chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder, Tremor, Vision blurred
Clinical narrative: Patient was given an entire diluted bottle 1.8 ml (6 doses) of a Pfizer purple cap vaccine for adults. She experienced arm soreness, headache, tiredness, and nausea for at least the next 3 days. Patient also experienced anxiety due most likely to the situation and not the vaccine itself.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: The patient passed out shortly after receiving the vaccine. The patient was talking and looking around shortly after passing out and the paramedics were called as a precautionary measure.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: could not move arm for 3 days. Extreme ache
Age: 15.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Welts appeared 1/19/2022 on arms, back, neck, buttocks, legs and hand. This continues to come and go with the use of Benadryl to alleviate the welts and itching. Have not sought medical treatment yet.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Palpitations
Clinical narrative: Routinely high blood pressure (140/90) and palpitations (110+ bpm) for multiple months. Benzodiazepine and muscle relaxant medicines for multiple months. After 6 months from inoculation, there is no symptom.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head abnormal, Thrombosis
Clinical narrative: It gives him constant headache at first. Now the headaches remain frequent.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Cytokine abnormal, Exercise tolerance decreased, Feeling abnormal, Headache, Inflammatory marker test
Clinical narrative: Since receiving the Pfizer shot I have had permanent tinnitus, vascular inflammation, brain fog,  pulsating tinnitus, chronic body aches, internal brain tremors, facial neuropathy, body twitches, temperature deregulation, headaches, nerve pain, and more. This began within 30 days of receiving the 2nd dose. Prior to this shot, I could run miles, surfed, and was in great shape with zero prior medical issues. Now I cannot exercise without brain fog, and vascular pain and more. I continue to suffer daily.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Neuralgia, Neuropathy peripheral, Pain, Temperature regulation disorder
Clinical narrative: Since receiving the Pfizer shot I have had permanent tinnitus, vascular inflammation, brain fog,  pulsating tinnitus, chronic body aches, internal brain tremors, facial neuropathy, body twitches, temperature deregulation, headaches, nerve pain, and more. This began within 30 days of receiving the 2nd dose. Prior to this shot, I could run miles, surfed, and was in great shape with zero prior medical issues. Now I cannot exercise without brain fog, and vascular pain and more. I continue to suffer daily.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Tremor, Vascular pain, Vasculitis
Clinical narrative: Since receiving the Pfizer shot I have had permanent tinnitus, vascular inflammation, brain fog,  pulsating tinnitus, chronic body aches, internal brain tremors, facial neuropathy, body twitches, temperature deregulation, headaches, nerve pain, and more. This began within 30 days of receiving the 2nd dose. Prior to this shot, I could run miles, surfed, and was in great shape with zero prior medical issues. Now I cannot exercise without brain fog, and vascular pain and more. I continue to suffer daily.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: [Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization  (EUA): Patient received 2 covid vaccine series and still presented with covid-19 pneumonia. 86-year old male with history of aortic regurgitation, arteriosclerotic vascular disease, BPH, carotid atherosclerosis, colon polyps, elevated LFTs, herpes zoster, irritable bowel syndrome, macular degeneration, pulmonary emphysema, right renal mass s/p right nephrectomy, diabetes
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder disorder, Dysuria, Functional gastrointestinal disorder
Clinical narrative: Urinary and intestinal issue 3 days after 1st dose of phizer vaccine for COVID lost feeling in bladder and intestines. Started getting better after 3 weeks. Got my 2nd dose 6 weeks after first because I wanted symptoms to get way better first and I didn't pee for like 17 hours. Thankfully most of the feels is back.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Vaccination failure
Clinical narrative: [Janssen Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Patient received the janssen vaccine on 11/24/2021. Patient presented with covid-19 pneumonia on 1/16/2021 - less than 60 days after the vaccine which signifies therapy failure.
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure diastolic increased, Heart rate increased
Clinical narrative: I received my second dose of Shingrix shingles vaccine on Monday, January 17. I have been wearing a smart watch for the last month which displays pulse on main dial. I noticed after the vaccine my pulse is running 90-105 bps, vs normal baseline of 70s. I checked my BP and found my diastolic BP was elevated about 20 pts. I checked the PI and found mention of rare tachycardia. I suspect I would not have noticed this reaction if not wearing a smartwatch, and that this reaction may be less "rare" than published.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, COVID-19 pneumonia, Diarrhoea, Imaging procedure abnormal
Clinical narrative: [Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Patient presented with covid 19 pneumonia after receiving vaccine on 1/22/2021 and 2/12/2021 signifying therapy failure. 62-year-old female with history of CLL pulmonary carcinoid tumor (s/p LLL lobectomy 2015), hypothyroidism, asthma, IDA presenting to the ED today with 5 days of fever, nausea, diarrhea, abdominal pain, malaise, sore throat. COVID +1/17; symptom onset 1/12. Meets sepsis criteria. Imaging shows left lung pneumonia.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Oropharyngeal pain, Pneumonia, Pyrexia
Clinical narrative: [Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Patient presented with covid 19 pneumonia after receiving vaccine on 1/22/2021 and 2/12/2021 signifying therapy failure. 62-year-old female with history of CLL pulmonary carcinoid tumor (s/p LLL lobectomy 2015), hypothyroidism, asthma, IDA presenting to the ED today with 5 days of fever, nausea, diarrhea, abdominal pain, malaise, sore throat. COVID +1/17; symptom onset 1/12. Meets sepsis criteria. Imaging shows left lung pneumonia.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Therapy non-responder
Clinical narrative: [Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Patient presented with covid 19 pneumonia after receiving vaccine on 1/22/2021 and 2/12/2021 signifying therapy failure. 62-year-old female with history of CLL pulmonary carcinoid tumor (s/p LLL lobectomy 2015), hypothyroidism, asthma, IDA presenting to the ED today with 5 days of fever, nausea, diarrhea, abdominal pain, malaise, sore throat. COVID +1/17; symptom onset 1/12. Meets sepsis criteria. Imaging shows left lung pneumonia.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Two days after receiving my Moderna covid vaccine booster I developed a hot, red a few inches distal to the injection site. It felt and looked 3 or 4 small bites/pinpricks, each about an inch in diameter with a hard, red center, painful and itchy, over appx a 3x3in area, 3-6in distal from where I was injected. The rash doubled in size, growing to 8 or 9 little red pinpricks over a 6x8ish area, got hotter, harder, and more painful over the next day. It stared to subside on the 4th day post-injection, and was gone by six days post-injection. I also developed a large bruise at the injection site.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Two days after receiving my Moderna covid vaccine booster I developed a hot, red a few inches distal to the injection site. It felt and looked 3 or 4 small bites/pinpricks, each about an inch in diameter with a hard, red center, painful and itchy, over appx a 3x3in area, 3-6in distal from where I was injected. The rash doubled in size, growing to 8 or 9 little red pinpricks over a 6x8ish area, got hotter, harder, and more painful over the next day. It stared to subside on the 4th day post-injection, and was gone by six days post-injection. I also developed a large bruise at the injection site.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute myocardial infarction, COVID-19, COVID-19 pneumonia, Deep vein thrombosis
Clinical narrative: [Pfizer Covid Vaccine] use for COVID-19 under Emergency Authorization (EUA): Patient received 2 doses on 8/26/2021 and 9/16/2021. Patient presented with covid-19 pneumonia on 1/17/22 which signifies therapy failure. 79 years old with past medical history significant for hypertension hyperlipidemia  and gout who was recently By his primary care physician was started on Lasix and lisnopril due to concern of possible CHF. He is being admitted for acute kidney injury, hyperkalemia, COVID infection. He has DVT, non-STEMI, cannot exclude PE. He is not hypoxic and denies any chest pain or shortness of breath No Known Allergies
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperkalaemia, Vaccination failure
Clinical narrative: [Pfizer Covid Vaccine] use for COVID-19 under Emergency Authorization (EUA): Patient received 2 doses on 8/26/2021 and 9/16/2021. Patient presented with covid-19 pneumonia on 1/17/22 which signifies therapy failure. 79 years old with past medical history significant for hypertension hyperlipidemia  and gout who was recently By his primary care physician was started on Lasix and lisnopril due to concern of possible CHF. He is being admitted for acute kidney injury, hyperkalemia, COVID infection. He has DVT, non-STEMI, cannot exclude PE. He is not hypoxic and denies any chest pain or shortness of breath No Known Allergies
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Aldolase increased, Antinuclear antibody positive, Blood creatine phosphokinase increased, Scleroderma-like reaction
Clinical narrative: Pfizer covoid 19 vaccine; scleroderma like reaction
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Condition aggravated
Clinical narrative: [Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization(EUA): Patient received the third dose of Covid Vaccine on 10/12/2021. Diagnosed with new onset Afib with RVR on 112/19/2021. 69-year-old female with history of paroxysmal atrial fibrillation now on Eliquis, actinic keratosis, asthma, elevated homocysteine, hypercholesterolemia, hypertension, hypercholesterolemia, nephrolithiasis, OA, renal mass, alpha gal allergy
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, COVID-19 pneumonia, Cardiac failure congestive, Dementia, Left ventricular failure
Clinical narrative: [Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Patient received 3 doses of Pfizer covid vaccine on 1/28/21,2/21/21, and 10/16/21. Patient presented with covid-19 pneumonia on 1/17/22 signifying therapy failure.
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: [Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Patient received 3 doses of Pfizer covid vaccine on 1/28/21,2/21/21, and 10/16/21. Patient presented with covid-19 pneumonia on 1/17/22 signifying therapy failure.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Dyspnoea, Pyrexia
Clinical narrative: [Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Patient received 2 doses of Pfizer Covid vaccine in May 2021. Patient presented with covid-19 pneumonia and admitted on 1/1/2022 signifying therapy failure.   59 yo M with Hx smoking, hypertension, headaches who presented to the hospital with shortness of breath, cough, fevers. Found on arrival to the emergency department COVID positive. Vaccinated, though no booster yet No known allergies
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: [Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Patient received 2 doses of Pfizer Covid vaccine in May 2021. Patient presented with covid-19 pneumonia and admitted on 1/1/2022 signifying therapy failure.   59 yo M with Hx smoking, hypertension, headaches who presented to the hospital with shortness of breath, cough, fevers. Found on arrival to the emergency department COVID positive. Vaccinated, though no booster yet No known allergies
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: [Pfizer COVID vaccine] use for COVID-19 under Emergency Use Authorization (EUA): booster given 5 months after primary series completed instead of intended 6 months.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: 30 MINS AFTER 1ST COVID SHOT HEART BEATING FAST TROUBLE BREATHING
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer dose was given 2 days after the 31 day refrigeration period.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymphadenopathy, Pain
Clinical narrative: The Pfizer covid vaccine cause breast pain and swollen lymph node in right armpit. Pain is constant as of the complaint I am filing.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out into hives 11 days after covid booster. No prior history of hives or any allergic reaction to anything. Had covid between first and second vaccine
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone decreased, Injection site pain, Thyroid cyst, Thyroid mass
Clinical narrative: Patient has developed a large Thyroid nodule after her 3rd shot- experienced soreness in her arm at injection site with 1st 2 doses Thyroid peroxidase antibody 0.8 T3 total 1.4 TSH 1.30 free T4 1.5 Thyroid ultrasouhd: 3.4cmx2.8cm x 2.4 cystic + solid nodule on L Thyroid -ill defined with significant septations -requires biopsy
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thyroxine free normal, Tri-iodothyronine normal, Ultrasound thyroid abnormal
Clinical narrative: Patient has developed a large Thyroid nodule after her 3rd shot- experienced soreness in her arm at injection site with 1st 2 doses Thyroid peroxidase antibody 0.8 T3 total 1.4 TSH 1.30 free T4 1.5 Thyroid ultrasouhd: 3.4cmx2.8cm x 2.4 cystic + solid nodule on L Thyroid -ill defined with significant septations -requires biopsy
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Patient is experiencing shoulder pain and injection site pain for 1 month following administration of vaccine per patients representative. He states that the injection was given in the shoulder area. Patient will visit doctor for further evaluation.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest X-ray abnormal, General physical health deterioration, Headache, Lung disorder
Clinical narrative: Within 20 minutes of my first dose I had a bad headache and felt sick on my stomach. I ended up with pneumonia I was so sick that day I couldn't go. I got progressively got worse. I don't remember how soon after I went to the doctor.  Before I went to the doctor I went to the ER then I went to Medical Clinic 5/21/2021 I still continue to have problems with my lungs and have to use inhalers  I was prescribed z-pack 250mg, cough medicine Mucinex, Cheratussin, and Tamiflu 2 inhalers albuterol and another I don't know the name of, Prednisone, Cetirizine 10MG,
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pneumonia, SARS-CoV-2 test negative
Clinical narrative: Within 20 minutes of my first dose I had a bad headache and felt sick on my stomach. I ended up with pneumonia I was so sick that day I couldn't go. I got progressively got worse. I don't remember how soon after I went to the doctor.  Before I went to the doctor I went to the ER then I went to Medical Clinic 5/21/2021 I still continue to have problems with my lungs and have to use inhalers  I was prescribed z-pack 250mg, cough medicine Mucinex, Cheratussin, and Tamiflu 2 inhalers albuterol and another I don't know the name of, Prednisone, Cetirizine 10MG,
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Nausea, Vertigo
Clinical narrative: Dizziness, Headache, Arthralgia, NauseaVomiting, Vertigo symptoms Narrative:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Dizziness, Headache, Arthralgia, NauseaVomiting, Vertigo symptoms Narrative:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient return for the second dose past the 28 days recommended so patient was advice to start the series over; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient return for the second dose past the 28 days recommended so patient was advice to start the series over) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient return for the second dose past the 28 days recommended so patient was advice to start the series over). On 26-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient return for the second dose past the 28 days recommended so patient was advice to start the series over) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2022-455530 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 17Jan2021 (Lot number: EL1283) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Jan2021, outcome "recovered" (2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site swelling
Clinical narrative: injection site had immediate swelling; injection site has a red circle around it now; missed the muscle and hit a blood vessel or a vein; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 15:20 (Lot number: EP7534) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Systemic lupus erythematosus" (ongoing), notes: Diagnosed about 10 years ago; "Hashimoto's disease" (ongoing); "hypothyroidism" (unspecified if ongoing), notes: since 26 years old. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE] taken for systemic lupus erythematosus (ongoing); SYNTHROID taken for hypothyroidism. Past drug history included: Aspirin, reaction(s): "allergic to aspirin", notes: also gets hives; Voltaren, start date: 1992, reaction(s): "hives", notes: for 6 weeks she had dinner plate sized hives and her whole body was covered; Ibuprofen, reaction(s): "hives". The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Mar2021, outcome "unknown", described as "missed the muscle and hit a blood vessel or a vein"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "injection site had immediate swelling"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "injection site has a red circle around it now". Therapeutic measures were taken as a result of incorrect route of product administration, vaccination site swelling, vaccination site erythema. Additional information: Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient also had no prior vaccinations (within 4 weeks) and no adverse events following prior vaccinations. It was reported that the patient stayed at the pharmacy for about 45 minutes after the injection. She said that they gave her an ice pack and instructions on what to do at home. It was reported that the patient continued with the ice pack. They said that she can put rubbing alcohol or witch-hazel on it, but she did not. She said that she did massage it after speaking with the pharmacist. She was also instructed to take Tylenol.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site pain
Clinical narrative: Flu like; Covid arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 28Jan2021 09:45 (Lot number: EL9264) at the age of 72 years as dose 1, single and intramuscular, administered in arm, administration date 17Feb2021 09:30 (Lot number: EN6200) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Feb2021, outcome "recovered" (19Mar2021), described as "Covid arm"; INFLUENZA LIKE ILLNESS (non-serious) with onset 17Feb2021 13:00, outcome "recovered" (19Mar2021), described as "Flu like". Additional Information: Prior vaccination: None  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Right Hand Hurting, Aching, Couldn't Hardly Bend Fingers or hold anything/The ball across from the thumb hurts and when she bends her fingers; Wears 2 rings on affected hand, cannot get the rings off, still swollen/ Has to use other hand to bend fingers down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 09:08 (Batch/Lot number: unknown, Expiration Date: 30Jun2021) at the age of 76 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetic. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Mar2021, outcome "not recovered", described as "Right Hand Hurting, Aching, Couldn't Hardly Bend Fingers or hold anything/The ball across from the thumb hurts and when she bends her fingers"; PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "not recovered", described as "Wears 2 rings on affected hand, cannot get the rings off, still swollen/ Has to use other hand to bend fingers down".  Additional information: AE(s) require a visit to does not require Emergency Room and Physician Office. Prior Vaccinations (within 4 weeks) reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Diarrhoea, Nasopharyngitis
Clinical narrative: colds; chills; bone pain; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "colds"; CHILLS (non-serious), outcome "unknown", described as "chills"; BONE PAIN (non-serious), outcome "unknown", described as "bone pain"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Paraesthesia, Superficial vein thrombosis
Clinical narrative: developed superficial vein thrombosis/started on 26May2021 as a lump behind the patient's right knee (upwards) and the second day it became bruised all surrounding areas; severe tingling and cramping of right leg/knee and foot; severe tingling and cramping of right leg/knee and foot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Apr2021 09:15 (Lot number: EW0176) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Anatomical site of injection: Right arm, Route of Administration: Intramuscular, Batch/Lot number: ER3737, Time: 9:15 AM), administration date: 29Mar2021, for COVID-19 immunization. The patient did not have prior vaccinations within 4 weeks. The following information was reported: SUPERFICIAL VEIN THROMBOSIS (medically significant) with onset 26May2021, outcome "recovered" (23Jun2021), described as "developed superficial vein thrombosis/started on 26May2021 as a lump behind the patient's right knee (upwards) and the second day it became bruised all surrounding areas"; PARAESTHESIA (non-serious), MUSCLE SPASMS (non-serious) all with onset 2021, outcome "unknown" and all described as "severe tingling and cramping of right leg/knee and foot". The event "developed superficial vein thrombosis/started on 26may2021 as a lump behind the patient's right knee (upwards) and the second day it became bruised all surrounding areas" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of superficial vein thrombosis. One month after the second covid vaccine dose, the patient developed superficial vein thrombosis. It started on 26May2021 as a lump behind the patient's right knee (upwards) and the second day it became bruised all surrounding areas. The patient decided to go to the ER as no improvement was seen. The doctor diagnosed the patient with SVT. The patient does not have any history of blood clots nor family history. After taking aspirin and doing warm compress for 3 weeks the issue resolved. During recovery, the patient developed severe tingling and cramping of right leg/knee and foot. The case was reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Drug ineffective, Feeling hot, Headache
Clinical narrative: i might having covid already; i might having covid already; don't feel like like doing anything; don't feel like eaten; headaches; chills; feel hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Apr2021 (Lot number: ER8736) at the age of 71 years as dose 2, single and administered in arm left, administration date 08Apr2021 (Lot number: ER8729) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Restless leg syndrome" (unspecified if ongoing); "Blood cholesterol abnormal" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Reflux" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol abnormal; TRIAMTERENE AND HYDROCHLOROTHIAZIDE taken for blood pressure increased; OMEPRAZOLE taken for gastrooesophageal reflux disease; VITAMIN D3. The patient might having covid already because she had all the symptoms . She didn't feel like eaten, she was having headaches, she felt chills, she felt hot, she did not take her temp, she did not know where her thermometer was, she didn't feel like doing anything. She was a very independent person. The outcome of all events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Suspected COVID-19
Clinical narrative: i might having covid already; i might having covid already; don't feel like like doing anything; don't feel like eaten; headaches; chills; feel hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Apr2021 (Lot number: ER8736) at the age of 71 years as dose 2, single and administered in arm left, administration date 08Apr2021 (Lot number: ER8729) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Restless leg syndrome" (unspecified if ongoing); "Blood cholesterol abnormal" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Reflux" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol abnormal; TRIAMTERENE AND HYDROCHLOROTHIAZIDE taken for blood pressure increased; OMEPRAZOLE taken for gastrooesophageal reflux disease; VITAMIN D3. The patient might having covid already because she had all the symptoms . She didn't feel like eaten, she was having headaches, she felt chills, she felt hot, she did not take her temp, she did not know where her thermometer was, she didn't feel like doing anything. She was a very independent person. The outcome of all events was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Bursitis, Injury, Lymphadenopathy
Clinical narrative: swollen lymph node in the front top middle of my left bicep; severe bursitis in that elbow; injury; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 (Lot number: EW0168) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergic to pollen" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE. Past drug history included: Nsaids, reaction(s): "hurt my stomach". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Er8729, Location of injection: Arm Left), administration date: 13Apr2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Aug2021, outcome "not recovered", described as "swollen lymph node in the front top middle of my left bicep"; BURSITIS (non-serious) with onset 01Aug2021, outcome "not recovered", described as "severe bursitis in that elbow"; INJURY (non-serious) with onset 01Aug2021, outcome "not recovered", described as "injury". The events "swollen lymph node in the front top middle of my left bicep", "severe bursitis in that elbow" and "injury" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, bursitis, injury.  Additional Information: The patient reported that he still has a swollen lymph node in the front top middle of his left bicep. He wants to know if this was normal this long after the vaccination. Patient have experienced some severe bursitis in that elbow as well. Patient have reported this already as an injury and have yet to hear from anyone on his concerns. His work was offering the booster next Thursday 13Jan2022 and was asking if he should get that based on his lymph node. The patient doesn't have a primary care giver at the moment except for occupational health. The patient had no covid prior to vaccination and has not been tested for covid post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Immunisation, Magnetic resonance imaging, Multiple sclerosis
Clinical narrative: booster; multiple sclerosis like symptoms.; If I've been bend over and I stand back up I'm lightheaded and I cannot...I have to sit down right away.; My left eye has gone bonkers...it bounces all over the place; my right eye is twitching constantly and I´m seeing double; I stumble a lot. My speech is messed up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The patient stumbled a lot. Her speech was messed up. If she had been bend over and she stood back up she was lightheaded and she could not. She had to sit down right away. Her left eye had gone bonkers. it bounced all over the place, it went left right left right really fast and then up and down. The latest symptom...was that her right eye was twitching constantly and she was seeing double now with that eye which was her good eye. they did another MRI and they were like "were not really sure about the MS but whatever it is, is killing your brain cell faster than it should be."" She describes this as multiple sclerosis like symptoms. She wants to know if this might be related to the Pfizer Biontech COVID-19 vaccine.  The patient had been sick since the day she got it (booster). No autoimmune system whatsoever. She was the first one in her doctors office to show this symptoms, kind of like MS symptoms. Walking, talking.    The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "multiple sclerosis like symptoms."; DIZZINESS (medically significant), outcome "unknown", described as "If I've been bend over and I stand back up I'm lightheaded and I cannot...I have to sit down right away."; EYE MOVEMENT DISORDER (medically significant), outcome "unknown", described as "My left eye has gone bonkers...it bounces all over the place"; VISUAL ACUITY REDUCED (medically significant), outcome "unknown", described as "my right eye is twitching constantly and I´m seeing double"; SPEECH DISORDER (medically significant), outcome "unknown", described as "I stumble a lot. My speech is messed up". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: unknown result, notes: were not really sure about the MS but whatever it is, is killing your brain cell faster than it should be. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Visual acuity reduced
Clinical narrative: booster; multiple sclerosis like symptoms.; If I've been bend over and I stand back up I'm lightheaded and I cannot...I have to sit down right away.; My left eye has gone bonkers...it bounces all over the place; my right eye is twitching constantly and I´m seeing double; I stumble a lot. My speech is messed up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The patient stumbled a lot. Her speech was messed up. If she had been bend over and she stood back up she was lightheaded and she could not. She had to sit down right away. Her left eye had gone bonkers. it bounced all over the place, it went left right left right really fast and then up and down. The latest symptom...was that her right eye was twitching constantly and she was seeing double now with that eye which was her good eye. they did another MRI and they were like "were not really sure about the MS but whatever it is, is killing your brain cell faster than it should be."" She describes this as multiple sclerosis like symptoms. She wants to know if this might be related to the Pfizer Biontech COVID-19 vaccine.  The patient had been sick since the day she got it (booster). No autoimmune system whatsoever. She was the first one in her doctors office to show this symptoms, kind of like MS symptoms. Walking, talking.    The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "multiple sclerosis like symptoms."; DIZZINESS (medically significant), outcome "unknown", described as "If I've been bend over and I stand back up I'm lightheaded and I cannot...I have to sit down right away."; EYE MOVEMENT DISORDER (medically significant), outcome "unknown", described as "My left eye has gone bonkers...it bounces all over the place"; VISUAL ACUITY REDUCED (medically significant), outcome "unknown", described as "my right eye is twitching constantly and I´m seeing double"; SPEECH DISORDER (medically significant), outcome "unknown", described as "I stumble a lot. My speech is messed up". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: unknown result, notes: were not really sure about the MS but whatever it is, is killing your brain cell faster than it should be. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Numbness in 95% of my body; legs and feet are the worst, lost ability to drive, balance and walking issues; legs and feet are the worst, lost ability to drive, balance and walking issues; trouble doing activities of daily living due to the numbness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 10:00 (Lot number: EN6199) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Top 8 allergens plus/Allergies" (unspecified if ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9289, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 10Feb2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA (hospitalization, disability) with onset 24Mar2021, outcome "not recovered", described as "Numbness in 95% of my body"; BALANCE DISORDER (hospitalization, disability), GAIT DISTURBANCE (hospitalization, disability) all with onset 24Mar2021, outcome "not recovered" and all described as "legs and feet are the worst, lost ability to drive, balance and walking issues"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hospitalization, disability) with onset 24Mar2021, outcome "not recovered", described as "trouble doing activities of daily living due to the numbness". The patient was hospitalized for hypoaesthesia, balance disorder, gait disturbance, loss of personal independence in daily activities (hospitalization duration: 5 day(s)). The events "numbness in 95% of my body", "legs and feet are the worst, lost ability to drive, balance and walking issues", "legs and feet are the worst, lost ability to drive, balance and walking issues" and "trouble doing activities of daily living due to the numbness" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of hypoaesthesia, balance disorder, gait disturbance, loss of personal independence in daily activities.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Gait disturbance, Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: Numbness in 95% of my body; legs and feet are the worst, lost ability to drive, balance and walking issues; legs and feet are the worst, lost ability to drive, balance and walking issues; trouble doing activities of daily living due to the numbness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 10:00 (Lot number: EN6199) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Top 8 allergens plus/Allergies" (unspecified if ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9289, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 10Feb2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA (hospitalization, disability) with onset 24Mar2021, outcome "not recovered", described as "Numbness in 95% of my body"; BALANCE DISORDER (hospitalization, disability), GAIT DISTURBANCE (hospitalization, disability) all with onset 24Mar2021, outcome "not recovered" and all described as "legs and feet are the worst, lost ability to drive, balance and walking issues"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hospitalization, disability) with onset 24Mar2021, outcome "not recovered", described as "trouble doing activities of daily living due to the numbness". The patient was hospitalized for hypoaesthesia, balance disorder, gait disturbance, loss of personal independence in daily activities (hospitalization duration: 5 day(s)). The events "numbness in 95% of my body", "legs and feet are the worst, lost ability to drive, balance and walking issues", "legs and feet are the worst, lost ability to drive, balance and walking issues" and "trouble doing activities of daily living due to the numbness" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of hypoaesthesia, balance disorder, gait disturbance, loss of personal independence in daily activities.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test, Urticaria
Clinical narrative: Hives; Dose 1 03Mar2021/ Dose 2 24Mar2021/ Dose Number 3 07Aug2021; Dose 1 03Mar2021/ Dose 2 24Mar2021/ Dose Number 3 07Aug2021; Dose 1 03Mar2021/ Dose 2 24Mar2021/ Dose Number 3 07Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Aug2021 (Lot number: FC3180) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertriglyceridemia that leads to pre-diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "bouts with acute pancreatitis" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; CLARITIN; FARXIGA; SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198), administration date: 03Mar2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955), administration date: 24Mar2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 07Aug2021, outcome "unknown" and all described as "Dose 1 03Mar2021/ Dose 2 24Mar2021/ Dose Number 3 07Aug2021"; URTICARIA (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Hives". The event "hives" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Omeprazole, Claritin, Farxiga, Synthroid, and more. Hives that started exactly ten days after the booster and have not gone away. She had them every day. She was managing them with heavy doses of antihistamines, but they were unbearable without meds. She had found a Facebook support group of people all experiencing the exact same thing. Treatment received for the adverse event at first steriods, now heavy antihistamines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. No known allergies.  Follow-up attempts are completed. No further information is expected.