chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Feeling abnormal, Pain in extremity, Swelling, Swelling face
Clinical narrative: she then felt like her "face was a little bit swollen" along with her "neck"; she then felt like her "face was a little bit swollen" along with her "neck"; Dry mouth; also had very little arm pain; face felt weird/little weird when she was trying to swallow; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 03Apr2021 16:00 as single dose for COVID-19 immunisation. Medical history included contrast dye allergy, pistachio allergy and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergy and took cephalosporin and experienced allergy. On 04Apr2021, she felt like her face was a little bit swollen along with her neck, dry mouth, face felt weird/little weird when she was trying to swallow and also had very little arm pain. It was reported that, she received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 3 April 2021. She explained she had listed the following allergies to the vaccination provider: contrast dye, amoxicillin, pistachio, and cephalosporin; then was monitored for 30 minutes after the injection. She specified she develops hives in reaction to the contrast dye but takes Benadryl before it to prevent the reaction. She explained that, she was scheduled at 4pm for the 1st shot, she left the facility at 4:30pm. At night, she woke up from sleep at 12:45 AM which is 8 hours later after receiving her 1st shot. She said her face felt weird, both sides of her neck were swollen. She stated it was a little weird when she was trying to swallow. She had a very dry mouth but her tongue was not swollen. She took two Benadryl 25 mg each total of 50mg. The next morning, she felt kind of the same thing: a little bit swollen, puffy in the face, her mouth was really dry and about 10 am until 11am in the morning she was fine until the rest of the week. She was scheduled to take the 2nd dose on 24Apr2021 at 10:30 am. Concerned what will happen next for the 2nd dose of covid vaccine. Therapeutic measures were taken as a result of events. The outcome of the events was Recovering/Resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Coagulation time, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: Fatigue; Trouble breathing; Brain fog; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date in Mar2021, the patient experienced fatigue, trouble breathing and had brain fog. It was reported that patient received her second dose of Pfizer 11Mar2021. She felt fatigue, trouble breathing with mask and a brain fog. Her doctor ran all kind of test because they saw she was short of breath with the mask. She never had that before. She only had these symptoms after she got the vaccine. It had been 31 or 32 days since she had these symptoms. The patient underwent lab tests and procedures which included blood clot work up, ECG and chest Xray which were found to be normal and had covid test which resulted in negative. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test
Clinical narrative: Fatigue; Trouble breathing; Brain fog; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date in Mar2021, the patient experienced fatigue, trouble breathing and had brain fog. It was reported that patient received her second dose of Pfizer 11Mar2021. She felt fatigue, trouble breathing with mask and a brain fog. Her doctor ran all kind of test because they saw she was short of breath with the mask. She never had that before. She only had these symptoms after she got the vaccine. It had been 31 or 32 days since she had these symptoms. The patient underwent lab tests and procedures which included blood clot work up, ECG and chest Xray which were found to be normal and had covid test which resulted in negative. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: Fatigue; Trouble breathing; Brain fog; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date in Mar2021, the patient experienced fatigue, trouble breathing and had brain fog. It was reported that patient received her second dose of Pfizer 11Mar2021. She felt fatigue, trouble breathing with mask and a brain fog. Her doctor ran all kind of test because they saw she was short of breath with the mask. She never had that before. She only had these symptoms after she got the vaccine. It had been 31 or 32 days since she had these symptoms. The patient underwent lab tests and procedures which included blood clot work up, ECG and chest Xray which were found to be normal and had covid test which resulted in negative. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: Fatigue; Trouble breathing; Brain fog; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date in Mar2021, the patient experienced fatigue, trouble breathing and had brain fog. It was reported that patient received her second dose of Pfizer 11Mar2021. She felt fatigue, trouble breathing with mask and a brain fog. Her doctor ran all kind of test because they saw she was short of breath with the mask. She never had that before. She only had these symptoms after she got the vaccine. It had been 31 or 32 days since she had these symptoms. The patient underwent lab tests and procedures which included blood clot work up, ECG and chest Xray which were found to be normal and had covid test which resulted in negative. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Feeling ill; Dizzy; nauseous; fatigued; Taste and smell off; Taste and smell off; Feel loopy and drugged; Feel loopy and drugged; This is a spontaneous report received from a contactable consumer (patient) reported herself. A 38-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration at left arm on 07Apr2021 12:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. Patient relevant medical history None. Patient do not have any allergic to medications, food or other products. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination,patient was the patient diagnosed with COVID-19. It was none patient received any other medications the patient received within 2 weeks of vaccination. Patient did not diagnose with COVID-19 prior to vaccination and since the vaccination the patient has not been tested for COVID-19. The patient experienced feeling ill, dizzy, nauseous, fatigued, taste and smell off, feel loopy and drugged on 07Apr2021 12:30. Patient did not receive any treatment for the events. Since the vaccination, patient has the patient been tested for COVID-19Outcome of events was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Sedation
Clinical narrative: Feeling ill; Dizzy; nauseous; fatigued; Taste and smell off; Taste and smell off; Feel loopy and drugged; Feel loopy and drugged; This is a spontaneous report received from a contactable consumer (patient) reported herself. A 38-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration at left arm on 07Apr2021 12:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. Patient relevant medical history None. Patient do not have any allergic to medications, food or other products. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination,patient was the patient diagnosed with COVID-19. It was none patient received any other medications the patient received within 2 weeks of vaccination. Patient did not diagnose with COVID-19 prior to vaccination and since the vaccination the patient has not been tested for COVID-19. The patient experienced feeling ill, dizzy, nauseous, fatigued, taste and smell off, feel loopy and drugged on 07Apr2021 12:30. Patient did not receive any treatment for the events. Since the vaccination, patient has the patient been tested for COVID-19Outcome of events was not resolved.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is spontaneous report from a contactable consumer (patient) from Medical information Team. A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, it was reported that the patient received the second dose of the Pfizer covid shot, yesterday, she was experiencing chills, and fever and wants to know how long will symptoms last. There was given the response which included side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body was building protection and should go away within a few days These side effects usually start within a day or two of getting the vaccine. Side effects might affect your ability to do daily activities, but they should go away in a few days. The outcome of the events was unknown.  No Follow-up attempts are needed. No further information was expected. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Hypoaesthesia, Limb injury, Pain, Paraesthesia
Clinical narrative: my left arm all of the sudden showed up as a bruise; left arm now is hurting me and it's tingling; left arm now is hurting me and it's tingling; my left arm is throbbing to the point that is shaking; my left arm is throbbing to the point that is shaking; My left arm goes numb it's tingling right now; going to sleep all the time; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation (age at the time of vaccination was 56 years). The patient's medical history and concomitant medications was not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date dose 1, single for COVID-19 immunisation. On an unspecified date patient reported, the second shot which was like a week and a half ago, well around Monday her left arm all of the sudden showed up as a bruise, where the vaccine went in, and her left arm was hurting her and it's tingling (per caller: symptoms started a week after second vaccine). She never had a problem with her left hand, four weeks into this her left arm was throbbing to the point that was shaking. Her left arm goes numb it's tingling right now, I have to change hands with my left arm, that's a problem. She never had tingling in left arm and going to sleep all the time. She would never had this pain unless they did not inject her. Her left arm goes numb it's tingling, she had to change hands with her left arm. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: my left arm all of the sudden showed up as a bruise; left arm now is hurting me and it's tingling; left arm now is hurting me and it's tingling; my left arm is throbbing to the point that is shaking; my left arm is throbbing to the point that is shaking; My left arm goes numb it's tingling right now; going to sleep all the time; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation (age at the time of vaccination was 56 years). The patient's medical history and concomitant medications was not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date dose 1, single for COVID-19 immunisation. On an unspecified date patient reported, the second shot which was like a week and a half ago, well around Monday her left arm all of the sudden showed up as a bruise, where the vaccine went in, and her left arm was hurting her and it's tingling (per caller: symptoms started a week after second vaccine). She never had a problem with her left hand, four weeks into this her left arm was throbbing to the point that was shaking. Her left arm goes numb it's tingling right now, I have to change hands with my left arm, that's a problem. She never had tingling in left arm and going to sleep all the time. She would never had this pain unless they did not inject her. Her left arm goes numb it's tingling, she had to change hands with her left arm. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Lethargy
Clinical narrative: tightness in the chest; Lethargic; slight labored breathing/shortness of Breath; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number : EN6206, Expiry Date: 30Jun2021), via an unspecified route of administration, administered in Left arm on 20Mar2021 11:00 (at the age of 49 year old) as dose 1, single for COVID-19 immunisation.  Medical history and concomitant medications reported as none.  No history of previous immunisations. Prior vaccination, patient did not receive any other vaccines within four weeks. After receiving the vaccine on 20Mar2021, patient had a little bit of slight labored breathing. Then on 02Apr2021, friday, she had tightness in the chest, and was kind of lethargic and had a little more labored breathing than usual. Also on the days, 3rd, and 4th of April, she experienced all these events. At the time of report, she still kind of feels it, where It is so slight, but not usual for her at all. She confirms that her side effects have been stable, but out of the ordinary. They are noticeable, but slight, not enough for her to go to the doctor or hospital. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Sleepy; feels so so bad; pain in your arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: ER8733), Solution for injection, via an unspecified route of administration, administered in Arm Left on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were reported as none. On 31Mar2021, patient experienced pain in arm, on 07Apr2021, she had fever, chills, felt so bad and sleepy. It was reported that, patient got her vaccine last Wednesday, 31 MAR 2021, stated she felt so good and only a pain in her arm, stated last night, one week after the vaccine, around 2 or 3 in the morning she had a fever of 102 degrees and a lot of chills and felt so bad. Treatment took Tylenol and felt a little better. Wanted to also know if the second dosage safe for her. Therapeutic measures were taken as a result adverse events, Tylenol. The outcome of event sleepy was not recovered and outcome of all other events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Fever; Chills; Sleepy; feels so so bad; pain in your arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: ER8733), Solution for injection, via an unspecified route of administration, administered in Arm Left on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were reported as none. On 31Mar2021, patient experienced pain in arm, on 07Apr2021, she had fever, chills, felt so bad and sleepy. It was reported that, patient got her vaccine last Wednesday, 31 MAR 2021, stated she felt so good and only a pain in her arm, stated last night, one week after the vaccine, around 2 or 3 in the morning she had a fever of 102 degrees and a lot of chills and felt so bad. Treatment took Tylenol and felt a little better. Wanted to also know if the second dosage safe for her. Therapeutic measures were taken as a result adverse events, Tylenol. The outcome of event sleepy was not recovered and outcome of all other events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: flu-like symptoms; runny nose; sore throat; coughing after 15 mins from getting the dose which got worse; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) dose 1 via an unspecified route of administration on 06Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced flu-like symptoms, runny nose, sore throat and coughing after 15 mins from getting the dose which got worse. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Pain in extremity, Pyrexia
Clinical narrative: I had a huge wave of fatigue and a slight fever.; Really bad sore arm.; throbbing headache; I got warm again with a slight fever; I had a huge wave of fatigue and a slight fever/really tired/tiredness came on; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose and experienced just sore arm and slight warmth. On an unspecified date in Mar2021, the patient had a huge wave of fatigue and a slight fever/really tired/tiredness came on, really bad sore arm, throbbing headache and got warm again with a slight fever. Patient stated, I just got my second shot of Pfizer Vaccine on 21Mar2021. Will there be any clinical trials of tring out a third dosage? I heard the company is looking into trying out a third shot of it seeing how it would react of an immune response I might be interested in doing it possibly. Patient stated my second dose I noticed side effects more than first. My second shot about 16-18 hours in (unspecified date in Mar2021), I had a huge wave of fatigue and a slight fever. Really bad sore arm. Then the next day had to call off of work had a throbbing headache when I woke up and just really tired and out of it for about 36 hours. I took a Aleve 12 hour relief that helped some after I woke up the day after shot but then I got warm again with a slight fever and tiredness came on. But after this went away, I felt fine on Tuesday March 23rd and returned back to work. Therapeutic measures were taken as a result of adverse events, Aleve 12-hour relief. The outcome of all the events was recovered on 23Mar2021.  No follow-ups are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Pain in extremity, Swelling
Clinical narrative: My big toe is like really painful and like swollen; My big toe is like really painful and like swollen; It's a little red and it's painful; joint of my big toe is really red and very painful; This is a spontaneous report from a contactable consumer (patient reported for herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EP6955 and Expiration date: 30Jun2021) via intramuscularly, in left arm on 29Mar2021 (at the age of 61-years-old) as dose 1, single for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had 1st COVID shot on Monday the 29th (29Mar2021). On 01Apr2021, the patient experienced big toe that was like really painful and like swollen. Big toe was like red, and that was not really swollen. It was a little red and painful. Patient stated the joint of his big toe was really red, very painful. The patient was still experiencing the adverse event and it had worsened than it was on last day (09Apr2021). The patient enquired if that was a normal reaction from the COVID shot. Patient just wanted to know if other people had that reaction. Patient received no treatment for the events. Patient stated due date of her second shot was on 19Apr2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: developed a rash after receiving second dose a week ago; This is a spontaneous report from a Pfizer-sponsored program  from a Contactable consumer, the patient. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient developed a rash after receiving second dose a week ago on an unspecified date (around 30Mar2021). The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Pain in the arm; Fatigue; Chills; Fever; Temperature is going up last time it was over 101; This is a spontaneous report received from a non-contactable consumer or other non-healthcare professional. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, I have a question. My husband got the vaccine (Unspecified Vaccine) yesterday, the first dose and he has had the virus back in the summer and he was having the side effect the usual ones that the people are having, on unknown date pain in the arm, fatigue, chills, fever. I am wondering, his Temperature is going up last time it was over 101 and it was usually 97. So, I just wanted to ask if we are able to give him acetaminophen to manage the fever and at what point would we need to take him to the medical care. The outcome of the events was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye pruritus, Macule, Pruritus
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program [Pfizer RXPathways] based on information received by Pfizer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route, administered in arm on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, it was reported that after the first dose, the patient had a red spot appear on the opposite arm. Patient also became itchy all over- back, arms, neck, eyeballs, etc. Benadryl helped a little with the itchy. 24 hours later the red spot was still there. The outcome of the events of became itchy all over- back, arms, neck, eyeballs, etc was recovering and other event of red spot appear on the opposite arm was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, SARS-CoV-2 test
Clinical narrative: joint pain; skin lesions; sores; fatigue; headache; This is a spontaneous report from a contactable consumer(patient). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (Age at Vaccination 41-year-old) as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. concomitant medications included alprazolam (XANAX). Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administration in Arm Left on 08Mar2021 10:00 AM (Age at Vaccination 41-year-old), as single dose for COVID-19 immunization. The patient has no reported allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 31Mar2021 covid test post vaccination negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. patient became sick 11 hours after first does and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left breast and still am and was diagnosed with Erythema multiforme major from a autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then I started bleeding again only 14days after my period ended again. The pain and bleeding was intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient did not receive treatment for the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. and never had skin issues or irregular or painful periods with this much bleeding. Patient underwent lab test which included SARS-CoV-2 test Negative on 31Mar2021.The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: joint pain; skin lesions; sores; fatigue; headache; This is a spontaneous report from a contactable consumer(patient). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (Age at Vaccination 41-year-old) as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. concomitant medications included alprazolam (XANAX). Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administration in Arm Left on 08Mar2021 10:00 AM (Age at Vaccination 41-year-old), as single dose for COVID-19 immunization. The patient has no reported allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 31Mar2021 covid test post vaccination negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. patient became sick 11 hours after first does and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left breast and still am and was diagnosed with Erythema multiforme major from a autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then I started bleeding again only 14days after my period ended again. The pain and bleeding was intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient did not receive treatment for the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. and never had skin issues or irregular or painful periods with this much bleeding. Patient underwent lab test which included SARS-CoV-2 test Negative on 31Mar2021.The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Pain in extremity
Clinical narrative: Headache; Pain in the arm; she has trouble with pain in her knees; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EJ1685), via an unspecified route of administration, administered in left arm on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history included thyroid (hypo). The patient concomitant medications included vitamin D3, ascorbic acid (VITAMIN C), tocopherol (VITAMIN E); all started an year ago. The patient had not received any other vaccine within 4 weeks. The patient had previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and experienced stomach upset. On an unknown date, the patient experienced pain in the arm, she have good and bad side effects, first of all she has trouble with pain in her knees and today she relieved from much pain in knees, headache, diarrhea. The patient was treated with Ibuprofen 40mg for headache. The patient was not visited to emergency room/ physician office, Relevant tests were none. No predisposing factors was found. No culture was performed. No use of specify antipyretic use. The outcome of the event pain in the arm was unknown and the other events was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Cough, Dyspnoea, Fatigue, Influenza like illness
Clinical narrative: general flu feeling; General malaise; clammy not feverish; chest congestion; coughing; I can't get a full deep breath; tired; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150) dose 1 via an unspecified route of administration, administered in the left arm on 06Apr2021 13:45 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hypertension. The patient concomitant medication was not reported. Patient experience general malaise and clammy feeling on 07Apr2021 which stopped in Apr2021 on an unspecified date (Thursday or Friday). It was relayed when asking about the general malaise, the clamminess and on an unknown date patient had general flu feeling which was gone and all the other symptoms were gone, on 07Apr2021, patient had chest congestion the only thing still which was ongoing. She noticed the coughing in Apr2021 on an unknown date (on Thursday or Friday). She had not been able to get a full deep breath since last in Apr2021 on an unspecified date (Thursday or Friday). She'd like this feeling to go away. The patient goes on to clarify she was still tired but was tired because she could not get a full breath, so she had been taken Mucinex twice a day and it seems to be helping and breaking up phlegmy crap. The coughing was also ongoing and was related to the chest congestion. She didn't see coughing and chest congesting as part of the side effects after the vaccine. Therapeutic measures were taken as a result of events. The clinical outcome of the event general malaise, clammy not feverish was reported as recovered on Apr2021 and general flu feeling was recovered on an unknown date. The clinical outcome of the events chest congestion, coughing, can't get a full deep breath, tired was reported as not recovered.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Respiratory tract congestion
Clinical narrative: general flu feeling; General malaise; clammy not feverish; chest congestion; coughing; I can't get a full deep breath; tired; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150) dose 1 via an unspecified route of administration, administered in the left arm on 06Apr2021 13:45 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hypertension. The patient concomitant medication was not reported. Patient experience general malaise and clammy feeling on 07Apr2021 which stopped in Apr2021 on an unspecified date (Thursday or Friday). It was relayed when asking about the general malaise, the clamminess and on an unknown date patient had general flu feeling which was gone and all the other symptoms were gone, on 07Apr2021, patient had chest congestion the only thing still which was ongoing. She noticed the coughing in Apr2021 on an unknown date (on Thursday or Friday). She had not been able to get a full deep breath since last in Apr2021 on an unspecified date (Thursday or Friday). She'd like this feeling to go away. The patient goes on to clarify she was still tired but was tired because she could not get a full breath, so she had been taken Mucinex twice a day and it seems to be helping and breaking up phlegmy crap. The coughing was also ongoing and was related to the chest congestion. She didn't see coughing and chest congesting as part of the side effects after the vaccine. Therapeutic measures were taken as a result of events. The clinical outcome of the event general malaise, clammy not feverish was reported as recovered on Apr2021 and general flu feeling was recovered on an unknown date. The clinical outcome of the events chest congestion, coughing, can't get a full deep breath, tired was reported as not recovered.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Lymphadenopathy
Clinical narrative: Pain on the chest on the side of the heart; Started to experience headache; Swollen lymph nodes; This is a spontaneous report from a Pfizer Sponsored Program from a contactable male consumer (patient) reported for himself. A male patient of unspecified age received first dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route on 06Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced headache, pain on the chest on the side of the heart and has swollen lymph nodes. He mentioned that the pain on the chest is getting worse and is in need of calling Emergency Services. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Calls for information about if a rash could be considered normal after he received the second dose of the Pfizer's COVID-19 vaccine; This is a spontaneous report from contactable male consumer (patient) of unknown age who reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 07Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient called for information about if a rash could be considered normal after he received the second dose of the Pfizer's COVID-19 vaccine.The event outcome was unknown.  No follow up attempts were possible. Information on lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Malaise, Pyrexia
Clinical narrative: she experienced flu-like symptoms; fever/low grade fever; chills; feeling unwell; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that she received her 1st dose on 29Mar2021, then on the 31Mar2021 she experienced flu-like symptoms like fever, chills, and feeling unwell. All adverse effects that patient felt were already gone. She only now had low grade fever. Caller asked how long it would last. Caller 2nd dose was on 19Apr2021. The outcome of the event fever/ low grade fever was not recovered, and the other events was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: whole body rash with welts, itching; whole body rash with welts, itching; whole body rash with welts, itching; This is a spontaneous report received from a contactable consumer (patient) reported for himself.   A 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8733) via unknown route of administration at left arm on 01Apr2021 at 13:15 (age at vaccination 26-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veterans administration facility. The patient had no other allergies. The patient medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient Concomitant medication (other medications) included Allegra for unknown indication within 2 weeks of vaccination. Prior to vaccination, was the patient was diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. After 3 days, the patient experienced whole body rash with welts and itching on 04Apr2021 at 17:30. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had received treatment for the events. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaginal haemorrhage, Vaginal haemorrhage
Clinical narrative: vaginal bleeding; This is a spontaneous report from a contactable consumer (patient reported for herself). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Right on 04Mar2021 at 09:00 (Batch/Lot Number: EN6202) as dose 2, single for covid-19 immunization (at the age of 58-years-old). The patient medical history included hysterectomy 4 years ago. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EL9267) via an unspecified route of administration in right arm on 13Feb2021 at 11:00 Am (at the age of 58 years old) as dose 1, single for COVID-19 immunization. The patient stated she had her second Pfizer vaccine a little over a month ago and she had a hysterectomy about 4 years ago. On 12Apr2021, the patient stated that she went to the bathroom this afternoon and she saw blood and she should not be having a period because she had a hysterectomy, Patient confirmed this was vaginal bleeding. It was stated that she knows there had been reports of this being a possible side effect of the vaccine. Patient queried if this was a side effect of the vaccine and how long this may last. No other additional vaccines administered on same date of the Pfizer vaccine. The patient did not visit emergency room and physician office due to the event. The outcome of the event was not recovered.  No follow-up attempts were needed. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021403456 same reporter/drug/AE, different patients
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Muscle spasms, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program COVAX US Support via a contactable consumer or other non-healthcare professional (patient).   A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (age at the time of vaccination was 61 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension (Blood pressure high), blood triglycerides increased (triglycerides high) both from an unknown date and unknown if ongoing. Concomitant medication(s) included progesterone (PROGESTERONE 40mg) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced hip cramping, pain in her hip, pain in her hip or by the gluet area, leg hurt a little bit on the right side but she is not hurting right now. Reportedly, the patient received the vaccine on 22Mar2021 and the following week the patient got up on the middle of the night and had pain in her hip or by the gluet area, it was cramping, it came on so suddenly she didn't think she was going to be able to stand. She woke up the next day and she was fine. She said last night, 08Apr2021, this event of cramping happened again, the same pain in the same area. She said this morning her leg hurt a little bit on the right side but she was not hurting right now. She enquired could this be from the vaccine. Reportedly, the event was persisting. Reportedly, the patient took the 1st dose last 22Mar2021 and the 2nd dose will be on 12Apr2021. She had experienced cramp on her gluteal area after a week. She said she would like to know if that is a side effect of the vaccine. Investigation Assessment was reported as no. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.