number: EK5730), intramuscularly on the left arm on 18Dec2020 at 13:15 at single dose for COVID-19 immunization and experienced injection site soreness (Day 1 and Day 2) and mild headache (Day 2). Patient experienced mild pain at injection site (Day 1 and Day2, 08Jan2021 12:00 PM) and Migraine (Day 2, 08Jan2021 12:00). COVID was not tested post vaccination. No treatment received. Patient was recovered from the events in Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Finger tips on left hand were numb/my fingers were numb; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female consumer received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot: EL0140 or EL, don't know if that's an O or 0, 14, O or 0), via an unspecified route of administration on an unspecified date about 10 o' clock at single dose on left arm for COVID-19 immunization. Medical history included type 2 diabetes, stent in right coronary artery and cardiac issues. Concomitant medication included metformin for diabetes mellitus and rosuvastatin calcium as cardiac medication. The consumer realized that the finger tips on her left hand were numb. By 2 pm her fingers were numb. The consumer 'can drive a needle across her palm' (not clear over the call and not clarified) and can't feel it. The outcome of the event was unknown. No treatment was received for the event.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer (friend). A patient of unspecified age and gender received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever on an unspecified date and it went away and patient was getting ready to take the second dose. The outcome of the event was recovered on unspecified date.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore throat on an unspecified date and it went away and patient was getting ready to take the second dose. The outcome of the event was recovered on unspecified date.  Information on the lot/ batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient).  A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. Patient received a long list of concomitant medications which were not specified. The patient experienced headache on 07Jan2021 with outcome of recovered in Jan2021.  Information on lot and batch number has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Left eye has been twitching; This is a spontaneous report from a contactable consumer (patient). This 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL0401), via an unspecified route of administration on 23Dec2020 at single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included fluoxetine hydrochloride (PROZAC) and clonazepam (KLONOPIN). Patient stated he got the vaccine at the hospital. Patient stated he was just calling because it was actually something that for the past like couple of weeks, it was like his left eye has been kind of twitching on an unspecified date. Patient stated he did not have lab work and treatment, it just happened like 2 weeks ago. Patient stated he did not visited any emergency clinic or physician's office and haven't seen anybody. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site vesicles
Clinical narrative: received the COVID-19 Vaccine really high, which was almost given into the shoulder bone / this is a complete medication error.; Vaccine really high and caused blisters she presumes at the injection site.; This is a spontaneous report from a contactable other HCP. This other HCP reported for a female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left deltoid at single dose for COVID-19 immunization on 09Jan2021 at 10:10 am. Patient's Medical History included seasonal allergies.  Relevant concomitant drugs were unknown. The patient  received the COVID-19 Vaccine really high, which was almost given into the shoulder bone and caused blisters she presumes at the injection site. It was almost on the very top of the shoulder. The blisters appeared one day after the injection on 09Jan2021. The patient presented to the clinic on 11Jan2021, with kind of a cluster of blisters; one blister was kind of longer than the other at about 7mm's. Patient  took ibuprofen and had been guarding her shoulder. The patient was a physician and cardiologist, she was worried that the vaccine was not effective. The blisters were reported as improving. Reporter stated that she could send a picture of these blisters, if needed.  The patient stated that the nurse who gave this COVID-19 vaccine injection to this patient, had been pulled from giving any more vaccines. This was a complete medication error. The patient removed the band aid from where the COVID-19 vaccine had been given and there were the blisters. The AE was not required a visit to Emergency Room, nor Physician office. No other Vaccinations received other than COVID-19 first dose were given in the last 4 weeks. No other AE's related to other vaccinations.  The information on the lot/batch number has been requested.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Fatigue, Limb discomfort, Respiratory arrest
Clinical narrative: tired; legs felt heavy; stopped breathing; This is a spontaneous report from a Pfizer-sponsored program a non-contactable consumer. A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 11:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient received vaccine around 11:00 a.m. About two hours later, he said he was tired and couldn't continue with the physical therapy he was doing. He was taken back to his room, where he said his legs felt heavy. Soon after, he stopped breathing. A nurse declared a do-not-resuscitate order. The patient died on 04Jan2021. It was not reported if an autopsy was performed. Outcome of stopped breathing was fatal. Outcome of tired and legs felt heavy was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: stopped breathing
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that an 83-year-old female patient (reporter mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included hospice care and dementia. The patient's concomitant medications were not reported. The patient died one day after getting vaccine. She was reportedly in good health the day before receiving vaccine. She was on hospice, frail, but in good condition and checked by a hospice nurse the day before which she reported her in good health considering. She was with dementia but stable in her health. The reporter read investigating 23 deaths of people receiving vaccine in similar conditions. The patient died on an unspecified date.  It was not reported if an autopsy was performed.; Reported Cause(s) of Death: died
Sex: U
Vaccine: FLUX
Symptoms: Arthralgia, Arthritis, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis; inflammation; pain in joints; allergic reaction to flu vaacine; Initial information was received on 12-Jan-2021 regarding an unsolicited valid serious case from consumer/ non-health care professional.  This case involves a patient of unknown age who experienced rheumatoid arthritis, allergic reaction to flu vaccine (hypersensitivity), inflammation and pain in joints (arthralgia), while the patient received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date were not reported)  via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced rheumatoid arthritis with inflammation and pain in joints (arthralgia) and allergic reaction to flu vaccine (hypersensitivity) (latency: unknown) following administration of INFLUENZA VACCINE.  The events rheumatoid arthritis, inflammation and arthralgia were assessed as medically significant.  No laboratory data was reported.  The patient was taking XELJANZ XR (TOFACITINIB CITRATE) 11 mg once daily via oral route for rheumatoid arthritis since AUG-2020.  It was not reported if the patient received any corrective treatment for hypersensitivity.  On an unknown date, the patient recovered from inflammation and arthralgia (reported as symptoms of rheumatoid arthritis, inflammation and arthralgia finally resolved).  At the time of report, outcome of rheumatoid arthritis and hypersensitivity were unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient of unknown age who had rheumatoid arthritis, allergic reaction, inflammation and pain in joints after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset was unknown. However, patient's laboratory data, concomitant medications ruling out alternate etiologies were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Approximately 5 minutes after receiving injection, patient reported feeling mildly short of air. 1410-BP 132/89 HR 104 SpO2 99% 1420-BP 130/86 HR 85 SpO2 99% - reports that symptoms have resolved. Denies need for further intervention. Education provided to seek medical attention for further sx Pt was ambulatory and left the clinic.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Redness, warmth, pain, RUE measuring 9.5cm x 15.0 cm noted on 1-17-2021 continues with redness (fading) on 1-21-2021 warmth. Denies pain unless bumped. Resident afebrile. Size remains unchanged
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness
Clinical narrative: 40 y/o female who refers dizziness 10 minutes after vaccination covid-19. also sensation of heaviness on back of neck.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine recipient requested vaccine be administered in the abdomen. This was discovered after the vaccine was given.  1"synringe given LLQ
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Ultrasound scan
Clinical narrative: Swollen painful lymph nodes (3) left axillary, tylenol/ibuprofen