chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: mild fever; Extreme fatigue; This is a spontaneous report received from a contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration in left arm on 08Apr2021 (Lot Number: EP7533) as single dose for COVID-19 immunization. The patient medical history not reported. Concomitant medication included azithromycin (ZITHROMAX) and hormonal birth control. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration in left arm on 19Mar2021 (Lot Number: ER8727) as single dose for COVID-19 immunization. The patient received hormonal birth control within 2 weeks of vaccination. On 09Apr2021 19:00, the patient experienced extreme fatigue and mild fever, 30 hours post vaccination of the second dose. The patient did not receive any treatment. The outcome of the events was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Illness, Pyrexia
Clinical narrative: felt sick; fever; Headache; Shortness of breath; Tiredness; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). This female patient of unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications included paracetamol (TYLENOL) and dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride (DAYQUIL). The patient received the 1st dose and after 2weeks, she felt sick. She had fever, headache, shortness of breath and tiredness. The patient took tylenol and dayquil. The 2nd dose schedule was on 17Apr2021 and she wanted to know if it's okay to receive it after she experienced adverse events. There were some unaddressed medical questions referred or forwarded to Medical Information. Outcome of the events was unknown.   The lot number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: flushed; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), dose 1 via an unspecified route of administration, administered in left arm on 24Mar2021 as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated that she did get flushed after the first and second vaccine. She stated that she noticed the flushed feeling after the first dose (24Mar2021) when she went back to the car and took off the mask. She stated she thought was she flushed, was it the mask or the vaccine? She stated that she got her first dose on 24Mar2021 and that the flushed feeling started a few hours after the injection. She confirmed that she recovered completely from it on the same day. She stated that she has been on medications for a long time and she has never had this reaction like she was having now. There is no history of all previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines Administered on Same Date of the Pfizer Suspect. AE did not require a visit to emergency room and physician Office. There is no prior Vaccinations (within 4 weeks). The outcome of the event was resolved on 24Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Dysgeusia, Influenza like illness
Clinical narrative: Knot in arm at injection site; Achy feeling joints; Arm was really sore; Hasn't had an appetite all day; Chills; Feels like I have the flu; metallicy taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Apr2021 at 14:00 (Lot number: EW0150, Expiry date: 31Jul2021) on the left arm as single dose for COVID-19 immunization. Medical history included ongoing hypertrophic cardiomyopathy that diagnosed probably 8 years ago. Family history included mother and father are diabetic. There was no concomitant medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 at 15:30 (Lot number: ER2613; Expiry date: 31Jul2021) on the left arm as single dose for COVID-19 immunization, that experienced a sore arm. There were no additional administered vaccines, no prior vaccinations within 4 weeks. Patient experienced a really metallicy taste in his mouth about 10 to 15 minutes after he received the Covid-19 vaccine. On 14Apr2021, the patient reported that he had a knot on his arm at the injection site. He had experiencing an achy feeling joints following the Covid-19 vaccine. His arm was really sore this morning, 14Apr2021, he can't lift his arm up past shoulder height without it hurting, and that when he went to rub his arm to massage the soreness out, he felt the knot in his arm. Patient also hasn't had an appetite all day long, he would think about eating something and it didn't sound good. Patient reported it was very unusual for him not to have an appetite, that he normally loves to eat. On 14Apr2021, patient was experiencing the chills off and on, he also felt like he had the flu. When queried for product details, patient reported that he was going to put his cheat glasses on, that the writing on his vaccine card was like micro writing. No events required a visit to emergency room or physician office. The outcome of events "Knot in arm at injection site", "Achy feeling joints", "Feels like I have the flu" was not recovered, while the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: Knot in arm at injection site; Achy feeling joints; Arm was really sore; Hasn't had an appetite all day; Chills; Feels like I have the flu; metallicy taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Apr2021 at 14:00 (Lot number: EW0150, Expiry date: 31Jul2021) on the left arm as single dose for COVID-19 immunization. Medical history included ongoing hypertrophic cardiomyopathy that diagnosed probably 8 years ago. Family history included mother and father are diabetic. There was no concomitant medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 at 15:30 (Lot number: ER2613; Expiry date: 31Jul2021) on the left arm as single dose for COVID-19 immunization, that experienced a sore arm. There were no additional administered vaccines, no prior vaccinations within 4 weeks. Patient experienced a really metallicy taste in his mouth about 10 to 15 minutes after he received the Covid-19 vaccine. On 14Apr2021, the patient reported that he had a knot on his arm at the injection site. He had experiencing an achy feeling joints following the Covid-19 vaccine. His arm was really sore this morning, 14Apr2021, he can't lift his arm up past shoulder height without it hurting, and that when he went to rub his arm to massage the soreness out, he felt the knot in his arm. Patient also hasn't had an appetite all day long, he would think about eating something and it didn't sound good. Patient reported it was very unusual for him not to have an appetite, that he normally loves to eat. On 14Apr2021, patient was experiencing the chills off and on, he also felt like he had the flu. When queried for product details, patient reported that he was going to put his cheat glasses on, that the writing on his vaccine card was like micro writing. No events required a visit to emergency room or physician office. The outcome of events "Knot in arm at injection site", "Achy feeling joints", "Feels like I have the flu" was not recovered, while the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he experienced a sore arm after his first dose of the Covid-19 vaccine on 23Mar2021.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: ER2613, Expiry Date: 31Jul2021) on 23Mar2021 15:30 in left arm as single dose for COVID-19 immunization. Medical history included ongoing hypertrophic cardiomyopathy which diagnosed probably 8 years ago; family medical history included mother and father are diabetic. Concomitant medications were none. No additional administered vaccines. No prior vaccinations (within 4 weeks).  Patient experienced a sore arm after his first dose of the Covid-19 vaccine on 23Mar2021. Patient reported that he recovered completely from the sore arm following the first dose. No emergency room visit required. No physician office visit. No relevant tests. Outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Nodule, Tenderness
Clinical narrative: felt tenderness; felt a nodule; Swollen lymph node; Tired; This is a spontaneous report from contactable consumer. A consumer (patient) reported for herself that the 55-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer Covid-19), via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:40-10:45 (Batch/Lot Number: ER8727) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tired on 26Mar2021 13:00 with outcome of recovered, felt tenderness on an unspecified date with outcome of unknown, felt a nodule on an unspecified date with outcome of unknown, swollen lymph node on an unspecified date with outcome of unknown.  Therapeutic measures were taken as a result of tired. The clinical course was reported as follows: She received her second dose at 1040 yesterday. Her first dose was fine, she was just tired. Today she was fine in the morning, she was is a little tired now, she seems to have a swollen lymph node like up on her neck, right above her clavicle. She noticed it was a side effect and is asking if it is temporary. She felt tenderness, felt a nodule. Caller asking will it go away in 48hours. Caller doesn't have a physician at this time. She got tired today at 1230. That was the primary symptom the first day after the first dose also. It was not so much that she couldn't function, she was just tired. Caller works remotely. She went and sat on the couch hoping to take a 15 minute cat nap. She laid down and thought why is her neck sore? She touched the area and felt the nodule. This was 1230-100pm this afternoon about 25-26 hours after the second shot. It's not worse or better. She was tired after the first vaccination on 25Mar2021 at 1040 or 1045. It started on 26Mar2021 about 24-28 hours after around 1300. It stopped on 27Mar2021, she awoke feeling fine, and recovered completely. Second dose LOT EW0158, left arm injection She is on no medications, she takes vitamin C and vitamin D in the mornings. She has no medical conditions. Caller tried here first and figured she would start here and if it was recommended to her to see a physician, she has one she has been referred to. No AE require a visit to Emergency Room or Physician Office. No relevant tests.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in her arm,where the injection site was; This is a spontaneous report from a contactable consumer (patient).  A 73-years-old female patient received first dose of bnt162b2 (BNT162B2), on 14Jan2021 (Lot Number: EL3247) as SINGLE DOSE in Arm Left for covid-19 immunisation.  Medical history included ongoing thyroid, diagnosed when she was 40, so 33 years ago, she has some immune thing, diverticulitis in Dec2020, and they did have to put her in the hospital because the thing perforated and they had to give her IV antibiotics, so she was on antibiotics for 2 weeks after that. Prior Vaccinations within 4 weeks was None. Concomitant medication included levothyroxine sodium (SYNTHROID) 75 mcg taken for thyroid disorder; thyroid (ARMOUR THYROID) 30 mg taken for thyroid disorder, both ongoing, just orally in the morning everyday by mouth.  She experienced soreness in her arm on 14Jan2021 where the injection site was and pretty much nothing more, no fever, no tiredness, no nothing. and lasted for about 2 days,was gone by 16Jan2021. she has recovered completely, she didn't have lasting effects.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: a lot of nausea; Very dizzy; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and  concomitant medications were not reported.  She received the Pfizer Covid Vaccine 10 days ago and felt consumer had a reaction. Consumer reported a lot of nausea and was very dizzy. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he tested positive with Covid-19 after he got the 2nd dose of the vaccine; he tested positive with Covid-19 after he got the 2nd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-Sponsored Program. A male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) and the first dose via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported), both as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called in because he tested positive for Covid-19 on an unknown date, after he received the second dose of the vaccine. He received the first dose of the vaccine on 09Mar2021 and the second dose on 30Mar2021. He's asking what's his incubation period. The event outcome was unknown.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: exhausted; Low grade fever; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient were exhausted after their second vaccine and had a low grade fever. Outcome was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Nasal congestion, Pain in extremity, Sinus disorder
Clinical narrative: sinus issues; stuffy nose; cough; hoarseness; soreness in both arms; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in right arm on 08Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Vaccination facility type was Clinic. Medical history included Parkinson's from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took the first dose of BNT162B2 via intramuscular administration administered in left arm on 18Mar2021 for COVID-19 immunisation and experienced sore arm, and took a Flu shot probably 25 years ago. The patient experienced cough on 09Apr2021 with outcome of recovering, hoarseness on 09Apr2021 with outcome of recovering, sinus issues on 09Apr2021 with outcome of recovering, soreness in both arms on 08Apr2021 with outcome of recovering, stuffy nose on 09Apr2021 with outcome of recovering. Patient had sinus drainage on 09Apr2021. AEs did not require a visit to Emergency Room and Physician Office. Clincial course reported as follow: Patient stated that it may be obvious by the sound of her voice that after the second dose of COVID vaccine on 08Apr2021, by the time patient woke up on 09Apr2021, she had developed a cough. The cough was getting better but her voice was very hoarse, and has also had sinus issues with it, stuffy nose and sinus drainage. Patient stated that the cough was worse last night and her husband was concerned because she had Parkinson's. Patient believed her height was 4'10" or 4'11" and her weight 80-85 pounds right now, she had Parkinson's and for that reason she carried a low weight. Patient stated that with the second COVID vaccine, it was weird because she could feel the pain in her left arm even though she got the dose of COVID vaccine in the right arm so both arms hurt after the second dose. The hoarseness, sinus issues, cough all started 09Apr2021 in the morning when patient woke up. She stated that those symptoms were improving. The pain in both arms after second dose was improved, the pain started on 08Apr2021 and that the pain started right when she was giving me the vaccine. Patient stated that after a flu shot that was probably 25 years ago. Patient stated that within 3 minutes of getting that flu shot her left sinus blocked up and stayed blocked up for 3 weeks (no treatment). When she told her doctor, the doctor recommended not getting any other flu shots.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick for a day and a half; This is a spontaneous report from contactable consumer (patient's mother) reported that a male patient of unspecified age received the BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was sick for a day and a half and had his shot a long time ago. Outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Influenza like illness, Pain, Vaccination site mass
Clinical narrative: Chills; aches; fluish; with a knot at the injection site; he felt burning in his injection arm; metallic taste in his mouth; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) on 13Apr2021 as single dose in arm for covid-19 immunization at the age of 59-year-old. The patient received the first dose bnt162b2 (Batch/Lot number was not reported) on 23Mar2021 as single dose administered in arm for covid-19 immunisation at the age of 59-year-old and experienced a little sore on injection arm in Mar2021 and a metallic taste in his mouth on 23Mar2021 with outcome of unknown. The patient medical history and concomitant medications were not reported. The patient felt burning in his injection arm about 10 minutes after injection on 13Apr2021. The patient woke up 14Apr2021 with a knot at the injection site and has been experiencing chills, aches, and feeling overall flu-ish. The patient also reported a metallic taste in his mouth when he got the vaccine on 13Apr2021. The outcome of events was unknown. No treatment information was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; aches; fluish; with a knot at the injection site; he felt burning in his injection arm; metallic taste in his mouth; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) on 13Apr2021 as single dose in arm for covid-19 immunization at the age of 59-year-old. The patient received the first dose bnt162b2 (Batch/Lot number was not reported) on 23Mar2021 as single dose administered in arm for covid-19 immunisation at the age of 59-year-old and experienced a little sore on injection arm in Mar2021 and a metallic taste in his mouth on 23Mar2021 with outcome of unknown. The patient medical history and concomitant medications were not reported. The patient felt burning in his injection arm about 10 minutes after injection on 13Apr2021. The patient woke up 14Apr2021 with a knot at the injection site and has been experiencing chills, aches, and feeling overall flu-ish. The patient also reported a metallic taste in his mouth when he got the vaccine on 13Apr2021. The outcome of events was unknown. No treatment information was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: falls; This is a spontaneous report from a contactable consumer. The consumer reported similar event for two patients, this is the first of two reports. A patient with unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was in a nursing home due to falls after receiving the vaccine. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC- same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: falls; This is a spontaneous report from a contactable consumer. The consumer reported similar event for two patients, this is the second of two reports.  A patient with unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was in a nursing home due to falls after receiving the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021424414 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Feeling abnormal, Nervousness, Urticaria
Clinical narrative: allergic reaction with the COVID-19 Vaccine; the inside of body felt like it was shaking. She said it was hard to describe the feeling, but it was like her inside was speeding; the inside of body felt like it was shaking. She said it was hard to describe the feeling, but it was like her inside was speeding; Hives; This is a spontaneous report from a contactable consumer reported for self. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took codeine and experienced an allergy to Codeine. She said with the codeine allergy the inside of body felt like it was shaking. She said it was hard to describe the feeling, but it was like her inside was speeding. She said she also would get hives with the codeine allergy. The patient experienced she had the same kind of allergic reaction with the COVID-19 vaccine as with her allergy to codeine on 2021, the inside of body felt like it was shaking. she said it was hard to describe the feeling, but it was like her inside was speeding on 2021, hives on 2021. The patient asked if she should get the second COVID-19 Vaccine and asked if she only got the first COVID-19 vaccine shot, how protected would she be. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Chills, Gait disturbance
Clinical narrative: headache; pain in the knee; fever; chills; bone pain; back pain/back pain felt like if her back was going to break; hand pain; difficulty to walk; incapable of holding or grabbing things; This is a spontaneous report from non-contactable consumer (patient). A 47-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 for COVID-19 immunisation, and she experienced mild to moderate symptoms like headache, muscle pain and back pain. The patient was being administered with second dose of Pfizer's vaccine on 02Apr2021. After second dose of vaccine she experienced pain in the knee, fever, chills, bone pain, headache, back pain and hands pain. The knee pain provoked her difficulty to walk, pain in hands is so intense that she is incapable of holding or grabbing things and back pain felt like if her back was going to break. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Headache, Pain in extremity, Pyrexia
Clinical narrative: headache; pain in the knee; fever; chills; bone pain; back pain/back pain felt like if her back was going to break; hand pain; difficulty to walk; incapable of holding or grabbing things; This is a spontaneous report from non-contactable consumer (patient). A 47-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 for COVID-19 immunisation, and she experienced mild to moderate symptoms like headache, muscle pain and back pain. The patient was being administered with second dose of Pfizer's vaccine on 02Apr2021. After second dose of vaccine she experienced pain in the knee, fever, chills, bone pain, headache, back pain and hands pain. The knee pain provoked her difficulty to walk, pain in hands is so intense that she is incapable of holding or grabbing things and back pain felt like if her back was going to break. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: experiencing low-grade fever for over 48 hours already.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient herself) reported that an unspecified aged female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 11Apr2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took COVID-19 vaccine. Patient had her 2nd dose of the Pfizer Covid-19 vaccine on 11Apr2021, and she mentioned that today she has been experiencing low-grade fever for over 48 hours already on an unspecified date in Apr2021. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: feeling some significant headache; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 24Mar2021 for covid-19 immunisation. The patient called to advise that she was feeling some significant headache after getting her second dose of the vaccine this afternoon, 14Apr2021 around 4 pm, because of this she took 2 tablets of Tylenol about 25 minutes ago and asking if she should continue using the Tylenol since someone advised her not to. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injury, Syncope
Clinical narrative: Sometime after 8 am on 18Apr2021, more than 13 hrs after receiving the Pfizer vaccine, the patient fainted in her bathroom and hurt her forehead; hurt her forehead; This is a spontaneous report from a contactable consumer.  A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: ER8731), via an unspecified route of administration, on 17Apr2021 at 16:15 (at the age of 33-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included contraception from an unknown date and unknown if ongoing. The patient has no known allergies.The patient was not pregnant at the time of vaccination. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medication included desogestrel, ethinylestradiol (RECLIPSEN) taken for contraception, start and stop date were not reported. On 18Apr2021 at 08:15,  more than 13 hours after receiving the Pfizer vaccine, the patient fainted in her bathroom and hurt her forehead. Treatment for the event fainted included wetting the patient's face as well as the application of a cold towel to the patient's forehead.  Since the vaccination the patient has not tested positive for COVID-19. The clinical outcome of syncope was reported as recovering. The clinical outcome of injury was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: is sick with a fever; is sick with a fever/101F at night; He has been having body aches, feer, full body aches; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 46-years-old male patient received first dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration as a single dose on 28Mar2021 for covid 19 immunization. The medical history included: the patient was infected with covid 19 on an unspecified date in Jan2021. The patient's concomitant medications were not reported. The patient enquired that he received first dose on 28Mar2021, and his second dose was due today (initially said 20Mar); is it okay to get it past 21 days. The caller reported that he was supposed to receive his second dose today, but he was sick with a fever on an unspecified date in 2021. He has been having body aches, feer, full body aches and 101F at night but takes NyQuil at night and then wakes up without a fever. He had Covid in January and this current illness is much worse. The outcome of the event fever was reported as recovered on an unspecified date in 2021 and other events were reported as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Lumbar puncture, Magnetic resonance imaging, Unresponsive to stimuli
Clinical narrative: unresponsive; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 12:45 (Lot Number: EW0158) as SINGLE DOSE for COVID-19 immunization. Medical history included melanoma brain cancer from an unknown date and unknown if ongoing. Concomitant medications included hydrocortisone, calcium carbonate, colecalciferol and meso zeaxanthin, xantofyl, zeaxanthin (MACUHEALTH WITH LMZ3); all taken for an unspecified indication, start and stop date were not reported. The patient previously had first dose of BNT162B2 (lot number: ER2613) on 23Mar2021 12:15 PM in the right arm for COVID-19 immunisation at 66 years old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient as not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The day following receiving the vaccination, the patient took her morning Hydrocortisone and fell asleep. Later that day, the patient became unresponsive on 14Apr2021 01:00 PM. The patient was admitted to the hospital and was released 2 days later. Many tests were performed including a Spinel Tap, MRI (brain - that is where my melanoma cancel was located), and a full panel of lab work on unspecified date. All tests responded normal. The patient was in the hospital for 2 days. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was given to the patient such as fluids, hydrocortisone and antibiotics. The outcome of the event was recovering.   Information on about lot/batch number has been requested.; Sender's Comments: Based on the information provided, this patient with a medical history  relevant for melanoma brain cancer from an unknown date and  ongoing. It was noted that the day following receiving the vaccination, the patient took her morning Hydrocortisone and fell asleep. Later that day, the patient became unresponsive. Although the reported event could be possibly related to  intercurrent melanoma brain cancer, due to the plausible temporal association, a possible contributory role of the BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy 09Feb2021 dx 12Feb2021; This is a spontaneous report from a contactable Physician. An 89-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, intramuscular on 23Jan2021 at 13:15 (Batch/Lot Number: EL3247) as single dose (at the age of 89 years-old) for COVID-19 immunisation.  Medical history included high blood pressure, spinal stenosis, kyphosis and known allergy to sulfa-hives. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included donepezil, methadone, sertraline, hydrocodone, metoprolol, alprazolam (XANAX), nifedipine, mirtazapine, hydralazine, and spironolactone; all taken from unknown dates for unspecified indications.  On 09Feb2021 the patient experienced Bell's palsy (diagnosed on 12Feb2021). The event resulted in emergency room visit. Therapeutic measures were taken as a result of Bell's palsy and included steroids and acyclovir. The patient was recovered from Bell's palsy on an unknown date. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 28Feb2021 at 14:15 (Lot number EN6203) for COVID-19 immunisation. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported  Bell's palsy and the use of BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Diarrhoea, Headache, Malaise
Clinical narrative: "I was going to pass out, thought I was going to die"; dry heaves; burning sensation inside my body; Severe Diarrhea; I had chills; headache; Feeling sick; This is a spontaneous report from a contactable consumer.   A 70-year-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 23Feb2021 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Dose 1 of BNT162B2 for COVID-19 immunisation was given on 29Jan2021 lot number unknown in right arm.  Medical history included macular degeneration from an unknown date, glaucoma from an unknown date, hypertension from an unknown date (controlled), and herpes zoster from 2017 to an unknown date. The patient is not pregnant. The patient did not have Covid-19 prior vaccination. The patient had no known allergies.  Concomitant medications included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication, start and stop date were not reported; and carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported.  Other medications in two weeks also included unspecified eye drops for glaucoma. No other vaccine was given in last four weeks.  The patient experienced "I was going to pass out, thought I was going to die" on 24Feb2021, dry heaves on 24Feb2021 with outcome of recovered, burning sensation inside my body on 24Feb2021 with outcome of recovered, severe diarrhea on 24Feb2021 with outcome of recovered, chills on 24Feb2021 with outcome of recovered, headache on 24Feb2021 with outcome of recovered and feeling sick on 24Feb2021 with outcome of recovered.  All events recovered on an unspecified date in 2021.  The patient was not Covid tested post vaccination.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience, Retching
Clinical narrative: "I was going to pass out, thought I was going to die"; dry heaves; burning sensation inside my body; Severe Diarrhea; I had chills; headache; Feeling sick; This is a spontaneous report from a contactable consumer.   A 70-year-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 23Feb2021 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Dose 1 of BNT162B2 for COVID-19 immunisation was given on 29Jan2021 lot number unknown in right arm.  Medical history included macular degeneration from an unknown date, glaucoma from an unknown date, hypertension from an unknown date (controlled), and herpes zoster from 2017 to an unknown date. The patient is not pregnant. The patient did not have Covid-19 prior vaccination. The patient had no known allergies.  Concomitant medications included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication, start and stop date were not reported; and carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported.  Other medications in two weeks also included unspecified eye drops for glaucoma. No other vaccine was given in last four weeks.  The patient experienced "I was going to pass out, thought I was going to die" on 24Feb2021, dry heaves on 24Feb2021 with outcome of recovered, burning sensation inside my body on 24Feb2021 with outcome of recovered, severe diarrhea on 24Feb2021 with outcome of recovered, chills on 24Feb2021 with outcome of recovered, headache on 24Feb2021 with outcome of recovered and feeling sick on 24Feb2021 with outcome of recovered.  All events recovered on an unspecified date in 2021.  The patient was not Covid tested post vaccination.  No follow-up attempts are possible; No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bronchospasm, Dyspnoea
Clinical narrative: Asthma; Brocho-spasm; shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 02Feb2021 (Batch/Lot Number: EL9269) as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for myalgia and headache from 01Feb2021 to an unspecified stop date. The patient previously took first dose of BNT162B2 (Lot number: EL1283) in the right arm on 13Jan2021 for COVID-19 immunization. Post-second shot the patient symptoms were mostly related to asthma/bronchospasm- 2days-shortness of breath(SOB) accordingly since then. Albuterol was given as a treatment for bronchospasm since 03Feb2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; Chills; This is a spontaneous report from a contactable consumer.   A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on left arm on 02Apr2021 09:00 (Batch/Lot Number: ER8737) at single dose (at the age of 27 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 VACCINE, solution for injection), dose 1 on 12Mar2021 (batch/lot number: EN6208), intramuscular on left arm for COVID-19 immunisation and experienced appendicitis/abdominal pain The patient experienced fever and chills on 02Apr2021 21:00. The patient received no treatment. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia
Clinical narrative: she had skin sensitivity on back; This is a spontaneous report from a non-contactable consumer reported for herself. A female patient of an unspecified age received bnt162b2 (Pfizer BioNTech Covid 19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated she had skin sensitivity on back after receiving first Pfizer vaccine. The 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: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Head discomfort
Clinical narrative: low grade fever; chills; significant GI upset including diarrhea; significant GI upset including diarrhea; throbbing, heavy and fuzzy head; fatigue; sore arm; throbbing, heavy and fuzzy head; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received second dose of BNT162B2 (PFIZER COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr 2021, the patient experienced low grade fever, chills, significant gastrointestinal upset including diarrhea, throbbing, heavy and fuzzy head, fatigue and sore arm. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: low grade fever; chills; significant GI upset including diarrhea; significant GI upset including diarrhea; throbbing, heavy and fuzzy head; fatigue; sore arm; throbbing, heavy and fuzzy head; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received second dose of BNT162B2 (PFIZER COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr 2021, the patient experienced low grade fever, chills, significant gastrointestinal upset including diarrhea, throbbing, heavy and fuzzy head, fatigue and sore arm. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Sars-Cov-2; tested positive for Sars-Cov-2; This is a spontaneous report from a contactable consumer (Patient) reported for himself. via Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-Biontech covid-19 vaccine, Formulation: solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on 31Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 16Apr2021(Last Friday), the patient tested positive for sars-cov-2. He called into ask if he can go ahead and get the second dose of the vaccine due on 20Apr2021. On 16Apr2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The events were considered as serious. The outcome of the events was reported as unknown.  Follow-up (18Apr2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that.  Information about Batch/Lot number has been requested.