chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Redness underneath my armpits; Rash on my elbow area; rash on both arms; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2 Lot number EL9269, expiry date not reported) via an unspecified route of administration on 06Feb2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness underneath my armpits and rash on my elbow area; rash on both arms on 06Feb2021. Consumer stated, "I just had a quick question about the side effects. I had the shot yesterday, the second one, Pfizer and then last night I noticed that I had redness underneath my armpits and also like a rash on my elbow area but not on the elbow. On the other side you know. A rash on both arms. One forced from the other. But nothing around the actual shot area. So, I do want to know is that normal thing or what?" The outcome of the events was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Very mild, but noticeable headaches; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old male patient received first single doseof BNT162B2 (Pfizer, Solution for injection, lot number: EL9263, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 25Jan2021 13:00 for COVID-19 immunization. The patient was 67-years-old at the time of vaccination. Facility type vaccine: Health Clinic facility. Medical history included hypertension. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medications/ other medications in two weeks included valsartan and levothyroxine sodium (SYNTHROID). There were no other vaccine given in four weeks. On 30Jan2021, the patient experienced very mild, but noticeable headaches beginning 5-7 days after the first vaccination and continue until day 14. No treatment was given for the event. Patient was not covid tested post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fear, Hyperhidrosis, Vomiting
Clinical narrative: Continuously vomiting; Chills one minute and then sweating the next; Chills one minute and then sweating the next; Frightened; This is a spontaneous report from contactable nurse. An 80-year-old female patient (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter's mother was just horribly ill and they do not know if they should be taking her to the emergency room. They do not know if there was some kind of medication they can give her to help her. She is continuously vomiting, she has the chills one minute and then sweating the next. "She is asking me to take her report and mentally I do not know she is so frightened because of the severity of these symptoms or that there is something really bad going on". Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: She had pain at site, in her arm; Tired; This is a spontaneous report from a contactable consumer (patient). A 54 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration (arm) on 05Feb2021 07:40 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  There were no concomitant medications.  The patient experienced she had pain at site, in her arm and tired on 07Feb2021. Patient does not see her physician very often. No treatment was given for she had pain at site, in her arm. Outcome of the event she had pain at site, in her arm was recovered on an unspecified date while unknown for tired.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Night sweats, SARS-CoV-2 test
Clinical narrative: very tired; very hot sweaty night; chills; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar events for two patients. This is the second of two reports.   A female patient of an unspecified age received bnt162b2, via an unspecified route of administration on 04Feb2021 at SINGLE DOSE for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Patient tested positive for the antibodies for COVID and they believed patient had a mild case of COVID (it was prior to COVID Vaccine). On the morning of 05Feb2021, the patient (and her husband) had chills most out of that day. That night, patient (and her husband) was very tired and then we went to bed at that night, they had a very hot sweaty night. They confirmed that they both had reaction and added that she was chillier than her husband during Friday. They assumed that was the reaction to the vaccination. Outcome of events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171538 Same reporter/ drug and event; different patients
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Ocular hyperaemia, Photophobia
Clinical narrative: right eye was blood shot, it was red; had to keep his eyes closed to keep light from coming in so he won't be in pain; had to keep his eyes closed to keep light from coming in so he won't be in pain; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 06Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that he was having some symptoms that has got worse and wanted to know if he should do something and wanted to know something what went with his eyes. His right eye was blood shot, it was red and daily amount of light that hits his eye was very painful so he had to keep his eyes closed to keep light from coming in so he won't be in pain. Patient was not able to give the lot number because it hurts too much when he tried to turn on the light to reach that (vaccine). Events started on Feb2021. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Malaise, Nipple pain, Pruritus
Clinical narrative: Both nipples on my chest, they hurt. I would say they are sore.; Area on the right leg itches; Does not feel well; This is a spontaneous report from a contactable consumer (patient's wife) and a non-contactable consumer (patient). A 96-year-old male patient received the second dose of BNT162B2 (BNT162B2, Solution for injection, lot number: 5L3248, expiry date: not reported), via an unspecified route of administration, on 03Feb2021 at a single dose for COVID-19 immunization. Medical history included thyroid (disorder) and triple bypass a number of years ago. Concomitant medications included apixaban (ELIQUIS), dutasteride (DUTASTERIDE), famotidine (PEPCID), fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), furosemide (FUROSEMIDE), nebivolol hydrochloride (BYSTOLIC), simvastatin (CRESTOR), and he also takes cholesterol and thyroid medicine. The patient previously received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL0142, expiry date: not reported), on 12Jan2021 for COVID-19 immunization (at the age of 96-year-old). The patient reported that both of his nipples hurt and his right leg itches on 07Feb2021. He further clarified, "My wife just told you that the symptoms that I am experiencing are, both nipples that would be the both nipples on my chest, they hurt. I would say that they are sore, and I have a area on the right leg itches and that just started. All these symptoms just started. Otherwise, I am okay." The patient's wife also reported that the patient does not feel well at the time of the report. The patient did not receive any treatment for the reported adverse events. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Tremor
Clinical narrative: pain all over her body; Her arm is sore; She hasn't been able to sleep; She was shaking last night; This is a spontaneous report from a contactable consumer (patient's child). A female patient of unspecified age received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 06Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got the vaccine (COVID 19 Vaccine by Pfizer) on 06Feb2021. And she had pain all over her body, her arm is sore, she hasn't been able to sleep, she was shaking at the night of 06Feb2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Vaccination site inflammation, Vaccination site pain
Clinical narrative: got a sore arm and it was somewhat inflamed at the site of the injection; got a sore arm and it was somewhat inflamed at the site of the injection; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL9269), via an unspecified route of administration on the arm on 06Feb2021 (at the age of 77years) at single dose for COVID-19 immunization. Medical history included cholesterol. Concomitant medication included atorvastatin (LIPITOR) for cholesterol (besides that, everything was fine and the range was normal because he was taking the pills). The patient received his vaccination yesterday (06Feb2021) at a hospital. On 07Feb2021, the patient got a sore arm and it was somewhat inflamed at the site of the injection. The patient have taken paracetamol (TYLENOL). The patient have checked the website and various other aspects. They said number 1, having a reaction like it was a good thing because it indicates his immune system was functioning as it should because of the foreign particle, which was encouraging and then it mentioned one should, if there was ice available put ice on the swelling to like cool down the inflammation and if one did not have the ice, one should use a cold wash support. The patient asked if that knowledge was a possible remedy. The outcome of the events was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Laboratory test, Pyrexia
Clinical narrative: I started running a fever and it is been going on and off, 101 or 102 and sometimes it is up to 104; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9269), via an unspecified route of administration on 06Feb2021 at 11:00 at single dose for COVID-19 immunisation. There were no medical history. The patient's concomitant medications were not reported. On 06Feb2021 at 14:00, the patient started running a fever and it is been going on and off, 101 or 102 and sometimes it is up to 104. The patient has been drinking Gatorade and have not taken any treatment, just taking Gatorade. The patient is not taking any medication but drinking Gatorade. The patient underwent lab tests and procedures which included laboratory test: unknown result on an unspecified date. The outcome of the event was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain management, Presyncope, Vaccination site pain
Clinical narrative: got dizzy and almost passed out; got dizzy and almost passed out; had slight pain at injection site/awoke with moderate pain (5/10); This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL9262), via an unspecified route of administration at the site of left arm at 12:45 on 28Jan2021 at single dose for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. Clinical course: patient was vaccinated about 12:45 pm with no ill effects. When she went to bed, she had slight pain at injection site. She awoke with moderate pain (5/10) about 1 am. She got up to get some paracetamol (TYLENOL). On the way to the kitchen, she got dizzy and almost passed out. She found a chair and rested. She went back to bed (with no paracetamol). No other problems. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. Adverse reactions did not result any serious consequences. The outcome of events was recovered on an unspecified date.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: completely covered with a rash; I was very tired; 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 MRNA VACCINE), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included thyroid disorder; patient also stated, "I have sinus and allergies because I am allergic to dust. Dust is everywhere. I get the runny nose." Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid. The patient reported "I have the vaccine on 3rd of this month and I had the Pfizer one and I was fine except I was very tired. I ended up going bed around 8 O'clock which is not like me but I was just so tired and then I woke up around 10 O'clock completely covered with a rash. So I took I had and allergy pills that had Benadryl in it so I took that and went to the bed. Next day all of it was gone. It was little bit left on my right cheek and my neck. I don't know if I still go for the other vaccine, this 24 or not. I didn't have temperature or anything." About the start date of the event, the patient further stated, "It was the 3rd between 10 or 10:30 in the night. It was 9 hours after I had the shot. I didn't have reaction right away, I was fine except I was tired, 9 hours later I have the rash." The patient stated that she was fine. Treatment for the event rash includes allergy pills that has Benadryl. The patient also asked if it was okay to go for second shot on the 24th. The patient was recovering from the rash while outcome of tiredness was not yet recovered.  Information about lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: small red welt appeared at injection site; small red welt appeared at injection site; arm pain returned; arm pain at site of injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9262), via an unknown route of administration on 29Jan2021 at 17:00 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported (did not have other medications in two weeks). The patient did not receive other vaccines within 4 weeks prior to vaccination. On 29Jan2021, the patient initially experienced arm pain at the site of injection; on 06Feb2021 at 08:00 (day 8 post vaccination) the patient experienced a small red welt at the injection site and arm pain returned. The patient did not receive any treatment for the events. The clinical outcome of the event vaccination site pain was recovered within approximately 36 hours; vaccination site erythema and vaccination site reaction was resolved on day 9; and pain in arm was recovering.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Rash erythematous, Swelling, White blood cell count
Clinical narrative: white count was low; Left arm got a red rash all the way up and down, my  shoulder to mid way between my elbow and hand and some swelling; Left arm got a red rash all the way up and down, my shoulder to mid way between my elbow and hand and some swelling; my arm hurt a little bit; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284) on left arm, intramuscular on 02Feb2021 at single dose for COVID-19 immunization. Medical history included pancreatic cancer stage IV metastasized, blood pressure (abnormal) and chemo. Concomitant medication included pancreatin (CREON) for pancreatic enzymes. The patient previously received the first dose of BNT162B2 on 12Jan2021 for COVID-19 immunization. The patient had a side effect and it's so weird, she was a cancer patient she was in (city, state) and she had her first Covid vaccine on 12Jan2021 and she had her second one on 02Feb2021 and not a reaction until yesterday (06Feb2021) her left arm got a red rash, all the way up and down her shoulder to mid way between her elbow and hand and some swelling and she just wanted to make sure. She did look at the sheet and it does say you can get a rash, she has no temperature and she wanted to make sure that's a part of it all. When clarified if the retired registered nurse wanted to if it was the side effects from Covid vaccine, she stated, she guessed so because she got it on Tuesday and her arm hurt a little bit (Feb2021) but no rash showed up until yesterday which was Saturday. The patient had blood work done last Monday on 01Feb2021 with unknown results. The patient reported that she knows her white count was low (unspecified date) because they could give her chemo, so she actually has blood work on Monday 01Feb2021. Treatment was not received and patient stated, it just showed up yesterday and her nurse told her not to put anything on it. The outcome of the events was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: white count was low; Left arm got a red rash all the way up and down, my  shoulder to mid way between my elbow and hand and some swelling; Left arm got a red rash all the way up and down, my shoulder to mid way between my elbow and hand and some swelling; my arm hurt a little bit; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284) on left arm, intramuscular on 02Feb2021 at single dose for COVID-19 immunization. Medical history included pancreatic cancer stage IV metastasized, blood pressure (abnormal) and chemo. Concomitant medication included pancreatin (CREON) for pancreatic enzymes. The patient previously received the first dose of BNT162B2 on 12Jan2021 for COVID-19 immunization. The patient had a side effect and it's so weird, she was a cancer patient she was in (city, state) and she had her first Covid vaccine on 12Jan2021 and she had her second one on 02Feb2021 and not a reaction until yesterday (06Feb2021) her left arm got a red rash, all the way up and down her shoulder to mid way between her elbow and hand and some swelling and she just wanted to make sure. She did look at the sheet and it does say you can get a rash, she has no temperature and she wanted to make sure that's a part of it all. When clarified if the retired registered nurse wanted to if it was the side effects from Covid vaccine, she stated, she guessed so because she got it on Tuesday and her arm hurt a little bit (Feb2021) but no rash showed up until yesterday which was Saturday. The patient had blood work done last Monday on 01Feb2021 with unknown results. The patient reported that she knows her white count was low (unspecified date) because they could give her chemo, so she actually has blood work on Monday 01Feb2021. Treatment was not received and patient stated, it just showed up yesterday and her nurse told her not to put anything on it. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: bad back pain under his right rib; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his COVID vaccine on Wednesday morning (03Feb2021) and he was having a really bad back pain under his right rib on Feb2021. The consumer was calling to find out if this was a side effect, and how and what was it that the patient needs to do because the consumer read that they were not supposed to take ibuprofen or any kind of pain medications. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Arm sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (reporter and reporter's husband). This is the first of two reports.   A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269 and expiry date: unknown),via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included diabetic and high blood pressure. Concomitant medication included metformin and, hydrochlorothiazide, losartan potassium (HYZAAR). Patient got the vaccine on 04Feb2021, last Thursday and the effects have not been bad, it was just arm sore on the same day. She did not have any headache but yesterday on 06Feb20021, she had a headache. No treatment was received for the events. The second dose was scheduled on 25Feb2021. Outcome of the events was recovered on Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021174383 same reporter, vaccine, different patient and event
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain lower, Diarrhoea, Flatulence, Pain
Clinical narrative: Intense intestinal upset and pain in lower abdomen coupled with gas and constant diarrhea; Intense intestinal upset and pain in lower abdomen coupled with gas and constant diarrhea; Intense intestinal upset and pain in lower abdomen coupled with gas and constant diarrhea; Intense intestinal upset and pain in lower abdomen coupled with gas and constant diarrhea; Continual pain all the next day with continued symptoms; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient (pregnant: No) received first dose of bnt162b2, via an unspecified route of administration in left arm on 06Feb2021 14:45 at single dose for COVID-19 immunization. Medical history included depression from an unknown date and unknown if ongoing.  Concomitant medication included trazodone, venlafaxine, birth control. The patient experienced intense intestinal upset and pain in lower abdomen coupled with gas and constant diarrhea, continual pain all the next day with continued symptoms on 06Feb2021 04:00 (as reported). Intense intestinal upset and pain in lower abdomen coupled with gas and constant diarrhea. had to sit on the toilet solidly for over an hour in the middle of the night and has continual pain all the next day with continued symptoms. The outcome of events was not resolved. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received for adverse events. Facility type vaccine: Other. No other vaccine in four weeks. Other medications in two weeks included: trazodone, venlafaxine, birth control. No COVID prior vaccination. No COVID tested post vaccination. No known allergies.  Information about batch/lot number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nipple pain, Pyrexia
Clinical narrative: feel feverish; nipples are so sore it's horrible; This is a spontaneous report from a contactable consumer. This 20-year-old female consumer reported that:  A 20-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose at left arm on 06Feb2021 12:30 for COVID-19 immunisation.  Medical history included postural orthostatic tachycardia syndrome (POTS), allergy to nuts. Patient was not pregnant.  The patient had not experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient previously received the 1st dose of bnt162b2 (BNT162B2) on an unknown date for COVID-19 immunisation.   The patient experienced felt feverish and her nipples were so sore, it was horrible on 06Feb2021 16:00. She stated she never had breast pain in her life. Patient received no treatment. COVID was not tested post vaccination. The outcome of events was unknown.    Information on the Lot/Batch Number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Dehydration, Dizziness, Fatigue
Clinical narrative: feel feverish; nipples are so sore it's horrible; This is a spontaneous report from a contactable consumer. This 20-year-old female consumer reported that:  A 20-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose at left arm on 06Feb2021 12:30 for COVID-19 immunisation.  Medical history included postural orthostatic tachycardia syndrome (POTS), allergy to nuts. Patient was not pregnant.  The patient had not experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient previously received the 1st dose of bnt162b2 (BNT162B2) on an unknown date for COVID-19 immunisation.   The patient experienced felt feverish and her nipples were so sore, it was horrible on 06Feb2021 16:00. She stated she never had breast pain in her life. Patient received no treatment. COVID was not tested post vaccination. The outcome of events was unknown.    Information on the Lot/Batch Number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Nasopharyngitis, Nausea, Pain
Clinical narrative: feel feverish; nipples are so sore it's horrible; This is a spontaneous report from a contactable consumer. This 20-year-old female consumer reported that:  A 20-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose at left arm on 06Feb2021 12:30 for COVID-19 immunisation.  Medical history included postural orthostatic tachycardia syndrome (POTS), allergy to nuts. Patient was not pregnant.  The patient had not experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient previously received the 1st dose of bnt162b2 (BNT162B2) on an unknown date for COVID-19 immunisation.   The patient experienced felt feverish and her nipples were so sore, it was horrible on 06Feb2021 16:00. She stated she never had breast pain in her life. Patient received no treatment. COVID was not tested post vaccination. The outcome of events was unknown.    Information on the Lot/Batch Number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: feel feverish; nipples are so sore it's horrible; This is a spontaneous report from a contactable consumer. This 20-year-old female consumer reported that:  A 20-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose at left arm on 06Feb2021 12:30 for COVID-19 immunisation.  Medical history included postural orthostatic tachycardia syndrome (POTS), allergy to nuts. Patient was not pregnant.  The patient had not experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient previously received the 1st dose of bnt162b2 (BNT162B2) on an unknown date for COVID-19 immunisation.   The patient experienced felt feverish and her nipples were so sore, it was horrible on 06Feb2021 16:00. She stated she never had breast pain in her life. Patient received no treatment. COVID was not tested post vaccination. The outcome of events was unknown.    Information on the Lot/Batch Number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sore; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients (husband and wife). This is the second (husband) of two reports. A male patient of an unspecified age received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number and expiration date) at unknown vaccination age via an unspecified route of administration on 04Feb2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The wife inquired on two question and one was for her husband. They got the Covid-19 Pfizer vaccine last Thursday (04Feb2021) and the effects have not been bad, it was just arm sore. The question is that her husband, he pulled the information when he took the shot that Monday and tomorrow (08Feb2021), he has a procedure for epidural steroid injection lumbar and he wanted to find out if it was safe for him to finish that procedure because they have the second dose just coming up on around 25Feb2021 (possible date). The outcome of the event was unknown.  The following information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021172098 same reporter, vaccine, different patient and event
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck pain, Vaccination site pain
Clinical narrative: sore neck; fatigue; Sore arm muscle at injection site; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in arm left, on 18Feb2021 15:00, as single dose for COVID-19 immunization, at workplace clinic. Patient's medical history included Asthma, Herpes, Bipolar 2 Disorder. Patient had no Allergies to medications, food, or other products. Concomitant medications included valacyclovir, montelukast and lamotrigine (within two weeks of vaccination). Historical vaccine included first dose of BNT162B2 (lot number; unknown), via an unspecified route of administration, in Left arm, on 28Jan2021 3:00 PM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 18Feb2021 15:00, the patient experienced sore arm muscle at injection site after injection and continuing into second day (19Feb2021); sore neck and fatigue starting the next morning. Patient was not received treatment for adverse events. Seriousness of the events was reported as non-serious. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain of skin
Clinical narrative: painful body aches/shooting pains; chills; skin tender to the touch; This is a spontaneous report from a contactable other hcp (reported for herself). A 50-years-old female patient received first bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EN5318), via an unspecified route of administration on 18Feb2021 14:00 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included bifidobacterium lactis (PROBIOTIC), ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 19Feb2021 02:00 patient experienced painful body aches/shooting pains, chills, skin tender to the touch. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event was recovered on unspecified date in Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills
Clinical narrative: chills; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number and expiry date unknown, via unspecified route of administration on Jan2021 at single dose for Covid-19 immunization. Medical history included covid prior vaccination. The patient's concomitant medications were not reported. In Jan2021, the patient experienced chills, weakness. The patient has not been tested since the vaccination. The patient did not receive treatment due to the events. The outcome of the events was recovered. The reporter considered the events non-serious; did not results in death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, no congenital anomaly/birth defect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain in extremity, Weight decreased
Clinical narrative: mild soreness in arm; trouble holding the tab of her jeans/ felt different while doing normal stuff/ hard for her to do detailed work like touching the button of the iPad or scratching her ear; had jerking movements rather than smooth movements/fine motor movements are different; stiffness in her hands, motion not fluid; lot of weight due; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 56, no unit) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine on 04Feb2021, she's scheduled to receive the second dose on Thursday. After she received the vaccine, she experienced mild soreness in her arm, not severe for a maximum of 48 hours. When she went for a long walk (1 hour), it was a very windy day and she didn't wear gloves, when she went back she had trouble holding the tab of her jeans, she lost strength in her left hand after she washed her hands with warm water everything was fine. A week later she felt different while doing normal stuff like washing rice because she rubs the rice in the palm of her hand, and it's in both hands now. It's hard for her to do detailed work like touching the button of the iPad or scratching her ear because she has to think about it be aware of the action and it feels weird, she's most better now but this sensation occasionally comes (She did not have any tingling. At times, some movements were jerky rather than smooth, stiffness in her hands, motion not fluid). Her fine monitor movements are different. She lost a lot of weight due to other reasons, so she's not sure if this was related to the weight loss that her extremities get cold. She would like to know if it's recommended or not that she received the second dose of the vaccine. The patient heard that there have been report of Bell's Palsy and the vaccine. She would like to know if Bell's Palsy is a neurological problem related to the vaccine. She was scheduled to get the second dose the next day from the time of report. The symptoms have decreased. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Influenza, Myocarditis, SARS-CoV-2 test
Clinical narrative: myocarditis; severe chest pain; developed severe flu symptoms; This is a spontaneous report from a contactable healthcare professional (patient). A 39-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration in the left arm on 02Feb2021 at 08:30 AM (at the age of 39 years old) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no medical history and had no known allergies. The patient had no COVID prior to vaccination. Concomitant medication included testosterone. The patient had no other vaccine in four weeks. The patient previously received the first dose of BNT162B2 on 12Jan2021 at 12:30 AM (at the age of 39 years old) in the left arm for COVID-19 immunization. The patient developed severe flu symptoms on 02Feb2021 at 20:30. The patient experienced chest pain and myocarditis on 12Feb2021 at 03:00 AM. It was reported that after 12 hours, the patient developed severe flu symptoms for the following 48 hours. Then she developed severe chest pain and was hospitalized for myocarditis. The patient was hospitalized in Feb2021 for 5 days. The patient received treatment for the events which included heart medications and heart angiogram. The patient was tested for COVID post vaccination which included blood test and nasal swab, both with negative results on 12Feb2021. The outcome of the event was recovering.  Information on the batch/lot number has been requested.; Sender's Comments: The event myocarditis was most likely due to influenza, which was an intercurrent infection, and unrelated to suspect vaccine BNT162B2. There is no plausible mechanism implicating BNT162B2 to the reported event based on the drug known safety profile. 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Suffocation feeling
Clinical narrative: felt almost like fainting; felt like she was drowning especially when going to sleep; chest tightness/felt tightness in her chest; She couldn't take a deep breath.; This is a spontaneous report from a contactable physician. A 39-years-old female patient received the first 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.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient received the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and experienced chest tightness. Patient started to experience this symptom the day after she got the 1st dose - Experiencing chest tightness/feeling of drowning especially when laying down to bed daily - No history of cough, fever, anxiety, depression. The patient got the shot during the first 10 to 15 minutes she felt almost like fainting, but she didn't. Patient was keep for 15 to 20 minutes after receiving the vaccine to monitor. The feeling didn't last long. The first ten days after the vaccine the patient felt tightness in her chest for no reason. In the patient's medical history, there is no history of asthma or reactive airway disease or anxiety or depression. For a total of 10 days the patient felt like she was drowning especially when going to sleep. She couldn't take a deep breath. She didn't have to seek medical attention or go to the ER. The outcome of events was unknown.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Chest discomfort, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; COVID bronchitis; chest tightness; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included she believed she was exposed to COVID-19 on 23Jan2021. Concomitant medications were not reported. The patient tested positive for COVID-19 on 30Jan2021. She received her second dose 41 days after the first dose because she was experiencing a cough and some chest tightness and she was told she had COVID bronchitis on an unspecified date in 2021. She received a prescription for Azithromycin (Z-pak) and methylprednisolone for COVID bronchitis. The second dose was administrated at present date. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray, Drug ineffective
Clinical narrative: Patient who received 2 doses of covid-19 vaccine (Pfizer) is now Covid positive with chest x-ray positive for covid pneumonia. Patient reports symptoms has started 5 days prior to admission, 2nd dose; Patient who received 2 doses of covid-19 vaccine (Pfizer) is now Covid positive with chest x-ray positive for covid pneumonia. Patient reports symptoms has started 5 days prior to admission, 2nd dose; This is a spontaneous report from a non-contactable Other HCP. An 87-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Feb2021 at 100 ug/ml (30mcg/0.3mL), single for Covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 87-year-old for Covid-19 immunisation. The patient who received 2 doses of cCvid-19 vaccine (Pfizer) was now Covid positive with chest X-ray positive for Covid pneumonia in Feb2021. Patient reports symptoms has started 5 days prior to admission, 2nd dose was administered 10 days prior to admission. No COVID tested post vaccination. Decadron and remdesivir were received for the event. Outcome of the events was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. However the short duration of 5 days since the vaccine second dose is given it is unlikely patient would have fully developed immunity.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body tinea, Skin exfoliation, Vaccination site erythema, Vaccination site pain
Clinical narrative: peeling like sunburn; slight inject site soreness; 2 circles appeared just above and below like a ringworm; dark rimmed, scaly, non itchy or painful red raised centers, above and below the inject site; This is a spontaneous report from a contactable nurse (reporting for herself).   A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318), via an unspecified route of administration on 02Feb2021 09:00 (at the age of 72) single dose left arm for covid-19 immunisation. Medical history included septicemia x2 15yr ago with hospitalizations (full recovery x2), oxygen therapy (full recovery x2), renal impairment and liver compromised (full recovery x2). Concomitant medication included oxybutynin hydrochloride (OXYBUTININ). No other vaccine was received in four weeks.  The patient experienced slight injection site soreness, 2 circles appeared just above and below like a ringworm, dark rimmed, scaly, non itchy or painful red raised centers, above and below the inject site, all on 06Feb2021, peeling like sunburn on an unspecified date. No treatment received. The outcome of peeling like sunburn was unknown, of the other events was recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Vaccination site pain
Clinical narrative: metallic taste same as experienced when receiving chemo last year; mild pain at injection; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL3247, via an unspecified route of administration on 24Feb2021 14:00 at a single dose in the right arm for COVID-19 immunization. Medical history included early breast cancer, metallic taste when receiving chemo last year in 2020. The patient had no allergies to medications, food, or other products. Concomitant medication included anastrozole and calcium carbonate, vitamin D.  The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced metallic taste same as experienced when receiving chemo last year and mild pain at injection on 24Feb2021 17:00. No treatment was received. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested positive for COVID-19 since the vaccination. The outcome of the events was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is still aching/right arm continues to throb; This is a spontaneous report from a contactable consumer (patient herself).  This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration, on 19Jan2021 (at 16:00, at the age of 76-years-old) at a single dose on the right arm for COVID-19 immunization, administered at hospital. No other vaccine was received in four weeks. No relevant medical history was provided. Past drug history included allergy to sulfur. Relevant concomitant medications included losartan.The patient stated 'my arm is still aching/right arm continues to throb'. The patient had not recovered from the event.