chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Panic reaction, Vaccination site pain, Vomiting
Clinical narrative: blackout/ I wasn't able to see him only hear his voice; panicking sensation; mild pain in the administration spot; then I vomited; excessive heat coming out of my body like hot flash; fell on my face; like excessive heat coming out of my body like hot flash , when my husband touched me it became worse I'm talking about the heat; This is a spontaneous report from a contactable consumer, the patient.  A 38-years-old (also reported as 45 years old)  non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration, in the right arm on 01Mar2021 at 13:30 (at the age of 38-years-old) as a single dose,  for covid-19 immunization. The facility in which the vaccine was given was Doctor's office/urgent care  The patient had no known medical history or allergies.  Concomitant medication were reported as yes but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 02Mar2021 04:00, the patient experienced  blackout/ I wasn't able to see him only hear his voice   (medically significant),  panicking sensation, , mild pain in the administration spot, vomited,  like excessive heat coming out of my body like hot flash,  fell on my face, when my husband touched me it became worse I'm talking about the heat. The reporter explained on mild pain in the administration spot, but after I went to bed I woke up to use the restroom and suddenly I had blackout and fell on my face It was panicking sensation my husband rushed for help he was talking to me but I wasn't able to see him only hear his voice then I vomited and there was like excessive heat coming out of my body like hot flash , when my husband touched me it became worse I'm talking about the heat and my eyes were widely open in a scary way. Body temperature was checked with a thermometer and it was 98.1. The patient went back to bed was feeling the same blackout sensation. Consumer stated she is a healthy person in all means and never had such thing before. The patient underwent lab tests and procedures which included body temperature: 98.1 on Mar2021. No treatment was given for the events. The clinical outcome of the events Blackout, Vaccination site pain, fell on face, panicking sensation, vomited, hot flash and Feeling hot was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood glucose fluctuation, Blood glucose increased, Blood pressure increased, Blood pressure measurement
Clinical narrative: allergic to something in the vaccine; Myoclonic jerking; I felt very hot; I started shaking uncontrollably.; Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar; This is a spontaneous report from a contactable consumer.   A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 at 16:00 (at the age of 64)(Batch/Lot Number: EN6205) as a single dose for covid-19 immunisation .  The vaccination was given at a hospital. There were no other vaccinations given within 4 weeks. The patient was not diagnosed with COVID prior to vaccination. Medical history included breast cancer and an allergy to sulfa drugs. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY); levothyroxine, liothyronine (NP THYROID). On 25Feb2021, about 2 hours after the vaccination (18:30) I felt very hot. I was not running a fever. I started shaking uncontrollably. The shaking was not chills. My husband took me to the emergency room. This was their summary. Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar level; Myoclonic jerking; Vaccine reaction I saw my general practitioner the following day and everything was back to normal. I am allergic to something in the vaccine and I am afraid to get the 2nd dose. No treatment was given for the events.The outcome of the events was recovered. The patient was not tested for COVID post vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Myoclonus, Tremor
Clinical narrative: allergic to something in the vaccine; Myoclonic jerking; I felt very hot; I started shaking uncontrollably.; Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar; This is a spontaneous report from a contactable consumer.   A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 at 16:00 (at the age of 64)(Batch/Lot Number: EN6205) as a single dose for covid-19 immunisation .  The vaccination was given at a hospital. There were no other vaccinations given within 4 weeks. The patient was not diagnosed with COVID prior to vaccination. Medical history included breast cancer and an allergy to sulfa drugs. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY); levothyroxine, liothyronine (NP THYROID). On 25Feb2021, about 2 hours after the vaccination (18:30) I felt very hot. I was not running a fever. I started shaking uncontrollably. The shaking was not chills. My husband took me to the emergency room. This was their summary. Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar level; Myoclonic jerking; Vaccine reaction I saw my general practitioner the following day and everything was back to normal. I am allergic to something in the vaccine and I am afraid to get the 2nd dose. No treatment was given for the events.The outcome of the events was recovered. The patient was not tested for COVID post vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mental impairment, Pain, Pyrexia
Clinical narrative: mental cloudiness; Febrile; fatigued; generalized aches; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration in the left arm (also reported as left deltoid) on 02Mar2021 12:15 as single dose for COVID-19 immunization. Medical history included obstructive sleep apnea (OSA), hypertension (HTN), obesity from and hypothyroidism. The patient had no known allergies. The patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID), estradiol and hydrochlorothiazide, losartan potassium (LOSARTAN HCT). No other vaccine in four weeks. The patient experienced mental cloudiness, febrile, fatigued and generalized aches on 03Mar2021. The patient received treatment for the events including Tylenol and work absence. No COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event mental cloudiness cannot be completely excluded based on temporal association.  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: U
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Face is very numb and it is kind of drooping to right side; Face is very numb and it is kind of drooping to right side; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), at unknown vaccination age via an unspecified route of administration on an unspecified date in 2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that "I am having side effects. My face is very numb, and it is kind of drooping to right side." The patient inquired as to what to do or where to go (to the hospital?). The patient mentioned that "I guess so, I am just going to go to the hospital." The patient received the vaccine on Wednesday (unspecified date in 2021) and this happened last night (05Feb2021). The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chills, Computerised tomogram, Dizziness
Clinical narrative: passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head.; Chills; fatigue; nausea; lightheadedness; vertigo; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EM9810) via an unspecified route of administration, administered on the left arm on 26Feb2021 15:15 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate (OS-CAL) and vitamin. The patient previously took BNT162B2 for COVID-19 immunisation (first dose on the left arm at 01:30 PM, lot number: EL 1283); and SHINGRIX vaccine in 2019, codeine and cipro and experienced allergies. On 27Feb2021 03:30 PM, the patient experienced chills, fatigue & then sudden nausea & lightheadedness that resulted in passing out. Unfortunately, the patient fell on a tile floor & hit her head resulting in a 1.5 inch gash in the back of her head. When she went to the ER, it was determined that she now had vertigo (which she never had before) but obviously hard to tell if it was a side effect of the vaccine or from the fall. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events which included CT scan, ekg, chest X-ray, bloodwk (unknown results) and Epley maneuver. The facility where the vaccine was administered was in a workplace clinic. 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. Post vaccination, the patient has not been tested for COVID-19. Patient is not pregnant. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fall, Fatigue, Loss of consciousness, Nausea
Clinical narrative: passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head.; Chills; fatigue; nausea; lightheadedness; vertigo; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EM9810) via an unspecified route of administration, administered on the left arm on 26Feb2021 15:15 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate (OS-CAL) and vitamin. The patient previously took BNT162B2 for COVID-19 immunisation (first dose on the left arm at 01:30 PM, lot number: EL 1283); and SHINGRIX vaccine in 2019, codeine and cipro and experienced allergies. On 27Feb2021 03:30 PM, the patient experienced chills, fatigue & then sudden nausea & lightheadedness that resulted in passing out. Unfortunately, the patient fell on a tile floor & hit her head resulting in a 1.5 inch gash in the back of her head. When she went to the ER, it was determined that she now had vertigo (which she never had before) but obviously hard to tell if it was a side effect of the vaccine or from the fall. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events which included CT scan, ekg, chest X-ray, bloodwk (unknown results) and Epley maneuver. The facility where the vaccine was administered was in a workplace clinic. 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. Post vaccination, the patient has not been tested for COVID-19. Patient is not pregnant. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Skin laceration, Vertigo
Clinical narrative: passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head.; Chills; fatigue; nausea; lightheadedness; vertigo; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EM9810) via an unspecified route of administration, administered on the left arm on 26Feb2021 15:15 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate (OS-CAL) and vitamin. The patient previously took BNT162B2 for COVID-19 immunisation (first dose on the left arm at 01:30 PM, lot number: EL 1283); and SHINGRIX vaccine in 2019, codeine and cipro and experienced allergies. On 27Feb2021 03:30 PM, the patient experienced chills, fatigue & then sudden nausea & lightheadedness that resulted in passing out. Unfortunately, the patient fell on a tile floor & hit her head resulting in a 1.5 inch gash in the back of her head. When she went to the ER, it was determined that she now had vertigo (which she never had before) but obviously hard to tell if it was a side effect of the vaccine or from the fall. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events which included CT scan, ekg, chest X-ray, bloodwk (unknown results) and Epley maneuver. The facility where the vaccine was administered was in a workplace clinic. 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. Post vaccination, the patient has not been tested for COVID-19. Patient is not pregnant. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Inappropriate schedule of product administration, Pulmonary oedema
Clinical narrative: had the coronavirus; fluid in the bottom of my lungs; having fluid in the bottom of her lungs that could not be replaced or removed and breathing problems; This is a spontaneous report from a Pfizer sponsored program . A contactable 57-year-old female consumer (patient) reported for herself that she received pneumococcal 13-val conj vac (dipht crm197 protein) (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. Patient got her pneumonia shot while she had the coronavirus because even with the shot she wound up having fluid in the bottom of her lungs that could not be replaced or removed and breathing problems, and she felt that if she hadn't got that shot then she would be in a totally different situation. Outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Oxygen consumption, Respiratory failure, SARS-CoV-2 test
Clinical narrative: admitted to inpatient medicine floor on 02Mar2021 for COVID-19 pneumonia; increasing O2 (oxygen) requirements; This is a spontaneous report from a contactable pharmacist reporting for a patient. A 70-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200), intramuscular, administered in Arm Left on 24Feb2021 as SINGLE DOSE for covid-19 immunisation at 70 years old on a hospital. Medical history included colitis ulcerative, rosacea, systemic lupus erythematosus from an unknown date. It was unknown if other vaccines were given in four weeks. No COVID prior vaccination. Concomitant medications included hydroxychloroquine taken for systemic lupus erythematosus; sulfasalazine taken for an unspecified indication; mercaptopurine taken for colitis ulcerative; and doxycycline (DOXYCYCLINE) taken for rosacea; all start and stop dates were not reported (other medications in two weeks). The patient was admitted to inpatient medicine floor on 02Mar2021 for COVID-19 Pneumonia (onset date 02Mar2021). The patient was transferred to ICU on 04Mar2021 given increasing O2 (oxygen) requirements (onset date 04Mar2021). Treatment included dexamethasone and tocilizumab. The patient underwent lab tests and procedures which included Nasal Swab (PCR) (Sars-Cov-2 Test): positive on 02Mar2021. Outcome of the events was unknown.; Sender's Comments: The event COVID-19 pneumonia is likely an intercurrent condition and unrelated to suspect drug BNT162B2. Full immunity is expected 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Clostridium difficile infection, Diarrhoea
Clinical narrative: Anything in it that could start my C. Diff again because I have been having Diarrhea; Anything in it that could start my C. Diff again because I have been having Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205 and expiration date 30Jun2021), via an unspecified route of administration on 02Mar2021 13:30 at single dose for Covid-19 immunization. The patient's medical history included C. Diff. The patient's concomitant medications were not reported. It was reported that patient got shot of vaccine on 02Mar2021 13:30 Tuesday and have a question, I have C. diff and never ask before that's only question and I wish to have asked my doctor but I wanted to know if this could start, was there anything in it that could start my C. Diff again because I have been having diarrhea.  The patient further stated "Is something to do with the Colon, it's a diarrhea type disease Is there something in the medication. It's an antibiotic (further clarification unknown hence captured as unspecified antibiotic), I cannot have it, I think.". "I have had the shot already but I got the diarrhea and I wanted to know if C.Diff is a part of this like I could get something from this shot, antibiotic or whatever because I cannot have that". "If I call my Doctor would my Doctor know if that could cause the problem that I have." The patient stated that), I could not have an antibiotic because they were afraid that I will get C. Diff again (further clarification unknown hence captured as unspecified antibiotic). They had a terrible time with me so I can't have any antibiotic." The outcome of the events was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Major depression, SARS-CoV-2 test
Clinical narrative: major depression; headache; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 13Feb2021 07:00, as single dose, for covid-19 immunisation, at the hospital. Medical history included COVID-19 (prior vaccination). The patient was not pregnant at the time of vaccination and has no allergies. There were no concomitant medications. On 15Feb2021 at 02:00, the patient experienced headache and major depression. The events resulted to physician office visit. No treatment was given for the events. The outcome of the events was not resolved.  Information on the batch/lot number has been requested.; Sender's Comments: The event major depression is likely an intercurrent medical condition and is unrelated to suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Malaise
Clinical narrative: next thing there was dairy cows flying over her bed; could hardly make it back to bed; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A female patient of an unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. Patient reported that she had the second shot at 11 AM in the morning, went to be and woke up at 8 AM. She could hardly make it back to bed and plopped back in bed the next thing there was dairy cows flying over her bed. By 11 AM she was feeling normal. Outcome of events was recovered.   Information on lot number/batch number has been requested.  Follow-up (08Mar2021): This case is being submitted to notify that the initial information for this case was first received by the Company on 08Mar2021 and not on 08Mar2020 as previously reported. Due to safety database technical limitations, the field "Initial Receipt Date" (i.e., Company first awareness date) can no longer be modified.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive and has symptoms of COVID after taking the first dose; Tested positive and has symptoms of COVID after taking the first doseTested positive and has symptoms of COVID after taking the first dose; This is a spontaneous report from a Pfizer sponsored program, contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (BNT162B2, solution for injection, Batch/Lot number: unknown), first dose administered via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical his-tory and concomitant medications was not reported. The patient tested positive and has symptoms of COVID after taking the first dose. She was also asking if she can take the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves patient (unknown demography) who was sick for awk (illness), after receiving INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. In 1959, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. In 1959, the patient developed a non-serious sick for awk (illness), approximately in the same year following the administration of INFLUENZA VACCINE. Also reported that: patient was now 79 years old and haven't had a flu shot, nor the flu. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was not reported for the event illness. There will be no information on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Allergy to vaccine
Clinical narrative: This case involves an adult patient who experienced patient was allergic to that flu vaccine (allergy to vaccine), while the patient received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious patient was allergic to that flu vaccine (allergy to vaccine) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Details of laboratory data was not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the event outcome is unknown. There will be no information on batch number for this case.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: hives; severe rash; Initial information was received on 10-Mar-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (Agency Inquiry Number: 00513226).  This case involves an adult female patient who experienced hives (urticaria), severe rash (rash), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  In October 2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date not reported] via an unknown route at left arm for prophylactic vaccination.  On an unknown date, the patient developed hives (urticaria), severe rash (rash) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from the reported events.  There will be no information on batch number for this case.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: First night and for about 24 hours very achy, chills, tired and headache. Arm sore where shot given.  Then that went away and on day 3, my arm swelled, was red and hot and had a hard lump.  That has continued and is still there, 10 days later. The swelling and redness is a bit better, but the soreness and heat are still present.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nodule, Pain, Peripheral swelling
Clinical narrative: First night and for about 24 hours very achy, chills, tired and headache. Arm sore where shot given.  Then that went away and on day 3, my arm swelled, was red and hot and had a hard lump.  That has continued and is still there, 10 days later. The swelling and redness is a bit better, but the soreness and heat are still present.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Starting in the afternoon after my shot I started feeling extremely cold. I had chills and my teeth were actually chattering at one point it was so bad. This gradually got worse as the evening went on. With it I also started feeling weak and fatigued. By 8pm I started to have a headache. Throughout the night symptoms worsened and I had a fever and more serious headache. My head was pounding so badly. I couldn't sleep at all. I also had a couple hot flashes to where I woke up sweating. Then I would feel frozen again. The nausea started during the night too. I thought I would throw up but didn't. At one point my heart was racing so fast I was a little concerned something bad would happen to me and contemplated going to the hospital. By morning I felt a little better, still nauseous and with a bad headache. My body was a little weak. These symptoms lasted all day Thursday. By that Friday morning I only had a little weakness and slight headache. By mid day Friday I was pretty much back to normal.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Nausea, Palpitations, Pyrexia
Clinical narrative: Starting in the afternoon after my shot I started feeling extremely cold. I had chills and my teeth were actually chattering at one point it was so bad. This gradually got worse as the evening went on. With it I also started feeling weak and fatigued. By 8pm I started to have a headache. Throughout the night symptoms worsened and I had a fever and more serious headache. My head was pounding so badly. I couldn't sleep at all. I also had a couple hot flashes to where I woke up sweating. Then I would feel frozen again. The nausea started during the night too. I thought I would throw up but didn't. At one point my heart was racing so fast I was a little concerned something bad would happen to me and contemplated going to the hospital. By morning I felt a little better, still nauseous and with a bad headache. My body was a little weak. These symptoms lasted all day Thursday. By that Friday morning I only had a little weakness and slight headache. By mid day Friday I was pretty much back to normal.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Starting in the afternoon after my shot I started feeling extremely cold. I had chills and my teeth were actually chattering at one point it was so bad. This gradually got worse as the evening went on. With it I also started feeling weak and fatigued. By 8pm I started to have a headache. Throughout the night symptoms worsened and I had a fever and more serious headache. My head was pounding so badly. I couldn't sleep at all. I also had a couple hot flashes to where I woke up sweating. Then I would feel frozen again. The nausea started during the night too. I thought I would throw up but didn't. At one point my heart was racing so fast I was a little concerned something bad would happen to me and contemplated going to the hospital. By morning I felt a little better, still nauseous and with a bad headache. My body was a little weak. These symptoms lasted all day Thursday. By that Friday morning I only had a little weakness and slight headache. By mid day Friday I was pretty much back to normal.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Dyspnoea, Vision blurred
Clinical narrative: episodes of shortness of breath, elevated temps of >101.5, < 104.8; blurred vision, dizziness
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Temperature reaching 100.1 and cycling down to 99..1. Chills
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Eye infection, Eyelid pain, Hordeolum
Clinical narrative: recurrent internal styes (hordeolum) in bilateral eyes. 3 styes in L eye and 1 in R eye following approximately 2 weeks after 2nd vaccination shot. Eventually Doxycycline was required to clear 3rd infection although as of this date 3-21-21 I am 7 days out from ending my antibiotic and another painful spot is appearing in L upper eyelid on lateral surface.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Sudden noticeable round swelling anterior right armpit about 5 cm wide with 2 hard swollen lymph nodes appreciated. Not hot, or red, but painful. Not limiting function. Treating with advil 200 mg every 8 hours to treat inflammation.  24 hours later, swelling slightly decreased but still painful. my husband a radiologist said this may be common. Also, at 16  hours post vaccine, I had shaking total body chills with no fever, just extreme cold for about 5 hours. Site of injection is without problem. Slight headache at 48  hours.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Sudden noticeable round swelling anterior right armpit about 5 cm wide with 2 hard swollen lymph nodes appreciated. Not hot, or red, but painful. Not limiting function. Treating with advil 200 mg every 8 hours to treat inflammation.  24 hours later, swelling slightly decreased but still painful. my husband a radiologist said this may be common. Also, at 16  hours post vaccine, I had shaking total body chills with no fever, just extreme cold for about 5 hours. Site of injection is without problem. Slight headache at 48  hours.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: One week after injection swelling,ichty ness  and warmth and redness at injection site. Started 03/19/2021 and is still there at this time 03/21/2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Pyrexia
Clinical narrative: Migraine ...2.5 days...beginning 12 hours after vaccination Chills...16 hours...beginning 15 hours after vaccination  Fever...9 hours...beginning  22 hours after vaccination
Age: 31.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Arthralgia, Blood creatine phosphokinase increased, Condition aggravated, Dermatomyositis, Malaise
Clinical narrative: I have  Dermatomyositis and CK was low in  2020. After taking the shot, of course I had a fever or other symtoms in the lists  ( like malaise etc )  But, my right leg muscle started hurting , so went to see a doctor . CK was about 380.  The pain didn't go away but I took the 2nd shot.  After the that, CK became 449.  My left shoulder and arm  muscles hurt a lot and  found CK was already went up to 1,464. Right now taking steroid and Immunosuppressant. I hadn't have Dermatomyositis symtoms for over 10 years but suddenly showed up,  I think this means it's related to the vaccine.
Age: 31.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: I have  Dermatomyositis and CK was low in  2020. After taking the shot, of course I had a fever or other symtoms in the lists  ( like malaise etc )  But, my right leg muscle started hurting , so went to see a doctor . CK was about 380.  The pain didn't go away but I took the 2nd shot.  After the that, CK became 449.  My left shoulder and arm  muscles hurt a lot and  found CK was already went up to 1,464. Right now taking steroid and Immunosuppressant. I hadn't have Dermatomyositis symtoms for over 10 years but suddenly showed up,  I think this means it's related to the vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Tendon pain
Clinical narrative: Lump in left arm, severe tendon pain in arm
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Oligomenorrhoea, Ultrasound scan vagina, Uterine leiomyoma
Clinical narrative: EXTREMELY HEAVY MENSTRUAL BLEEDING OCCURED ON THE DAY OF THE  SHOT, CLUMPS OF BLOOD WERE RELEASED AND THIS HEAVY CLUMP MENSTRUATION LASTED FOR OVER 2 WEEKS, LEADING ME TO SEEK MEDICAL HELP.  PERIOD LASTED 3 WEEKS AND MENSTRUATION HAS BEEN IRREGULAR EVER SINCE
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on body left arm and high thighs; using cortisone and Zyrtec for relief
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site rash, Injection site reaction, Skin warm
Clinical narrative: 2 raised red heated circular rashes near injection site. Appeared 11 days after injection. About 6-7 inches in diameter. Slightly painful but not impacting daily activities.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Had the chills, body aches, headache, nausea, muscle pain and fever all happen at once about 8 hours after receiving the vaccine and continued throughout the night. Took 2 Tylenol to help with symptoms. Still feeling very weak and achey this morning but no chills, nausea or fever currently
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Had the chills, body aches, headache, nausea, muscle pain and fever all happen at once about 8 hours after receiving the vaccine and continued throughout the night. Took 2 Tylenol to help with symptoms. Still feeling very weak and achey this morning but no chills, nausea or fever currently
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Severe headache within 2 hours of the shot, followed by significant Tinnitus (constant high pitch ringing) in both ears. The Tinnitus was noticeable the next morning and at 2 weeks post vaccine continues to be a problem.  Tinnitus is a new condition and I have never had the problem previously.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Pain, Pyrexia
Clinical narrative: 3/20/2021 1215 - Intensified migraine within 10 minutes of injections - migraine lasted for 8 hours. 3/21/2021 0500 - woke with a migraine; chills; body aches in the shoulders, arms, chest and back; fever 100.7; fatigue
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral artery occlusion, Cerebrovascular accident, Diplopia, Dysphagia, Gait inability
Clinical narrative: SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability to swallow properly, see without double vision, and walk again.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal
Clinical narrative: SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability to swallow properly, see without double vision, and walk again.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Irritability, Pain
Clinical narrative: Headache, pain throughout entire body, irritable
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on left arm, same as injection site.  Starts approximately where injected and travels down to inside of elbow. At the time of reporting, no itching or burning as of yet.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Rash, Urticaria
Clinical narrative: Hives increasing all over my body.  They started on my right arm and chest and worsened over the course of the day.  I took a Benadryl and that helped the inflammation.  The rash then showed up on my ears and left arm and hand and became much worse on my chest and right arm.  It has currently spread to my legs and in my scalp area.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: I have a red raised warm bump where I was injected about the size of a nickel
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: COVID Arm
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Mammogram, Ultrasound scan
Clinical narrative: Lump in left breast. Resulting in imaging and consult with breast surgeon. Needle biopsy to follow.  Dr. thinks this is an intramammary lymph node inflammation that has resulted in a lump.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccination site discomfort
Clinical narrative: Vaccine site discomfort, chills, low grade fever, bad headache and body aches. Lasted about 12 hours after onset of symptoms.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Lip erythema, Lip swelling, Skin irritation
Clinical narrative: No problems until around 1PM noticed a irritation, marked with bright red  areas on inside of upper portion of cheeks and some redness under top lip.  Progressed quickly - and around 4PM noticed discomfort increasing. Around 1430 my  upper lip began to swell and it looked like their was fluid under reddness.  On my way to ER the swelling continued , and got worse traveling to the other side of my lips and above my lips to under my nose.  While at ER my bottom lip started to also swell.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: No problems until around 1PM noticed a irritation, marked with bright red  areas on inside of upper portion of cheeks and some redness under top lip.  Progressed quickly - and around 4PM noticed discomfort increasing. Around 1430 my  upper lip began to swell and it looked like their was fluid under reddness.  On my way to ER the swelling continued , and got worse traveling to the other side of my lips and above my lips to under my nose.  While at ER my bottom lip started to also swell.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Rash, Swelling
Clinical narrative: Rash & pain. Swelling  present after 1 week and itchy. Redness.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal pain, Pyrexia
Clinical narrative: Fever 102F. Occurred after 2 doses of APAP taken for musculoskeletal pain. Fever brought under control by alternating ibuprofen with acetaminophen. Fatigue and musculoskeletal pain for 4 days after vaccination.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Feeling jittery, Paraesthesia oral
Clinical narrative: Lip tingling, SOB for few seconds that resolved prior to my evaluation, feeling jittery/anxious. Vitals taking, pt reassured, symptoms resolved within minutes
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Peripheral swelling, Rash erythematous, Swelling
Clinical narrative: Just under 2 weeks later (12th day) on my left arm where vaccine shot was given developed a red raised warm rash at the site and about 2-3 inch  radius around it. I was fatigued all week unlike my normal. Slept 12 hours 2 nights prior to noticing the rash.  2nd day of the rash (13th day) moved out another few inches in radius, fingers are swollen. Icing area a few times.  took Advil 1-2 a day.  will start Benadryl or allegro on day 2.  will call my doctor on Monday Day 14.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Seventeen hours after vaccine, woke up at 5:30 am to extreme dizziness, vomiting, nausea, sweat, chills, and headache.  These symptoms lasted all day and into the night with some minor relief.  Following morning woke up to light-headed, headache, and some dizziness.  Throughout out the second day symptoms diminished some what and was able to get up out of bed and walk around.  Still feeling light-headed.  The following days experience ligh headedness in the morning and serious dizziness when laying down for the night.  After about an hour of getting up, feel almost normal but not fully.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Seventeen hours after vaccine, woke up at 5:30 am to extreme dizziness, vomiting, nausea, sweat, chills, and headache.  These symptoms lasted all day and into the night with some minor relief.  Following morning woke up to light-headed, headache, and some dizziness.  Throughout out the second day symptoms diminished some what and was able to get up out of bed and walk around.  Still feeling light-headed.  The following days experience ligh headedness in the morning and serious dizziness when laying down for the night.  After about an hour of getting up, feel almost normal but not fully.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 103 degrees
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Fatigue, Oropharyngeal pain, Pruritus, Rash
Clinical narrative: 1st day - Nothing.   2nd day - Extreme Fatigue, Rash and Itching on Chest, Sharp Pains in Heart, Sore Throat  (It's now 5 days and still having periodic sharp pains in heart and throat still hurts)
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site - ongoing. Fatigue and tiredness - ongoing.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Nausea, Pain in extremity
Clinical narrative: Sore arm, stomach pain, nausea, diarrhea, bloating
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Migraine, Muscle tightness, Myalgia
Clinical narrative: Severe migraine 9 days after vaccine. Lower back pain, tight muscles, aches.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle and joint aches, fever (100.8), chills, extreme fatigue lasting for approximately 16 hours. Treated with Tylenol
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Pain
Clinical narrative: Upper back and left side, breast pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: One week to the day after the shot my arm started itching at injection site. As day progressed I developed large red whelp.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Platelet count decreased
Clinical narrative: I had my blood work on March 8th, and my platelet count normally in around 200, was  39. Subsequent blood work on March 11th, my platelet count went up to 54. I went to see my Primary Care Physician; saw his PA. She sent me for CBC test and platelet test.  That test was on March 11th, blood work came back at 69.  I have another blood test scheduled on March  22nd. Will see what it is.  MY CONCERN is that on Friday March 26 I am scheduled for my second vaccine dose. I am not sure I should take it.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on groin and shin on both legs.   Lasted 3-4 days.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gastrointestinal disorder, Malaise
Clinical narrative: feeling sick; stomach cramps; can't go to the bathroom; This is a spontaneous report from a contactable consumer calling on behalf of her husband.  A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The reporter and her husband had both received the first dose of Pfizer-BioNTech COVID-19 vaccine and were scheduled today (10Feb2021), at around 2:40 for the second dose. He is feeling sick since this morning (10Feb2021), with stomach cramps, and "can't go to the bathroom". The clinical outcomes of feeling sick, stomach cramps and "can't go to the bathroom" were unknown.    Information about lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Dizziness, Hypotension, Nausea
Clinical narrative: fever, dizziness, nausea, weakness, swelling of face, break out in hives, low blood pressure