chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Haematocrit normal, Haemoglobin normal, Lymphocyte count increased
Clinical narrative: Initially started swelling then the arm became red with a large blister few days later skin peeled
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume normal, Mean platelet volume increased, Neutrophil count decreased
Clinical narrative: Initially started swelling then the arm became red with a large blister few days later skin peeled
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Platelet count normal, Red blood cell count normal, Skin exfoliation, White blood cell count normal
Clinical narrative: Initially started swelling then the arm became red with a large blister few days later skin peeled
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: discomfort/soreness at injection site ten days following vaccination, after immediate injection site soreness/discomfort had subsided for over a week.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Arteriogram carotid normal, Dysarthria, Facial asymmetry, Neurological symptom
Clinical narrative: Stroke like symptoms consisting of facial asymmetry & slurred speech. Patient sent to stroke facility w/ Neurology services.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Swelling in axillary region of the right arm, the arm the injection was administered
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Tremor
Clinical narrative: At around 11pm I had the chills, I was shaking pretty bad, no fever and I had a major headache. I do not have any access to tylenol and I will wait to take some when I arrive home at 7am. Its about 530am and I still have a headache. I've been drinking lots of water and I feel nauseous now.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA COVID 19/Pfizer EL 9264  Nausea, tiredness, headache, muscle pain, flu Like symptoms, Ached all over for 14 hours......took Advil and symptoms subsided
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA COVID 19/Pfizer EL 9264  Nausea, tiredness, headache, muscle pain, flu Like symptoms, Ached all over for 14 hours......took Advil and symptoms subsided
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis
Clinical narrative: The first dose of vaccine gave me nasal bleeding on the ninth day and the second dose gave me nasal bleeding on the second day.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Headache, Pyrexia, Skin warm
Clinical narrative: FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR  36 HOURS
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Some vaccine leaked out of suringe onto my arm as was being injected. I had also taken 400 mg of ibuprofen at 8 am to prermpt any side effects, not knowing that might impact anyobody development. I am concerned i wont have adequate antibodies from both events
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: 1/29: sore Left arm 1/30: rash on Left arm 2/1: rash on Left arm improved, sore armpit 2/2: rash on left armpit with itchiness
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: ~18 hours after second moderna vaccine, I experienced High  fever ~101F, sweating, chills. Lymph nodes around neck are swollen. Significant arm pain at site of injection, which is extremely painful and unable to lift or lay on arm. Mild headache and joing pains.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Lymphadenopathy, Pyrexia, Sleep disorder
Clinical narrative: ~18 hours after second moderna vaccine, I experienced High  fever ~101F, sweating, chills. Lymph nodes around neck are swollen. Significant arm pain at site of injection, which is extremely painful and unable to lift or lay on arm. Mild headache and joing pains.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Asthma, Bone pain, Chest discomfort, Lymphoedema
Clinical narrative: Started to notice severe left-sided lumbar spine pain, severe left iliac crest pain radiating down left leg to above knee area, lymphatic edema. Treatment with acupuncture and massage therapy has helped alleviate the severity of the previous mentioned symptoms to where they are now tolerable.   Slight chest heaviness and slight exacerbation of asthma symptoms which have been controlled with asthma inhalers.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Spinal pain
Clinical narrative: Started to notice severe left-sided lumbar spine pain, severe left iliac crest pain radiating down left leg to above knee area, lymphatic edema. Treatment with acupuncture and massage therapy has helped alleviate the severity of the previous mentioned symptoms to where they are now tolerable.   Slight chest heaviness and slight exacerbation of asthma symptoms which have been controlled with asthma inhalers.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: 2:AM on Feb 18 started chills while sleeping.   Had hot tea and blankets and it subsided.  fever of 100-101 throughout the day.  Sleeping. Pain at injection site . Symptoms lasted about a day and a half. This was the first dose!
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Face oedema, Pruritus, Rash, Rash macular
Clinical narrative: Yesterday, Feb 1st around 5 p.m., I noticed a rash on my neck and my neck became very itchy. Today, Feb 2nd, upon waking my face is puffy, red & blotchy.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bicarbonate increased, Blood pH increased, Cardiac arrest, Endotracheal intubation, Hypoxic-ischaemic encephalopathy
Clinical narrative: Cardiac arrest of unknown etiology.  Sudden collapse with PEA  requiring  CPR and intubation. Now has severe anoxic encephalopathy and expect death.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: PCO2 increased, PO2 abnormal, Pulseless electrical activity, Resuscitation, Syncope
Clinical narrative: Cardiac arrest of unknown etiology.  Sudden collapse with PEA  requiring  CPR and intubation. Now has severe anoxic encephalopathy and expect death.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Confusional state, Vomiting
Clinical narrative: Found confused, vomited, admitted and dx with ICH.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sore shoulder, bicep sore, pain with movements
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain at the injection site the next day. it was not bad and was gone by the 3rd day
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Macule
Clinical narrative: Period very very late for jam and just dark brown spotting very end of jan beginning of feb. unusual
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Urticaria
Clinical narrative: Moderna COVID-19 Vaccine EUA Hives Rash on hands and feet, severe itching and irritation, along with pain. Currently lasting more than 3 days but seems to be winding down on the third day
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Local reaction, Pigmentation disorder, Swelling, Tenderness
Clinical narrative: Day 6, developed large local reaction w/ erythema, swelling, tenderness. Splotchy, 10cm x 5cm
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Patient received immunization from vial containing diluent in the amount of 1.0 rather than 1.8 ml 0.9% sodium chloride, so dose was concentrated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Pyrexia
Clinical narrative: 2nd dose received 8am 1/27. Fever, 102.1 and severe headache 1/28, 12 am.  Developed Shingles 1/28, 10 pm. Shingles lesions continue to develop at the time of this report, despite starting Valtrex 1/29 am
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Flushing, Hyperhidrosis, Injection site pain, Malaise
Clinical narrative: Flushing, hives, tachycardia, diaphoresis to 140s within 3 minutes of vaccine. At vaccination site, blood pressure 104/60, slightly lower than normal blood pressure. At vaccination site, patient was given 25 mg Benadryl IM. HR started going down about 15 minutes after Benadryl. HR went down to 90s upon arrival to the ED. HR is normally in the 60s. No further treatment in the ED.  Patient did experience fever  up to 101 and malaise for 3 days after vaccine. Along with pain at injection site.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Urticaria
Clinical narrative: Flushing, hives, tachycardia, diaphoresis to 140s within 3 minutes of vaccine. At vaccination site, blood pressure 104/60, slightly lower than normal blood pressure. At vaccination site, patient was given 25 mg Benadryl IM. HR started going down about 15 minutes after Benadryl. HR went down to 90s upon arrival to the ED. HR is normally in the 60s. No further treatment in the ED.  Patient did experience fever  up to 101 and malaise for 3 days after vaccine. Along with pain at injection site.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Pain in extremity
Clinical narrative: Sacral Herpes Outbreak; Arm soreness; A spontaneous report  was received from a healthcare professional, who was a 69-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness and a sacral herpes outbreak.  The patient's medical history was not provided. No concomitant product use was reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the day of vaccination, the patient experienced arm soreness.   On 14 Jan 2021, the patient experienced a sacral herpes outbreak high on her right butt cheek. Treatment for the event, included valaciclovir.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, arm soreness and sacral herpes outbreak, was unknown.; Reporter's Comments: This case concerns a 69-years-old female patient, who experienced a serious unexpected event of herpes simplex and non-serious unexpected event of pain in extremity. The event of pain in extremity occurred 1 day (same day) after first dose of mRNA-1273, lot # 013L20A. The event of herpes simplex occurred 2 days after first dose of mRNA-1273, lot # 013L20A. Concomitant medication included Valacyclovir. Treatment details were not provided.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest X-ray, Dyspnoea, Hyperhidrosis
Clinical narrative: Tested positive for COVID-19; Weakness; Sweating; Shortness of Breath; A spontaneous report was received from a healthcare professional concerning a 89-year-old, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and tested positive for COVID-19, experienced weakness, sweating, and shortness of breath.   The patient's medical history included diabetes mellitus, hypertension, hypercholesterolemia, and benign prostatic hyperplasia. Products known to have been used by the patient, within two weeks prior to the event, included metformin, glimepiride, atorvastatin, acetylsalicylic acid, norvastatin, irbesartan, triamterene, finasteride, mirabegron.   On 13 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient experienced weakness, sweating, and shortness of breath.    On an unknown date, the patient tested positive for COVID-19 and was admitted to the hospital for supervision.  Chest x-ray results were negative. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, tested positive for COVID-19, was considered not resolved. The outcome of the events, weakness, sweating, and shortness of breath, was unknown.; Reporter's Comments: This case concerns a 89 year-old, male patient with history of diabetes mellitus, hypertension, hypercholesterolemia, who experienced events of tested positive for COVID-19, weakness, sweating, and shortness of breath.  The events occurred 3 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.  However, the patient was positive for COVID and may provide an explanation for the events.  Further information have been requested.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Weakness; Sweating; Shortness of Breath; A spontaneous report was received from a healthcare professional concerning a 89-year-old, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and tested positive for COVID-19, experienced weakness, sweating, and shortness of breath.   The patient's medical history included diabetes mellitus, hypertension, hypercholesterolemia, and benign prostatic hyperplasia. Products known to have been used by the patient, within two weeks prior to the event, included metformin, glimepiride, atorvastatin, acetylsalicylic acid, norvastatin, irbesartan, triamterene, finasteride, mirabegron.   On 13 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient experienced weakness, sweating, and shortness of breath.    On an unknown date, the patient tested positive for COVID-19 and was admitted to the hospital for supervision.  Chest x-ray results were negative. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, tested positive for COVID-19, was considered not resolved. The outcome of the events, weakness, sweating, and shortness of breath, was unknown.; Reporter's Comments: This case concerns a 89 year-old, male patient with history of diabetes mellitus, hypertension, hypercholesterolemia, who experienced events of tested positive for COVID-19, weakness, sweating, and shortness of breath.  The events occurred 3 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.  However, the patient was positive for COVID and may provide an explanation for the events.  Further information have been requested.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Fall, Gait inability, Malaise
Clinical narrative: Fell; Weakness in legs; got so weak; His legs just continued to get worse/He could not get up without help; He could not walk; This is a spontaneous report from a contactable nurse reported for her father.  An 87-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, intramuscular on left arm on 13Jan2021 (Time the vaccination was given: 13:00-13:15) at the age of  87-years-old at single dose for prevention because of age group.  Medical history included covid-19 in Jun2020, forgetful from an unknown date, he got a little forgetful sometimes, so he may have forgotten to tell her.  This occurred prior to getting the vaccine.  The patient's concomitant medications were not reported.  Prior Vaccinations (within 4 weeks) was none. Family medical history was none. The patient got the Pfizer COVID vaccine last week on 13Jan2021, he was really sick in Jan2021. The patient had weak legs anyway, but he got so weak.  Weakness in legs started at night on 13Jan2021, around 20:00. No emergency room (ER) or physician's office required. He never complained of any symptoms and did not know if there were other symptoms, because he did not complain.  He fell on Thursday night on 14Jan2021. He got the vaccine around 1:00-1:15pm, and got so weak, that he went to the bathroom and he fell in the floor.  His legs just continued to get worse.  It started on Wednesday night on 13Jan2021.  He could not walk in Jan2021.  Thursday was the worst. By Friday, it started to get better.  He did not get hospitalized.  He could not get up without help. The patient had Covid 19 in Jun2020. He had a lot of symptoms after receiving the first dose of the vaccine. The reporter reported her father fell in the bathroom while brushing his teeth and her brother had to come over to get him up. The reporter was starting to wonder if he should take the second dose. The outcome of the events Weakness in legs and fell was resolving and of the other events was unknown. The reporter considered event Weakness in legs was serious due to medically significant and disabling; considered event fall was serious due to medically significant.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of the events muscular weakness, fall and gait disturbance cannot be excluded. The events are confounded by the elderly patient's underlying conditions. The impacts of this report on the benefit/risk profile of the 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: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Fell; Weakness in legs; got so weak; His legs just continued to get worse/He could not get up without help; He could not walk; This is a spontaneous report from a contactable nurse reported for her father.  An 87-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, intramuscular on left arm on 13Jan2021 (Time the vaccination was given: 13:00-13:15) at the age of  87-years-old at single dose for prevention because of age group.  Medical history included covid-19 in Jun2020, forgetful from an unknown date, he got a little forgetful sometimes, so he may have forgotten to tell her.  This occurred prior to getting the vaccine.  The patient's concomitant medications were not reported.  Prior Vaccinations (within 4 weeks) was none. Family medical history was none. The patient got the Pfizer COVID vaccine last week on 13Jan2021, he was really sick in Jan2021. The patient had weak legs anyway, but he got so weak.  Weakness in legs started at night on 13Jan2021, around 20:00. No emergency room (ER) or physician's office required. He never complained of any symptoms and did not know if there were other symptoms, because he did not complain.  He fell on Thursday night on 14Jan2021. He got the vaccine around 1:00-1:15pm, and got so weak, that he went to the bathroom and he fell in the floor.  His legs just continued to get worse.  It started on Wednesday night on 13Jan2021.  He could not walk in Jan2021.  Thursday was the worst. By Friday, it started to get better.  He did not get hospitalized.  He could not get up without help. The patient had Covid 19 in Jun2020. He had a lot of symptoms after receiving the first dose of the vaccine. The reporter reported her father fell in the bathroom while brushing his teeth and her brother had to come over to get him up. The reporter was starting to wonder if he should take the second dose. The outcome of the events Weakness in legs and fell was resolving and of the other events was unknown. The reporter considered event Weakness in legs was serious due to medically significant and disabling; considered event fall was serious due to medically significant.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of the events muscular weakness, fall and gait disturbance cannot be excluded. The events are confounded by the elderly patient's underlying conditions. The impacts of this report on the benefit/risk profile of the 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Laboratory test normal, Lethargy, Rash
Clinical narrative: Shingles rash; did have lethargy and was dragging; did have lethargy and was dragging; This is a spontaneous report from a contactable healthcare professional reporting for self. This 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on 11Jan2021 at left deltoid at single dose for COVID Prevention. Medical history and concomitant medications were none.  Her health had improved over the last six months and she was on no medications, and her labs had been good. The patient previously received first dose of BNT162B2 (lot number: EJ1685) via IM injection into the left deltoid on 23Dec2020 at single dose for COVID Prevention. She stated that she may have had some dragging after the first dose, but it was after the holidays and she was laying around anyway, so if she did, it was not of note to her at the time.  She confirmed that she received no other vaccines on the same day as either her first dose, nor her second dose of the vaccine. The patient experienced shingles rash starting on 14Jan2021. It was reported that the patient received her second dose of vaccine last Monday (11Jan2021). The Thursday following that (14Jan2021), she noticed a small patch of a rash on her right side, and she did not think much of it at first, because she had been gardening. But she stated that by Friday, it was clear that she had the initial onslaught of Shingles. She stated that over the weekend, the rash had taken a very predicable course, where it is now in circles around her body. She had had no other sentinel events, she had not been sick, she was not stressed, the only thing was that four days prior to the rash, she got the last COVID shot. She just wanted there to be accuracy in known side effects because she was 56 years old, but she was not immunosuppressed at all, and she knew that it would be given to people 65 and older soon. Patient stated that she was no sick as a dog, but two days after receiving the second dose, she did have lethargy and was dragging on 14Jan2021. She thought after the second dose, the vaccine may have hit her immune system. The outcome of shingles rash was not recovered and reported as worsened, outcome of other events was unknown. The reporter considered the event shingles rash was serious as medically significant and was related to the vaccine.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of shingles rash cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021092332 same patient/drug, different event separated with time
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Arthralgia, Chills, Cough, Dizziness
Clinical narrative: Tested positive for COVID 19/headache/chills/coughing; Tested positive for COVID 19/headache/chills/coughing; Dizziness; joint pain all over the body; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients (himself and wife). This is report 1 of 2.   A male patient of an unspecified age received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache, dizziness, joint pain all over the body and chills, coughing on 17Jan2021. Patient was trying to figure out for a lot of the symptoms how long does it last. His symptoms started 17Jan2021 morning. The second dose for patient is scheduled on 02Feb2021. The patient was tested positive for COVID 19 on Wednesday, 20Jan2021. He stated he reported a few days ago about some symptoms they had. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056973 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID 19/headache/chills/coughing; Tested positive for COVID 19/headache/chills/coughing; Dizziness; joint pain all over the body; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients (himself and wife). This is report 1 of 2.   A male patient of an unspecified age received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache, dizziness, joint pain all over the body and chills, coughing on 17Jan2021. Patient was trying to figure out for a lot of the symptoms how long does it last. His symptoms started 17Jan2021 morning. The second dose for patient is scheduled on 02Feb2021. The patient was tested positive for COVID 19 on Wednesday, 20Jan2021. He stated he reported a few days ago about some symptoms they had. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056973 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Malaise
Clinical narrative: received first dose of Pfizer COVID vaccine then tested positive for COVID 19/Headache/Chills; received first dose of Pfizer COVID vaccine then tested positive for COVID 19/Headache/Chills; Dizziness; Joint pain all over the body; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar events for 2 patients (himself and wife). This is report 2 of 2, the report for the wife.   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced headache, dizziness, joint pain all over the body and chills on 14Jan2021. The reporter himself and his wife got the shot on Tuesday the past week (12Jan2021), he was trying to figure out for a lot of the symptoms how long does it last, like the headache, dizziness, both him and his wife were experiencing this. His wife's symptoms began on Thursday 14Jan2021, she started getting sick with joint pain all over the body and chills. The second dose for both of them was scheduled on 02Feb2021. The patient then tested positive for COVID 19 on Wednesday, 20Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056969 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received first dose of Pfizer COVID vaccine then tested positive for COVID 19/Headache/Chills; received first dose of Pfizer COVID vaccine then tested positive for COVID 19/Headache/Chills; Dizziness; Joint pain all over the body; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar events for 2 patients (himself and wife). This is report 2 of 2, the report for the wife.   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced headache, dizziness, joint pain all over the body and chills on 14Jan2021. The reporter himself and his wife got the shot on Tuesday the past week (12Jan2021), he was trying to figure out for a lot of the symptoms how long does it last, like the headache, dizziness, both him and his wife were experiencing this. His wife's symptoms began on Thursday 14Jan2021, she started getting sick with joint pain all over the body and chills. The second dose for both of them was scheduled on 02Feb2021. The patient then tested positive for COVID 19 on Wednesday, 20Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056969 similar report from same reporter
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Muscle swelling
Clinical narrative: approx. 1 hour following inject experienced severe head ache with blurred vision; approx. 10 days following injection large swelling, redness, and warmth at injection site, appears like muscle swelling to size/shape of an egg
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: approx. 1 hour following inject experienced severe head ache with blurred vision; approx. 10 days following injection large swelling, redness, and warmth at injection site, appears like muscle swelling to size/shape of an egg
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Approximately 18 hours after dose I experienced a quick onset of severe fatigue (i.e. hard to get out of bed), chills & mild fever (100F). Additionally, my arm was mildly swollen, warm & very painful. Symptoms lasted for about 10 hours and then quickly disappeared. Tx: Tylenol 100mg .
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Approximately 18 hours after dose I experienced a quick onset of severe fatigue (i.e. hard to get out of bed), chills & mild fever (100F). Additionally, my arm was mildly swollen, warm & very painful. Symptoms lasted for about 10 hours and then quickly disappeared. Tx: Tylenol 100mg .
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received immunization from vial containing diluent in the amount of 1.0 rather than 1.8 ml 0.9% sodium chloride, so dose was concentrated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy on left side of the face
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Migraine, Myalgia, Nausea
Clinical narrative: Extreme muscle and body aches Fever - 101 Chills Migraine Loss of appetite Nausea
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Extreme muscle and body aches Fever - 101 Chills Migraine Loss of appetite Nausea
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Vomiting
Clinical narrative: Intensive vomiting all night after receiving the vaccine, fatigue, chills, muscle aches
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Heart rate increased, Hypertension, X-ray
Clinical narrative: Racing pulse and High blood pressure
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Chest X-ray, Dyspnoea, Echocardiogram
Clinical narrative: Racing pulse and High blood pressure
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Heart rate, Heart rate increased, Hypertension, Palpitations
Clinical narrative: Racing pulse and High blood pressure
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 9 days after the injection I noticed two red splotches at injection shot. It was very red and hot. This was not there before. I checked the injection site closely 48 hours after the injection was given. I am able to complete my duties at work at a slow pace.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pruritus
Clinical narrative: Itchy neck, head, back and knees. Was released to go home and take Benadryl. Headache later that night into Sunday and Monday. Chills and muscle aches
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Dizziness, Ear discomfort, Flushing, Heart rate increased
Clinical narrative: Facial flushing that was more prominent on the left side of my face and left ear flushing and burning, dizziness, nausea., and rapid pounding heart beat. This started 45 minutes after receiving the vaccine. About 1 1/2 hours symptoms still persisted so took 50mg of Benadryl and slept for 2 hours. Upon waking up facial flushing, dizziness, and pounding heart rate still present but was better. Continued to have left sided cluster headache and face flushing for 48 hours. Also was sore in my left arm down my left side to the bottom of my rib cage all the way up my left neck and sore into my left chest.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Nausea, Neck pain, Pain in extremity
Clinical narrative: Facial flushing that was more prominent on the left side of my face and left ear flushing and burning, dizziness, nausea., and rapid pounding heart beat. This started 45 minutes after receiving the vaccine. About 1 1/2 hours symptoms still persisted so took 50mg of Benadryl and slept for 2 hours. Upon waking up facial flushing, dizziness, and pounding heart rate still present but was better. Continued to have left sided cluster headache and face flushing for 48 hours. Also was sore in my left arm down my left side to the bottom of my rib cage all the way up my left neck and sore into my left chest.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Low grade fever, chills and fatigue - 600mg ibuprofen - resolved
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Injection site pain, Palpitations, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection site. patient then stated she felt tingling in her hands, feet, and mouth. Patient also stated that she felt her heart racing. BP 172/103, HR 149, SPO2 100% on room air. Denies SOB and difficulty breathing. Pt was transferred to ED. In ED was given oral prednisone and diphenhydramine. Assessment for possible drug reaction, not thought to be anaphylaxis, with mild anxiety contributing. Patient monitored and discharged in stable condition.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pharyngeal swelling
Clinical narrative: Got the vaccine at 5:03 waited in the clinic for 15 min and left at about 5:27 started feeling throat swelling and numbness in my right side of the face. Got home at 5:35 called a Doctor and He told me to take Benadryl 50mg. Took it and 5-6 min I felt the swelling went down.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Cold sweat, Computerised tomogram head, Dysarthria, Facial paralysis
Clinical narrative: On 1/26/2021, resident had an elevated blood pressure of 183/102 and he was cold and clammy.   Resident sent to ER via 911.  He was sent home that same day.  On 1/27/2021, resident found sitting in his apartment with a facial droop, slightly slurred speech and left sided weakness.  Resident had also fallen the previous night and on the morning of 1/27/2021.  Resident transported to the ER for evaluation and treatment and was admitted with diagnosis of  TIA; rule out stroke.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hemiparesis, Hypertension, Transient ischaemic attack
Clinical narrative: On 1/26/2021, resident had an elevated blood pressure of 183/102 and he was cold and clammy.   Resident sent to ER via 911.  He was sent home that same day.  On 1/27/2021, resident found sitting in his apartment with a facial droop, slightly slurred speech and left sided weakness.  Resident had also fallen the previous night and on the morning of 1/27/2021.  Resident transported to the ER for evaluation and treatment and was admitted with diagnosis of  TIA; rule out stroke.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bells palsy
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches 1 day
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient received immunization from vial containing diluent in the amount of 1.0 rather than 1.8 ml 0.9% sodium chloride, so dose was concentrated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray abnormal, Chills, Dyspnoea, Lung opacity
Clinical narrative: Cant get her breath, intensely weak, chills.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, SARS-CoV-2 test positive
Clinical narrative: Cant get her breath, intensely weak, chills.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Pain, Raynaud's phenomenon
Clinical narrative: For 10 days I experienced reynauds syndrome in my hands and feet. Terrible painful touch sensations as well. 8/10 pain. Then it resolved. I received my second dose yesterday.  So far I just feel like every bone in my body hurts and I feel like I have rabdo.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Confusional state
Clinical narrative: Daughter contacted the clinical location for vaccination to inquire regarding if her mother was confused when at the location to receive her vaccine as she ended up in the ED 2 hours later with a diagnosis of stroke.  completing VAERs due to how closely the vaccine was to the event.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting, diarrhea,  fever, generalized intense pain. Fatigue still experiencing at this time
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: One week later injection site is red, warm, swollen and itching
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site rash, Pain, Pyrexia, Rash erythematous
Clinical narrative: Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This started on Feb. 2.  Also had fever of 100 degrees, body aches, headache for about 36 hours, it started 12 hours after I received the vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This started on Feb. 2.  Also had fever of 100 degrees, body aches, headache for about 36 hours, it started 12 hours after I received the vaccine.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: vomiting, 100 degree fever
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Asthma, Blood test, Chest X-ray, Chills, Cough
Clinical narrative: Jan 12, injection  Jan 13 Survey?- no symptoms and completed survey Jan 14 early am sore arm and raised knot at injection size of Quarter (showed someone) January 15 mild headache Jan 16 knot at injection site remains.  Congestion. headache. Deep cough use of rescue inhaler Jan 17 addition to symptoms above aches,  chills Jan 18 additional use of rescue inhaler increased deep cough, tired Jan 19 completed survey referencing symptoms. After survey,  said someone would follow up? no f/u to date. Also Left 2 msgs at employee health. worked remotely addition: hoarseness. Knot gone with mild soreness. Cough Jan 20 took sick time. mild headache. hoarseness continues, congestion, tired, cough, Itchiness at injection site * Left Message at Employee Health Jan 21 less aches. Continued cough and rescue inhaler use Jan 22 Nurse from employee Health called back and said they could only document my file and there's nothing they can do. itchiness at injection site. Pat no scratching.  January 23 Asthma attack, tingling at injection site. See pictures below. large raised welt 10:36 p.m. January 24 welt flattening. Looks like ring worm at injection  January 25 flat welt.  redness lighter.  January 26 Slight itchiness at injection site redness lighter and  smaller see picture below. January 23 Image January 23 Image  January 26 Image January 27 Cough, hoarseness continues, sluggish January 28 Made appointment with PCP. Blood work and chest Xray January 29 Cough and hoarseness. Diagnosed asthma/bronchitis.  Prescribe correct inhaler and Zpac
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Dysphonia, Fatigue, Headache, Impaired work ability, Injection site erythema
Clinical narrative: Jan 12, injection  Jan 13 Survey?- no symptoms and completed survey Jan 14 early am sore arm and raised knot at injection size of Quarter (showed someone) January 15 mild headache Jan 16 knot at injection site remains.  Congestion. headache. Deep cough use of rescue inhaler Jan 17 addition to symptoms above aches,  chills Jan 18 additional use of rescue inhaler increased deep cough, tired Jan 19 completed survey referencing symptoms. After survey,  said someone would follow up? no f/u to date. Also Left 2 msgs at employee health. worked remotely addition: hoarseness. Knot gone with mild soreness. Cough Jan 20 took sick time. mild headache. hoarseness continues, congestion, tired, cough, Itchiness at injection site * Left Message at Employee Health Jan 21 less aches. Continued cough and rescue inhaler use Jan 22 Nurse from employee Health called back and said they could only document my file and there's nothing they can do. itchiness at injection site. Pat no scratching.  January 23 Asthma attack, tingling at injection site. See pictures below. large raised welt 10:36 p.m. January 24 welt flattening. Looks like ring worm at injection  January 25 flat welt.  redness lighter.  January 26 Slight itchiness at injection site redness lighter and  smaller see picture below. January 23 Image January 23 Image  January 26 Image January 27 Cough, hoarseness continues, sluggish January 28 Made appointment with PCP. Blood work and chest Xray January 29 Cough and hoarseness. Diagnosed asthma/bronchitis.  Prescribe correct inhaler and Zpac
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Injection site nodule, Injection site pain, Injection site paraesthesia, Injection site pruritus, Injection site swelling
Clinical narrative: Jan 12, injection  Jan 13 Survey?- no symptoms and completed survey Jan 14 early am sore arm and raised knot at injection size of Quarter (showed someone) January 15 mild headache Jan 16 knot at injection site remains.  Congestion. headache. Deep cough use of rescue inhaler Jan 17 addition to symptoms above aches,  chills Jan 18 additional use of rescue inhaler increased deep cough, tired Jan 19 completed survey referencing symptoms. After survey,  said someone would follow up? no f/u to date. Also Left 2 msgs at employee health. worked remotely addition: hoarseness. Knot gone with mild soreness. Cough Jan 20 took sick time. mild headache. hoarseness continues, congestion, tired, cough, Itchiness at injection site * Left Message at Employee Health Jan 21 less aches. Continued cough and rescue inhaler use Jan 22 Nurse from employee Health called back and said they could only document my file and there's nothing they can do. itchiness at injection site. Pat no scratching.  January 23 Asthma attack, tingling at injection site. See pictures below. large raised welt 10:36 p.m. January 24 welt flattening. Looks like ring worm at injection  January 25 flat welt.  redness lighter.  January 26 Slight itchiness at injection site redness lighter and  smaller see picture below. January 23 Image January 23 Image  January 26 Image January 27 Cough, hoarseness continues, sluggish January 28 Made appointment with PCP. Blood work and chest Xray January 29 Cough and hoarseness. Diagnosed asthma/bronchitis.  Prescribe correct inhaler and Zpac
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Respiratory tract congestion, Sluggishness, Urticaria
Clinical narrative: Jan 12, injection  Jan 13 Survey?- no symptoms and completed survey Jan 14 early am sore arm and raised knot at injection size of Quarter (showed someone) January 15 mild headache Jan 16 knot at injection site remains.  Congestion. headache. Deep cough use of rescue inhaler Jan 17 addition to symptoms above aches,  chills Jan 18 additional use of rescue inhaler increased deep cough, tired Jan 19 completed survey referencing symptoms. After survey,  said someone would follow up? no f/u to date. Also Left 2 msgs at employee health. worked remotely addition: hoarseness. Knot gone with mild soreness. Cough Jan 20 took sick time. mild headache. hoarseness continues, congestion, tired, cough, Itchiness at injection site * Left Message at Employee Health Jan 21 less aches. Continued cough and rescue inhaler use Jan 22 Nurse from employee Health called back and said they could only document my file and there's nothing they can do. itchiness at injection site. Pat no scratching.  January 23 Asthma attack, tingling at injection site. See pictures below. large raised welt 10:36 p.m. January 24 welt flattening. Looks like ring worm at injection  January 25 flat welt.  redness lighter.  January 26 Slight itchiness at injection site redness lighter and  smaller see picture below. January 23 Image January 23 Image  January 26 Image January 27 Cough, hoarseness continues, sluggish January 28 Made appointment with PCP. Blood work and chest Xray January 29 Cough and hoarseness. Diagnosed asthma/bronchitis.  Prescribe correct inhaler and Zpac
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lips double in size
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Rash macular
Clinical narrative: On the 8th day the injection site became blotchy, red & itchy.  On day 9 the site was solid red and warm to the touch.  On day 10 the redness was gone, but the itch remained until day 12.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Injection site discomfort, Lymphadenopathy
Clinical narrative: Abdominal cramps, followed by diarrhea that lasted  8-12 hours.  Reporting this because I don't see it among listed  common side effects.  Other family member shared same food and had no symptoms  Do have mild site discomfort and probable axillary lymphadenopathy but see that these are not uncommon
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Neck pain
Clinical narrative: Residual pain in his arm pit- radiates to his neck and radiates down his arm to elbow