chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis
Clinical narrative: Abrupt onset of a severe colitis attack requiring trip to ER; This is a spontaneous report from a contactable consumer. This 53-years-old female consumer (patient) reported for herself that:  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 16:45 (Batch/Lot Number: EP7533) as single dose at the age of for COVID-19 immunisation.  Medical history included endometriosis and ulcerative colitis (had been in remission over 20 years prior to this occurrence), allergy toTetracycline. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) within 2 weeks of vaccination included elderberry [sambucus nigra] (manufacturer unknown), ascorbic acid, zinc (manufacturer unknown), colecalciferol (VITAMIN D, manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced abrupt onset of a severe colitis attack requiring trip to ER on 16Apr2021 20:00. The patient was hospitalized for the event and has been treated with antibiotics and prednisone. Therapeutic measures were taken as a result of the event. Since the vaccination, the patient has not been tested for COVID-19.  The outcome of event was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to arthropod sting
Clinical narrative: Allergic reactions to insect bites such as bed bugs, fleas, spiders, mosquitoes, etc.; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 31Mar2021 at 10:45 AM (Lot Number: ER8734), as single dose, for COVID-19 immunisation. The patient's medical history was not reported. The patient has not been diagnosed with COVID-19 prior to vaccination. Patient has never been allergic to any medication. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced allergic reactions to insect bites such as bed bugs, fleas, spiders, mosquitoes, etc. (medically significant) on 18Apr2021 at 10:00 AM with outcome of not recovered. The event required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the event and included treatment with Mometasone Furoate Ointment 0.1%, Calamine Plus. On 20Apr2021 the patient visited his doctor who told him that these bites were from bugs that may have been connected to an allergic reaction to the vaccine. The patient has not been tested for COVID-19 since the vaccination.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Aphthous ulcer, Dyspnoea, Feeding disorder, Nucleic acid test
Clinical narrative: developed more than 6 canker sores in the back and roof of his mouth; developed more than 6 canker sores in the back and roof of his mouth; this has made it extremely painful to breathe, much less try to eat or drink anything; developed more than 6 canker sores in the back and roof of his mouth; this has made it extremely painful to breathe, much less try to eat or drink anything; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0176), via an unspecified route of administration, administered in the left arm on 05Apr2021 as 2nd dose, single for covid-19 immunization. Medical history included vestibular schwannoma, vestibular migraine, chronic sinusitis, hypothyroidism, and hyperlipidemia. Concomitant medications included atorvastatin; clarithromycin (BIAXIN); budesonide and; levothyroxine - all taken for unspecified indications, start and stop dates were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8732) administered in the left arm on an unspecified date for covid-19 immunization. The patient previously took levocetirizine (XYZAL) and experienced allergic. Prior to the vaccination, the patient was not diagnosed with covid-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The vaccine was administered in the doctor's office/urgent care. On 27Apr2021 08:00 "within 24 hours" (as reported) of receiving the second dose of the Pfizer covid-19 vaccine, the patient developed more than 6 canker sores in the back and roof of his mouth; this has made it extremely painful to breathe, much less try to eat or drink anything. The only way he can eat anything was to take several OTC pain killers to dull the pain (of canker sores). No treatment was received for the other remaining adverse event. To the patient's understanding, this was an extremely rare side effect of the Pfizer covid-19 vaccine. The adverse events resulted in emergency room department or urgent care. The patient had not recovered from the adverse events at the time of the report. The adverse events were assessed with seriousness criterion of medically significant. The patient had a negative qualitative NAAT nasal swab on 19Apr2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm just a little sore; This is a spontaneous report from a contactable consumer (patient). This 35-year-old non-pregnant female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK8732) on 31Mar2021 at 07:00, in right arm, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have COVID. After the first vaccination the patient was ok, her arm was just a little sore on an unspecified date in 2021. Event outcome was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021492259 same patient, vaccine, different dose and event
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 03:00 PM (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included prior to vaccination, the patient was diagnosed with COVID-19; had known allergies and other medical history. The patient had other medications received within 2 weeks of vaccination, name was unspecified. Reported Event: I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes. The events resulted in Emergency room/department or urgent care.  adverse event start date 27Apr2021, adverse event start time 03:00 PM. No treatment received for events. The Serious was reported as No. The event outcome was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 03:00 PM (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included prior to vaccination, the patient was diagnosed with COVID-19; had known allergies and other medical history. The patient had other medications received within 2 weeks of vaccination, name was unspecified. Reported Event: I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes. The events resulted in Emergency room/department or urgent care.  adverse event start date 27Apr2021, adverse event start time 03:00 PM. No treatment received for events. The Serious was reported as No. The event outcome was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity
Clinical narrative: diagnosed with Sciatica; intense pain in her buttocks; Pain in Hip; Pain in leg; Unable to sit; Unable to sleep; unable to sit, sleep and therefore work; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 28Mar2021 (Lot Number: ER8732) as single dose for covid-19 immunisation. Medical history included high blood pressure, known allerges:-illins and some other medications. Concomitant medications included prednisone taken for an unspecified indication, start and stop date were not reported and high blood pressure medication. The patient previously received first dose of bnt162b2 on 07Mar2021 (Batch/lot number - EN6199) for COVID-19 immunization. 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. Clinical course reported as: On 30Mar2021 (about 36 hours after injection, reported as 30Mar2021 07:00) patient woke up with intense pain in her buttocks, hip and leg. It was the worst pain ever, even lasting now but easing up finally. 2 weeks later she was diagnosed with Sciatica. She never had Sciatica before nor did she had symptoms that resemble Sciatica before. She was unable to sit, sleep and therefore work. The pain was the worst she ever experienced. Fast forward to now and she was finding out that she was not the only one that all of a sudden has Sciatica issues after the vaccine. She thought it was related. She was struggling but doing much better compared with the 1st 3 weeks. She 1st thought it couldn't be related but she had 2 other friends who all of a sudden have similar symptoms to her after getting the vaccine. So that was why she was reporting this. Treatment received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica, Sitting disability
Clinical narrative: diagnosed with Sciatica; intense pain in her buttocks; Pain in Hip; Pain in leg; Unable to sit; Unable to sleep; unable to sit, sleep and therefore work; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 28Mar2021 (Lot Number: ER8732) as single dose for covid-19 immunisation. Medical history included high blood pressure, known allerges:-illins and some other medications. Concomitant medications included prednisone taken for an unspecified indication, start and stop date were not reported and high blood pressure medication. The patient previously received first dose of bnt162b2 on 07Mar2021 (Batch/lot number - EN6199) for COVID-19 immunization. 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. Clinical course reported as: On 30Mar2021 (about 36 hours after injection, reported as 30Mar2021 07:00) patient woke up with intense pain in her buttocks, hip and leg. It was the worst pain ever, even lasting now but easing up finally. 2 weeks later she was diagnosed with Sciatica. She never had Sciatica before nor did she had symptoms that resemble Sciatica before. She was unable to sit, sleep and therefore work. The pain was the worst she ever experienced. Fast forward to now and she was finding out that she was not the only one that all of a sudden has Sciatica issues after the vaccine. She thought it was related. She was struggling but doing much better compared with the 1st 3 weeks. She 1st thought it couldn't be related but she had 2 other friends who all of a sudden have similar symptoms to her after getting the vaccine. So that was why she was reporting this. Treatment received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Disease recurrence, IgA nephropathy, Urine analysis
Clinical narrative: Diagnoses with IGa Nephropathy in Aug2019 / 2 days after taking the vaccine it triggered his symptoms; Diagnoses with IGa Nephropathy in Aug2019 / 2 days after taking the vaccine it triggered his symptoms; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm at age of 17-years, on 28Apr2021 16:00 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included IgA nephropathy from Aug2019. Concomitant medication included enalapril (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with IgA Nephropathy in Aug2019 - dx confirmed through biopsy. 2 days after taking the vaccine it triggered his symptoms of large amounts of blood and protein in his urine. His urine was bright red. Labs were ordered by his nephrologist and would be done today (on 03May2021). The adverse event result in "Doctor or other healthcare professional office/clinic visit". Adverse event started at 18:30 on 01May2021. There was no treatment for events. The patient did not diagnose with COVID-19 prior to vaccination and not test for COVID-19 since the vaccination. Events outcome was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Abdominal pain upper, Chills, Diarrhoea, Feeling of body temperature change
Clinical narrative: excruciating pain in her stomach; could not sleep at night; chills; sweating; she was sweating cold chills, then hot; diarrhea; she had severe abdomen pain in her right lower side; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on an unspecified date (Lot Number: Ek0153) at age of 36-year-old as unknown, single for COVID-19 immunization.  Medical history was none. The patient's concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medications the patient received within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 31Mar2021 07:00 Am (Lot Number: Ek8732) at age of 35-year-old for Covid-19 Immunization. On 21Apr2021 21:00, after the second shot was way worse she could not sleep at night she was sweating cold chills, then hot. The diarrhea, her body acting that night she had severe abdomen pain in her right lower side that worked its way up to the whole right side of her stomach to all around her stomach. Went to the doctor the next day didn't do nothing assumed it was possibly a bug even though she live in the house with three other people who had none of the symptoms. The next night she was at the ER because she woke up at 3 o clock in the morning and excruciating pain in her stomach. The doctor is assuming that it was a possible side effect maybe that was just going to go away did not want to give her x-rays or a CT scan he said he did not feel it was necessary but if she wanted the radiation he will go ahead and do it. Seriousness criteria reported as disabling/incapacitating. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included Dicyclomine 20mg. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021491110 same patient, vaccine, different dose and event
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia
Clinical narrative: excruciating pain in her stomach; could not sleep at night; chills; sweating; she was sweating cold chills, then hot; diarrhea; she had severe abdomen pain in her right lower side; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on an unspecified date (Lot Number: Ek0153) at age of 36-year-old as unknown, single for COVID-19 immunization.  Medical history was none. The patient's concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medications the patient received within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 31Mar2021 07:00 Am (Lot Number: Ek8732) at age of 35-year-old for Covid-19 Immunization. On 21Apr2021 21:00, after the second shot was way worse she could not sleep at night she was sweating cold chills, then hot. The diarrhea, her body acting that night she had severe abdomen pain in her right lower side that worked its way up to the whole right side of her stomach to all around her stomach. Went to the doctor the next day didn't do nothing assumed it was possibly a bug even though she live in the house with three other people who had none of the symptoms. The next night she was at the ER because she woke up at 3 o clock in the morning and excruciating pain in her stomach. The doctor is assuming that it was a possible side effect maybe that was just going to go away did not want to give her x-rays or a CT scan he said he did not feel it was necessary but if she wanted the radiation he will go ahead and do it. Seriousness criteria reported as disabling/incapacitating. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included Dicyclomine 20mg. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021491110 same patient, vaccine, different dose and event
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: not sure if had COVID right now; not sure if had COVID right now; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified gender and age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first vaccine, and the second vaccine will be tomorrow. The patient was not sure if he/she had a COVID right now. The patient was not sure and wanted to tell how he/she felt. The patient was not sure if this was COVID and thought maybe not maybe yes. The patient needed to talk to somebody to know about it and about how he/she was feeling. The outcome of the event was unknown.    No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My knees also hurt; Dizziness; Skin was very pale and cold to the touch.; Profuse sweating.; Fatigue; Muscle Pain; Fainting 9 hours after administration; I had my first headache.; I had pins and needles in fingers 4 and 5 in the arm of vaccine administration; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:30 (Lot Number: EW0170), at age of 53 years old, at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took asparagus for Allergy. Reported Event: Immediately after the vaccine, I had pins and needles in fingers 4 and 5 in the arm of vaccine administration. 3 hours after vaccine, I had my first headache. Severe headache, dizziness, fainting 9 hours after administration. During fainting episode, skin was very pale and cold to the touch. Profuse sweating. This was on the same day as vaccine administration. For the next 3 days, I laid in bed with fatigue, severe headache, and muscle pain. After 10 days, I still feel weak, I get tired after walking half a mile, and I have episodes of dizziness during the day. My lower extremities, from the knee down, are weak and sometimes it is hard to walk. My knees also hurt. This is still present 10 days after the vaccine. Outcome for events was unknown. Prior to vaccination, whether the patient was diagnosed with COVID-19 Was Unknown, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Muscular weakness, Myalgia, Pain in extremity, Pallor
Clinical narrative: My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My knees also hurt; Dizziness; Skin was very pale and cold to the touch.; Profuse sweating.; Fatigue; Muscle Pain; Fainting 9 hours after administration; I had my first headache.; I had pins and needles in fingers 4 and 5 in the arm of vaccine administration; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:30 (Lot Number: EW0170), at age of 53 years old, at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took asparagus for Allergy. Reported Event: Immediately after the vaccine, I had pins and needles in fingers 4 and 5 in the arm of vaccine administration. 3 hours after vaccine, I had my first headache. Severe headache, dizziness, fainting 9 hours after administration. During fainting episode, skin was very pale and cold to the touch. Profuse sweating. This was on the same day as vaccine administration. For the next 3 days, I laid in bed with fatigue, severe headache, and muscle pain. After 10 days, I still feel weak, I get tired after walking half a mile, and I have episodes of dizziness during the day. My lower extremities, from the knee down, are weak and sometimes it is hard to walk. My knees also hurt. This is still present 10 days after the vaccine. Outcome for events was unknown. Prior to vaccination, whether the patient was diagnosed with COVID-19 Was Unknown, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My knees also hurt; Dizziness; Skin was very pale and cold to the touch.; Profuse sweating.; Fatigue; Muscle Pain; Fainting 9 hours after administration; I had my first headache.; I had pins and needles in fingers 4 and 5 in the arm of vaccine administration; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:30 (Lot Number: EW0170), at age of 53 years old, at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took asparagus for Allergy. Reported Event: Immediately after the vaccine, I had pins and needles in fingers 4 and 5 in the arm of vaccine administration. 3 hours after vaccine, I had my first headache. Severe headache, dizziness, fainting 9 hours after administration. During fainting episode, skin was very pale and cold to the touch. Profuse sweating. This was on the same day as vaccine administration. For the next 3 days, I laid in bed with fatigue, severe headache, and muscle pain. After 10 days, I still feel weak, I get tired after walking half a mile, and I have episodes of dizziness during the day. My lower extremities, from the knee down, are weak and sometimes it is hard to walk. My knees also hurt. This is still present 10 days after the vaccine. Outcome for events was unknown. Prior to vaccination, whether the patient was diagnosed with COVID-19 Was Unknown, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian vein thrombosis, Pain, Poor peripheral circulation, SARS-CoV-2 test negative
Clinical narrative: thrombosis in left ovary vein; blood in her legs was not circulating well; pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 30Mar2021 (Batch/Lot Number: EN6204) as 2nd dose, single for covid-19 immunisation. The first dose was received on 10Mar2021 (lot number: EN6204). Medical history included allergy to cherry. Patient was not pregnant. The patient's concomitant medications were not reported. No other vaccines were received within 4 weeks prior. The patient previously took cortisone and experienced allergy. On 05Apr2021, patient was admitted to hospital with thrombosis in left ovary vein. Moreover, blood in her legs was not circulating well, causing her so much pain. The event resulted in emergency care. Patient was given anticoagulants as treatment for 6 months. Patient was discharged on 08Apr2021. Patient had not been diagnosed with COVID prior to vaccination and had been tested post vaccination on an unspecified date with negative results. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever, chills, shortness of breath persisting over a week after the vaccine; Fever, chills, shortness of breath persisting over a week after the vaccine; Fever, chills, shortness of breath persisting over a week after the vaccine; This is a spontaneous report from a non-contactable other hcp. A 23-years-old no pregnant female patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Apr2021 16:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, shortness of breath persisting over a week after the vaccine on 28Apr2021 with outcome of unknown. The event shortness of breath result in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Events are non serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hyperhidrosis, Influenza like illness, Loss of consciousness
Clinical narrative: flu like symptoms; headache; Shaky; pass out; feel faint; felt a bit achy; sweat; very weak; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 29Apr2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. at the age of 51 years old. The patient medical history was not reported. The patient was not pregnant.  Concomitant medication(s) included loratadine, pseudoephedrine (CLARIDIN-D) (medications the patient received within 2 weeks of vaccination). The patient previously took bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:30 AM (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. 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 experienced pass out, feel faint, felt a bit achy, sweat, very weak,shaky all on 30Apr2021 07:30, flu like symptoms and headache on an unspecified date. Reported as: I received my shot on Thursday afternoon. Friday morning, I woke up and felt a bit achy, but otherwise OK. I drove my daughter to school and in the car on the way, I began to feel faint. I pulled over, broke into a sweat, and proceeded to pass out in the drivers seat. My daughter called my friend who picked us up. I was shaky, and very weak. I went home, had fluids and slept for the remainder of the day with flu like symptoms and a headache. By Sunday, I was back to normal. Since the vaccination, the patient has not  been tested for COVID-19. The outcome of the events was recovered.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain, Syncope
Clinical narrative: flu like symptoms; headache; Shaky; pass out; feel faint; felt a bit achy; sweat; very weak; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 29Apr2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. at the age of 51 years old. The patient medical history was not reported. The patient was not pregnant.  Concomitant medication(s) included loratadine, pseudoephedrine (CLARIDIN-D) (medications the patient received within 2 weeks of vaccination). The patient previously took bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:30 AM (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. 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 experienced pass out, feel faint, felt a bit achy, sweat, very weak,shaky all on 30Apr2021 07:30, flu like symptoms and headache on an unspecified date. Reported as: I received my shot on Thursday afternoon. Friday morning, I woke up and felt a bit achy, but otherwise OK. I drove my daughter to school and in the car on the way, I began to feel faint. I pulled over, broke into a sweat, and proceeded to pass out in the drivers seat. My daughter called my friend who picked us up. I was shaky, and very weak. I went home, had fluids and slept for the remainder of the day with flu like symptoms and a headache. By Sunday, I was back to normal. Since the vaccination, the patient has not  been tested for COVID-19. The outcome of the events was recovered.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a contactable nurse (patient's sister). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 15Jan2021 at 18:30 (Lot Number: EL1283) at 1st dose, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included rabeprazole sodium (ACIPHEX) taken for acid digestion. On 31Jan2021 at 08:00, patient had a stroke (very mild stroke with just some care needed but, not much). She was not able to receive the second dose because she was in the hospital. Caller would like to consult on some guidelines for receiving the vaccine after 6 weeks. The reported wanted to know if the patient need to start all over again. The patient was hospitalized for stroke (cerebrovascular accident) from 31Jan2021 to 03Feb2021 and then went to Rehabilitation right after and was there for 2 weeks. She was currently doing speech therapy because that is what she qualifies for. Things were improving, she has been released from physical rehab but still qualifies for the speech therapy. Outcome of the event was recovering.; Sender's Comments: Based on the limited information and the advanced age, the event stroke is considered more likely an intercurrent medical condition that was unrelated to BNT162B2. Additional information including detailed event information, relevant present and past medical conditions would be needed to better assess the case. 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.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Legs were hot to touch and hurt to walk on.; Legs were hot to touch and hurt to walk on.; This is a spontaneous report from a non-contactable consumer (patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 30Apr2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history included vascular, Clotting, and Immune disease. The patient's concomitant medications were not reported. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on an unknown date for covid-19 immunisation. On 02May2021, the patient experienced Legs were hot to touch and hurt to walk on. The events caused physician office visit and hospitalization. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Fall, Hallucination, Obsessive-compulsive personality disorder
Clinical narrative: Hallucinations; Compulsive Behavior; Weakness; Falling; Confusion; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Mar2021 (Lot Number: EN6201) as 2nd dose, single for covid-19 immunization. The patient received the 1st dose of bnt162b2 (lot number EP6955) on 09Feb2021 in left arm for covid-19 immunization. Medical history included parkinsons. The patient had no other vaccine in four weeks, not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. Concomitant medications included rivastigmine (EXELON PATCH 10). The patient experienced hallucinations, compulsive behavior, weakness, falling, and confusion; all in Apr2021 with outcome of recovering. Therapeutic measures were taken as a result of the events and patient stopped taking exelon. The events resulted in doctor or other healthcare professional office/clinic visit.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia, Ulcer haemorrhage
Clinical narrative: bleeding ulcer; pneumonia; COVID infection; COVID infection (one month after he received the first covid vaccine); This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The wife called on behalf of husband who received the first dose on 16feb2021 while he was in rehab facility. The patient was not able to get the second dose as he became sick with bleeding ulcer and had to go to hospital for 2 weeks. After he was released from hospital, on 16Mar2021 he was diagnosed with pneumonia and COVID infection (one month after he received the first covid vaccine). The wife was asking if her husband has to start over with the series given it has been almost 3 months since his first dose. The patient was hospitalized for bleeding ulcer (ulcer haemorrhage) for 15 days. The outcome of the events was unknown.  Information on the batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Dizziness, Investigation, Muscular weakness, Neck pain
Clinical narrative: needle like pain across back and neck; needle like pain across back and neck; weakness in left arm; initial faintness at onset; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0170), via an unspecified route of administration administered in the right arm on 01May2021 12:30 as 1st dose, single for covid-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccination. The patient was not diagnosed with covid-19 prior to the vaccination. The patient experienced extreme needle like pain across back and neck - the pain still continues, weakness in left arm, and initial faintness at onset. Due to these, the patient then went to the emergency room and all tests were "neg" on 03May2021. The patient was released with script for pain and muscle relaxer, but no treatment was received for the adverse events. The adverse events occurred on 03May2021 01:00, reported as approximately 36 hours after receiving the vaccine. The patient had not recovered from the adverse events at the time of the report. The patient has not been tested for covid-19 since the vaccination.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burns third degree, Computerised tomogram, Condition aggravated, Dysstasia, Electrocardiogram
Clinical narrative: needle like pain across back and neck; needle like pain across back and neck; weakness in left arm; initial faintness at onset; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0170), via an unspecified route of administration administered in the right arm on 01May2021 12:30 as 1st dose, single for covid-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccination. The patient was not diagnosed with covid-19 prior to the vaccination. The patient experienced extreme needle like pain across back and neck - the pain still continues, weakness in left arm, and initial faintness at onset. Due to these, the patient then went to the emergency room and all tests were "neg" on 03May2021. The patient was released with script for pain and muscle relaxer, but no treatment was received for the adverse events. The adverse events occurred on 03May2021 01:00, reported as approximately 36 hours after receiving the vaccine. The patient had not recovered from the adverse events at the time of the report. The patient has not been tested for covid-19 since the vaccination.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Loss of consciousness, Muscular weakness, Myocardial infarction, Neck pain
Clinical narrative: needle like pain across back and neck; needle like pain across back and neck; weakness in left arm; initial faintness at onset; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0170), via an unspecified route of administration administered in the right arm on 01May2021 12:30 as 1st dose, single for covid-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccination. The patient was not diagnosed with covid-19 prior to the vaccination. The patient experienced extreme needle like pain across back and neck - the pain still continues, weakness in left arm, and initial faintness at onset. Due to these, the patient then went to the emergency room and all tests were "neg" on 03May2021. The patient was released with script for pain and muscle relaxer, but no treatment was received for the adverse events. The adverse events occurred on 03May2021 01:00, reported as approximately 36 hours after receiving the vaccine. The patient had not recovered from the adverse events at the time of the report. The patient has not been tested for covid-19 since the vaccination.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Sensitive skin, Swelling face, Syncope
Clinical narrative: needle like pain across back and neck; needle like pain across back and neck; weakness in left arm; initial faintness at onset; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0170), via an unspecified route of administration administered in the right arm on 01May2021 12:30 as 1st dose, single for covid-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccination. The patient was not diagnosed with covid-19 prior to the vaccination. The patient experienced extreme needle like pain across back and neck - the pain still continues, weakness in left arm, and initial faintness at onset. Due to these, the patient then went to the emergency room and all tests were "neg" on 03May2021. The patient was released with script for pain and muscle relaxer, but no treatment was received for the adverse events. The adverse events occurred on 03May2021 01:00, reported as approximately 36 hours after receiving the vaccine. The patient had not recovered from the adverse events at the time of the report. The patient has not been tested for covid-19 since the vaccination.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Dyspnoea, Fatigue, Muscle tightness
Clinical narrative: minor injection muscle site tightness & pain; minor injection muscle site tightness & pain; fevers; muscle aches; shortness of breath; lung pain; severe swelling; pain in my neck&shoulders; pain in my neck&shoulders; fatigue; On April 6th, I tested positive for Covid; The patient received the Pfizer unspecified vaccine on the same date (28Mar2021).; This is a spontaneous report from a contactable consumer (patient).   This is the 1st of 2 reports, for the 1st dose.   A 59 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 13:00 (Lot Number: ER8737) at age of 59 years old as single dose for covid-19 immunisation.  The patient received the Pfizer unspecified vaccine (lot number=ER8735, dose number 2, vaccine location=Left Arm) on the same date (28Mar2021).  Medical history included restless legs syndrome, poison ivy (severe allergy to poison ivy). Concomitant medication(s) within 2 weeks of vaccination included clonazepam 0.5mg. Reported Event: "I had my first shot in my left arm on March 28th. I only had minor injection muscle site tightness & pain that resonated down my left arm for 2-4 days. On April 6th, I tested positive for Covid (Nasal Swab) and experienced fevers, muscle aches shortness of breath, lung pain, severe swelling & pain in my neck & shoulders which persisted until April 16th. I had a second COVID PCR test on April 16th (Nasal Swab). which was also positive. I also have experienced severe fatigue since the onset of Covid on April 6th with only mild relief coming over the last few days beginning on May 1st." Adverse events result in Emergency room/department or urgent care, patient recovered with lasting effects, and no treatment received for events. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome for events was Recovered/Resolved with Sequel(except for Product use for unapproved combination).  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021497277 same patient, same drug, different AE, different dose of vaccine.