chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: CN5318, via an unspecified route of administration at right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. Medical history was not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date. There were no concomitant medications. On 29Jan2021, at 7 pm, the patient was nauseous and weak. At 9 pm, the patient was really unwell, tired, headache, muscle aches and nausea. She slept all Friday night, all day Saturday. Late around Sunday was finally able to get out of bed. Asked if she should see a doctor. The patient was still nauseous and weak. The outcome of the events nausea and weak was not recovered. The outcome of other events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: CN5318, via an unspecified route of administration at right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. Medical history was not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date. There were no concomitant medications. On 29Jan2021, at 7 pm, the patient was nauseous and weak. At 9 pm, the patient was really unwell, tired, headache, muscle aches and nausea. She slept all Friday night, all day Saturday. Late around Sunday was finally able to get out of bed. Asked if she should see a doctor. The patient was still nauseous and weak. The outcome of the events nausea and weak was not recovered. The outcome of other events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Illness, Pain, SARS-CoV-2 test
Clinical narrative: sick; Ached all over; felt really bad; This is a spontaneous report from a contactable consumer (patient) reported that 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 13Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that three and a half days later (Jan2021) she got really sick. The patient ached all over on Jan2021, and for two days felt really bad on Jan2021. She did not seem to have the typical COVID symptoms. She got tested for COVID and did not have it. Over the next few days she gradually felt better, and then 10 days later she felt fine. She was due to have the second shot this Wednesday (03Feb2021). She was unsure if she should take it or not. The outcome of the events was recovered on Jan2021.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Pain
Clinical narrative: sick; Ached all over; felt really bad; This is a spontaneous report from a contactable consumer (patient) reported that 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 13Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that three and a half days later (Jan2021) she got really sick. The patient ached all over on Jan2021, and for two days felt really bad on Jan2021. She did not seem to have the typical COVID symptoms. She got tested for COVID and did not have it. Over the next few days she gradually felt better, and then 10 days later she felt fine. She was due to have the second shot this Wednesday (03Feb2021). She was unsure if she should take it or not. The outcome of the events was recovered on Jan2021.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Illness, Pain, SARS-CoV-2 test
Clinical narrative: she hurt all over; had no appetite; chills; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 13Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Jan2021 (3.5 days later), the patient was hurt all over, she had no appetite and had chills. The patient did not have fever. The patient reported she is due to have her second dose on 03Feb2021 and she asked whether or not she should receive the second dose. She stated she heard the second dose was worse in regard to adverse reactions than the first dose and was wondering if this is true. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Pain
Clinical narrative: she hurt all over; had no appetite; chills; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 13Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Jan2021 (3.5 days later), the patient was hurt all over, she had no appetite and had chills. The patient did not have fever. The patient reported she is due to have her second dose on 03Feb2021 and she asked whether or not she should receive the second dose. She stated she heard the second dose was worse in regard to adverse reactions than the first dose and was wondering if this is true. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dyspnoea, Fatigue
Clinical narrative: a lot of the same symptoms from the covid virus; chills; low grade fever; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; tired; weak; feeling lousy; also had the breathing problem with the virus; This is a spontaneous report from a non-contactable Consumer. A female patient of an unspecified age receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced a lot of the same symptoms from the covid virus, chills, low grade fever, everything hurt, muscles, head, tired, weak, feeling lousy, also had the breathing problem with the virus on an unspecified date.  The outcome of events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101407 same reporter/drug/events, different patients
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: a lot of the same symptoms from the covid virus; chills; low grade fever; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; tired; weak; feeling lousy; also had the breathing problem with the virus; This is a spontaneous report from a non-contactable Consumer. A female patient of an unspecified age receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced a lot of the same symptoms from the covid virus, chills, low grade fever, everything hurt, muscles, head, tired, weak, feeling lousy, also had the breathing problem with the virus on an unspecified date.  The outcome of events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101407 same reporter/drug/events, different patients
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: a lot of the same symptoms from the covid virus; chills; low grade fever; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; tired; weak; feeling lousy; also had the breathing problem with the virus; This is a spontaneous report from a non-contactable Consumer. A female patient of an unspecified age receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced a lot of the same symptoms from the covid virus, chills, low grade fever, everything hurt, muscles, head, tired, weak, feeling lousy, also had the breathing problem with the virus on an unspecified date.  The outcome of events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101407 same reporter/drug/events, different patients
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: slight soreness; This is a spontaneous report from a contactable healthcare professional (patient). This 24-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 19Jan2021 at 19:00 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (lot number EK9231) intramuscularly in the right arm on 29Dec2020 at 18:45. On 20Jan2021 the patient experienced slight soreness. No treatment was provided for the event. The clinical outcome of slight soreness was recovered on an unspecified date. It was also reported the patient was not tested for COVID-19 post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive after taking the vaccine; tested positive after taking the vaccine; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was tested positive after taking the vaccine on an unspecified date in 2021. She wanted to know if she will continue with the second dose which is on 24Feb2021. Lab data included: COVID-19 tested positive in 2021. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: severe chills; fever; body aches; fatigue; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El9266/expiration date: not provided), via an unspecified route of administration, on 11Feb2021 at 09:00 as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included aortic aneurysm on an unspecified date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El8982/expiration date: not provided), via an unspecified route of administration, on 22Jan2021 as a single dose for COVID-19 IMMUNIZATION. The patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Vitamin D, atorvastatin, metoprolol, and omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Feb2021 at 09:40 (40 minutes after receiving the vaccine, the patient experienced headache but reported that it was manageable and gone after a few hours. Later that evening on 11Feb2021 at 19:00, the patient experienced severe chills, fever, body aches, headache, fatigue. Symptoms lasted for over 48 hours. The patient started to feel some relief Saturday evening but still had annoyance headache on one side. The patient did not receive any treatment for these events. The outcome of the events severe chills, fever, body aches, headache, fatigue was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Joint injury, Skin disorder
Clinical narrative: wrist pain; wrist pain and it locked up.; little bumps on the back of her hand; Headache; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EJ1686) on 03Jan2021 in the morning  before 12:00 pm (at 70 years) at single dose in right arm for COVID-19 immunization.Medical history included hypertension from 2002. Concomitant medication included enalapril for hypertension from 2002  (she tried several things- unspecified-before enalapril, took a number of months before she found something to tolerate). The patient on 24Aug2015 (at 65 years) took varicella zoster vaccine live (oka/merck)  (ZOSTAVAX) for immunization and experienced shingles (it started a couple months after the shot, she had skin discoloration, black spots over the skin, caused by her bathing suit and the pool water, and it stayed for about 1.5 years, she was using a cream. It was maybe 2 years before it disappeared). Patient received first dose of the vaccine on 03Jan2021, after in Jan2021, she had a headache, a week and half later pain in wrist and wrists locked up, pain floated up to the back of her hand, continued since, locking of wrist stopped, pain continued, little bumps came on the back of hand.Patient added she may have had headache the second day (as reported), it came and went, she didn't pay attention, she had a headache morning and it gone as of 15Feb2021, but still came and went. Wrists locking up recovered before 24Jan2021. Bumps on back of hand started the same time, it came and went, stayed most of last week, still had it this week, about the same.No blood tests done since this happened.Final outcome of headache was unknown. Wrists locking up recovered in Jan2021. Bumps on back not recovered. wrist pain was recovering.Patient took the second dose of the vaccine (lot EN5318)  on 24Jan2021 in the afternoon (maybe 2 or 3:00PM) at single dose in left arm for COVID-19 immunization. On 12Feb2021 patient lost part of mobility in the small finger of the right hand, can't lift it all the way above. Patient was scheduled to go to the doctor on 15Feb2021 in the afternoon. Patient saw joint pain listed on contraindications, would like to know the nature of the joint pain described from side effects of the covid vaccine. She was concerned of a blood clot, unsure what happened or what can cause it, was unsure if it was muscular or something. Patient would like to know whether blood clots and muscle pain have been reported as a side effect of the covid vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: increased blood pressure; spiked heart rate; nausea; dizziness almost to the point of fainting; dizziness almost to the point of fainting; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter wants to know if it is recommended for her to get the second dose of the bnt162b2 after she has experienced side effects from the first dose. The patient stated that she had increased blood pressure, spiked heart rate, nausea, dizziness almost to the point of fainting that the patient ended up in the emergency room. The patient also wanted to know if she has to wait some time before she gets the second dose and how long she can wait. The patient queried does she have to start over if she waits longer than the recommended period? The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Presyncope
Clinical narrative: increased blood pressure; spiked heart rate; nausea; dizziness almost to the point of fainting; dizziness almost to the point of fainting; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter wants to know if it is recommended for her to get the second dose of the bnt162b2 after she has experienced side effects from the first dose. The patient stated that she had increased blood pressure, spiked heart rate, nausea, dizziness almost to the point of fainting that the patient ended up in the emergency room. The patient also wanted to know if she has to wait some time before she gets the second dose and how long she can wait. The patient queried does she have to start over if she waits longer than the recommended period? The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: cellulitis in elbow of injected arm; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 15Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included known allergies to penicillin and sulfa. Concomitant medication included acyclovir. The patient was not pregnant at the time of vaccination. The patient experienced cellulitis in elbow of injected arm on 03Feb2021 07:00 with outcome of recovering. Therapeutic measures were taken as a result of cellulitis in elbow of injected arm (cellulitis) with doxycycline as treatment. The event resulted in doctor or other healthcare professional office/clinic visit. The patient already took the second dose of BNT162B2 (lot number: EL9264) on 05Feb2021 08:00 at the right arm.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported cellulitis 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: severe headache; arm hurting/arm sore; This is a spontaneous report from a contactable consumer. This consumer reported for herself that an 86-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: 20May2021) at the age of 86-years, via an unspecified route of administration in upper right arm on 22Jan2021 at single dose for COVID-19 immunization. Medical history included compromised immune system (diagnosed many years before) and ongoing one kidney functioning. Concomitant medications were none. The patient experienced severe headache and arm hurting on 22Jan2021. It was reported that the first shot wasn't bad, the first all she had was a severe headache and arm hurting. It looks like she had the first on 22Jan2021, the headache and arm hurting started towards the evening on 22Jan2021, the shot was taken earlier in the day, and they started in the evening, her headache was quite severe, but with paracetamol (TYLENOL) it went away, the arm was still sore from the second single dose of BNT162B2 on 12Feb2021 for COVID-19 immunisation, but was slightly better. Outcome of the event headache was recovered/resolved in 2021 while of rest was recovering/resolving.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise
Clinical narrative: feeling sick with covid symptoms; feeling sick with covid symptoms; feeling sick with covid symptoms; This is a spontaneous report from a Pfizer Sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Jan2021 at single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient felt sick with COVID symptoms on 03Feb2021. Second dose is scheduled 11Feb2021. Patient wondered when she should receive the second dose of the vaccine. The outcome of events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: first shot was 2 weeks ago. Yesterday he tested positive for covid; first shot was 2 weeks ago. Yesterday he tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported a male patient (Reporter's Father) of an unspecified age received first dose of bnt162b2 (lot number unknown), via an unspecified route of administration, on Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had covid vaccine, first shot was 2 weeks ago. Yesterday he tested positive for covid. Inquiring how protected is he with vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm with first dose; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via intramuscular on left arm on 24Jan2021 at 18:30 at single dose for COVID-19 immunization. The relevant medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: autoimmune disease, PBC (Primary biliary cholangitis) (PBC is her autoimmune condition and was diagnosed 10 years ago). Concomitant medications were reported as none. The patient had sore arm with first dose on 24Jan2021. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Breast induration, Breast pain, Chest discomfort
Clinical narrative: heavy feeling in her chest; The top right quadrant of her right breast hardened and it was "incredibly painful" for her; The top right quadrant of her right breast hardened and it was "incredibly painful" for her; fever (102F); chills; fatigue; joint and muscle pain; joint and muscle pain; swelling of the lymph nodes; she felt intoxicated/drugged up; she felt intoxicated/drugged up; watery effect on her right eye; pain in her lower leg; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, via an unspecified route of administration on 11Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first dose of COVID-19 vaccine on Thursday, 11Feb2021. Immediately, she felt intoxicated/drugged up and had a watery effect on her right eye. When she got home, she experienced pain in her lower leg. The next day, 12Feb2021, she experienced fever of 102 Fahrenheit, chills, fatigue, joint and muscle pain, and swelling of lymph nodes. On Sunday, 14Feb2021, she had a heavy feeling in her chest. The top right quadrant of her right breast hardened, and it was incredibly painful for her. She said everything has been resolved except for her breast. She has spoken with her 2 doctors and asked her to contact Pfizer for her adverse events. She wanted to know if what she was experiencing was normal and wanted to know the recommendation for the second dose of the vaccine. The outcome of the events breast induration and breast pain was not recovered and recovered on Feb2021 for all other events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling drunk, Lacrimation increased, Lymphadenopathy
Clinical narrative: heavy feeling in her chest; The top right quadrant of her right breast hardened and it was "incredibly painful" for her; The top right quadrant of her right breast hardened and it was "incredibly painful" for her; fever (102F); chills; fatigue; joint and muscle pain; joint and muscle pain; swelling of the lymph nodes; she felt intoxicated/drugged up; she felt intoxicated/drugged up; watery effect on her right eye; pain in her lower leg; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, via an unspecified route of administration on 11Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first dose of COVID-19 vaccine on Thursday, 11Feb2021. Immediately, she felt intoxicated/drugged up and had a watery effect on her right eye. When she got home, she experienced pain in her lower leg. The next day, 12Feb2021, she experienced fever of 102 Fahrenheit, chills, fatigue, joint and muscle pain, and swelling of lymph nodes. On Sunday, 14Feb2021, she had a heavy feeling in her chest. The top right quadrant of her right breast hardened, and it was incredibly painful for her. She said everything has been resolved except for her breast. She has spoken with her 2 doctors and asked her to contact Pfizer for her adverse events. She wanted to know if what she was experiencing was normal and wanted to know the recommendation for the second dose of the vaccine. The outcome of the events breast induration and breast pain was not recovered and recovered on Feb2021 for all other events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Sedation
Clinical narrative: heavy feeling in her chest; The top right quadrant of her right breast hardened and it was "incredibly painful" for her; The top right quadrant of her right breast hardened and it was "incredibly painful" for her; fever (102F); chills; fatigue; joint and muscle pain; joint and muscle pain; swelling of the lymph nodes; she felt intoxicated/drugged up; she felt intoxicated/drugged up; watery effect on her right eye; pain in her lower leg; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, via an unspecified route of administration on 11Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first dose of COVID-19 vaccine on Thursday, 11Feb2021. Immediately, she felt intoxicated/drugged up and had a watery effect on her right eye. When she got home, she experienced pain in her lower leg. The next day, 12Feb2021, she experienced fever of 102 Fahrenheit, chills, fatigue, joint and muscle pain, and swelling of lymph nodes. On Sunday, 14Feb2021, she had a heavy feeling in her chest. The top right quadrant of her right breast hardened, and it was incredibly painful for her. She said everything has been resolved except for her breast. She has spoken with her 2 doctors and asked her to contact Pfizer for her adverse events. She wanted to know if what she was experiencing was normal and wanted to know the recommendation for the second dose of the vaccine. The outcome of the events breast induration and breast pain was not recovered and recovered on Feb2021 for all other events.   Information on the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dehydration, Disorientation, Gait inability
Clinical narrative: Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't/wouldn't eat; Dehydrated; This is a spontaneous report from two contactable consumers (primary reporter was patient's husband). An 80-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included ended up in the hospital for 2 weeks with pneumonia and COVID-19 at the end of last Summer. The patient's concomitant medications were not reported. The patient's husband reported that the patient received the first Covid shot about a week to two weeks ago. She went to the facility and got the shot and was fine afterwards until she came home. Later that afternoon, she started showing symptoms of problems, was weak and couldn't walk, disoriented, wanted to sleep, was incoherent, couldn't/wouldn't eat, was very, very much having trouble, shallow breathing. He tried to stay right her and eventually it got to be scary for him with her shallow breathing. He ended up calling an ambulance and she went to the hospital. They gave her tests and was there until about 4 or 5 in the morning before she started showing signs. She was dehydrated was a part of it. The tests were showing the symptoms were improving and she was beginning to come out of it fortunately with doctor's care because he didn't know what to do. He had been going through materials and she is coming up on another shot next Monday and does not want her to go through that if it can be helped. She was coming up for the second shot. Saw something on the tv that rattled him to his bones. It had been found that people who had Covid virus previously and then got the shot may not need a second shot. He is trying to flush that out to whether or not that is something or not that she should be considering. They have the card to go back to the same place for the second shot and they are trying to figure if they need to set up an appointment now. Hoping that this was the worse of it and it is hard for them to call back and his physician is not an expert on this and he got Pfizer's office contact number and decided to call. Outcome of the events was recovering.  Information on the batch/ lot number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hypopnoea, Incoherent, Investigation, Somnolence
Clinical narrative: Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't/wouldn't eat; Dehydrated; This is a spontaneous report from two contactable consumers (primary reporter was patient's husband). An 80-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included ended up in the hospital for 2 weeks with pneumonia and COVID-19 at the end of last Summer. The patient's concomitant medications were not reported. The patient's husband reported that the patient received the first Covid shot about a week to two weeks ago. She went to the facility and got the shot and was fine afterwards until she came home. Later that afternoon, she started showing symptoms of problems, was weak and couldn't walk, disoriented, wanted to sleep, was incoherent, couldn't/wouldn't eat, was very, very much having trouble, shallow breathing. He tried to stay right her and eventually it got to be scary for him with her shallow breathing. He ended up calling an ambulance and she went to the hospital. They gave her tests and was there until about 4 or 5 in the morning before she started showing signs. She was dehydrated was a part of it. The tests were showing the symptoms were improving and she was beginning to come out of it fortunately with doctor's care because he didn't know what to do. He had been going through materials and she is coming up on another shot next Monday and does not want her to go through that if it can be helped. She was coming up for the second shot. Saw something on the tv that rattled him to his bones. It had been found that people who had Covid virus previously and then got the shot may not need a second shot. He is trying to flush that out to whether or not that is something or not that she should be considering. They have the card to go back to the same place for the second shot and they are trying to figure if they need to set up an appointment now. Hoping that this was the worse of it and it is hard for them to call back and his physician is not an expert on this and he got Pfizer's office contact number and decided to call. Outcome of the events was recovering.  Information on the batch/ lot number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Atrial fibrillation, Body temperature, Chest pain, Chronic obstructive pulmonary disease
Clinical narrative: chest pains; fever over a 100°F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose on 25Jan2021 and experienced health issues in Jan2021 as AFib, diabetic, COPD, stomach issues, and reported to "have a lot of issues". The primary doctor thought it's better for her to get the dose than get COVID-19. Patient also reported that about 20 minutes after the first dose on 25Jan2021, patient had chest pains, from one side clear across the other side and took a Nitro, and patient had fever over a 100 degree F for 24 hours. The outcome of the events was unknown.   Information on about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Pyrexia
Clinical narrative: chest pains; fever over a 100°F; AFib; diabetic; COPD; stomach issues; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received first dose on 25Jan2021 and experienced health issues in Jan2021 as AFib, diabetic, COPD, stomach issues, and reported to "have a lot of issues". The primary doctor thought it's better for her to get the dose than get COVID-19. Patient also reported that about 20 minutes after the first dose on 25Jan2021, patient had chest pains, from one side clear across the other side and took a Nitro, and patient had fever over a 100 degree F for 24 hours. The outcome of the events was unknown.   Information on about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Premature baby, Tachycardia foetal
Clinical narrative: The baby had to be delivered at 35 3/7 weeks; Exposure during pregnancy; Fetal tachycardia noted 1 week after the 2nd dose of the vaccine. The infant had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring; This is a Spontaneous report from a contactable physician. This physician reported information for a mother and baby. This is baby report.   A neonate's  mother (mother was reported as 35-year-old) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN ), intramuscular on 02Feb2021  as a single dose for COVID-19 immunization. The patients mothers medical history and concomitant medications were not reported. The baby experienced fetal tachycardia noted 1 week after the 2nd dose of the vaccine in Feb2021 (also reported as 02Feb2021). The baby had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring on. The patient was hospitalized for 5 days. The clinical outcome of Fetal tachycardia noted 1 week after the 2nd dose of the vaccine. The baby had to be delivered at 35 3/7 weeks due to non-reassuring status during monitoring was unknown.  Information on lot number was requested.; Sender's Comments: Based on the available information a causal relationship between events "fetal tachycardia noted 1 week after the 2nd dose of the vaccine" and  "the baby had to be delivered at 35 3/7 weeks" and  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021166872 mother/fetus
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest pain, Dizziness, Headache, Myalgia
Clinical narrative: AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Palpitations, Paraesthesia
Clinical narrative: AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.