chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Minor nausea; Feeling unwell; Arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0182) via an unspecified route of administration in left arm on 13Jun2021 10:00 as 2nd dose, single for COVID-19 immunization. Patient medical history included high BP, migraines and known allergies to Compazine. The concomitant medications included estradiol, amitriptyline, propranolol HCL ER. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0178) via an unspecified route of administration in left arm on 23May2021 10:00 as 1st dose, single for COVID-19 immunization. Vaccine facility type was reported as Pharmacy or Drug Store. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Patient was 52-years-old and was not pregnant at the time of vaccination. On 14Jun2021 at 05:00, patient experienced injection site pain, tiredness, headache, muscle pain, joint pain, minor nausea, feeling unwell, arm pain.  Patient did not receive any treatment for the adverse events. The outcome of the events was not resolved.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Atrial fibrillation, Blood test, Condition aggravated, Dehydration
Clinical narrative: After 1st Dose:Fatigue lasting for several weeks. Occasional A-Fib episodes lasting less than 60 seconds. On 5/17/2021 I experienced an A-Fib episode lasting 40 minutes and was seen at the ER and was treated for dehydration, and severe Electrolyte deficiency : Potassium, Calcium and Magnesium. Began to experience edema of lower legs which resolves 80 % after bedrest and returns the following day with activity.   After 2nd dose: ( 5/20/2021)  experienced Extreme Fatigue, Headache, Joint Pain, Muscle pain immediately following vaccine. Extreme Fatigue,  Muscle Pain in Shoulders, Neck, Calves and almost daily mild A-Fib episodes continue up to and including today.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Electrolyte imbalance, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: After 1st Dose:Fatigue lasting for several weeks. Occasional A-Fib episodes lasting less than 60 seconds. On 5/17/2021 I experienced an A-Fib episode lasting 40 minutes and was seen at the ER and was treated for dehydration, and severe Electrolyte deficiency : Potassium, Calcium and Magnesium. Began to experience edema of lower legs which resolves 80 % after bedrest and returns the following day with activity.   After 2nd dose: ( 5/20/2021)  experienced Extreme Fatigue, Headache, Joint Pain, Muscle pain immediately following vaccine. Extreme Fatigue,  Muscle Pain in Shoulders, Neck, Calves and almost daily mild A-Fib episodes continue up to and including today.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test increased, Myalgia, Oedema peripheral, Ultrasound scan normal
Clinical narrative: After 1st Dose:Fatigue lasting for several weeks. Occasional A-Fib episodes lasting less than 60 seconds. On 5/17/2021 I experienced an A-Fib episode lasting 40 minutes and was seen at the ER and was treated for dehydration, and severe Electrolyte deficiency : Potassium, Calcium and Magnesium. Began to experience edema of lower legs which resolves 80 % after bedrest and returns the following day with activity.   After 2nd dose: ( 5/20/2021)  experienced Extreme Fatigue, Headache, Joint Pain, Muscle pain immediately following vaccine. Extreme Fatigue,  Muscle Pain in Shoulders, Neck, Calves and almost daily mild A-Fib episodes continue up to and including today.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Similar Rx to 1st dose w/ SOB, chest tightness, & CP that resolved after approx 1hr in medical observation.  Obtained baseline VS prior to dose.  Vax admin at 1115, SOB reported @ 1125.  Benadryl 50mg PO admin @ 1133 for SOB w/ CP/heaviness.  1141 - VSS and symptoms reported as resolving and "much better"  Lungs CTAx5 lobes, Pt AOx3 w/ intermittent smiling/talking.  Symptoms resolved and VSS and released w/ family at 1207  1112 - BP 126/86, HR 68bpm, RR 16, O2 100% RA 1125 - BP 180/127, HR 87bpm, RR 20-24, O2 98% RA 1130 - BP 144/98, HR 87bpm, RR 20, O2 99% RA 1141 - BP 147/93, HR 75bpm, RR 18, O2 98% RA 1200 - BP 137/82, HR 66bpm, RR 18, O2 97% RA 1207 - BP 139/90, HR 67bpm, RR 16-18, O2 97% RA
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache
Clinical narrative: Severe joint Pain all extremities. Headache, dizziness, strong fatigue.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Patient reported chest pains within first 15 minutes which resolved after 30 minutes.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: PT RECEIVED MODERNA AS 1ST DOSE ON 05/18/21 AND THEN RECEIVED PFIZER AS 2ND DOSE 6/10/21. PT DID NOT REPORT ANY ADVERSE EFFECTS.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Pain
Clinical narrative: 101.4 temp General achyness
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient explained that he is still experiencing a burning pain in his left shoulder daily with some numbness and tingling in his fingertips occasionally when he moves his arm. He feels that the pain flares up when he lays down at night.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Balance disorder, Blood glucose, Blood thyroid stimulating hormone, Chest X-ray
Clinical narrative: About a week later from both shots I experienced extreme dizziness that lasted 5 seconds   A total of 4 dizzy spells that totally frightened me. I went to the ER had MRI and multiple tests done for stroke, heart attack mass. All perfect! Thank God It?s been 5 weeks after second shot and at times I still feel at times unsteady and fearful it will happen again.  I am a very healthy person exercise not overweight and eat healthy.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Dizziness, Echocardiogram normal, Electrocardiogram normal, Fear
Clinical narrative: About a week later from both shots I experienced extreme dizziness that lasted 5 seconds   A total of 4 dizzy spells that totally frightened me. I went to the ER had MRI and multiple tests done for stroke, heart attack mass. All perfect! Thank God It?s been 5 weeks after second shot and at times I still feel at times unsteady and fearful it will happen again.  I am a very healthy person exercise not overweight and eat healthy.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Haemoglobin, International normalised ratio, Magnetic resonance imaging normal, Metabolic function test
Clinical narrative: About a week later from both shots I experienced extreme dizziness that lasted 5 seconds   A total of 4 dizzy spells that totally frightened me. I went to the ER had MRI and multiple tests done for stroke, heart attack mass. All perfect! Thank God It?s been 5 weeks after second shot and at times I still feel at times unsteady and fearful it will happen again.  I am a very healthy person exercise not overweight and eat healthy.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: About a week later from both shots I experienced extreme dizziness that lasted 5 seconds   A total of 4 dizzy spells that totally frightened me. I went to the ER had MRI and multiple tests done for stroke, heart attack mass. All perfect! Thank God It?s been 5 weeks after second shot and at times I still feel at times unsteady and fearful it will happen again.  I am a very healthy person exercise not overweight and eat healthy.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Death, SARS-CoV-2 test positive
Clinical narrative: Death on 3/12/2021. Primary cause of death was COPD, with COVID-19 listed as an underlying cause.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness postural, Headache, Pyrexia
Clinical narrative: dizziness upon standing; FEVER; headed h; chills; This a spontaneous report from a non-contactable consumer (patients father) via a sales representative. A 14-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date as a single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation, (No reaction on previous exposure to vaccine). The patient experienced fever, dizziness upon standing, 'headed h' (as reported), chills for which Tylenol and EmergenC was taken. The symptoms were relieved but returned a few hours later and patient dosed Tylenol again. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: about a month after receiving the vaccine I started to notice ringing in my ears.  It seems to be getting worse, not going away
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt expressed she can pass out after vaccines and blood draws.  i explained process, side effects and what to expect.  I had pt look at her mom during admin.  Patient did fabulous and told she did amazing as not even a speck of blood.  About 5 mins later i asked pt hiow she was, which was good.  About 15 mins later, she seemed lethargic and said she was dizzy.  I asked questions, took Temp and got ice packs.  I then called EMS as patient was not responding appropriastely.  BP, O2, HR were perfect
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Pain in extremity
Clinical narrative: Shingles rash developed around right under arm about three days after soreness and burning began on 6/6. Rash appeared on 6/9 and I received diagnosis as Shingles and given valacyclovir on 6/11.  Finished course of medicine (7 days) and Rash is still healing as of  6/25
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a contactable physician via Pfizer sales representative. A patient of an unspecified age and gender received second dose of meningococcal group B RLP2086 (TRUMENBA; Suspension for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the physician gave meningococcal group B RLP2086 to the patient with other adolescent vaccines (unspecified) and the patients had fever following immunizations on an unspecified date. The outcome of the event was reported as unknown.   No follow up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was 17 and administered the MODERNA vaccine. no symptoms occurred.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Cystitis, Vulval abscess
Clinical narrative: Patient presented to the on 4/26/2021 for cystitis, cellulitis. Patient hospitalized on 4/30/2021 for vulvar abscess and cellulitis. These visits are within 6 weeks of receiving COVID vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anxiety, Chest discomfort, Dysphagia, Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: ANXIETY-Medium, Additional Details: WE CALLED 911, paramedics came and her oxygen, heart rate, bpwas fine. pt was given option of going to hospital, but she did not want to go.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Costochondritis, Full blood count, Hypertension, International normalised ratio
Clinical narrative: Left Chest pain followed by diagnosis of costochondritis, accompanied by acute hypertension.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Troponin
Clinical narrative: Left Chest pain followed by diagnosis of costochondritis, accompanied by acute hypertension.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Administered with 008C21A on 5/21, date updated to 5/20. Vaccine was administered on 5/20/21 but logged after 12:00am on 5/21/2021.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: fevers; This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. This physician reported same event for 2 different patients. This is 2nd of 2 cases.  A patient of an unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, Suspension for injection, Batch/Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that she gave meningococcal group b rlp2086 to patient with other adolescent vaccines and patient had fevers following immunizations on an unspecified date. Event took place after use of product. The outcome of event was unknown.  No follow-up attempts are possible. No further information expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactate dehydrogenase increased, C-reactive protein increased, Chest X-ray normal, Chest pain, Echocardiogram normal
Clinical narrative: Patient is a previously healthy 15 year-old presenting with chest pain and elevated troponin in the setting of recently receiving his second COVID vaccine.   He was in his USOH and received his second COVID vaccine 6/17. He subsequently experienced tactile fevers, headache, and malaise for two days that resolved. Then 6/21 he developed congestion and chest pain. It is in the center of his chest, not pleuritic but worsened with sneezing/coughing. Tylenol/Motrin help, but given persistence of the pain he presented to the hospital ED.   Lyme titers were sent, troponin at 1814 was 2.12, then at 1646 2.49 (normal <0.06), chem was normal, CBC had wbc 11.5 with 66% neut and Hgb 12.3. EKG and CXR were reportedly normal. He received Tylenol and Ativan and was transferred for further management.   In the ED, he was afebrile with normal VS. Repeat troponin was 0.25. EKG was normal. Given elevated troponin, he is being admitted for further workup and serial cardiac enzymes and EKG.  Hospital Course: Patient was admitted to the cardiology floor for troponin and chest pain monitoring. His troponin levels were trended x4 and showed return to normal. Just prior to discharge, troponin level was 0.04 (normal < 0.09). His EKG was normal throughout, and at discharge showed normal sinus rhythm. He did not have any chest pain prior to leaving the hospital. On discharge, he was tolerating a normal diet. Plan for return was discussed with family for cardiac MR on 6/25. Return precautions were discussed and family expressed understanding.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram QT interval, Electrocardiogram normal, Haemoglobin normal, Headache, Magnetic resonance imaging heart
Clinical narrative: Patient is a previously healthy 15 year-old presenting with chest pain and elevated troponin in the setting of recently receiving his second COVID vaccine.   He was in his USOH and received his second COVID vaccine 6/17. He subsequently experienced tactile fevers, headache, and malaise for two days that resolved. Then 6/21 he developed congestion and chest pain. It is in the center of his chest, not pleuritic but worsened with sneezing/coughing. Tylenol/Motrin help, but given persistence of the pain he presented to the hospital ED.   Lyme titers were sent, troponin at 1814 was 2.12, then at 1646 2.49 (normal <0.06), chem was normal, CBC had wbc 11.5 with 66% neut and Hgb 12.3. EKG and CXR were reportedly normal. He received Tylenol and Ativan and was transferred for further management.   In the ED, he was afebrile with normal VS. Repeat troponin was 0.25. EKG was normal. Given elevated troponin, he is being admitted for further workup and serial cardiac enzymes and EKG.  Hospital Course: Patient was admitted to the cardiology floor for troponin and chest pain monitoring. His troponin levels were trended x4 and showed return to normal. Just prior to discharge, troponin level was 0.04 (normal < 0.09). His EKG was normal throughout, and at discharge showed normal sinus rhythm. He did not have any chest pain prior to leaving the hospital. On discharge, he was tolerating a normal diet. Plan for return was discussed with family for cardiac MR on 6/25. Return precautions were discussed and family expressed understanding.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myocardial necrosis marker, Neutrophil percentage, Pyrexia, QRS axis
Clinical narrative: Patient is a previously healthy 15 year-old presenting with chest pain and elevated troponin in the setting of recently receiving his second COVID vaccine.   He was in his USOH and received his second COVID vaccine 6/17. He subsequently experienced tactile fevers, headache, and malaise for two days that resolved. Then 6/21 he developed congestion and chest pain. It is in the center of his chest, not pleuritic but worsened with sneezing/coughing. Tylenol/Motrin help, but given persistence of the pain he presented to the hospital ED.   Lyme titers were sent, troponin at 1814 was 2.12, then at 1646 2.49 (normal <0.06), chem was normal, CBC had wbc 11.5 with 66% neut and Hgb 12.3. EKG and CXR were reportedly normal. He received Tylenol and Ativan and was transferred for further management.   In the ED, he was afebrile with normal VS. Repeat troponin was 0.25. EKG was normal. Given elevated troponin, he is being admitted for further workup and serial cardiac enzymes and EKG.  Hospital Course: Patient was admitted to the cardiology floor for troponin and chest pain monitoring. His troponin levels were trended x4 and showed return to normal. Just prior to discharge, troponin level was 0.04 (normal < 0.09). His EKG was normal throughout, and at discharge showed normal sinus rhythm. He did not have any chest pain prior to leaving the hospital. On discharge, he was tolerating a normal diet. Plan for return was discussed with family for cardiac MR on 6/25. Return precautions were discussed and family expressed understanding.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 antibody test negative, Troponin T increased, Viral titre, White blood cell count increased
Clinical narrative: Patient is a previously healthy 15 year-old presenting with chest pain and elevated troponin in the setting of recently receiving his second COVID vaccine.   He was in his USOH and received his second COVID vaccine 6/17. He subsequently experienced tactile fevers, headache, and malaise for two days that resolved. Then 6/21 he developed congestion and chest pain. It is in the center of his chest, not pleuritic but worsened with sneezing/coughing. Tylenol/Motrin help, but given persistence of the pain he presented to the hospital ED.   Lyme titers were sent, troponin at 1814 was 2.12, then at 1646 2.49 (normal <0.06), chem was normal, CBC had wbc 11.5 with 66% neut and Hgb 12.3. EKG and CXR were reportedly normal. He received Tylenol and Ativan and was transferred for further management.   In the ED, he was afebrile with normal VS. Repeat troponin was 0.25. EKG was normal. Given elevated troponin, he is being admitted for further workup and serial cardiac enzymes and EKG.  Hospital Course: Patient was admitted to the cardiology floor for troponin and chest pain monitoring. His troponin levels were trended x4 and showed return to normal. Just prior to discharge, troponin level was 0.04 (normal < 0.09). His EKG was normal throughout, and at discharge showed normal sinus rhythm. He did not have any chest pain prior to leaving the hospital. On discharge, he was tolerating a normal diet. Plan for return was discussed with family for cardiac MR on 6/25. Return precautions were discussed and family expressed understanding.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Sore left arm around 9pm on June 24, 2021. Around 10:30pm on June 24, 2021 chills, 100 degree fever, and aches. Continued through the night and continuing as of June 25, 2021.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Systemic: Weakness-Mild, Additional Details: Patient felt dizziness and just fell down and recover right away . I pharmacist gave some water and check vital and she was fine and made her sit down for 30 min. then send her home
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after the expiration date of 04/28/21. Patient reports no adverse events.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after the expiration date of 04/28/21. Patient reports no adverse events.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Headache, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Pt fainted a minute after recieving his vaccine. Was unresponsive for a few seconds and got up after. Bite his tongue from the fall head first. Paramedics were called and he was quickly evaluated with no vitals out of range. He went home and napped and after follow up call, feels better now 7 hours later. He confirmed had light headache,was tired so napped and also had tingling in his arm and also confirmed he did not drink water or eat anything before his visit. Now he feels fine.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lethargy, Syncope, Tongue biting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Pt fainted a minute after recieving his vaccine. Was unresponsive for a few seconds and got up after. Bite his tongue from the fall head first. Paramedics were called and he was quickly evaluated with no vitals out of range. He went home and napped and after follow up call, feels better now 7 hours later. He confirmed had light headache,was tired so napped and also had tingling in his arm and also confirmed he did not drink water or eat anything before his visit. Now he feels fine.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after the expiration date of 04/28/21. Patient reports no adverse events.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Swelling
Clinical narrative: she received her 2nd Moderna vaccine 5/5/21 at a pharmacy. she presented to my clinic on 5/7/21 with complaints of left sided upper body swelling/itching (including her face, which had improved by time of presentation) and left arm soreness. she had visible erythema, swelling, and tenderness of upper left arm but no other physical exam abnormalities at the time of my evaluation on 5/7/21.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: she received her 2nd Moderna vaccine 5/5/21 at a pharmacy. she presented to my clinic on 5/7/21 with complaints of left sided upper body swelling/itching (including her face, which had improved by time of presentation) and left arm soreness. she had visible erythema, swelling, and tenderness of upper left arm but no other physical exam abnormalities at the time of my evaluation on 5/7/21.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Furuncle, Pain
Clinical narrative: 12cm boil, diarrhea, achy, multiple clinic visits and outpatient IV antibiotics.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Feeling abnormal, Nausea, Pain
Clinical narrative: FEELING BAD LACK OF ENERGY, DIAREA, NAUSEA HURTING IN LOWER RIGHT SIDE
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A was logged. Both lots expired on 5/13/2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Abnormal loss of weight, Atrial fibrillation, Bladder catheterisation
Clinical narrative: I was very sick to my stomach, I had  severe stomach pain. I started throwing up and was dry heaving, when I got to the hospital I found out I had C diff, a UTI, and the hospital admitted me I spent 3 weeks in the hospital. I was in 2 separate hospitals for a total of 7 weeks. I had serious complications, I went into A fib with my heart, I got neuropathy from my chest down I was numb all over. I had severe UTIs, they kept putting catheters in me. I was so sick I couldn't eat and I lost 35lbs. I thought I was going to die.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium difficile infection, Computerised tomogram, Feeding disorder, Hypoaesthesia, Laboratory test
Clinical narrative: I was very sick to my stomach, I had  severe stomach pain. I started throwing up and was dry heaving, when I got to the hospital I found out I had C diff, a UTI, and the hospital admitted me I spent 3 weeks in the hospital. I was in 2 separate hospitals for a total of 7 weeks. I had serious complications, I went into A fib with my heart, I got neuropathy from my chest down I was numb all over. I had severe UTIs, they kept putting catheters in me. I was so sick I couldn't eat and I lost 35lbs. I thought I was going to die.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Neuropathy peripheral, Retching, Urinary tract infection, Vomiting
Clinical narrative: I was very sick to my stomach, I had  severe stomach pain. I started throwing up and was dry heaving, when I got to the hospital I found out I had C diff, a UTI, and the hospital admitted me I spent 3 weeks in the hospital. I was in 2 separate hospitals for a total of 7 weeks. I had serious complications, I went into A fib with my heart, I got neuropathy from my chest down I was numb all over. I had severe UTIs, they kept putting catheters in me. I was so sick I couldn't eat and I lost 35lbs. I thought I was going to die.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: I was very sick to my stomach, I had  severe stomach pain. I started throwing up and was dry heaving, when I got to the hospital I found out I had C diff, a UTI, and the hospital admitted me I spent 3 weeks in the hospital. I was in 2 separate hospitals for a total of 7 weeks. I had serious complications, I went into A fib with my heart, I got neuropathy from my chest down I was numb all over. I had severe UTIs, they kept putting catheters in me. I was so sick I couldn't eat and I lost 35lbs. I thought I was going to die.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Sex: U
Vaccine: COVID19
Symptoms: Gingival swelling
Clinical narrative: After 2 weeks of getting my Pfizer shot I had extremely swollen gums; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported) via an unspecified route of administration, on an unspecified date, as UNKNOWN, SINGLE for covid-19 immunization . The patient medical history was not reported. The patient's concomitant medications were not reported.  On an unspecified date, after 2 weeks of getting Pfizer shot, the patient had extremely swollen gums. After almost more than 2 months they are better because patient using top quality toothpaste for gums as a therapeutic measure, but they are still there. The patient would like to know someone other also having this issue. Outcome of the event is was recovering at the time of the report.  Information on the lot/batch number has been requested
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: COVID symptoms began 3/16, positive test 3/19, hospital admission 3/22, death 4/1
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Joint swelling, Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: daily fatigue  pain in the right leg from the thigh and knee Knee is swollen went to doctor and told to get sonogram on June 17 after results of sonogram doctor prescribed Xzrelto
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Injection site pain
Clinical narrative: Was good for first 18 days. Then big bruise on my arm. Doctors confirmed not a blood clot and said I was good. Keep having lots of pain in the arm at the injection site 4-5 months later
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Demyelination, Dysarthria, Dysphemia, Facial paralysis
Clinical narrative: 6/3/21 at 1230 pm: Sudden onset of right arm numbness progressing to transient blurry vision, difficulty walking, right lower extremity weakness, difficulty moving his mouth, stuttering,  imbalance, and right sided facial droop.   He was admitted to hospital on 6/4/21. Found to have a demyelinating process (see imaging report below). He received IVIG treatment and IV steroids with some (but incomplet)e improvement and was discharged to Rehab on 6/16/21 on oral steroids. However, he had recurrence and progression of symptoms and was sent back to hospital on 6/19/21 with worsening right sided hemiplegia. He underwent repeat high dose IV steroids and initiation of plasmapharesis. He has currently (as of 6/25/21) completed 3 of 5 runs of plasmapharesis with marked improvement in symptoms but still has significant right sided motor deficits.   Neurologists here now feel comfortable making a diagnosis of multiple sclerosis. He will likely be discharging home for ongoing therapy and treatment after he completes plasmapharesis  on 6/28/21.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Hemiplegia, Hypoaesthesia, Immunoglobulin therapy, Magnetic resonance imaging abnormal
Clinical narrative: 6/3/21 at 1230 pm: Sudden onset of right arm numbness progressing to transient blurry vision, difficulty walking, right lower extremity weakness, difficulty moving his mouth, stuttering,  imbalance, and right sided facial droop.   He was admitted to hospital on 6/4/21. Found to have a demyelinating process (see imaging report below). He received IVIG treatment and IV steroids with some (but incomplet)e improvement and was discharged to Rehab on 6/16/21 on oral steroids. However, he had recurrence and progression of symptoms and was sent back to hospital on 6/19/21 with worsening right sided hemiplegia. He underwent repeat high dose IV steroids and initiation of plasmapharesis. He has currently (as of 6/25/21) completed 3 of 5 runs of plasmapharesis with marked improvement in symptoms but still has significant right sided motor deficits.   Neurologists here now feel comfortable making a diagnosis of multiple sclerosis. He will likely be discharging home for ongoing therapy and treatment after he completes plasmapharesis  on 6/28/21.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Motor dysfunction, Multiple sclerosis, Muscular weakness
Clinical narrative: 6/3/21 at 1230 pm: Sudden onset of right arm numbness progressing to transient blurry vision, difficulty walking, right lower extremity weakness, difficulty moving his mouth, stuttering,  imbalance, and right sided facial droop.   He was admitted to hospital on 6/4/21. Found to have a demyelinating process (see imaging report below). He received IVIG treatment and IV steroids with some (but incomplet)e improvement and was discharged to Rehab on 6/16/21 on oral steroids. However, he had recurrence and progression of symptoms and was sent back to hospital on 6/19/21 with worsening right sided hemiplegia. He underwent repeat high dose IV steroids and initiation of plasmapharesis. He has currently (as of 6/25/21) completed 3 of 5 runs of plasmapharesis with marked improvement in symptoms but still has significant right sided motor deficits.   Neurologists here now feel comfortable making a diagnosis of multiple sclerosis. He will likely be discharging home for ongoing therapy and treatment after he completes plasmapharesis  on 6/28/21.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuromyelitis optica spectrum disorder, Plasmapheresis, Toxic leukoencephalopathy, Vision blurred, White matter lesion
Clinical narrative: 6/3/21 at 1230 pm: Sudden onset of right arm numbness progressing to transient blurry vision, difficulty walking, right lower extremity weakness, difficulty moving his mouth, stuttering,  imbalance, and right sided facial droop.   He was admitted to hospital on 6/4/21. Found to have a demyelinating process (see imaging report below). He received IVIG treatment and IV steroids with some (but incomplet)e improvement and was discharged to Rehab on 6/16/21 on oral steroids. However, he had recurrence and progression of symptoms and was sent back to hospital on 6/19/21 with worsening right sided hemiplegia. He underwent repeat high dose IV steroids and initiation of plasmapharesis. He has currently (as of 6/25/21) completed 3 of 5 runs of plasmapharesis with marked improvement in symptoms but still has significant right sided motor deficits.   Neurologists here now feel comfortable making a diagnosis of multiple sclerosis. He will likely be discharging home for ongoing therapy and treatment after he completes plasmapharesis  on 6/28/21.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Nausea, Syncope, Tremor, Vomiting
Clinical narrative: Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient was given vaccine and walked to observation area, with mom. He sat down and few minutes later he started shaking, seemed to faint/was unresponsive. He slipped/was lowered to ground where he came to, but started vomiting. He vomited several times and was confused. 911 was called and the paramedics arrived. Water was offered by pharmacy staff, but was not taken. Paramedic stated to pharmacist that patient did not show signs of being post-seizure. Patient was put on strecther by paramedics
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, No adverse event, Syringe issue, Underdose
Clinical narrative: Defective retractable syringe. Syringe retracted before dose was fully administered and over half of the dose did not make it into the patient's arm. Administered another full dose to the patient with no issue.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Condition aggravated, Fatigue, Insomnia
Clinical narrative: knee and shoulder pain, insomnia, low back pain, chronic pain, fatigue, sleep related leg cramps
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms, Pain
Clinical narrative: knee and shoulder pain, insomnia, low back pain, chronic pain, fatigue, sleep related leg cramps
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Palpitations, Rash
Clinical narrative: After my first shot of Pfizer, I have been feeling short of breath, heart raising, rashes, brain fog, etc.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: had very bad symptoms and they are not well until today; This is a spontaneous report from a non-contactable consumer. A female patient (sister) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), route of administration, start and stop date, batch/lot number and dose were not reported, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced had very bad symptoms and they are not well until today. The outcome of the event 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-2021703343 same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Illness, Therapeutic response unexpected
Clinical narrative: He had the strength in his legs to be able to stand up without pushing himself up, something he has not been able to do for some time (uses wheelchair and lift chair); He got sick; This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient's spouse). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history included multiple sclerosis (ongoing) and wheelchair user (ongoing). Concomitant medications were not reported. The patient got sick for 24 hours after receiving 2nd injection like many others. 24 hours later, patient was just fine. However, he had the strength in his legs to be able to stand up without pushing himself up. It was some-thing he has not been able to do for some time (uses wheelchair and lift chair). The reporter stated that this was a huge surprise. It lasted for 5 days and was very nice little side effect even if it lasted only 5 days. The outcome of sickness was recovered.  Information regarding the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Confusional state, Dyspnoea, Hypoaesthesia, Palpitations
Clinical narrative: My whole body was numb for 1hr and 30 min; unsteady balance; confusion; palpitations; sob; This is a spontaneous report from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 25May2021 as dose number unknown, single for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. On unspecified date 2021, The patient experienced Later on in the day patient experienced severe side effects that was on listed patient whole body was numb for 1hour and 30 min, unsteady balance, confusion, palpitations, and sob. patients understand the sob because had asthma but otherwise perfect health. The outcome of event was unknown.  Information on the lot/batch number has been requested. ; Reporter's Comments: Reporter provided verification of contact address on 11Jun2021 CEP D #3110
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Feeling abnormal, Pain
Clinical narrative: Lost my sense of taste and smell; Lost my sense of taste and smell; Body is achy; I felt pretty lousy; Very tired; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0181; Expiration Date was reported as 11Jun2021), via an unspecified route of administration on 11Jun2021 (reported as Friday evening) as single dose for COVID-19 immunization. Medical history included cough from unspecified date in Jun 2021 reported as about a week prior to getting the shot but get bronchitis a lot and gets sick at anything but had no other symptoms other than cough, bronchitis. The patient concomitant medications were not reported. It was reported that the patient took vaccine on Friday evening and felt pretty lousy all weekend and actually had almost every symptom of COVID right now, so she asked what happen if got the shot if you already had COVID. Patient stated that she lost sense of taste and smell, body is achy, very tired Patient stated that she get sick at anything but had no other symptoms other than cough and usually gets bronchitis. But then after the vaccine I started getting all the mentioned symptoms. The outcome of the events was unknown.  Consumer was unwilling to complete the report. Hence, limited information available.  No follow up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fever; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient, self-reported) via Pfizer sales representative. A 13-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on unspecified date, as a single dose for COVID-19 immunization. The patient reported that 2 sisters experienced similar symptoms. On an unspecified date, the patient experienced fever chills and fatigue which resolved in 24 hours. The events took place after use of product. The reporter did not wish to be contacted for follow-up. Outcome of the events was resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Neck pain
Clinical narrative: He felt a little pain in his neck and his legs felt heavy.; He felt a little pain in his neck and his legs felt heavy.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration on an unspecified date in May2021 (at the age of 68-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included nephrolithiasis (caller reported that in 28 years he has missed 2 days of work with kidney stones). The patient's concomitant medications were not reported. He do not drink or smoke, and walks 3-4 miles daily 5-7 days per week. On an unspecified date in May2021, the patient experienced he felt a little pain in his neck and his legs felt heavy, he felt a little pain in his neck and his legs felt heavy. Patient reported that he received the first dose of the Covid-19 vaccine about a month ago and about 2 weeks ago on Wednesday, he got the second dose. Caller reported that he received the first dose of the Covid-19 vaccine about 3 weeks before the second dose. The clinical outcome of the he felt a little pain in his neck and his legs felt heavy, he felt a little pain in his neck and his legs felt heavy were unknown.  Information on lot/batch number was available. Additional information has been requested.