chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Loss of personal independence in daily activities, Movement disorder, Paraesthesia
Clinical narrative: she had the prickly feeling like when her nerves were regenerating; feeling draining from my right arm from the site of the shot downward to my finger tips/ I lost more and more feeling; numbness in my peripheral nerves/have not fully regained the feeling in my palm and fingers; trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue; could not get my arm to move and steer the car properly; weakness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number : ER2613) via an unspecified route of administration, administered on the right arm on 21Mar2021 10:30 at a single dose for COVID-19 immunization. Medical history included GBS (when I was 20 years old), Type 2 diabetes mellitus and high blood pressure related to type 2. Concomitant medications included rosuvastatin and metoprolol succinate. The patient previously took paracetamol (TYLENOL) and experienced allergies (anything with Tylenol). In less than 5 hours after the vaccine (21Mar2021 03:30 PM), patient started to feel the feeling draining from her right arm from the site of the shot downward to her finger tips. As each hour passed, she lost more and more feeling. She had complete numbness in her peripheral nerves for over 48 hours and have not fully regained the feeling in her palm and fingers. She had trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue and nearly caused an accident yesterday b/c she could not get her arm to move and steer the car properly. It has considerable weakness as well. The feeling between her right and left arm were distinctly different and it's really frightening. She was scared she won't get the feeling back in her right arm fully. From my elbow down was still a significant issue. Last 01Apr2021 she did have one incident where she had the prickly feeling like when her nerves were regenerating. The events resulted to a doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Outcome of the events was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: she had the prickly feeling like when her nerves were regenerating; feeling draining from my right arm from the site of the shot downward to my finger tips/ I lost more and more feeling; numbness in my peripheral nerves/have not fully regained the feeling in my palm and fingers; trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue; could not get my arm to move and steer the car properly; weakness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number : ER2613) via an unspecified route of administration, administered on the right arm on 21Mar2021 10:30 at a single dose for COVID-19 immunization. Medical history included GBS (when I was 20 years old), Type 2 diabetes mellitus and high blood pressure related to type 2. Concomitant medications included rosuvastatin and metoprolol succinate. The patient previously took paracetamol (TYLENOL) and experienced allergies (anything with Tylenol). In less than 5 hours after the vaccine (21Mar2021 03:30 PM), patient started to feel the feeling draining from her right arm from the site of the shot downward to her finger tips. As each hour passed, she lost more and more feeling. She had complete numbness in her peripheral nerves for over 48 hours and have not fully regained the feeling in her palm and fingers. She had trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue and nearly caused an accident yesterday b/c she could not get her arm to move and steer the car properly. It has considerable weakness as well. The feeling between her right and left arm were distinctly different and it's really frightening. She was scared she won't get the feeling back in her right arm fully. From my elbow down was still a significant issue. Last 01Apr2021 she did have one incident where she had the prickly feeling like when her nerves were regenerating. The events resulted to a doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Outcome of the events was not recovered.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: I have developed an illness closely resembling pneumonia; This is a spontaneous report received from a contactable consumer (patient). A 32-year-male patient received bnt162b2 (BNT162B2), first dose via an unspecified route of administration, administered in Arm Left on 02Apr2021 15:00 (reported as 3:00 PM) (Batch/Lot Number: Unknown, reason=Misplaced/discarded) as SINGLE DOSE for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient had no known allergies, not tested positive post vaccination, no covid prior to vaccination and no other vaccine in four weeks. The patient's concomitant medications were not reported. The patient reported that: "i have developed an illness closely resembling pneumonia " on 04Apr2021. The outcome of the event was not recovered. There was no treatment for the reported events. The event resulted in Emergency room/department or urgent care.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Electrocardiogram, Fibrin D dimer, Pallor
Clinical narrative: I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Thrombosis
Clinical narrative: I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest pain, Dizziness, Heart rate increased, Red blood cell sedimentation rate normal
Clinical narrative: I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Loss of personal independence in daily activities, Pain, Swelling
Clinical narrative: severe chest pain and left shoulder down to hand and neck; severe chest pain and left shoulder down to hand and neck; internal swelling; Feeling discomfort; unable to perform daily activities; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), via an unspecified route of administration, administered in arm right on 30Mar2021 13:00 (at the age of 63-years-old) as a single dose for covid-19 immunization. The vaccine was administered. The patient medical history included diabetic and blood pressure. The patient had no known allergies. The patient previously received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), administered in arm left on 09Mar2021 11:30 PM (at the age of 63-years-old) for covid-19 immunization and had left shoulder joint pain for about 10 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. It was reported that after the second dose, on the second day (reported on 02Apr2021 at 06:00 AM) had to go to emergency hospital due to severe chest pain and left shoulder down to hand and neck. Developed internal swelling 10 times more than normal. Feeling discomfort and unable to perform daily activities. The events resulted in Emergency room/department or urgent care, Hospitalization for 1 day. No treatment was received for the events. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, auditory, Psychotic disorder
Clinical narrative: Auditory hallucination; Psychosis; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 04Mar2021 12:00 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. The first dose was received on 08Feb2021 (lot number: EL9262) on the left arm.  Medical history included post-traumatic stress disorder, and sleep deprivation for the last 4 years. The patient's concomitant medications were not reported. Patient reported having some weird symptoms the last month. Some of this, she has had but some of this she absolutely hasn't had until right around the second dose of Pfizer COVID-19 Vaccine. She had struggled with some mental health issues most of her life. This last month she reported experiencing auditory hallucinations on Mar2021. She had auditory hallucinations before around the time she gave birth to her son, it was stress induced. In the past like what she got with her son, she would get a song stuck in her head, more like an OCD thing and it was stress induced. This time she would hear really critical things. Patient stated the auditory hallucinations she was experiencing in the last month were different. This last week on 2021, patient reported hearing her neighbors yelling and screaming and actually called the cops on them. She never in her life has she experienced this, these are more paranoia thing. The doctors don't think it was schizophrenia because that usually starts in the 20s. She does not have a family history of this. She has PTSD from her son's rare heart condition, like pretty severely and just had major medical appointment where they gave her bad news. The auditory hallucination could be stress related, but she was trying to turn over every rock. They're trying to monitor it over the next 6 months. Patient thought it was highly unlikely that it was related to the Pfizer COVID-19 Vaccine but could be stress induced. Patient stated that the auditory hallucination she was having currently doesn't fit the normal type that schizophrenia usually does, like it's normally specific people, other people have different experiences, it could also be sleep deprivation or stress induced, but she has been having sleep deprivation for the last 4 years, so it just starting now is odd. The event was getting worse until she sought help for it and now it was slowly getting better. Patient went to Emergency Department three times, third time on 28Mar2021 when she was hospitalized and stated doctors diagnosed her with psychosis. It was all a blur. She was discharged April Fool's Day. She went into the Emergency Department on Friday 26Mar2021, before that it was either the 24Mar2021 or 25Mar2021. The first 2 Emergency Department visits they did not want to admit her, they said they thought she was just really stressed and really sleep deprived. Outcome of the events was recovering.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial flutter, Electrocardiogram, Heart rate, SARS-CoV-2 test, Tachycardia
Clinical narrative: Also had .34 Troponin level; Atrial Flutter episode; Heart racing at 165 BPM; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 19Mar2021 at 16:00 (batch/lot number: EP7534) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included prucalopride succinate (MOTEGRITY) taken for an unspecified indication, start and stop date were not reported. Nine days post vaccine (as reported; pending clarification), the patient had a atrial flutter episode with heart rate at 165 bpm. She went to ER and the atrial flutter was confirmed via EKG. Also had .34 troponin level. She was kept overnight and multiple test were run. She was healthy, active with no other risk factors. The start date of the adverse events were reported as 03Apr2021 (as reported; pending clarification). The adverse events resulted in emergency room/department or urgent care. Treatment was received for the adverse events which included blood thinner, Lipator (as preventative). The events were assessed as serious with the serious criteria of hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, COVID-19 swab taken at ER on 04Apr2021 with negative test result. The outcome of the events was recovered on an unspecified date.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Also had .34 Troponin level; Atrial Flutter episode; Heart racing at 165 BPM; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 19Mar2021 at 16:00 (batch/lot number: EP7534) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included prucalopride succinate (MOTEGRITY) taken for an unspecified indication, start and stop date were not reported. Nine days post vaccine (as reported; pending clarification), the patient had a atrial flutter episode with heart rate at 165 bpm. She went to ER and the atrial flutter was confirmed via EKG. Also had .34 troponin level. She was kept overnight and multiple test were run. She was healthy, active with no other risk factors. The start date of the adverse events were reported as 03Apr2021 (as reported; pending clarification). The adverse events resulted in emergency room/department or urgent care. Treatment was received for the adverse events which included blood thinner, Lipator (as preventative). The events were assessed as serious with the serious criteria of hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, COVID-19 swab taken at ER on 04Apr2021 with negative test result. The outcome of the events was recovered on an unspecified date.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Appendicitis, Computerised tomogram, Fatigue
Clinical narrative: Appendicitis; Abdominal pain/abdominal soreness; stomach started bothering her; not feeling well; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 25Mar2021 10:00 at a single dose for COVID-19 immunisation. Medical history included ongoing asthma (Never smoked a cigarette in my life), Hypothyroidism (started taking levothyroxine about 23 years ago), Diverticulitis (hospitalized for it once in 2015), allergy and environmental allergies. Concomitant medications included levothyroxine for hypothyroidism, loratadine for asthma is triggered by allergies, montelukast for allergy from 2017, fluticasone propionate, salmeterol xinafoate (SALMETEROL AND FLUTICASONE) taken for asthma from 2017, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma attack and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for environmental allergies from 2017 all were ongoing. The patient previously received first dose of BNT162B2 on 03Mar2021 for COVID-19 immunization (IM left arm); flu vaccine (Received every year for the past 14 years) and pneumonia vaccine (gotten the pneumonia vaccine the year prior) both for Immunisation. On 26Mar2021, caller stated that she was not feeling well, her stomach started bothering her and she thought she was going to have diarrhea, but she did not. She was really tired, stating she had to take her mom to an appointment, which was about an hour away and patient slept in the car on the way, and noted that she never sleeps in the car. Felt really really tired. On 28Mar2021 her stomach pain started. She thought it was diverticulitis and that she has history of having diverticulitis years ago and being hospitalized for it once in 2015. She got very sick very quickly. She went to the emergency room on 28Mar2021 at about 1130 and they did a CT scan and found out it was her appendix and she was operated on that afternoon at which time they removed her appendix. Appendicitis require a visit to the emergency room. The patient was hospitalized for appendicitis from 28Mar2021 to 29Mar2021. The doctor told her that she was very fortunate, there was a slight perforation and there was no leakage and she was able to go home on early Monday evening. Shortly after the surgery she felt better. She still does not feel 100% still tired. Glad she got the surgery when she did and it did not rupture. Stated she did not need pain medication. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events appendicitis and stomach started bothering her was recovered on 29Mar2021, not feeling well recovered on 28Mar2021, event tired as not recovered while unknown for the other event.   Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Appendicitis; Abdominal pain/abdominal soreness; stomach started bothering her; not feeling well; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 25Mar2021 10:00 at a single dose for COVID-19 immunisation. Medical history included ongoing asthma (Never smoked a cigarette in my life), Hypothyroidism (started taking levothyroxine about 23 years ago), Diverticulitis (hospitalized for it once in 2015), allergy and environmental allergies. Concomitant medications included levothyroxine for hypothyroidism, loratadine for asthma is triggered by allergies, montelukast for allergy from 2017, fluticasone propionate, salmeterol xinafoate (SALMETEROL AND FLUTICASONE) taken for asthma from 2017, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma attack and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for environmental allergies from 2017 all were ongoing. The patient previously received first dose of BNT162B2 on 03Mar2021 for COVID-19 immunization (IM left arm); flu vaccine (Received every year for the past 14 years) and pneumonia vaccine (gotten the pneumonia vaccine the year prior) both for Immunisation. On 26Mar2021, caller stated that she was not feeling well, her stomach started bothering her and she thought she was going to have diarrhea, but she did not. She was really tired, stating she had to take her mom to an appointment, which was about an hour away and patient slept in the car on the way, and noted that she never sleeps in the car. Felt really really tired. On 28Mar2021 her stomach pain started. She thought it was diverticulitis and that she has history of having diverticulitis years ago and being hospitalized for it once in 2015. She got very sick very quickly. She went to the emergency room on 28Mar2021 at about 1130 and they did a CT scan and found out it was her appendix and she was operated on that afternoon at which time they removed her appendix. Appendicitis require a visit to the emergency room. The patient was hospitalized for appendicitis from 28Mar2021 to 29Mar2021. The doctor told her that she was very fortunate, there was a slight perforation and there was no leakage and she was able to go home on early Monday evening. Shortly after the surgery she felt better. She still does not feel 100% still tired. Glad she got the surgery when she did and it did not rupture. Stated she did not need pain medication. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events appendicitis and stomach started bothering her was recovered on 29Mar2021, not feeling well recovered on 28Mar2021, event tired as not recovered while unknown for the other event.   Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure measurement, Dizziness, Head discomfort, Hypertension
Clinical narrative: Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; Lymph nodes in head, neck and under arms swollen; very high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Six days after the vaccine (on 23Mar2021 10:15 ), the patient started to feel light headed, unbalanced. Blacked out on March 23rd for a very short time. Having trouble to focus with his eyes. Head feels full. Lymph nodes in head, neck and under arms swollen. Very high blood pressure and now needing medication for that. These last two weeks have been a nightmare and thinking he was going to die and was in the Emergency room. No treatment was received for the events. Event blacked out seriousness was medically significant. The events outcome was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Lymphadenopathy, Vision blurred
Clinical narrative: Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; Lymph nodes in head, neck and under arms swollen; very high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Six days after the vaccine (on 23Mar2021 10:15 ), the patient started to feel light headed, unbalanced. Blacked out on March 23rd for a very short time. Having trouble to focus with his eyes. Head feels full. Lymph nodes in head, neck and under arms swollen. Very high blood pressure and now needing medication for that. These last two weeks have been a nightmare and thinking he was going to die and was in the Emergency room. No treatment was received for the events. Event blacked out seriousness was medically significant. The events outcome was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Migraine, Muscle tightness, Nasopharyngitis
Clinical narrative: life stopping migraine; tighten muscles around the back of my neck and shoulder muscles; VERY nauseated; small fever; be cold; chills; soaked in sweat; This is a spontaneous report from a contactable consumer(patient). A 42-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 13Mar2021 (Batch/Lot Number: F(E)N6208) as SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included Stroke, anorexia, gastroparesis, asthma, thyroid, low BP, hypotension, known allergies -Sulfa, Paxil, Demerol. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 09Feb2021 10:30 AM (Batch/Lot Number: EM9809 as SINGLE DOSE for covid-19 immunisation. Concomitant medications received within 2 weeks of vaccination included Fentanyl patch, seroquel, trazodone, ambien, baclofen. The patient previously took paxil and experienced known allergies-sulfa, demerol and experienced known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 14Mar2021 at 04:00, the patient experienced life stopping migraine, tighten muscles around the back of my neck and shoulder muscles, very nauseated, small fever, be cold, chills, soaked in sweat. The patient did not receive any treatment for the events. Outcome of all the events was recovered with sequelae.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: life stopping migraine; tighten muscles around the back of my neck and shoulder muscles; VERY nauseated; small fever; be cold; chills; soaked in sweat; This is a spontaneous report from a contactable consumer(patient). A 42-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 13Mar2021 (Batch/Lot Number: F(E)N6208) as SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included Stroke, anorexia, gastroparesis, asthma, thyroid, low BP, hypotension, known allergies -Sulfa, Paxil, Demerol. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 09Feb2021 10:30 AM (Batch/Lot Number: EM9809 as SINGLE DOSE for covid-19 immunisation. Concomitant medications received within 2 weeks of vaccination included Fentanyl patch, seroquel, trazodone, ambien, baclofen. The patient previously took paxil and experienced known allergies-sulfa, demerol and experienced known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 14Mar2021 at 04:00, the patient experienced life stopping migraine, tighten muscles around the back of my neck and shoulder muscles, very nauseated, small fever, be cold, chills, soaked in sweat. The patient did not receive any treatment for the events. Outcome of all the events was recovered with sequelae.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Head discomfort, Headache, Myalgia
Clinical narrative: extreme fatigue; joint pain; muscle pain; nerve pain; hives; large red skin blotches on arm where vaccinated; Swelling in limbs; Headache; head pressure; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6208), in left arm on 18Mar2021 04:30 PM (at the age of 43-year-old) at single dose for COVID-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD) and seborrhea. No allergies to medications, food, or other products were reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported, no other medications were received by the patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 06:30 PM the patient experienced extreme fatigue, joint pain, muscle pain, nerve pain, hives, large red skin blotches on arm where vaccinated, swelling in limbs, headache and head pressure. The events were reported as serious since resulted in disability or permanent damage. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event as steroid pills, ibuprofen, aspercreme rubs and ice pack. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Peripheral swelling, Rash macular, Urticaria
Clinical narrative: extreme fatigue; joint pain; muscle pain; nerve pain; hives; large red skin blotches on arm where vaccinated; Swelling in limbs; Headache; head pressure; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6208), in left arm on 18Mar2021 04:30 PM (at the age of 43-year-old) at single dose for COVID-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD) and seborrhea. No allergies to medications, food, or other products were reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported, no other medications were received by the patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 06:30 PM the patient experienced extreme fatigue, joint pain, muscle pain, nerve pain, hives, large red skin blotches on arm where vaccinated, swelling in limbs, headache and head pressure. The events were reported as serious since resulted in disability or permanent damage. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event as steroid pills, ibuprofen, aspercreme rubs and ice pack. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Lip swelling, Oral pain, Oropharyngeal pain, Pain in jaw
Clinical narrative: Mouth hurt very bad.; I was having an autoimmune reaction to the vaccine; I woke up and my lips abs tongue were swollen; I woke up and my lips abs tongue were swollen; I could smile and it hurt to talk.; I went to ER because my throat was also starting to hurt; This is a spontaneous report from a contactable consumer (patient).  A 37-year-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Mar2021 at 11:00 in left arm at single dose for COVID-19 immunisation (lot number was En6202). Medical history included Inflammatory bowel disease (IBD), chronic anemia, l5-s1 disc herniation, obesity, Gastrooesophageal reflux disease (GERD), migraine, known allergies: benzoyl peroxide and Cefalexin, mouth ulcers. Historical vaccine included first dose of received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Feb2021 at 11:00 in right arm at single dose for COVID-19 immunisation (lot_number En6203). The patient was not pregnant at the time of vaccination. Concomitant medications included chlorthalidone; budesonide; ferrous sulfate. The patient had 2-3 mouth ulcers already forming when she received 2nd shot; the patient had IBD and mouth ulcers often happen to her. On 21Mar2021, the patient woke up and her lips abs tongue were swollen. The patient could smile and it hurt to talk. Mouth hurt very bad. The patient went to ER because her throat was also starting to hurt and she was worried it would swell like her lips. ER doctor said the patient was having an autoimmune reaction to the vaccine on 21Mar2021 at 07:00. The patient was no treated for the events. The patient recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Mouth hurt very bad.; I was having an autoimmune reaction to the vaccine; I woke up and my lips abs tongue were swollen; I woke up and my lips abs tongue were swollen; I could smile and it hurt to talk.; I went to ER because my throat was also starting to hurt; This is a spontaneous report from a contactable consumer (patient).  A 37-year-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Mar2021 at 11:00 in left arm at single dose for COVID-19 immunisation (lot number was En6202). Medical history included Inflammatory bowel disease (IBD), chronic anemia, l5-s1 disc herniation, obesity, Gastrooesophageal reflux disease (GERD), migraine, known allergies: benzoyl peroxide and Cefalexin, mouth ulcers. Historical vaccine included first dose of received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Feb2021 at 11:00 in right arm at single dose for COVID-19 immunisation (lot_number En6203). The patient was not pregnant at the time of vaccination. Concomitant medications included chlorthalidone; budesonide; ferrous sulfate. The patient had 2-3 mouth ulcers already forming when she received 2nd shot; the patient had IBD and mouth ulcers often happen to her. On 21Mar2021, the patient woke up and her lips abs tongue were swollen. The patient could smile and it hurt to talk. Mouth hurt very bad. The patient went to ER because her throat was also starting to hurt and she was worried it would swell like her lips. ER doctor said the patient was having an autoimmune reaction to the vaccine on 21Mar2021 at 07:00. The patient was no treated for the events. The patient recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: 27MAR2021 had heart attack; This is a spontaneous report from a support program, received from a contactable consumer. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on 18Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that received first dose on 18Mar2021, scheduled to receive second dose on 08Apr2021. On 27Mar2021 he had heart attack. He was asking if he should receive second dose. He was taking LIPITOR and PLAVIX. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 01:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included ADHD, depression, High Blood Pressure, high cholesterol, Allergies to medications, food, or other products:Penicillin. Concomitant medications included losartan (LOSARTAN); paroxetine hydrochloride (PAXIL CR); atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); all taken for unspecified indications, start and stop dates were not reported. On 04Apr2021 12:00, the patient experienced Bell's Palsy. The patient did not receive treatment for the event. The outcome of the event was not recovered.     Information about batch/lot number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Lost consciousness approximately 3 minutes after receiving first dose of vaccine. was feeling fine after vaccine until they stood up.; This is a spontaneous report received from a contactable consumer (patient). A 17-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153, expiration date unknown), via unspecified route of administration in left arm on 05Apr2021 at 11:30 AM at a single dose for COVID-19 immunization. The medical history was not reported. Patient did not receive any other vaccine in four weeks. No allergies to medications, food, or other products No known allergies. Concomitant medications included birth control pills (other medications in two weeks). On 05Apr2021 at 11:30 AM, the patient lost consciousness approximately 3 minutes after receiving first dose of vaccine and was feeling fine after vaccine until they stood up. Treatment included the emergency room/department or urgent care, treatment was EKG, concussion test. No covid prior vaccination. There was no covid test performed post vaccination. The patient considered the event as non-serious. The patient recovered from the event on 05Apr2021.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: received the first dose of the vaccine on 17Mar2021, tested positive for Covid on 25Mar2021; This is a spontaneous report from a contactable consumer via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Mar2021 I received my 1st Pfizer covid vaccine. On 25Mar2021 I was infused with Bamlanivimab after testing positive for Covid. The caller stated she reviewed what she had written and realized she wrote it wrong. She received the first dose of the vaccine on 17Mar2021, tested positive for Covid on 25Mar2021 and received this medication on the 25Mar2021 as well. The outcome of event was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Gait disturbance, Limb discomfort, Myocardial infarction
Clinical narrative: my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; I was afraid I was having a heart attack; Initial hyperactivity; tiredness; chest pains; urge to vomit; body aches all over; This is a spontaneous report received from a contactable consumer (patient herself). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration in left arm on 01Apr2021 at 16:00 (at the age of 49-year-old) as a single dose for COVID-19 immunization. The patient's medical history included issues with anemia in the past and known allergies: Tree nuts was all that I am aware of (allergies to medications, food, or other products: Tree nuts was all that I am aware of). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccine within four weeks of vaccination. The patient did not receive other medications within two weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. No COVID prior vaccination. The patient was not tested for COVID post vaccination. It was reported that the, initial hyperactivity on 04Apr2021 (patient think it was the anticipation of the shot), followed by tiredness that evening on 04Apr2021, Friday, Saturday, and Sunday. With the exception of having lunch with a friend on Saturday and stopping by to check on her mom, patient stayed home all weekend because she was feeling very tired. Late Sunday night after going to bed she awoke with chest pains and the urge to vomit on 04Apr2021. Patient was up and down vomiting for several hours and began to experience body aches all over on 04Apr2021. At one point she was afraid she was having a heart attack on 04Apr2021. On Monday morning and throughout the day she was still experiencing body aches and stayed home from the office. Patient slept propped up on the living room sofa Monday night because lying down made her body aches worse. Today, Tuesday 06Apr2021, her right leg was still bothering her, it feels a little bloated, so she was walking slower than usual. Otherwise she feel normal. The events were considered as serious (life threatening, hospitalization) by the consumer. No treatment medications were received for the adverse events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.