chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dry mouth, Lymphadenopathy, Mammogram
Clinical narrative: have developed swelling of my lymph nodes/lymph node in her left neck is very swollen; dizzy; dried up her mouth; It seems to be getting worse. It seems like the swelling is traveling up on her neck getting closer to her ear lobe; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in right arm on 06Mar2021 08:30 (at the age of 69-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included anxiety. Concomitant medications included clonazepam (KLONOPIN) taken for anxiety, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no adverse events following prior vaccinations. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in right arm on 13Feb2021 (at the age of 69-year-old) as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, the patient had developed swelling of my lymph nodes/lymph node in her left neck is very swollen, and also experienced dizzy and dried up her mouth, where it seems to be getting worse. it seems like the swelling is traveling up on her neck getting closer to her ear lobe. The patient visited physician office regarding the event. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown result, mammogram: negative result. The outcome of all the events was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: have developed swelling of my lymph nodes/lymph node in her left neck is very swollen; dizzy; dried up her mouth; It seems to be getting worse. It seems like the swelling is traveling up on her neck getting closer to her ear lobe; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in right arm on 06Mar2021 08:30 (at the age of 69-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included anxiety. Concomitant medications included clonazepam (KLONOPIN) taken for anxiety, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no adverse events following prior vaccinations. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in right arm on 13Feb2021 (at the age of 69-year-old) as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, the patient had developed swelling of my lymph nodes/lymph node in her left neck is very swollen, and also experienced dizzy and dried up her mouth, where it seems to be getting worse. it seems like the swelling is traveling up on her neck getting closer to her ear lobe. The patient visited physician office regarding the event. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown result, mammogram: negative result. The outcome of all the events was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Fall, Insomnia
Clinical narrative: extremely weak; Dizziness/dizzy; restless night and slept very little; low-grade fever/temperature; Fell down; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, solution for injection, lot number: EN6207 and expiration date: 30Jul2021) administered on right arm on 29Mar2021 12:15 PM (at age of 73 years) as dose 2, single for Covid-19 immunization. Medical history included Covid in Jul2020. Patient did not take any other vaccinations with in four weeks prior to the first administration date of the suspect vaccine. The concomitant medication included mecobalamin (B12) shot in Mar2021. The historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, lot number: EN6206 and expiration date: 30Jun2021) administered in the left arm as a single dose at 12:15 on an unknown date (at age of 73 years) for Covid-19 immunization. Consumer reported that his wife received the 2nd dose of the Pfizer Covid19 Vaccine yesterday (29Mar2021) at 12:15 pm and had no immediate reactions. Last night his wife had a restless night and slept very little and had a low-grade fever/temperature. Today, on 30Mar2021 his wife was extremely weak and dizziness/dizzy. Patient also experienced fell down on an unknown date in 2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: extremely weak; Dizziness/dizzy; restless night and slept very little; low-grade fever/temperature; Fell down; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, solution for injection, lot number: EN6207 and expiration date: 30Jul2021) administered on right arm on 29Mar2021 12:15 PM (at age of 73 years) as dose 2, single for Covid-19 immunization. Medical history included Covid in Jul2020. Patient did not take any other vaccinations with in four weeks prior to the first administration date of the suspect vaccine. The concomitant medication included mecobalamin (B12) shot in Mar2021. The historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, lot number: EN6206 and expiration date: 30Jun2021) administered in the left arm as a single dose at 12:15 on an unknown date (at age of 73 years) for Covid-19 immunization. Consumer reported that his wife received the 2nd dose of the Pfizer Covid19 Vaccine yesterday (29Mar2021) at 12:15 pm and had no immediate reactions. Last night his wife had a restless night and slept very little and had a low-grade fever/temperature. Today, on 30Mar2021 his wife was extremely weak and dizziness/dizzy. Patient also experienced fell down on an unknown date in 2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Colonoscopy, Gastrointestinal disorder, Muscle spasms
Clinical narrative: Chills; Muscle aches; Joint aches pain; sore arm for a couple of days; Developed similar GI issues- mild cramping, queezy stomach; Developed similar GI issues- mild cramping, queezy stomach; Developed similar GI issues- mild cramping, queezy stomach; This is a spontaneous report from a contactable consumer or other non-HCP (Patient himself). A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration on 22Mar2021 (last Monday) (at the age of 48 years-old), as a single dose for COVID-19 immunization. Patient medical history included irritable bowel syndrome (IBS) for years and eats a gluten free diet, and gastrointestinal disorder (GI issues), with his problems so he does not feel it is diet related and easily dismisses this. Patient is feeling about right before the vaccination. The concomitant medications (Other Products) were not reported. On 22Mar2021, the patient experienced chills, muscle aches, joint aches pain 5-6 hours after and through the night and next day started about 5-6 hours after and went for about 24 hours, sore arm for a couple of days; and on an unspecified date in 2021 developed similar GI issues (grumbly stomach and then go and are fine)- mild cramping, queezy stomach (last Wednesday). On an unspecified date, the patient underwent lab tests and procedures because of his stomach issues which included colonoscopy: came back clean (reported as a few months ago). Patient reported that there has been no vomiting or fever no throwing up. This is the only symptom that is still lingering. Patient is confident it is not a GI tract problem. Reporter states the symptoms are a grumbly stomach and then go and are fine and then it gets grumbly again and they go again. States it's nothing gas it's just odd. Investigation assessment was not provided. Reporter wanted to know whether other people experienced this. Because he was scheduled in 3 weeks to get another one should he needs extra precautious for the 2-3 days after the next vaccination incase its worse and how long will it last. Patient is asking whether a silver lining to all this is there that our immune systems are properly prepared if we get the virus. The outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: Chills; Muscle aches; Joint aches pain; sore arm for a couple of days; Developed similar GI issues- mild cramping, queezy stomach; Developed similar GI issues- mild cramping, queezy stomach; Developed similar GI issues- mild cramping, queezy stomach; This is a spontaneous report from a contactable consumer or other non-HCP (Patient himself). A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration on 22Mar2021 (last Monday) (at the age of 48 years-old), as a single dose for COVID-19 immunization. Patient medical history included irritable bowel syndrome (IBS) for years and eats a gluten free diet, and gastrointestinal disorder (GI issues), with his problems so he does not feel it is diet related and easily dismisses this. Patient is feeling about right before the vaccination. The concomitant medications (Other Products) were not reported. On 22Mar2021, the patient experienced chills, muscle aches, joint aches pain 5-6 hours after and through the night and next day started about 5-6 hours after and went for about 24 hours, sore arm for a couple of days; and on an unspecified date in 2021 developed similar GI issues (grumbly stomach and then go and are fine)- mild cramping, queezy stomach (last Wednesday). On an unspecified date, the patient underwent lab tests and procedures because of his stomach issues which included colonoscopy: came back clean (reported as a few months ago). Patient reported that there has been no vomiting or fever no throwing up. This is the only symptom that is still lingering. Patient is confident it is not a GI tract problem. Reporter states the symptoms are a grumbly stomach and then go and are fine and then it gets grumbly again and they go again. States it's nothing gas it's just odd. Investigation assessment was not provided. Reporter wanted to know whether other people experienced this. Because he was scheduled in 3 weeks to get another one should he needs extra precautious for the 2-3 days after the next vaccination incase its worse and how long will it last. Patient is asking whether a silver lining to all this is there that our immune systems are properly prepared if we get the virus. The outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis viral
Clinical narrative: viral bronchitis; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced viral bronchitis (for over a week now, it started on Saturday) on 20Mar2021 and caller initiated the call to report for her friend . Therapeutic measures were taken as antibiotics, Benezonetate and Salbutamol inhaler for the event. reporter wanted to know if she can cancel her second dose schedule on 30Mar2021. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dyspnoea, Fatigue, Neck pain
Clinical narrative: shortness of breath; tingling in the right hand; pain in the middle of upper back; pain in the right lower neck and shoulders; pain in the right lower neck and shoulders; fatigue; sleepiness; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in right arm on 24Mar2021 (Age at vaccination: 66-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history reported as none. Concomitant medication was not reported. It was mentioned that, patient cannot see that good, needs glasses and magnifier to read the COVID patient card. After vaccination maybe about 2-3 days ago on 26Mar2021 patient started getting maybe some pain sort of maybe in the right side of the upper shoulder area, sort of in the middle of back between the shoulder blades it was pretty severe pain and it would come and go. Patient thought it would subside, there was also more drowsiness this time. Patient was not having this before the second dose, said the first dose was fine. Patient was wondering if this seems like it could be a side effect of the vaccine. The outcome of the events back pain, neck pain and arthralgia were not recovered while other events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Somnolence
Clinical narrative: shortness of breath; tingling in the right hand; pain in the middle of upper back; pain in the right lower neck and shoulders; pain in the right lower neck and shoulders; fatigue; sleepiness; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in right arm on 24Mar2021 (Age at vaccination: 66-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history reported as none. Concomitant medication was not reported. It was mentioned that, patient cannot see that good, needs glasses and magnifier to read the COVID patient card. After vaccination maybe about 2-3 days ago on 26Mar2021 patient started getting maybe some pain sort of maybe in the right side of the upper shoulder area, sort of in the middle of back between the shoulder blades it was pretty severe pain and it would come and go. Patient thought it would subside, there was also more drowsiness this time. Patient was not having this before the second dose, said the first dose was fine. Patient was wondering if this seems like it could be a side effect of the vaccine. The outcome of the events back pain, neck pain and arthralgia were not recovered while other events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Influenza, Pain
Clinical narrative: temperature/Fever; sleeping a lot; feel tired/tired and sleepy; aches and pains a little bit; sleepy; headache; tingling of tongue, lips, mouth; felt like he was going to get the flu; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7534) via an unspecified route of administration, administered in arm left on 24Mar2021 13:08 (age at the time of vaccination was 63 years), as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included borderline diabetes, asymptomatic Covid-19 infection, ongoing depression, ongoing blood pressure, ongoing counteract the statin helps with cramps and ongoing cholesterol. The patient's concomitant medications included ongoing atorvastatin (LIPITOR) at 20 mg, once daily for cholesterol and ongoing valsartan via orally at an unknown dose once a day for blood pressure taking for very long time, ongoing bioflavonoids nos, lecithin, quercetin, ubidecarenone (CO-Q-10 PLUS) via orally at 100 mg, once a day taking for about 10 months for counteract the statin helps with cramps and ongoing fluoxetine hydrochloride (PROZAC) via orally at 40 mg once daily for depression taking from 1999. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior vaccinations (within 4 weeks), he did not receive any other vaccines. Family history and relevant tests were none. Right away he had tingling of tongue, lips, mouth that went away after an hour. That night he felt like he was going to get the flu only times three on 24Mar2021. Mentioned he also previously had COVID 19. On the 28Mar2021 and he had to cancel a flight because he had fever/ temperature (on 27Mar2021). The fever was gone by the 29Mar2021. He had headache, aches and pains a little bit on 25Mar2021. Since the next day after the vaccination, he was sleeping a lot and feel tired/ very sleepy and sleeping the whole day from 25Mar2021. He was asking what the expected time for this was to go away. He was planning to receive the second dose of the vaccine on 14Apr2021. Mentioned he had COVID 19 infection but was asymptomatic. He tested positive at the hospital on 24Dec2020. They gave him some type of serum that he had to go back the following day and get a second time. He did not know what it was but it was the same thing they gave to a number of people for COVID. He did not visit emergency room and physician office. The patient underwent lab tests and procedures which included Covid-19: positive on 24Dec2020. The outcome of events headache, fever/ temperature, aches and pains a little bit was recovered on 29Mar2021, tingling of tongue, lips, mouth and felt like he was going to get the flu was recovered on 24Mar2021 and outcome of other events was not recovered.  No follow-up attempts were needed. No further information was expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pyrexia, SARS-CoV-2 test positive, Somnolence
Clinical narrative: temperature/Fever; sleeping a lot; feel tired/tired and sleepy; aches and pains a little bit; sleepy; headache; tingling of tongue, lips, mouth; felt like he was going to get the flu; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7534) via an unspecified route of administration, administered in arm left on 24Mar2021 13:08 (age at the time of vaccination was 63 years), as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included borderline diabetes, asymptomatic Covid-19 infection, ongoing depression, ongoing blood pressure, ongoing counteract the statin helps with cramps and ongoing cholesterol. The patient's concomitant medications included ongoing atorvastatin (LIPITOR) at 20 mg, once daily for cholesterol and ongoing valsartan via orally at an unknown dose once a day for blood pressure taking for very long time, ongoing bioflavonoids nos, lecithin, quercetin, ubidecarenone (CO-Q-10 PLUS) via orally at 100 mg, once a day taking for about 10 months for counteract the statin helps with cramps and ongoing fluoxetine hydrochloride (PROZAC) via orally at 40 mg once daily for depression taking from 1999. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior vaccinations (within 4 weeks), he did not receive any other vaccines. Family history and relevant tests were none. Right away he had tingling of tongue, lips, mouth that went away after an hour. That night he felt like he was going to get the flu only times three on 24Mar2021. Mentioned he also previously had COVID 19. On the 28Mar2021 and he had to cancel a flight because he had fever/ temperature (on 27Mar2021). The fever was gone by the 29Mar2021. He had headache, aches and pains a little bit on 25Mar2021. Since the next day after the vaccination, he was sleeping a lot and feel tired/ very sleepy and sleeping the whole day from 25Mar2021. He was asking what the expected time for this was to go away. He was planning to receive the second dose of the vaccine on 14Apr2021. Mentioned he had COVID 19 infection but was asymptomatic. He tested positive at the hospital on 24Dec2020. They gave him some type of serum that he had to go back the following day and get a second time. He did not know what it was but it was the same thing they gave to a number of people for COVID. He did not visit emergency room and physician office. The patient underwent lab tests and procedures which included Covid-19: positive on 24Dec2020. The outcome of events headache, fever/ temperature, aches and pains a little bit was recovered on 29Mar2021, tingling of tongue, lips, mouth and felt like he was going to get the flu was recovered on 24Mar2021 and outcome of other events was not recovered.  No follow-up attempts were needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pustule, Rash papular
Clinical narrative: hands broke out, they have pustules, they are red and scaly with raised bumps; hands broke out, they have pustules, they are red and scaly with raised bumps; This is a spontaneous report from a contactable consumer (patient's husband) received via the Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 23Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medication included adalimumab (HUMIRA) taken for rheumatoid arthritis. The patient was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 02Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. On an unspecified date in Mar2021, the patient's hands broke out, they have pustules, they are red and scaly with raised bumps. Clinical course of events was as follow: The patient received the first dose of the COVID-19 vaccine on 02Mar2021, and the second dose on 23Mar2021, the patient had reactions to both doses of the vaccine; on the first one, she had a muscular pain or tightness sensation around her back area around "the bra line", this sensation lasted for at least a few days. The patient was taking Humira at the time of administration. Prior to the second dose of the vaccine, her treatment with Humira was suspended. After receiving the second dose of the vaccine, the patient experienced a severe reaction in her hands, her hands broke out, they have pustules, they are red and scaly with raised bumps. This was 90% in her hands with a little bit of reaction in her arm area and mostly in the palm of her hands and in between her fingers. Usually, the patient would receive treatment with prednisone for her skin reaction but the dermatologist refused to give her that treatment to avoid altering the response of the patient to the vaccine. The reporter mentioned that this could be related to the COVID-19 vaccine and the fact that they stopped taking Humira could have made the reaction worst. The reporter wanted to know if there was any information in regards to possible interaction between the use of Humira, Prednisone and the COVID-19 vaccine. The outcome of events hands broke out, they have pustules, they are red and scaly with raised bumps was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Rash erythematous, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: noticed red spots in it; she was nervous; It is not swollen but the redness is about the size of a tennis ball and warm to touch; her left arm was also warm to the touch, and had swelling like the size of a tennis ball; redness on her arm where she got the shot; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number EN6705 was reported, Expiry: unknown), via an unspecified route of administration into arm left on 23Mar2021;9:00 as DOSE 2, SINGLE for covid-19 immunization (at the age of 57-Years-old). The patient medical history included heart issues and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number EN6198 was reported), via an intramuscular route of administration on an unspecified date on left arm as DOSE 1, SINGLE for covid-19 immunization. On 28Mar2021, the patient had experienced redness on her arm where she got the shot and on 29Mar2021, the patient had experienced her left arm was warm to the touch and she had swelling like the size of a tennis ball on her left arm. On 30Mar2021 the patient had experienced noticed red spots in it and she was nervous. Further explained that there were red dots, or big red spots, in the swelled area on her left arm, redness on her arm where she got the shot, it was reported that she called her family doctor, and her doctor said to put a warm cloth on her left arm and wait a week to see if her left arm got better. She said she was nervous and didn't want to wait a week to see what would happen, so she called Pfizer. Therapeutic measures were taken for the AE and treatment included with Tylenol, clarified as generic Equate brand Acetaminophen 500mg.The clinical outcome of redness on her arm where she got the shot, her left arm was warm to the touch, and she had swelling like the size of a tennis ball on her left arm were not recovered and unknown for she was nervous.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Epistaxis, Pain
Clinical narrative: 5 hours after vaccination the tinnitus started/Tinnitus got louder by the day, waking me up in the night; stomach pain; diarrhea; vomiting; my nose were dripping blood; weak; On day 10 my jaw locked up in the morning; Pain in left side, radiating towards the ear; Face is swollen on left side; tongue is tingling; This is a spontaneous report from a contactable consumer or other non-health care professional (patient reported for herself). A 45-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6206, Expiry date: not reported), via an unspecified route of administration, administered in arm right on 10Mar2021 at 16:00 (04:00 PM) (at the age of 45-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included breast cancer survivor, pulmonary embolism survivor, and known allergies: CT contrast. The patient concomitant medication included anastrozole taken for an unspecified indication, start and stop date were not reported. No other vaccine was administered in 4 weeks. No COVID prior vaccination. No COVID tested post vaccination. On 10Mar2021 at 21:00 (09:00 PM), the patient experienced 5 hours after vaccination the tinnitus started/tinnitus got louder by the day, waking me up in the night. In Mar2021, patient also experienced 26 hours later stomach pain, diarrhea, vomiting, my nose was dripping blood, weak for 3 more days, on day 10 my jaw locked up in the morning, pain in left side, radiating towards the ear, face is swollen on left side, tongue is tingling. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. Outcome of all the events was not recovered.  Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swelling face, Tinnitus, Trismus, Vomiting
Clinical narrative: 5 hours after vaccination the tinnitus started/Tinnitus got louder by the day, waking me up in the night; stomach pain; diarrhea; vomiting; my nose were dripping blood; weak; On day 10 my jaw locked up in the morning; Pain in left side, radiating towards the ear; Face is swollen on left side; tongue is tingling; This is a spontaneous report from a contactable consumer or other non-health care professional (patient reported for herself). A 45-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6206, Expiry date: not reported), via an unspecified route of administration, administered in arm right on 10Mar2021 at 16:00 (04:00 PM) (at the age of 45-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included breast cancer survivor, pulmonary embolism survivor, and known allergies: CT contrast. The patient concomitant medication included anastrozole taken for an unspecified indication, start and stop date were not reported. No other vaccine was administered in 4 weeks. No COVID prior vaccination. No COVID tested post vaccination. On 10Mar2021 at 21:00 (09:00 PM), the patient experienced 5 hours after vaccination the tinnitus started/tinnitus got louder by the day, waking me up in the night. In Mar2021, patient also experienced 26 hours later stomach pain, diarrhea, vomiting, my nose was dripping blood, weak for 3 more days, on day 10 my jaw locked up in the morning, pain in left side, radiating towards the ear, face is swollen on left side, tongue is tingling. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. Outcome of all the events was not recovered.  Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Headache, Pain
Clinical narrative: diarrhea; headaches; achy feelings; coughing; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included glucosamine taken for an unspecified indication, start and stop date were not reported and (Pharmacy Name) Silver Multivitamin. Historical Vaccine included yellow fever shot on an unspecified date (couple decades ago) and experienced lymph nodes under her left armpit was swollen. On an unspecified date, the patient experienced diarrhea (twice but doesn't have a sensitive stomach), headaches, achy feelings, and coughing. The patient asked if taking pain relievers  after vaccination would neutralize the effect of the COVID-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: I immediately got a bruise from the vaccine the size of a quarter; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the arm on 18Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 25Feb2021 for COVID-19 immunisation and experienced no reaction or anything. On an unspecified date, the patient experienced immediately got a bruise from the vaccine the size of a quarter. The event was treated with baby aspirin. It was reported that the patient had no other side effects and it's yellowing now, looking more like a disappearing bruise. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pruritus
Clinical narrative: Really, super itchy eyes; dizziness; This is a spontaneous report from a contactable consumer(patient) via medical information team. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8732, Expiry Date: Unknown) via an unspecified route of administration, administered in left arm on 30Mar2021 11:30 (at the age of 46 year-old) as dose 1, single for COVID-19 immunization. Medical history included allergies (seasonal allergies): allergic to mold, penicillin, and jalapenos Ongoing from an Unspecified date. There was no Family Medical History Relevant to AE. Concomitant medications was not reported. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and No other Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient had not received any other vaccine within 4 weeks. It was reported that on 30Mar2021 patient experienced Brief period of dizziness, for 5 seconds then it was gone, she stayed in the waiting room for 10 minutes then drove home. She stated on her way home she had itchy eyes, Really, super itchy eyes at home but now it was gone. She didn't know if the vaccine made her eyes itchy. Reporter stated she would follow up with her HCP if she started having problems breathing and stuff. Adverse event did not require an Emergency Room or Physician Office visit. Reporter queried that as She has seasonal allergies if she could still take her Claritin and Flonase was it okay to take Claritin after the vaccine. And also stated she did not take these before the vaccine because she was not sure if she could. However, she had some major itchy eyes, but it has subsided. There was no relevant Tests. Treatment was Not provided. Reporter seriousness for the events were Unspecified. The Outcome of the events were recovered on 30Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Having injection site redness and a bit itching; Having injection site redness and a bit itching; This is a spontaneous report from a contactable consumer.     A 60-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date on a Friday as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having injection site redness and a bit itching. The reporter wanted to know if the patient can take any cream. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Flushing, Staring
Clinical narrative: she feels "flush everywhere, especially her chest and warm/hot feeling; she feels "flush everywhere, especially her chest and warm/hot feeling; she feels "woozey, like my eyes are glazed over; red; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 30Mar2021 as dose 1, single for COVID-19 immunisation. Patient stated she had her first Pfizer vaccine on 30Mar2021 she felt flush everywhere, especially her chest and warm/hot feeling and red everywhere. She also stated, she felt woozey, like her eyes are glazed over.The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: She had arm redness and soreness after receiving the 1st dose; She had arm redness and soreness after receiving the 1st dose; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73 (unit not reported) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included stage 4b cancer; patient had undergone hysterectomy due to endometrial cancer; abdominal tumors then lead to stage 4b cancer. Concomitant medications included pembrolizumab (KEYTRUDA) taken for endometrial stage 4b cancer, start and stop date were not reported; VITAMINS NOS and AHCC mushroom extract; both taken for an unspecified indication, start and stop dates were not reported. The patient experienced she had arm redness and soreness after receiving the 1st dose on an unspecified date. The outcome of events was unknown. The patient asked if she could take Benadryl or Claritin for her symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal disorder, Myalgia, Pain in extremity
Clinical narrative: her arm is still hurting/it would hurt when she would move her arm up and down, to the point where she would need her other arm to lift it; her arm is still hurting/it would hurt when she would move her arm up and down, to the point where she would need her other arm to lift it; a muscle and joint pain; a muscle and joint pain; This is a spontaneous report from a contactable consumer.  A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 23Mar2021 16:00 (Batch/Lot Number: ER8730) as dose 2, single (at the age of 45 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1, via an unspecified route of administration on 02Mar2021 17:00 (Batch/Lot Number: EN6200) as dose 1, single on left arm and experienced it was a muscle and joint pain and it was the same type of pain she experienced with the 1st dose. The patient experienced on 24Mar2021, her arm is still hurting. She mentioned that it is not hurt to touch, she had no rash, but it would hurt when she would move her arm up and down, to the point where she would need her other arm to lift it. She clarified that it was a muscle and joint pain and it was the same type of pain she experienced with the 1st dose but the only difference is that this lasts longer (Mar2021). The outcome of "her arm is still hurting/it would hurt when she would move her arm up and down, to the point where she would need her other arm to lift it" was not recovered and other events were unknown.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Feeling of body temperature change
Clinical narrative: She does not have energy to do anything; She was hot and cold; Headache; Chills; Joint pain; Nausea; Tired/tiredness; Not feeling too well; This is a spontaneous report from a contactable consumer, other non HCP (patient reported for self). A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 24Mar2021 at 16:20 (at the age of 49-years) as dose 1, single for COVID-19 immunization. The patient relevant history included none. The patient medical history included heart condition diagnosed in 2014. Family medical history relevant to AE(s) were none. The patient's concomitant medications were not reported. The patient had not received any vaccination within 4 weeks prior to Covid vaccine. There we no AE reported following prior vaccination. The patient did not have a history of previous immunizations with the Pfizer vaccine considered as suspect (reported as none). It was reported that, patient got the vaccination from Pfizer last Wednesday and she was having some side effects that have been going on since Monday.  Patient adds that it has been going on early Monday morning.  She was just wondering if it is side effects from the Pfizer vaccine or should she be contacting her doctor. After vaccination, the patient was not feeling too well (unspecified date in Mar 2021). On 28Mar2021, the patient had experienced Tired/tiredness, chills, joint pain, nausea; on 29Mar2021 had headache and on 30Mar2021 she did not have energy to do anything, she was feeling hot and cold. The patient adds that she has already talked to her physician and the physician said it could be like a week so if caller was not feeling better within 72 hours to give the physician a call. Relevant tests: patient stated as, no not yet. Therapeutic measures were taken as a result of headache which included treatment with alternates Ibuprofen and Tylenol and for nausea included Zofran and so it was under control. The patient did not receive any additional treatments. The outcome of the event nausea was recovering; Tired/tiredness, headache, chills, joint pain was not recovered while Energy decreased, asthenia feeling of body temperature change was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea
Clinical narrative: She does not have energy to do anything; She was hot and cold; Headache; Chills; Joint pain; Nausea; Tired/tiredness; Not feeling too well; This is a spontaneous report from a contactable consumer, other non HCP (patient reported for self). A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 24Mar2021 at 16:20 (at the age of 49-years) as dose 1, single for COVID-19 immunization. The patient relevant history included none. The patient medical history included heart condition diagnosed in 2014. Family medical history relevant to AE(s) were none. The patient's concomitant medications were not reported. The patient had not received any vaccination within 4 weeks prior to Covid vaccine. There we no AE reported following prior vaccination. The patient did not have a history of previous immunizations with the Pfizer vaccine considered as suspect (reported as none). It was reported that, patient got the vaccination from Pfizer last Wednesday and she was having some side effects that have been going on since Monday.  Patient adds that it has been going on early Monday morning.  She was just wondering if it is side effects from the Pfizer vaccine or should she be contacting her doctor. After vaccination, the patient was not feeling too well (unspecified date in Mar 2021). On 28Mar2021, the patient had experienced Tired/tiredness, chills, joint pain, nausea; on 29Mar2021 had headache and on 30Mar2021 she did not have energy to do anything, she was feeling hot and cold. The patient adds that she has already talked to her physician and the physician said it could be like a week so if caller was not feeling better within 72 hours to give the physician a call. Relevant tests: patient stated as, no not yet. Therapeutic measures were taken as a result of headache which included treatment with alternates Ibuprofen and Tylenol and for nausea included Zofran and so it was under control. The patient did not receive any additional treatments. The outcome of the event nausea was recovering; Tired/tiredness, headache, chills, joint pain was not recovered while Energy decreased, asthenia feeling of body temperature change was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: Nausea; Diarrhea; Low grade fever; Muscle aches; Joint aches; Vomiting; Tired; Extremely exhausted; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 77 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing She has arthritis. The patient's concomitant medications were not reported. The patient experienced nausea on 27Mar2021 with outcome of unknown, diarrhoea on 27Mar2021 with outcome of recovered, low grade fever on 27Mar2021 with outcome of recovered, muscle aches causing myalgia on 27Mar2021 with outcome of unknown, joint aches causing arthralgia on 27Mar2021 with outcome of not recovered, extremely exhausted causing fatigue on Mar2021 with outcome of unknown, vomiting on 27Mar2021 with outcome of recovered, tired causing fatigue on 27Mar2021 with outcome of unknown.    Follow up (30Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported that: Additional information regarding adverse events were updated.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea; Diarrhea; Low grade fever; Muscle aches; Joint aches; Vomiting; Tired; Extremely exhausted; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 77 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing She has arthritis. The patient's concomitant medications were not reported. The patient experienced nausea on 27Mar2021 with outcome of unknown, diarrhoea on 27Mar2021 with outcome of recovered, low grade fever on 27Mar2021 with outcome of recovered, muscle aches causing myalgia on 27Mar2021 with outcome of unknown, joint aches causing arthralgia on 27Mar2021 with outcome of not recovered, extremely exhausted causing fatigue on Mar2021 with outcome of unknown, vomiting on 27Mar2021 with outcome of recovered, tired causing fatigue on 27Mar2021 with outcome of unknown.    Follow up (30Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported that: Additional information regarding adverse events were updated.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.