chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Facial pain, Neck mass, Neck pain
Clinical narrative: lumps in back of neck, they hurt; lumps in back of neck, they hurt; pain goes around into jaw, up into the face; pain goes around into jaw, up into the face; ear hurts; felt dizzy; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 23Jan2021 at a single dose for covid-19 immunization. Medical history included high blood pressure (Diagnosed 3 to 4 years ago) and thyroid disorder. There were no concomitant medications. It was reported that the patient got the vaccine on Saturday and went home and fell asleep, woke up and had lumps in back of neck, they hurt, pain goes around into jaw, up into the face and ear hurts. The patient just tried a hot compress, a hot cloth on there, it seemed to help a little bit for a while. Took some Advil and that helped a little bit, but when it wears off it comes back. Adds she felt dizzy too, and still felt like that too, it started right after she got it, and it comes and goes. The outcome of the event dizzy was unknown while not recovered for the remaining events.  Information about lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: lumps in back of neck, they hurt; lumps in back of neck, they hurt; pain goes around into jaw, up into the face; pain goes around into jaw, up into the face; ear hurts; felt dizzy; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 23Jan2021 at a single dose for covid-19 immunization. Medical history included high blood pressure (Diagnosed 3 to 4 years ago) and thyroid disorder. There were no concomitant medications. It was reported that the patient got the vaccine on Saturday and went home and fell asleep, woke up and had lumps in back of neck, they hurt, pain goes around into jaw, up into the face and ear hurts. The patient just tried a hot compress, a hot cloth on there, it seemed to help a little bit for a while. Took some Advil and that helped a little bit, but when it wears off it comes back. Adds she felt dizzy too, and still felt like that too, it started right after she got it, and it comes and goes. The outcome of the event dizzy was unknown while not recovered for the remaining events.  Information about lot/batch number has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea, Vomiting
Clinical narrative: Nausea; Diarrhea; Kind of not feeling good; Throwing up; This is a spontaneous report received from a contactable consumer (patient's daughter). A 91-year-old (also reported as 92-year-old) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), intramuscular on the right arm, on 25Jan2021 19:00, at single dose, to prevent covid/COVID-19 immunization. There were no medical history and concomitant medications. It was reported that the patient had the first shot of the vaccine on 25Jan2021 at 19:00 (yesterday). The patient was surprised that the shot did not hurt going in and she was not having any pain in the arm. On 26Jan2021 (this morning), the patient was experiencing nausea, diarrhea, was throwing up and was feeling kind of not good. The patient stated that the side effects were ongoing. No treatment was given for the events. The outcome of the events was not resolved.  Information about batch/lot number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Illness, Pain in extremity, Vomiting
Clinical narrative: Little back problems, lower back; hurts(Back); My arm is hurting; my arm was killing me; my arm hurts; I throw up twice yesterday; I got a little sick; I just got a little chill; I got chills on the lower part of my back; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration at the age of 50 years, on 25Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated, "Yesterday I took my second vaccine shot and my side effects this morning was a little back problems, lower back, my arm is hurting, and I throw up twice yesterday, I got a little sick. So, I just wanted to call and let somebody know." It was also stated, "Yesterday when I got home after the shot, I just got a little chill and then I laid down, I throw up twice and I just laid down and laid down. And when I woke up I was calling you all since 1 in the morning because my arm was killing me." It was stated, "Yes, my arm hurts and my back, I am in my house and I got the back thing on for, the heating pad (treatment), just for my back." The consumer stated, "I took aspirin because I throw up twice yesterday so I just took aspirin. And then I was laid down and I woke up this morning and I took one in the morning. I have been trying to call you all morning, all morning I just got, just to let you know that my arm is hurting and I got a chills on the lower part of my back." Therapeutic measures were taken as a result of little back problems, lower back; hurts(back) (back pain), i throw up twice yesterday (vomiting). The outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Migraine, Nausea
Clinical narrative: sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was more diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: May2021), via intramuscular route of administration on 26Jan2021 at 11:30 at 0.3 mL, single on the left arm for COVID-19 immunization. Medical history included ongoing migraine and vomiting. Concomitant medications included ongoing sumatriptan succinate (IMITREX) for migraine, ongoing nadolol for migraine, ongoing sertraline for migraine, and ongoing ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). On 26Jan2021 at 13:00, the patient experienced really bad migraine. The patient always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea. The husband does not know if it was because of the shot or if it was because of the warm front that they are receiving because sometimes that can trigger her migraines. The husband reported that it was pretty typical for her and she will sleep with a fan on, but today she is actually covered up (for clarification) and does not want the fan on. Patient also started sweating and got nauseated on an unspecified date. The husband wanted to know if he needs to take her to the doctor. The outcome of the events really bad migraine and diarrhea was not recovered while the other events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain, Pain in extremity
Clinical narrative: bad pain in the arm; pain in the arm like can barely move it; little soreness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262 and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included breast cancer. Concomitant medication included letrozole. Patient received the vaccine on Saturday and last night on 25Jan2021 and the morning of 26Jan2021, patient was having a very bad pain in the arm like can barely move it. She was fine until last night. She had a little soreness on Saturday (23Jan2021) and the night of 25Jan2021 and the morning of 26Jan2021, she can barely lift it. The pain was really a lot and patient did not know if this was normal. She knew that there was supposed to be some soreness right afterwards but this was like a day and a half later. Patient took TYLENOL as treatment for the events. Outcome of the events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Nausea, Off label use
Clinical narrative: suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); Headache; Chills; Nausea; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686), via an unspecified route of administration on the arm/deltoid, on 07Jan2021, at single dose, for covid-19 immunization. Medical history included suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP). The patient had questions about some side effects from the COVID vaccine. She stated she received the first dose on 07Jan2021. About a week after that or maybe 7 to 9 days after the first shot, she started having side effects and was given a handout of a different side effects and risk of the vaccine and; she had like 4 or 5 of the side effects on Jan2021 such as headache, chills, nausea and swollen lymph node. She started with the headache initially then the chills, and nausea, and then lymph node. Her lymph nodes were still swollen. She informed was due to get the "booster" vaccine this Thursday (28Jan2021) and she just wanted to call and see if she should still go and get the booster vaccine with the swollen lymph nodes. She added she did get a test for the COVID this past Thursday (21Jan2021), because of the symptoms, and it was negative. She had the test because she didn't know if it was the vaccine side effect because the side effect also fell in line with actual COVID symptoms. She wanted to make sure that she didn't have the virus. At the time of the report she had not recovered from the adverse events headache, chills, nausea and swollen lymph node and she did not receive any treatment for these. The outcome of the other remaining events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, SARS-CoV-2 test
Clinical narrative: suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); Headache; Chills; Nausea; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686), via an unspecified route of administration on the arm/deltoid, on 07Jan2021, at single dose, for covid-19 immunization. Medical history included suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP). The patient had questions about some side effects from the COVID vaccine. She stated she received the first dose on 07Jan2021. About a week after that or maybe 7 to 9 days after the first shot, she started having side effects and was given a handout of a different side effects and risk of the vaccine and; she had like 4 or 5 of the side effects on Jan2021 such as headache, chills, nausea and swollen lymph node. She started with the headache initially then the chills, and nausea, and then lymph node. Her lymph nodes were still swollen. She informed was due to get the "booster" vaccine this Thursday (28Jan2021) and she just wanted to call and see if she should still go and get the booster vaccine with the swollen lymph nodes. She added she did get a test for the COVID this past Thursday (21Jan2021), because of the symptoms, and it was negative. She had the test because she didn't know if it was the vaccine side effect because the side effect also fell in line with actual COVID symptoms. She wanted to make sure that she didn't have the virus. At the time of the report she had not recovered from the adverse events headache, chills, nausea and swollen lymph node and she did not receive any treatment for these. The outcome of the other remaining events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899 and expiry date: unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first vaccine back and everything went great. She had that usual arm pain on Jan2021. There was no treatment for the event. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Dysstasia, Gait disturbance
Clinical narrative: Her back went out; She can't stand, she can't walk because of that; Her back went out; She can't stand, she can't walk because of that; Her back went out; She can't stand, she can't walk because of that; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as COVID 19 VACCINE; lot number: EL3249; expiration date: unknown) at unknown age of vaccination via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that got the first dose of the vaccine last Friday (22Jan2021) and last Saturday (23Jan2021) her back went out. She further reported that means she can't stand, she can't walk because of that. The patient inquired if she can take Prednisone and if she will take Prednisone, would that affect the efficacy of the vaccine. The outcome of the events was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Lymphadenopathy, Neck pain, Paraesthesia
Clinical narrative: swollen lymph node under his left arm; I feel tingling in my arm; I turn my neck to the right side, I feel like little pain on the neck side; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and diabetes. Concomitant medication included lisinopril for blood pressure, amlodipine, atorvastatin and metformin for diabetes. The patient previously received first dose of BNT162B2 on 02Jan2021 for COVID-19 immunization. The patient had his second shot of his COVID 19 vaccine and then the first day was okay but the second day (24Jan2021) was, he had like swollen lymph node under his left arm. And also, he felt tingling in his arm. And when he turned his neck to the right side, he felt like little pain on the neck side. "I don't know if this will go away or what. This is the third day I had the vaccine." Consumer stated, "I took Ibuprofen." The patient underwent lab tests and procedures which included lab on an unspecified date with unknown results (the patient don't have it, his primary care have it). Outcome of the events was not recovered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Influenza, Nasal congestion
Clinical narrative: Had stomach cramps for three hours. It was very painful, it felt like he had a knife sticking in him.; Severe headache; Flu symptoms; Congestion; This is a spontaneous report from a contactable consumer reporting for himself. A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1686), intramuscular on left arm on 09Jan2021 12:45 at SINGLE DOSE for to prevent COVID-19 (covid-19 immunisation), at 74 years old. Medical history included ongoing severe COPD from 2014, and ongoing idiopathic pulmonary fibrosis from 2020. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EH9899) on 28Dec2020 (age at vaccination 74 years old) and experienced First Covid-19 Vaccine: flu-like symptoms, whole left arm muscle was sore, joint in his elbow was like somebody had a knife sticking in it. No other prior vaccinations within 4 weeks. The patient stated that the first day was okay. The patient experienced had stomach cramps for three hours. It was very painful, it felt like he had a knife sticking in him (Wednesday night), and severe headache on 20Jan2021 for 3 days (also reported as lasted Wednesday, Thursday, Friday and half a day Saturday/3.5 days), and flu symptoms and congestion on an unspecified date Jan2021. The patient thought he had food poisoning, but his wife ate the same food he did. Patient stated he didn't have food poisoning. He stated that after 3.5 hours of lying in bed and not being able to move, the cramping just went away, like someone flipping a light switch. His flu symptoms have gone away as of 26Jan2021. He stated that during reporting time, was the best he felt after the shot which was a week ago. He stated he was over the side effects as of reporting. The events did not require emergency room or physician office visit. No relevant lab tests. Patient mentioned he was getting a complete blood workup. Outcome of the event "Had stomach cramps for three hours. It was very painful, it felt like he had a knife sticking in him" was recovered on 20Jan2021, severe headache was recovered on 23Jan2021, Flu symptoms and Congestion were recovered on 26Jan2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Headache, Limb discomfort, Nightmare, Off label use
Clinical narrative: I really hurt so bad all over; I hurt all over like right leg, left leg, upper body; Headache; My arm was just little uncomfortable; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; I am getting nightmares, it's like I am struggling; Fibromyalgia/never have 'flare-up' this bad; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL1283; expiration date: unknown) at 67-year-old age of vaccination via an unspecified route of administration in the left arm on 21Jan2021 at a single dose for covid-19 immunization. Medical history included fibromyalgia. The patient's concomitant medications were not reported. The patient reported that she got her vaccine on a 21Jan2021 (Thursday) and on Friday (22Jan2021), her arm was just little uncomfortable but its fine. On Saturday by 4 o' clock (23Jan2021), she really hurt so bad all over and with headaches. By Sunday (24Jan2021), it went down a little bit and it was going away but last night (unspecified date in 2021), it hit again it just waking her up and she was getting nightmares, it's like she was struggling. She mentioned that she has a history of Fibromyalgia, but she never has 'flare-up' this bad on unspecified date in 2021. It was reported that the patient with fibromyalgia was given Pfizer Covid-19 Vaccine. She further stated that she hurt all over like right leg, left leg, upper body. The patient received treatment of acetaminophen (TYLENOL). The adverse events did not require an emergency room/ physician office. She mentioned that she has read all literature, it says you can get side effects, but this isn't normal. The outcome of the events limb discomfort, pain and headache were recovering while the outcome of the other events was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product use issue
Clinical narrative: I really hurt so bad all over; I hurt all over like right leg, left leg, upper body; Headache; My arm was just little uncomfortable; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; I am getting nightmares, it's like I am struggling; Fibromyalgia/never have 'flare-up' this bad; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL1283; expiration date: unknown) at 67-year-old age of vaccination via an unspecified route of administration in the left arm on 21Jan2021 at a single dose for covid-19 immunization. Medical history included fibromyalgia. The patient's concomitant medications were not reported. The patient reported that she got her vaccine on a 21Jan2021 (Thursday) and on Friday (22Jan2021), her arm was just little uncomfortable but its fine. On Saturday by 4 o' clock (23Jan2021), she really hurt so bad all over and with headaches. By Sunday (24Jan2021), it went down a little bit and it was going away but last night (unspecified date in 2021), it hit again it just waking her up and she was getting nightmares, it's like she was struggling. She mentioned that she has a history of Fibromyalgia, but she never has 'flare-up' this bad on unspecified date in 2021. It was reported that the patient with fibromyalgia was given Pfizer Covid-19 Vaccine. She further stated that she hurt all over like right leg, left leg, upper body. The patient received treatment of acetaminophen (TYLENOL). The adverse events did not require an emergency room/ physician office. She mentioned that she has read all literature, it says you can get side effects, but this isn't normal. The outcome of the events limb discomfort, pain and headache were recovering while the outcome of the other events was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Investigation, Night sweats, Pain in extremity
Clinical narrative: woke up in the middle of the night sweating; whole left shoulder, arm and hand was very sore and achy; whole left shoulder, arm and hand was very sore and achy; This is a spontaneous report from a contactable consumer (patient).  An 81-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 at a single dose on the right arm to be inoculated against the virus. The patient has no medical history and there were no concomitant medications. The patient reported that she got the Pfizer vaccine shot last Thursday, 22Jan2021 and while she was there she didn't have any reaction. She had the vaccine in her right arm because she was left handed and by the time she got home, her whole left shoulder, arm and hand was very sore and achy. She had trouble with her left shoulder, she didn't know if it was the co-incident (as reported) or not and then it kind of then the patient took some Tylenol and it kind of eased up. The patient then reported that on 22Jan2021, Friday night, she woke up in the middle of the night sweating and that happened during the night and in the morning it went, but it is still there but she still has soreness in her left shoulder, arm and hand and it kept her up last night. She didn't know if this was going to be a symptom of the vaccine. She wanted to know that when she will get the second one, is it going to be worst and what she was supposed to do. The patient was scheduled to get the second dose on 11Feb2021. The patient reported unspecified labs with unknown results. The outcome of the events whole left shoulder, arm and hand was very sore and achy was not recovered while the outcome of woke up in the middle of the night sweating was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin burning sensation
Clinical narrative: cheeks started to get kind of red and burning; cheeks started to get kind of red and burning; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration, on 25Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer Covid19 shot yesterday on 25Jan2021 and as soon as she got home her cheeks started to get kind of red and burning and it subsequently did it through the night. This morning it seemed better. However, this afternoon it started again. She wanted to know what that was about and stated that it has to be a side effect. She asked if there was anyone reporting this. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, SARS-CoV-2 test
Clinical narrative: Very lethargic; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar event for two patients. This is the second of the two reports (husband).  A male patient (Age: 71; unit was not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported) on 18Jan2021 at a single dose for COVID-19 immunization at the clinic. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient was very lethargic. The patient had COVID test in Jan2021 (results were not provided). The patient had no symptoms. The outcome of the event, 'very lethargic', was unknown. The patient was due to get the second dose of vaccination on "the 8th", but the schedule has not been filled up yet.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115530 same reporter/product/event, different patient
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Nausea, Vomiting
Clinical narrative: Lightheaded; Weakness; Nauseated; Vomiting; did not have an appetite; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Medical history included stroke 14 years ago.  Concomitant medication included warfarin. The patient was lightheaded, did not have an appetite and experienced weakness on Jan2021. She was even nauseated and threw up earlier on Jan2021. She wanted to know what can she do.  She had nauseousness and vomiting. She vomited one time but she was not currently vomiting and just took some Ginger ale to settle her stomach. Patient was asking what to drink or does she take any Tylenol or let it. Outcome of the events was unknown. The date of second dose was 16Feb2021  Information about batch/lot number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Lightheaded; Weakness; Nauseated; Vomiting; did not have an appetite; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Medical history included stroke 14 years ago.  Concomitant medication included warfarin. The patient was lightheaded, did not have an appetite and experienced weakness on Jan2021. She was even nauseated and threw up earlier on Jan2021. She wanted to know what can she do.  She had nauseousness and vomiting. She vomited one time but she was not currently vomiting and just took some Ginger ale to settle her stomach. Patient was asking what to drink or does she take any Tylenol or let it. Outcome of the events was unknown. The date of second dose was 16Feb2021  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Wife have had a reaction, the rash; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. It was stated, "I have a married couple on the other line. He took the Covid-19 vaccine, the wife have had a reaction, the rash, but the husband had no reaction." The reporter stated, "Correct, she had a rash 4 days after (Jan2021). We had the vaccine on Wednesday and the rash appeared on Sunday." Therapeutic measures (Prednisone) were taken as a result of wife have had a reaction, the rash (rash). The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Chills; trying that he won't throw up; This is a spontaneous report from a contactable consumer. A male patient (reporter's Dad) of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: Unknown) on 25Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced chills and he is trying that he won't throw up in Jan2021. Patient got the first COVID shot yesterday (Clarified as 25Jan2021) about 2:30 and about 26 hours later, he has no symptoms or nothing and just an hour ago it's been about 26 hours he has chills. Reporter asked if that is common. Reporter think he is trying that he won't throw up. Reporter have been thinking if he had the chills just a few hours after he got the shot. It's been about 26 hours. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  Medical history included patient took allergy medications before the 1st dose.  The patient's concomitant medications were not reported.  The patient experienced nausea and vomiting hours after 1st dose, and hesitant to take the 2nd shot. The outcome of events was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Apathy, Chills, Fatigue, Fear
Clinical narrative: nausea; vomiting; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  Medical history included patient took allergy medications before the 1st dose.  The patient's concomitant medications were not reported.  The patient experienced nausea and vomiting hours after 1st dose, and hesitant to take the 2nd shot. The outcome of events was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Headache, Hypersensitivity, Injected limb mobility decreased, Injection site pain
Clinical narrative: nausea; vomiting; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  Medical history included patient took allergy medications before the 1st dose.  The patient's concomitant medications were not reported.  The patient experienced nausea and vomiting hours after 1st dose, and hesitant to take the 2nd shot. The outcome of events was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Malaise, Nasopharyngitis, Nausea, Retching
Clinical narrative: nausea; vomiting; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  Medical history included patient took allergy medications before the 1st dose.  The patient's concomitant medications were not reported.  The patient experienced nausea and vomiting hours after 1st dose, and hesitant to take the 2nd shot. The outcome of events was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Sinus disorder, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  Medical history included patient took allergy medications before the 1st dose.  The patient's concomitant medications were not reported.  The patient experienced nausea and vomiting hours after 1st dose, and hesitant to take the 2nd shot. The outcome of events was unknown.   Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Said arm has been sore; This is a spontaneous report from a Pfizer-Sponsored Program Pfizer. A non-contactable consumer reported for a male patient with unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported arm had been sore for couple days after 1st dose. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: nausea is not huge; soreness is not huge; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reported for herself. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced soreness was not huge and nausea was not huge in Feb2021, she just wanted to know if she can take pain relievers. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pruritus
Clinical narrative: itching on the skin of the back; Headache; malaise; This is a spontaneous report from a contactable consumer.  A 67-year-old female patient received the second dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 04Feb2021 at 09:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date in Jan2021 (age at vaccination: 67 years) at 09:00 on the left arm for COVID-19 immunization. Prior to vaccination, was the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced itching on the skin of the back, headache and malaise on 05Feb2021 at 07:00. It was unknown if the patient received treatment for the events. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Loss of personal independence in daily activities, Prothrombin time prolonged, Syncope
Clinical narrative: Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a physician for 2.5 weeks; This is a spontaneous report from a contactable physician (patient)  A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Jan2021 12:30 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease and allergies. The patient was not pregnant. Concomitant medication included lansoprazole (PREVACID).  The patient experienced rigors and severe back pain, syncope, prolonged pt and loss of work as a physician for 2.5 weeks on 12Jan2021 with outcome of recovered with sequelae in Feb2021. The events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized due to the events for 2 days.  The patient received steroids, pain meds, muscle relaxers as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile causality between event chills and syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be excluded. The events prolonged PT and loss of work as a physician for 2.5 weeks are attributed to intercurrent conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Rash
Clinical narrative: shortness of breath; bad headaches; chest pain; rash on his neck and behind his ears; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number N5318), via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced shortness of breath, bad headaches, chest pain and rash on his neck and behind his ears, all on  an unspecified date in 2021.  The events were all serious as they involved hospitalization from 02Feb2021 to 03Feb2021. Details were as follows: patient received the first dose of the vaccine on 27Jan2021;  he had a lot of bad side effects and  went to the hospital: shortness of breath, bad headaches, chest pain, rash on his neck and behind his ears. All  this happened a few days after receiving the vaccine. He had an appointment with his cardiologist and he will have a cardiac catheter placed on 19Feb2021. The second dose of the vaccine was scheduled for 18Feb2021. The outcome of the events were unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Facial paralysis, Feeling cold, Myalgia, Vaccination site pruritus
Clinical narrative: Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freezing; severe allergic reaction; Bell's Palsy; This is a spontaneous report from a contactable consumer (parent). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in the left arm, on 23Jan2021 (at the age of 27-years-old) at a single dose for COVID-19 immunization. Medical history included Bell's Palsy (motor nerves involved) from 2017 to 2017. Concomitant medications included unspecified birth control. The patient had no prior vaccinations within four weeks of vaccination. The patient experienced Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction on an unspecified date. It was reported that the Bell's Palsy lasted 8 days and was considered a modified Bell's Palsy because it only sensorial nerves were involved. It was reported that the patient did not receive any treatment for Bell's Palsy. The clinical outcome of Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction was recovered on an unspecified date.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freezing; severe allergic reaction; Bell's Palsy; This is a spontaneous report from a contactable consumer (parent). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in the left arm, on 23Jan2021 (at the age of 27-years-old) at a single dose for COVID-19 immunization. Medical history included Bell's Palsy (motor nerves involved) from 2017 to 2017. Concomitant medications included unspecified birth control. The patient had no prior vaccinations within four weeks of vaccination. The patient experienced Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction on an unspecified date. It was reported that the Bell's Palsy lasted 8 days and was considered a modified Bell's Palsy because it only sensorial nerves were involved. It was reported that the patient did not receive any treatment for Bell's Palsy. The clinical outcome of Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction was recovered on an unspecified date.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Both legs from knees down got swollen and were painful to touch, walk on, etc.; Both legs from knees down got swollen and were painful to touch, walk on, etc.; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EX923, in hospital, via an unspecified route of administration in left arm from 19Jan2021 at 20:45 (at age of 66 years) at single dose for COVID-19 immunization. Medical history included spinal stenosis, arthritis and allergy to penicillin, all from an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medication included gabapentin, meloxicam (MOBIC), zinc, ascorbic acid (VIT C), magnesium and cinnamomum verum stem bark/elettaria cardamomum fruit/syzygium aromaticum (CINNAMOL). On 24Jan2021 at 16:00 both patient's legs from knees down got swollen and were painful to touch, walk on, etc. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with steroids. The reported events were resolving at the time of the report.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Nausea
Clinical narrative: some pain in my left shoulder; severe pain in my lower back; significant nausea; This is a spontaneous report from a contactable physician (patient).  An 82-year-old female patient received second dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on 10Feb2021 12:00 at single dose on right arm for covid-19 immunisation.  Medical history included ongoing allergy to perfumes/scents, ongoing allergy to linseed oil, ongoing chronic osteoarthritis (six joint replacements), GERD, hypertension.  Concomitant medication included duloxetine hydrochloride (CYMBALTA), enalapril, ferrous sulfate, gabapentin. The patient previously received first dose of bnt162b2 on 20Jan2021 11:00 for covid-19 immunisation and experienced no adverse event. The patient stated that, "I had no reaction, not even a sore arm, after the first shot.  However, for two days (Feb2021) so far after the second shot I have severe pain in my lower back, some pain in my left shoulder, and significant nausea." No treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The outcome of the events was not resolved.   Information on Lot/Batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Constipation, Headache, Hyperhidrosis
Clinical narrative: Joint pain in arm, shoulder, hip, and leg on side of injection site; joint pain in arm, shoulder, hip, and leg on side of injection site; Joint pain in arm, shoulder, hip, and leg on side of injection site; fever of 99.8 F; Headache; Constipation; Sweating, so much sweating; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 10Feb2021 (13:00) (at the age of 32years) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration on 20Jan2021 (12:00PM) (at the age of 32years) for COVID-19 immunization. The patient has no medical history; no allergies to medications, food, or other products. Concomitant medication included vitamin B complex (VITAMIN B) also reported as "B vitamin supplement" taken from an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced joint pain in arm, shoulder, hip, and leg on side of injection site. The patient woke up with fever of 99.8 F that ended approximately 03:00 PM on 11Feb2021. The patient also experienced headache, constipation and sweating, so much sweating. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event fever was recovered on 11Feb2021; the outcome of other events was recovered on an unspecified date. This case is non-serious.