chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Skin tightness, Vision blurred
Clinical narrative: 8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Wheezing
Clinical narrative: Chest "burning", faint wheeze left lower lobe on lung exam Treatment: Solumedrol 125 mg IM. Albuterol nebulizer 2.5mg/3mL Symptoms resolved after treatment
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Blindness transient, Chills, Hyperhidrosis, Loss of consciousness
Clinical narrative: lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer. A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249), intramuscular in left arm on 14Jan2021 12:00 at a single dose to prevent COVID-19. Medical history included shingles recently and was not given any medicine for that and breast cancer when she was 29 so she can't have shots on her right side. There were no concomitant medications.  On 15Jan2021 05:00, she went to the bathroom and everything went black. When her eyesight did come back after a while, she was sweating badly and had the chills.  As soon as her husband helped her get back to bed, she started sweating really bed. Her nightclothes were soaked, it wasn't like a normal sweat. She also got the cold chills. She got the cold chills right after she had the experience with her eyesight. She was just kind of achy. However, the sweating, chills, and achiness are all listed on the form she has. She isn't really worried about that. The patient was more concerned about the fact she couldn't see anything. Caller wanted to know if losing her eyesight is a side effect of the vaccine. She confirmed her eyesight came back. The outcome of the event losing her eyesight was recovered while the outcome of the remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer. A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249), intramuscular in left arm on 14Jan2021 12:00 at a single dose to prevent COVID-19. Medical history included shingles recently and was not given any medicine for that and breast cancer when she was 29 so she can't have shots on her right side. There were no concomitant medications.  On 15Jan2021 05:00, she went to the bathroom and everything went black. When her eyesight did come back after a while, she was sweating badly and had the chills.  As soon as her husband helped her get back to bed, she started sweating really bed. Her nightclothes were soaked, it wasn't like a normal sweat. She also got the cold chills. She got the cold chills right after she had the experience with her eyesight. She was just kind of achy. However, the sweating, chills, and achiness are all listed on the form she has. She isn't really worried about that. The patient was more concerned about the fact she couldn't see anything. Caller wanted to know if losing her eyesight is a side effect of the vaccine. She confirmed her eyesight came back. The outcome of the event losing her eyesight was recovered while the outcome of the remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Fatigue, Flushing
Clinical narrative: Chills, cold sweats, facial flushing, fatigue, muscle/joint pain
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Chills, cold sweats, facial flushing, fatigue, muscle/joint pain
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperreflexia, Hypoaesthesia, Limb discomfort, Muscular weakness, Paraesthesia
Clinical narrative: by night bilateral arm heaviness; 8 days out: right forearm weakness paresthesia/pins and needles sensation across neck shoulders extending to upper arms; 7 days after 2nd injection right foot/calf numbness; quadriceps weakness/11 days out left quadriceps weakness; This is spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in right arm on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hypothyroidism and known allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), colecalciferol (VITAMIN D), and ubidecarenone (COQ10). Patient previously received the first dose of BNT162B2 on 15Dec2020 09:00 in right arm for COVID-19 immunization. 7 days after 2nd injection right foot/calf numbness quadriceps weakness on 12Jan2021 21:00. 8 days out: right forearm weakness paresthesia on 13Jan2021. 11 days out left quadriceps weakness, by night bilateral arm heaviness on 16Jan2021. 12 days out pins and needles sensation across neck shoulders extending to upper arms on 17Jan2021. Deep tendon reflexes intact throughout. Bladder function intact. Events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was not received for these events. Outcome of events was not resolved.  Information about lot/batch number is requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test negative
Clinical narrative: Suffered a massive MCA stroke; This is a spontaneous report from a Contactable Nurse. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization.  Medical history included covid prior vaccination.  Known allergies: None. The patient's concomitant medications were not reported. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right arm on 21Dec2020 03:00 PM at single dose for COVID-19 immunization. The patient was not pregnant while receiving vaccine. Facility type vaccine: Hospital. If other vaccine in four weeks: No. Other medications in two weeks: No. The patient suffered a massive MCA (Middle cerebral artery) stroke on 21Jan2021 08:00 after getting second covid vaccine with outcome of not recovered.  No history of hypertension, elevated cholesterol or medical issues. No medication being taken. Daily BP (Blood pressure) reading normal. Covid test post vaccination: Nasal Swab-PCR on 22Jan2021 with result negative. If treatment for AE: Unknown. The event was resulted in: Emergency room/department or urgent care, Hospitalization (Number of days hospitalization: 4), Life threatening illness (immediate risk of death from the event), Disability or permanent damage.; Sender's Comments: The event middle cerebral artery stroke appeared 8 days after administration BNT162B2. The Company considers that the event is less likely related to suspect BNT162B2 injection given the weak time association. The status (bleeding or infarction) and cause of the stroke would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema of eyelid, Eye swelling, Periorbital swelling
Clinical narrative: like a blood clot; All around eye is real swollen and puffy and in corner/don't know if it looks like a bruise or it's like a blood clot or something; like a bruise; a red, dark red spot/not on the eye but up on the eyelid it looks like; all around his eye was real swollen and puffy and in the corner, not on the eye but up on the eyelid it looks like; This is a spontaneous report from a contactable consumer. An 85-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number like EL1283), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. Medical history included slightly elevated blood pressure from an unknown date. Concomitant medication included clopidogrel besylate (CLOPIDOGREL) for blood pressure; hydrochlorothiazide, losartan potassium (LOSARTAN + HIDROCLOROTIAZIDA) as blood thinner and several of drugs. The patient had the Covid vaccine on the 12Jan2021 and yesterday (14Jan2021) as they noticed his eye, all around his eye was real swollen and puffy and in the corner, not on the eye but up on the eyelid it looks like, the reporter didn't know if it looks like a bruise or it's like a blood clot or something and it's still there, it hasn't gone away and they didn't know if this was from the vaccine, the reporter didn't know if it's bruise or if it's a clot the reporter didn't know, it's a red, dark red spot. after we had the vaccine they gave us a paper that had some information on it and it said on there they should advise them if on blood thinners, they did not told beforehand and the patient was on blood thinners. No treatment was received. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: After about a week of getting the vaccine my left arm starter a red raised rash around the injection site. It was not itchy. Just red raised rash
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bowel movement irregularity, Diarrhoea, Diarrhoea haemorrhagic
Clinical narrative: She was cleaned out, pretty much cleaned out of her bowels, but she kept getting pains and started passing blood clots; She kept getting pains; Bad stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date unknown), via an unspecified route of administration, on 14Dec2020 10:00 at a single dose for COVID-19 immunization. Medical history included hypertension from an unknown date. Concomitant medication included atorvastatin, losartan, alprazolam, mirtazapine, and several medications because of her age and she has hypertension. The patient had her vaccine on 14Dec2020 at about 10 o'clock and a couple of hours later she began getting really bad stomach cramps and had diarrhea for most of the day and about 11 o'clock of 14Dec2020 she reported she was cleaned out, pretty much cleaned out of her bowels, but she kept getting pains and started passing blood clots. Treatment for the events include Some Pepto-Bismol (as reported). The outcome of the event "bad stomach cramps" was not recovered, and for other events was unknown.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neuropathy peripheral
Clinical narrative: Normally, patient has neuropathy but it has never been this bad before and it has never been that high up.; Terrible cramps in both legs and thighs; This is a spontaneous report from a contactable consumer who reported for herself, a 93-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 15Jan2021, at the age of 93 years, at a single dose for COVID-19 immunization. Medical history included diabetes and neuropathy, both ongoing. Concomitant medications included unspecified medicines including one for diabetes. The patient stated that she received her shot yesterday, 15Jan2021 and last night, same day of vaccination 15Jan2021, she had terrible cramps in both legs and thighs and was just wondering if that was one of the symptoms. Normally, patient has neuropathy but it has never been this bad before and it has never been that high up (15Jan2021). The outcome of the events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Severe swelling in right arm and hives. Entire upper arm involvement. Hot to the touch and extremely painful.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Blood cholesterol normal, Electrocardiogram abnormal, Loss of consciousness, Malaise
Clinical narrative: acute myocardial infarction; He was found by his secretary unconscious; feeling unwell; This is a spontaneous report from a contactable nurse.  A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), intramuscular in the left arm on 19Jan2021 (at 68-years-old) as a single dose for COVID-19 immunization.   Medical history included blood cholesterol of 200 (not further specified).  The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included irbesartan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 19Jan2020 at 08:00, after the vaccine, that patient was at work and was feeling unwell and the patient was found by his secretary unconscious. An ambulance was called. The patient's blood pressure was 79/38 and electrocardiogram showed acute myocardial infarction. He underwent one stent placement with the remaining arteries normal. He was also started on ticagrelor (BRILINTA), metoprolol (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient immediately improved and was feeling well and resumed exercise. The clinical outcomes of the unconscious, acute myocardial infarction, and feeling unwell were recovering. The events required emergency room visit and were assessed as serious for requiring hospitalization for 2 days and being life-threatening.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: There is not a reasonable possibility that reported events acute myocardial infarction, unconsciousness and feeling unwell are related to BNT162B2.  The events are more likely intercurrent medical condition for this elderly patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Stent placement
Clinical narrative: acute myocardial infarction; He was found by his secretary unconscious; feeling unwell; This is a spontaneous report from a contactable nurse.  A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), intramuscular in the left arm on 19Jan2021 (at 68-years-old) as a single dose for COVID-19 immunization.   Medical history included blood cholesterol of 200 (not further specified).  The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included irbesartan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 19Jan2020 at 08:00, after the vaccine, that patient was at work and was feeling unwell and the patient was found by his secretary unconscious. An ambulance was called. The patient's blood pressure was 79/38 and electrocardiogram showed acute myocardial infarction. He underwent one stent placement with the remaining arteries normal. He was also started on ticagrelor (BRILINTA), metoprolol (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient immediately improved and was feeling well and resumed exercise. The clinical outcomes of the unconscious, acute myocardial infarction, and feeling unwell were recovering. The events required emergency room visit and were assessed as serious for requiring hospitalization for 2 days and being life-threatening.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: There is not a reasonable possibility that reported events acute myocardial infarction, unconsciousness and feeling unwell are related to BNT162B2.  The events are more likely intercurrent medical condition for this elderly patient. 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: Death, Myocardial infarction
Clinical narrative: passed away-heart attack; This is a spontaneous report from a contactable consumer, the daughter of the patient from a Pfizer Sponsored program Pfizer First Connect.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 19Jan2021 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 24Jan2021, the patient passed away due to a heart attack.  It was not reported if an autopsy was performed.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away-heart attack
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Delirium, Vomiting
Clinical narrative: Delirious; He woke up sick on stomach and throwing up; He woke up sick on stomach and throwing up; This is a spontaneous report from a contactable consumer (son). An 87-year-old male patient received BNT162B2 (lot number: EK9231, expiration date: 30Apr2021) first dose on 15Jan2021 around lunch time at single dose for COVID-19 immunization. Medical history included high sugar and COPD (Chronic obstructive pulmonary disease). Concomitant medications included gabapentin, metformin, ferrous sulfate, acetylsalicylic acid (ASPIRIN 81). Patient took the vaccine 15Jan2021 around lunch time and this morning (16Jan2021) he woke up sick on stomach and throwing up and kind of 'deluce' or delirious. Consumer just started giving patient fluids and Pepto Bismol as treatment. The outcome of the events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: Had COVID December 19, 2020. Had 1st dose Pfizer on 1/6 and 3 hrs after had heart palpitations, dizzy, HR 110-115. Lasted for 48 hours intermittently. 1/29 15 minutes after 2nd dose was dizzy. @ 1120 B/P 110/79 sats 100%, HR 67, @1126 B/P 107/80, HR 72. Stayed for 40 minutes and left feeling fine. Takes no meds, In 2002 had GI Ulcers and was treated and Allergic to Proton Pump  Inhibitors- hives, heart palpitations, generalized swelling, dyspnea
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Heart rate increased, Pleurisy, X-ray normal
Clinical narrative: It was probably a Pleurisy and put me on a steroid (Unspecified Medication); I am a little bit more winded today than I was before and my heart rate is a little faster than I normally run; I am a little bit more winded today than I was before and my heart rate is a little faster than I normally run; Pain in my left shoulder clavicle area when I took a really deep breath and it got worse; Pain in my left shoulder clavicle area when I took a really deep breath and it got worse; This is a spontaneous report from a contactable consumer (patient). A patient received second dose of bnt162b2 (Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient had second Covid vaccination (manufacturer not clarified, hence is this a Pfizer product tab left unchecked) on the 8th (not clarified). This Friday (15Jan2021), patient started getting pain in left shoulder clavicle area when took a really deep breath and it got worse yesterday. So, patient went to Institute, they did a test X-ray on 16Jan2021 and they did not see anything. He said, it was probably Pleurisy and put me on a steroid (Unspecified Medication). Today, like the pain is a little bit better but patient was a little bit more winded today than it was before and heart rate was a little faster (17Jan2021) than normally run and just do not know if this was something that was being reported or what. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Functional gastrointestinal disorder, Influenza like illness, Muscle spasms
Clinical narrative: 245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bowel dysfunction Following day, flu like symptoms, chills, aches, etc Rash still has not gone away I have had abdominal cramping and significant pain.  It has worsened to resemble the pain I had prior to my hysterectomy and endometriosis ablation/scar tissue removal.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain, Rash
Clinical narrative: 245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bowel dysfunction Following day, flu like symptoms, chills, aches, etc Rash still has not gone away I have had abdominal cramping and significant pain.  It has worsened to resemble the pain I had prior to my hysterectomy and endometriosis ablation/scar tissue removal.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Injection site lymphadenopathy, Malaise, Oedema peripheral
Clinical narrative: Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph nodes under my armpit/kind of benign; Generalized malaise low grade; Headache; Both eyes are very swollen; inflammatory prosthesis in my eye; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247) via an unspecified route of administration at arm on 15Jan2021 11:00 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Nurse stated that she just wanted to report what she thinks is adverse reaction to the Covid-19 vaccine from Pfizer not sure what to do about it at this point. She was vaccinated Friday 11 o'clock in the afternoon. Both days felt really fine. Last night (16Jan2021) got some fullness under her armpit which was on the same side as the vaccine, which looked like swollen lymph nodes under her armpit which you can see was kind of benign. But in addition to that some generalized malaise lowgrade and headache (Jan2021). Seems totally fine but her both eyes are very swollen (Jan2021). Nurse took some ibuprofen (ADVIL)-600 mg, she was taking Prednisone for inflammatory prosthesis in her eye as treatment (Jan2021). Outcome of the events was unknown.   The nurse considered the occurrence of the events are because of COVID-19 Vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Eye inflammation cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives/welts / Pruritus / Rash
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Injection site pain, Pain in extremity
Clinical narrative: Day 2 after injection just injection site pain and tired. Severe hips/knees/ankles/wrists/back pain on day 5 and 6 after injection and calves pain and tightness.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Skin tightness
Clinical narrative: Day 2 after injection just injection site pain and tired. Severe hips/knees/ankles/wrists/back pain on day 5 and 6 after injection and calves pain and tightness.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Headache, Nausea, Oral discomfort
Clinical narrative: Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash
Clinical narrative: Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Insomnia
Clinical narrative: Chills, vertigo, malaise, dry cough, fatigue, muscle/joint pain, insomnia; ibuprofen as needed is helpful
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Vertigo
Clinical narrative: Chills, vertigo, malaise, dry cough, fatigue, muscle/joint pain, insomnia; ibuprofen as needed is helpful
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: 1100 VACC. SHOT GIVEN. 1105 C/O LEFT SHOULDER AND  NECK PAIN WITH 3:10.  VS:  BP:  144/98, P:  87; R: 20; 02 SAT R.A.:  97%.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Pain, Pain in jaw
Clinical narrative: 2:30 PM joint pain, aching, 3:00 AM swollen throat and neck, trouble breathing, chest and jaw pain. 5 AM all good but he joint pain remained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling
Clinical narrative: 2:30 PM joint pain, aching, 3:00 AM swollen throat and neck, trouble breathing, chest and jaw pain. 5 AM all good but he joint pain remained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pharyngeal paraesthesia, Salivary hypersecretion, Speech disorder, Swollen tongue
Clinical narrative: Received COVID vaccine and within 2 minutes developed tongue "thickness", throat tingling, overactive salivary glands, light-headed.  States speech was affected due to tongue swelling.  No respiratory distress.  Took Benadryl 25mg approx. 45 minutes after symptom onset.  Symptoms improved 1 hour after taking Benadryl dose.  Does NOT plan to receive 2nd dose due to immediate allergic reaction.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: Received COVID vaccine and within 2 minutes developed tongue "thickness", throat tingling, overactive salivary glands, light-headed.  States speech was affected due to tongue swelling.  No respiratory distress.  Took Benadryl 25mg approx. 45 minutes after symptom onset.  Symptoms improved 1 hour after taking Benadryl dose.  Does NOT plan to receive 2nd dose due to immediate allergic reaction.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever- while feeling great
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: 10 days following shot I developed over the next few days (now day 3 or 4) a growing red rash with darker red bumps in it, very itchy the size of a navel orange.  I put topical Benadryl on it and it is less itchy after thatt.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, body aches, extreme headache and low grade temperature overnight.  Used ibuprofen and Tylenol to reduce temperature.  Headache, body aches improve a bit but persist after medication.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritability, Pain in extremity, Poor quality sleep, Swelling
Clinical narrative: On the two hour ride home, my arm would ache then be fine.  I was cranky, not myself, going to bed, I woke several times as I rolled over onto my right arm.  When I awoke early, I was swollen from Head to Toes, my eyes were slits, my bracelets and rings were swollen into my skin, and my toes and ankles were large. AND I was grouchy about everything.  As the day went on I was just mad about everything,  I began to drink lots of water and tried to exercise to get the swelling down.   About noon, my eyes and face began to ease, but my body didn't ease till about 2pm, as my rings and bracelets were movable  then. I am still swollen and still angry and it is Friday.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Eye swelling, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: On the two hour ride home, my arm would ache then be fine.  I was cranky, not myself, going to bed, I woke several times as I rolled over onto my right arm.  When I awoke early, I was swollen from Head to Toes, my eyes were slits, my bracelets and rings were swollen into my skin, and my toes and ankles were large. AND I was grouchy about everything.  As the day went on I was just mad about everything,  I began to drink lots of water and tried to exercise to get the swelling down.   About noon, my eyes and face began to ease, but my body didn't ease till about 2pm, as my rings and bracelets were movable  then. I am still swollen and still angry and it is Friday.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: On the two hour ride home, my arm would ache then be fine.  I was cranky, not myself, going to bed, I woke several times as I rolled over onto my right arm.  When I awoke early, I was swollen from Head to Toes, my eyes were slits, my bracelets and rings were swollen into my skin, and my toes and ankles were large. AND I was grouchy about everything.  As the day went on I was just mad about everything,  I began to drink lots of water and tried to exercise to get the swelling down.   About noon, my eyes and face began to ease, but my body didn't ease till about 2pm, as my rings and bracelets were movable  then. I am still swollen and still angry and it is Friday.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Confusional state, Dizziness, Fall, Head injury
Clinical narrative: Moderna COVID-19 Vaccine EUA - Approx 17 h post vaccine pt became dizzy and lost consciousness, fell, hit head. Awoke shaking & confused, generalized strong tingling sensation for 45 min post. Severe headache immediately post vaccine, had resolved. Febrile at 100.7F with ibuprofen. Called PCP who determined symptoms to be vagally mediated, pt recovered at home with no evident sequelae.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immediate post-injection reaction, Loss of consciousness, Paraesthesia, Tremor
Clinical narrative: Moderna COVID-19 Vaccine EUA - Approx 17 h post vaccine pt became dizzy and lost consciousness, fell, hit head. Awoke shaking & confused, generalized strong tingling sensation for 45 min post. Severe headache immediately post vaccine, had resolved. Febrile at 100.7F with ibuprofen. Called PCP who determined symptoms to be vagally mediated, pt recovered at home with no evident sequelae.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Peripheral swelling
Clinical narrative: Injection site became more sore a week to 9 days after vaccine.  Arm was red and swollen about 6 inches down and 4 inches wide.  After 2 days of observing it, it was no better so I went to urgent care to get it checked 01/16.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Myalgia
Clinical narrative: Patient was vaccinated on 1/13/2021 with second dose of pneumonia vaccine and that evening developed muscle aches on and off temperature ranging from 100-101, also chills noted. Patient  stated that the second day was when she noticed the increase in muscle aches so she called for follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: 1/25/2021 11:59:51 AM >  1145: BP 138/74, P 73, O2 98 Five minutes after receiving vaccine patient c/o numbness and tingling in L arm where vaccine was administered with radiating pain to L shoulder, RN added 10 minutes to observation and educated patient to go to the nearest ER if symptoms aren't resolved 1/26/2021 09:08:07 AM > called to check on patient, message left
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Day 9 after first dose my arm has large - 5 inches long red itchy area
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache over the crown of the headache 1 day following the 1st injection, continued headache now, 2 weeks later
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, Swelling, Hot, Painful at injection site
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Monoplegia
Clinical narrative: SYMPTOMS: SEVERE, SORE/STIFF LEFT ARM - COULD NOT RAISE MY ARM TO TAKE MY SHIRT OFF AT NIGHT - HAD NO MOBILITY.  SUBSIDED OVER A PERIOD OF 72+ HOURS.  1 WEEK LATER THE SEVERE SORE/STIFF SITUATION REAPPEARED, COULD NOT TAKE MY NIGHTGOWN OFF THE NEXT MORNING AND COULD NOT PUT A SEATBELT ON OR DRIVE, DRY MYSELF AFTER A SHOWER, ETC.... THIS CONDITION, WHILE IT HAS DIMINISHED TO A POINT, BUT NOT COMPLETELY HAS BEEN PRESENT FOR 3 WEEKS. 1/25/21 I RECEIVED MY SECOND VACCINE IN MY RIGHT ARM.  WITHIN 3-5 MINUTES I HAD A BURNING SENSATION AT THE SITE OF THE LEFT INJECTION, I AM WRITING TO  YOU ALMOST A WEEK AFTER THE SHOT AND THE SORENESS STILL PERSISTS. THE RIGHT ARM WAS SORE AT THE INJECTION SITE ONLY LIMITED AFFECT ON MY ARM MOVEMENT. THAT HAS SUBSIDED A BIT.  BUT MY LEFT ARM IS STILL A PROBLEM. I HAVE BEEN IN TOUCH WITH BOTH MY DOCTOR AND MODERNA. IN EACH CASE THEY BOTH RECOMMENDED ADVIL AND THAT I SHARE MY REACTION WITH ALL OF YOU. THIS HAS  BEEN A VERY LONG A DIFFICULT REACTION TO THESE 2 VACCINES. I RECOGNIZE THAT ANY REACTION IS BETTER THAN COVID BUT THIS SERIOUS REACTION IS UNEXPECTED.  THE DOCTOR'S ASSESSMENT BOTH TELEPHONE AND IN-PERSON VISIT, ASSURED ME THAT IT WAS NOT HEART, ROTATOR CUFF OR BURSITIS RELATED. THE DOCTOR SUGGESTED IT WAS MOST LIKELY A VACCINE RELATED EVENT.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: SYMPTOMS: SEVERE, SORE/STIFF LEFT ARM - COULD NOT RAISE MY ARM TO TAKE MY SHIRT OFF AT NIGHT - HAD NO MOBILITY.  SUBSIDED OVER A PERIOD OF 72+ HOURS.  1 WEEK LATER THE SEVERE SORE/STIFF SITUATION REAPPEARED, COULD NOT TAKE MY NIGHTGOWN OFF THE NEXT MORNING AND COULD NOT PUT A SEATBELT ON OR DRIVE, DRY MYSELF AFTER A SHOWER, ETC.... THIS CONDITION, WHILE IT HAS DIMINISHED TO A POINT, BUT NOT COMPLETELY HAS BEEN PRESENT FOR 3 WEEKS. 1/25/21 I RECEIVED MY SECOND VACCINE IN MY RIGHT ARM.  WITHIN 3-5 MINUTES I HAD A BURNING SENSATION AT THE SITE OF THE LEFT INJECTION, I AM WRITING TO  YOU ALMOST A WEEK AFTER THE SHOT AND THE SORENESS STILL PERSISTS. THE RIGHT ARM WAS SORE AT THE INJECTION SITE ONLY LIMITED AFFECT ON MY ARM MOVEMENT. THAT HAS SUBSIDED A BIT.  BUT MY LEFT ARM IS STILL A PROBLEM. I HAVE BEEN IN TOUCH WITH BOTH MY DOCTOR AND MODERNA. IN EACH CASE THEY BOTH RECOMMENDED ADVIL AND THAT I SHARE MY REACTION WITH ALL OF YOU. THIS HAS  BEEN A VERY LONG A DIFFICULT REACTION TO THESE 2 VACCINES. I RECOGNIZE THAT ANY REACTION IS BETTER THAN COVID BUT THIS SERIOUS REACTION IS UNEXPECTED.  THE DOCTOR'S ASSESSMENT BOTH TELEPHONE AND IN-PERSON VISIT, ASSURED ME THAT IT WAS NOT HEART, ROTATOR CUFF OR BURSITIS RELATED. THE DOCTOR SUGGESTED IT WAS MOST LIKELY A VACCINE RELATED EVENT.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient received his immunization about 11:15 am.  He was sent to the observation area.  about 1:10 pm the nurse informed me patient had developed a rash on the left side of his face.  I administered Chewable Diphenhydramine and kept patient for 30 minutes of further observation.  Patient improved and was discharged to his home.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no side effects  2nd dose given too soon
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Myalgia, Pyrexia
Clinical narrative: Elevated fever Full body muscle aches Headache Ophthalmalgia
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy, Myalgia
Clinical narrative: Joint and muscle pain/ lethargy
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Egg shaped Lymphnode in armpit of Left Arm and Lymphnode  Swelling in neck. now getting  same feeling in Rt Arm Pit.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: Within 16 hours, fever of 102, extreme fatigue, significant headache, body aches throughout, sore arm, chills, lymph nodes under arm receiving vaccine swollen, temperature of 100.5 48 hours later.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Within 16 hours, fever of 102, extreme fatigue, significant headache, body aches throughout, sore arm, chills, lymph nodes under arm receiving vaccine swollen, temperature of 100.5 48 hours later.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Headache, Myalgia
Clinical narrative: muscle and joint pain chills nausea headache sore, swollen and red arm
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: muscle and joint pain chills nausea headache sore, swollen and red arm
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: I received my first vaccination on 12/28/2020, given very high in my right arm.  I noticed a tingling in my left arm within the first 15 minutes of the injection.  As I worked the rest of my evening shift, the tingling continued.  The next morning, my left arm was numb from the shoulder to the fingertips.  I could move my fingers and arm, but could not feel pain, hot or cold.  I called the employee health nurse, who told me that most symptoms resolve in 24 hours.  I took a day off and rested the arm.  The feeling came back gradually in the afternoon.  However, my hand was numb the following two mornings.  The symptoms resolved in 72 hours.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt began to feel light headed and dizzy 20 mins post injection
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Ocular discomfort, Vision blurred
Clinical narrative: Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed blurry vison; 1/25/21 - had an e-visit ; 1/26/21 - evaluated by her PCP referred to ophthalmologist; 1/27/21 - evaluated by ophthalmologist and referred to retina specialist as she had pressure behind her eye; 1/29/21 - retina specialist used laser to decrease pressure behind her eye.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Vasovagal syncope
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 2 Very enlarged supraclavicular lymph nodes.  Remain large    today and got  2nd dose 01/29/2021
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain, Paraesthesia, Pruritus
Clinical narrative: 10 min after receiving injection developed itching of scalp, along hair line right upper forehead, left upper arm, left lower leg.  At approx 20 min after receiving injection continued to develop itching right lower lip, anterior neck, left ear, right lower arm.  Small hive noted anterior neck and right lower arm. Hives resolved in approx one hour without treatment.  Approximately 2 hrs after receiving injection continued to have itching and 'prickly' feeling on skin.  Benadryl 25mg taken, with some relief of itching.  Approximately 4 hours after injection an additional Benadryl 25mg taken.  Itching resolved.  On 1/28/21, day after injection, at approximately 12:00 pm, body aches and chills, Temp 100 degrees developed.  Tylenol was taken.  Approximately 4:00pm chills and body aches worsened, Temp 99.6.  Ibuprofen 400mg taken.  at 10:30pm increase of body aches and chills Temp 102 Ibuprofen 800mg taken, Benadryl 50mg taken.  Day 3, 1/29/21,  temp normal mild body aches and chills continue at 1:45 pm.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 10 min after receiving injection developed itching of scalp, along hair line right upper forehead, left upper arm, left lower leg.  At approx 20 min after receiving injection continued to develop itching right lower lip, anterior neck, left ear, right lower arm.  Small hive noted anterior neck and right lower arm. Hives resolved in approx one hour without treatment.  Approximately 2 hrs after receiving injection continued to have itching and 'prickly' feeling on skin.  Benadryl 25mg taken, with some relief of itching.  Approximately 4 hours after injection an additional Benadryl 25mg taken.  Itching resolved.  On 1/28/21, day after injection, at approximately 12:00 pm, body aches and chills, Temp 100 degrees developed.  Tylenol was taken.  Approximately 4:00pm chills and body aches worsened, Temp 99.6.  Ibuprofen 400mg taken.  at 10:30pm increase of body aches and chills Temp 102 Ibuprofen 800mg taken, Benadryl 50mg taken.  Day 3, 1/29/21,  temp normal mild body aches and chills continue at 1:45 pm.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature increased, Chest discomfort, Chest pain
Clinical narrative: " COVID-19 Vaccine EUA" Day 3 following injection 1-11-21--Difficult breating, chest pressure all day and night. Extreme fatique and weakness. Day 4 following---continued difficulty breathing and chest pressure continuous. Moderate fatique and weakness.  Day 5 following--- breathing difficulty improved significantly. Right arm muscle spasms and severe pain radiating to neck and chest and back (right side only), and stiffening of right hand and fingers. Tingling in are and pale color along with it feeling very cold. Small rash also at injection site. Moderate fatique and weakness. Day 6 following---breathing back to normal. Arm stiffening better.  Still severe pain in right arm, neck, chest and back muscles. Less fatique and weakness.  Day 7 following---Pain in right side of body continued. Chest tightness and cough started. 100 Temperature at 7pm. Fatique and weakness worsened.  Day 8 following--- Pain in right side of body continued w a little less severity. Chest tightness and cough w 99.8 temperature.  Day 9 -10following--- Pain in right side continues now with injection site (R arm) red, itcy and warm at site.  Days 11-18----symptoms at there least. Overall felt well. Day 19 following--- sore throat, heavy chest tightness and cough w slight breathing difficulty.  Day 20 following ---Severe body aches, cough, lowgrade fever of 99, Extreme fatigue. Sore throat. Difficulty breathing, moderately. Unable to work. Day 21 (today 1-29-21)---chest tightness, cough, lowgrade fever 99.