chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: pregnant with no reported adverse event; Adacel was administered which was expired on 21Nov2021 with no reported adverse event; Initial information received on 23-Dec-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 39 years old female patient who was pregnant and was administered Adacel which was expired on 21nov2021 with no reported adverse event and received treatment with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The gestation period at onset was not reported. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 22-Dec-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE suspension for injection 0.5 ml once, lot C5630AA, expiry date: 21-Nov-2021 (strength was unknown) via intramuscular route in the left deltoid as prophylactic vaccination.  On 22-DEC-2021 the patient developed a non-serious event "adacel was administered which was expired on 21Nov2021 with no reported adverse event" (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "pregnant with no reported adverse event "(exposure during pregnancy) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Relevant prenatal testing after exposure was not reported.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Adacel was administered which was expired on 21Nov2021 with no reported adverse event, pregnant with no reported adverse event).  At time of reporting, the outcome was Unknown for the event Adacel was administered which was expired on 21Nov2021 with no reported adverse event and was Unknown for the event pregnant with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 39.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: pregnant with no reported adverse event; Adacel was administered which was expired on 21Nov2021 with no reported adverse event; Initial information received on 23-Dec-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 39 years old female patient who was pregnant and was administered Adacel which was expired on 21nov2021 with no reported adverse event and received treatment with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The gestation period at onset was not reported. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 22-Dec-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE suspension for injection 0.5 ml once, lot C5630AA, expiry date: 21-Nov-2021 (strength was unknown) via intramuscular route in the left deltoid as prophylactic vaccination.  On 22-DEC-2021 the patient developed a non-serious event "adacel was administered which was expired on 21Nov2021 with no reported adverse event" (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date the patient developed a non-serious event "pregnant with no reported adverse event "(exposure during pregnancy) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Relevant prenatal testing after exposure was not reported.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Adacel was administered which was expired on 21Nov2021 with no reported adverse event, pregnant with no reported adverse event).  At time of reporting, the outcome was Unknown for the event Adacel was administered which was expired on 21Nov2021 with no reported adverse event and was Unknown for the event pregnant with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: This case involves an unknown age female patient who experienced excruciating pain in arm, muscle aches; debilitating aches in her legs and buttocks and headache while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In December 2021, the patient received a dose  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, formulation, strength, dose and lot number not reported via unknown route in unknown administration site for immunisation. In DEC-2021 the patient developed a non-serious event "excruciating pain in arm" (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. In DEC-2021 the patient developed a non-serious event "muscle aches; debilitating aches in her legs and buttocks" (myalgia) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. In DEC-2021 the patient developed a non-serious event "headache" (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that "Patient had excruciating pain in her arm, but not the arm the vaccine was administered in. Pain went away after 15 minutes. Compared pain to heart attack. - Muscle aches that are not normal muscle aches. Caller stated they were debilitating aches in her legs and buttocks for about four days. - Headache; caller stated she does not usually have headaches". Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable for all the events. It was not reported if the patient received a corrective treatment for the events (excruciating pain in arm, muscle aches; debilitating aches in her legs and buttocks, headache). At time of reporting, the outcome was Recovered / Resolved in December 2021 for the events (excruciating pain in arm, muscle aches; debilitating aches in her legs and buttocks) and was Unknown for the event (headache).
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: This case involves a 64 year old male patient who experienced itchiness and rash while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "itchiness"? (pruritus) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious event "rash" (unknown latency) following the administration of INFLUENZA VACCINE. It was reported, "Caller states she has a 64 year old patient that had a previous reaction to a flu shot a few years back and the patient developed a rash and some itchiness afterwards. Caller did state that the patient received FLUBLOK afterwards with no reaction or issues. Caller does not believe the patient has an egg allergy since he does eat egg products, and believes he may have had a reaction to the preservative in the original vaccine." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the events (itchiness, rash). At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event itchiness and was Recovered / Resolved on an unknown date for the event rash.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Vomiting
Clinical narrative: This spontaneous case was received on 06-Dec-2021 from other healthcare professional via agency(reference number: SEQW21-05853) and concerned a 26-year-old, female patient.  The patient's medical history and concomitant medications were not reported.   On 13-Dec-2018, the patient was vaccinated with Afluria Quadrivalent (Flu Vaccine Egg Split QIV; dose: 0.5 ml; route of administration, anatomical location: not reported) for influenza prevention. The batch number was reported YF39207 expiry date 30-Jun-2019.  On the same day, one to two hours after vaccination the patient started vomiting and same evening noticed hives around the injection site. The hives resolved two to three days after.  At the time of initial reporting, the patient had recovered from the events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: The events Vomiting and Vaccination site urticaria was assessed as related to Afluria Quadrivalent.; Sender's Comments: The events Vomiting and Vaccination site urticaria was assessed as related to Afluria Quadrivalent.
Age: 29.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Product administration error, Syncope
Clinical narrative: Passed out/fainted; The patient received Flucelvax Quadrivalent and Spikevax on the same day, both in left deltoid; This spontaneous case was received on 22-Dec-2021 from a pharmacist (reference number: SEQW21-06337) and concerned a 29-year-old, male patient.  The patient's concurrent condition included hypoglycaemia before injections (the patient had not eaten all day before receiving both vaccines). The was not taking any concomitant medications.   On 22-Dec-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: left deltoid) for influenza prophylaxis The batch number reported was 309621 and expiry date 30-Jun-2022.  On the same day, the patient was vaccinated with a non-company, co-suspect Spikevax (elasomeran; route of administration: intramuscular, anatomical location: left deltoid, dose and indication: not reported) (explicitly coded as 'Product administration error'). The batch number was not reported.  On the same day, shortly after receiving Flucelvax Quadrivalent and Spikevax, the patient fainted/passed out for less than a minute. Pharmacist called for an ambulance and provided a Coke for the patient to drink in the meantime. Pharmacist stated that patient felt fine after drinking the Coke and walked out with the paramedics.  On the same day, the patient recovered from the event.  The reporter did not provide a causality assessment.  The event of 'faint' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: On the same day, shortly after receiving Flucelvax Quadrivalent and Spikevax, the patient fainted for less than a minute. Causality is assessed as possibly related, although confounded by co-suspect. The patient received Flucelvax Quadrivalent and Spikevax on the same day, both in left deltoid. Product administration error is assessed as unrelated per company's conventions.; Sender's Comments: On the same day, shortly after receiving Flucelvax Quadrivalent and Spikevax, the patient fainted for less than a minute. Causality is assessed as possibly related, although confounded by co-suspect. The patient received Flucelvax Quadrivalent and Spikevax on the same day, both in left deltoid. Product administration error is assessed as unrelated per company's conventions.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Epistaxis, Platelet count
Clinical narrative: NOSE BLEED; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: dry eyes, knee osteoarthritis, and mobic allergy. The patient was previously treated with meloxicam. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 23-NOV-2020 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid, chondroitin sulfate/citroflavonoid/glucosamine sulfate/manganese, ciclosporin, ergocalciferol, and hydrochlorothiazide. On DEC-2020, the patient experienced nose bleed. On 22-APR-2021, Laboratory data included: Platelet count (NR: not provided) 265. On 22-OCT-2021, Laboratory data included: Platelet count (NR: not provided) 239. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Went down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed on 20-AUG-2021. This report was non-serious. This case, involving the same patient is linked to 20211225951.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Menstrual disorder
Clinical narrative: Menstruation change. I have my period regularly every 28 days. The day I had the booster vaccine, I was about 14 days from the last day of my period (halfway). I ended up getting my period early and still have it. Other symptoms included in first 24 hours: slightly raised temperature (under 100 degrees F), chills and body aches, headache, fatigue, back cramps, leg cramps, soreness in left arm (where injected), and neck soreness
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Muscle spasms, Neck pain, Pain
Clinical narrative: Menstruation change. I have my period regularly every 28 days. The day I had the booster vaccine, I was about 14 days from the last day of my period (halfway). I ended up getting my period early and still have it. Other symptoms included in first 24 hours: slightly raised temperature (under 100 degrees F), chills and body aches, headache, fatigue, back cramps, leg cramps, soreness in left arm (where injected), and neck soreness
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Periarthritis
Clinical narrative: Soreness at injection site on right arm and down the side of arm; resulting in limited mobility of right arm. Patient had challenges moving, lift, pushing, and pulling items when using right arm.  As situation worsened patient was unable to raise effected arm above head and had major limitations and inability picking up items over 1lb.  Patent was notified soreness was a side effect of vaccination and diagnosed by primary care doctor with tendinitis in July and given additional time to see if issue would clear up.  After an additional visit with PCD patient was referred to physical therapy in Oct 2021.  Physical therapy diagnosed patient with frozen shoulder in Nov 2021.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Similar reaction on previous exposure to drug
Clinical narrative: After vaccine I am experiencing numbness in my hands and arms.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Chest X-ray abnormal, Electrocardiogram ST-T segment abnormal, Pulmonary embolism
Clinical narrative: Bilateral large pulmonary emboli with right ventricular strain requiring immediate hospitalization and anticoagulation
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast abnormal
Clinical narrative: Bilateral large pulmonary emboli with right ventricular strain requiring immediate hospitalization and anticoagulation
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Heavy menstrual bleeding, Menstruation irregular, Myalgia
Clinical narrative: Muscle aches, dizziness, vomiting, nausea,  Diarrhea, changes in menstrual cycle such as increased duration, increased flow and shortened and inconsistent cycles.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oligomenorrhoea, Polymenorrhoea, Vomiting
Clinical narrative: Muscle aches, dizziness, vomiting, nausea,  Diarrhea, changes in menstrual cycle such as increased duration, increased flow and shortened and inconsistent cycles.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Urticaria
Clinical narrative: Itchy skin, hives,  wheals, swollen lymph nodes
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vertigo
Clinical narrative: Issue with Benign Vertigo that required physical therapy to resolve. Vertigo began after 3 weeks of neck pain stopped. Vertigo started immediately following neck pain resolving.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever after 8 days No appetite Lethargic Red bumps on body
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Eye discharge
Clinical narrative: Approx 12 hrs after dose, experienced fever, chills, jaw ache, muscle aches, eye discharge, headache, & dizziness.  The fever and chills abated after a few hours; the headache persisted resulting in a lack of energy, appetite, or ability to do anything other than sleep for the next 24-30 hours.  After that I noticed a rash covering my trunk with a few spots on back, arms, and legs.  I also experienced mouth sores / fever blisters.  Benedryl (oral & topical applications) have helped with rash although it has not disappeared.  This was the booster dose.  I had no reaction to 1st dose other than sore arm (injection site).  2nd dose caused fever, chills, headache & exhaustion but no rash & recovery much quicker than booster.  I weigh between 100-105 lbs.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Loss of personal independence in daily activities, Myalgia, Oral herpes
Clinical narrative: Approx 12 hrs after dose, experienced fever, chills, jaw ache, muscle aches, eye discharge, headache, & dizziness.  The fever and chills abated after a few hours; the headache persisted resulting in a lack of energy, appetite, or ability to do anything other than sleep for the next 24-30 hours.  After that I noticed a rash covering my trunk with a few spots on back, arms, and legs.  I also experienced mouth sores / fever blisters.  Benedryl (oral & topical applications) have helped with rash although it has not disappeared.  This was the booster dose.  I had no reaction to 1st dose other than sore arm (injection site).  2nd dose caused fever, chills, headache & exhaustion but no rash & recovery much quicker than booster.  I weigh between 100-105 lbs.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Pyrexia, Rash, Stomatitis
Clinical narrative: Approx 12 hrs after dose, experienced fever, chills, jaw ache, muscle aches, eye discharge, headache, & dizziness.  The fever and chills abated after a few hours; the headache persisted resulting in a lack of energy, appetite, or ability to do anything other than sleep for the next 24-30 hours.  After that I noticed a rash covering my trunk with a few spots on back, arms, and legs.  I also experienced mouth sores / fever blisters.  Benedryl (oral & topical applications) have helped with rash although it has not disappeared.  This was the booster dose.  I had no reaction to 1st dose other than sore arm (injection site).  2nd dose caused fever, chills, headache & exhaustion but no rash & recovery much quicker than booster.  I weigh between 100-105 lbs.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: It is unknown if the patient recieved a .25mL or .5mL dose of Moderna. The vaccinator at first did not remember if he had taken a 1st dose series amount. The tally sheet showed correct amount of boosters and full doses going out that day, and it was charted as patient recieving a full dose of moderna. The vaccinator reports that he was pretty sure he did the correct dose. I left that day and still do think that patient recieved the correct dose, but I have now sufficent evidence to be unsure of the dosage the patient recieved. I attempted to do a report and contact the patient today, however it was the wrong patient information I had. I have sent an email to the patient and will attempt to call her tomorrow during the day.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Bone pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Painful swelling and welts on arm. Extreme muscle and bone  aches. Painful lumps under injected arm. Adverse neck pain/ stiffness
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Painful swelling and welts on arm. Extreme muscle and bone  aches. Painful lumps under injected arm. Adverse neck pain/ stiffness
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Arthralgia, Complication associated with device, Contusion, Dysphagia
Clinical narrative: It started with swollen lymph node that lasted ~3 days. 10 days after the vaccination, patient had hives that covered her back even though she had not been exposed to allergens. The urticaria spread to other parts of the body, including hands, neck and head, groin, knees, ankles, and buttocks. Additionally, angioedema was present in the face, knees, and hands with joint pain throughout the body. Regular treatment with benadryl and zyrtec did not seem to affect the urticaria and angioedema much. Patient went to the ER as her face was swelling considerably and she was having trouble swallowing due to swelling of the throat. Due to difficulties with the IV, she was given oral Prednisone. 4.5 hours after consumption of the first dose, much or the urticaria on the face and neck as well as the angioedema had cleared up. There is some bruising near the hives which leads me to believe that it may be urticarial vasculitis.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pharyngeal swelling, Swelling face, Urticaria
Clinical narrative: It started with swollen lymph node that lasted ~3 days. 10 days after the vaccination, patient had hives that covered her back even though she had not been exposed to allergens. The urticaria spread to other parts of the body, including hands, neck and head, groin, knees, ankles, and buttocks. Additionally, angioedema was present in the face, knees, and hands with joint pain throughout the body. Regular treatment with benadryl and zyrtec did not seem to affect the urticaria and angioedema much. Patient went to the ER as her face was swelling considerably and she was having trouble swallowing due to swelling of the throat. Due to difficulties with the IV, she was given oral Prednisone. 4.5 hours after consumption of the first dose, much or the urticaria on the face and neck as well as the angioedema had cleared up. There is some bruising near the hives which leads me to believe that it may be urticarial vasculitis.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives. Initially itchiness on palms of hands then itchiness throughout body. The past 1-2 weeks the itchiness/hives are most intense around neck, shoulders, and upper back. There is itchiness on feet. Allergy medicine works but without medicine, the hives and itchiness comes back.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Numbness, tingling, and light pain in right leg. Vaccine about midday and symptoms can about 10 hours later.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, injection site soreness
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Malaise, Nausea, Pain
Clinical narrative: Flu-ish symptoms going on second day, starting eight hours post shot.  Body aches, chills, malaise, slight nausea
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test negative, Taste disorder
Clinical narrative: Everything tastes off or bad, salt has extremely strong taste. Also had muscle spasms
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Catheterisation cardiac, Chest pain, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: ST elevation on ECG Elevated troponin level chest pain Normal LV systolic function, absence of global or regional systolic myocardial dysfunction
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased, X-ray
Clinical narrative: ST elevation on ECG Elevated troponin level chest pain Normal LV systolic function, absence of global or regional systolic myocardial dysfunction
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Malaise
Clinical narrative: Systemic: Hypertension-Severe, Additional Details: Patient presented to pharmacy on 12/31 and wanted to report a side effect he though was related to his first dose of pfizer. Patient had previously had Covid twice before being vaccinated on 12/21. He said about 2 hours after vaccination he was not feeling well and had is BP checked and in came out to 250/125. He was rechecked 5 hours after this and everything had normalized.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Influenza like illness, Muscle spasms, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Two weeks after the first dose, I started experiencing restless leg type symptoms at night. Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. 12 hours after the second dose (12/19/2021), experienced severe Charlie Horse cramps in calve muscles along with flu like symptoms (fever, chills, body aches). Worst of the muscle cramping ended by the next morning, however every night since then I am walking up in the middle of the night with muscle aches, twitching, pins and needles in calves (both legs). In the morning, calves feel like bricks, very stiff, throughout the day experience pins and needles in legs.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Paraesthesia, Pyrexia, Sleep disorder
Clinical narrative: Two weeks after the first dose, I started experiencing restless leg type symptoms at night. Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. 12 hours after the second dose (12/19/2021), experienced severe Charlie Horse cramps in calve muscles along with flu like symptoms (fever, chills, body aches). Worst of the muscle cramping ended by the next morning, however every night since then I am walking up in the middle of the night with muscle aches, twitching, pins and needles in calves (both legs). In the morning, calves feel like bricks, very stiff, throughout the day experience pins and needles in legs.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Paraesthesia, Restless legs syndrome
Clinical narrative: Two weeks after the first dose, I started experiencing restless leg type symptoms at night. Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. 12 hours after the second dose (12/19/2021), experienced severe Charlie Horse cramps in calve muscles along with flu like symptoms (fever, chills, body aches). Worst of the muscle cramping ended by the next morning, however every night since then I am walking up in the middle of the night with muscle aches, twitching, pins and needles in calves (both legs). In the morning, calves feel like bricks, very stiff, throughout the day experience pins and needles in legs.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: pt was sitting in monitoring area for observation after vaccine. tech noticed pt leaning and nurse who gave vaccine immediately responded, layed her down and elevated pt legs. pt had pulse and was breathing but not responding to  verbal commands. EMS was called. pt responded and opened her eyes and was alert shortly after laying down. Ambulance arrived, evaluated pt. pt declined to go to hospial. Pt stayed at the pharmacy for another 30 min. pt has history of fainting after lab draws.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Electrocardiogram normal, Feeling cold, Hypertension, Panic attack
Clinical narrative: Systemic: Chills-Medium, Systemic: Hypertension-Mild, Systemic: Tachycardia-Mild, Additional Details: 10 mins after Pt received vaccine she reported she had chills and was cold. Pt was slightly hypertensive at 145/93 and HR of 116 temp 98.3. Pt did not feel light headed, had no trouble breathing and was AOx4. Medics called at Pt request and full work up done. Medics cleared EKG. Described as Pt panic attack. Last BP 122/83 HR 90 RR 18 and temp 97.8. After Pt assessment complete, Pt wanted to go home and call if she noticed any further symptoms. Medics walked Pt to car with no adverse reaction.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Systemic: Chills-Medium, Systemic: Hypertension-Mild, Systemic: Tachycardia-Mild, Additional Details: 10 mins after Pt received vaccine she reported she had chills and was cold. Pt was slightly hypertensive at 145/93 and HR of 116 temp 98.3. Pt did not feel light headed, had no trouble breathing and was AOx4. Medics called at Pt request and full work up done. Medics cleared EKG. Described as Pt panic attack. Last BP 122/83 HR 90 RR 18 and temp 97.8. After Pt assessment complete, Pt wanted to go home and call if she noticed any further symptoms. Medics walked Pt to car with no adverse reaction.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fear of injection, Hypotension, Injection site pain, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Additional Details: The pharmcist gave the vaccine to the patient around 2:15 pm ; pt was ok for first 10 min. she sat with her mom, then by 15 min, pt fainted. She regained conscience immediately, she was given some juice to drink, the new Rph on duty came to work at 2:30 PM and monitored patients blood pressure, it was 63/55, pt said she could talk, mean while we called 911. when the ems came, they checked her for the vitals. MOm told the ems people than the patient has a phobia of vaccination,
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back injury, Cardiac monitoring, Chest X-ray, Chest injury, Computerised tomogram head
Clinical narrative: Multiple episodes of syncope resulting in facial, head, back, rib injuries/lacerations. Required transport to ER by ambulance and kept overnight for observation.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram neck, Face injury, Head injury, Laboratory test, Skin laceration
Clinical narrative: Multiple episodes of syncope resulting in facial, head, back, rib injuries/lacerations. Required transport to ER by ambulance and kept overnight for observation.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Multiple episodes of syncope resulting in facial, head, back, rib injuries/lacerations. Required transport to ER by ambulance and kept overnight for observation.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Movement disorder, Muscular weakness, Thinking abnormal
Clinical narrative: Systemic: Confusion-Medium, Systemic: Weakness-Severe, Additional Details: patient reports "terrible" confusion, muscle weakness for 3 days.  Much better after 3 days but is still having "problems with movement and thinking clearly"
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient called on 12/28/21 to report had a pronounced body rash on 12/27/21 the day after receiving her booster shot....she said it was the same kind of rash that she gets when she takes a medication that she is allergic to.....I asked her if she got this same reaction when she received her intial and second doses of moderna and she said she did not have any reaction....patient was also calling her doctor as well to report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Cough, Decreased appetite
Clinical narrative: Pain at injection site and further down arm towards elbow and also into armpit starting by 9 PM.  Woke up with acute pain in sites described at 3 AM on 31st and also profuse sweating and chills.  Headache started by 4 AM and persisted for 12 hours.  The sweating and chills came and went until 4Pm.  Lack of appetite and  tiredness kept me in bed until 4PM on the 31st.    Also had a minor occasional cough that was accompanied by sharp pain in right lung similar to pain from pneumonia.  Appetite restored by 6 Pm, but even though I'd slept most of the day, went to bed by 10:30 and slept through night.  As of 7:30 on the 1st only symptom remaining is pain at injection site and surrounding area.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Injection site pain, Pulmonary pain
Clinical narrative: Pain at injection site and further down arm towards elbow and also into armpit starting by 9 PM.  Woke up with acute pain in sites described at 3 AM on 31st and also profuse sweating and chills.  Headache started by 4 AM and persisted for 12 hours.  The sweating and chills came and went until 4Pm.  Lack of appetite and  tiredness kept me in bed until 4PM on the 31st.    Also had a minor occasional cough that was accompanied by sharp pain in right lung similar to pain from pneumonia.  Appetite restored by 6 Pm, but even though I'd slept most of the day, went to bed by 10:30 and slept through night.  As of 7:30 on the 1st only symptom remaining is pain at injection site and surrounding area.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Kidney infection, Vertigo
Clinical narrative: Yeast infection, kidney infection, vertigo
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Injected limb mobility decreased, Injection site pain, Joint dislocation
Clinical narrative: Pain level in left dislocated shoulder arm rose from a 3 to 7 level and now about a consistent 5.   Right upper arm had some pain and limit from rotator cuff but after the booster pain rose to 5/6 level and now difficult to raise arm even after some stretches which previously got arm movement to near normal.  Pain in either arm not relieved with meds (Tramadol 50mg) nor Motrin, Aleve, etc
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Injection site pain, Myalgia
Clinical narrative: Elevated heart rate ~20bpm higher resting heart rate  (~10 hrs after injection) Fever ~101F  (~27 hrs after injection) Nausea (~27 hrs after injection) Headache (~18 hrs after injection) Muscle soreness (~10 hrs after injection) Injection site soreness (4-5 hrs after injection) Tiredness  (~10 hrs after injection)  Most symptoms dissipated roughly 34hrs after injection. If not gone severity greatly reduced.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Elevated heart rate ~20bpm higher resting heart rate  (~10 hrs after injection) Fever ~101F  (~27 hrs after injection) Nausea (~27 hrs after injection) Headache (~18 hrs after injection) Muscle soreness (~10 hrs after injection) Injection site soreness (4-5 hrs after injection) Tiredness  (~10 hrs after injection)  Most symptoms dissipated roughly 34hrs after injection. If not gone severity greatly reduced.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Eye discharge, Eye irritation, Lacrimation increased, Rash
Clinical narrative: RECURRING RASH ON BOTH ARMS, BOTH LEGS, BUTTOCKS, CHEST AREA RIGHT BELOW THE NECK, BACK AREA RIGHT BELOW THE NAPE OF THE NECK, FACIAL RASH WHERE I NORMALLY SHAVE, MY FOREHEAD, AND THE DISCHARGE FROM MY TWO EYES ARE WATERY AND BURNING SENSATION.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmic migraine, Visual impairment
Clinical narrative: Ocular Migrane - distortion of partial field of vision in both eyes, just to left of center of field of view; distortion similar to what is seen on a digital television when the signal is degraded.  Most of the rest of the field of view appeared to be normal.  Condition last for up to 30 minutes.  Has repeated on occasion since, most recent, today 1/1/2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild frontal headache in the mornings
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Inflammation, Laboratory test normal, Lymphadenitis, Pain
Clinical narrative: Fast heart rate, fever for 2+ days ranging from 100-102, body aches. Right arm inflamed, lymph in right armpit inflamed
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fast heart rate, fever for 2+ days ranging from 100-102, body aches. Right arm inflamed, lymph in right armpit inflamed
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling, Lymphadenopathy, Muscle fatigue
Clinical narrative: 8-10 hours post-dose: 1. Headache - treated with OTC meds, lasting  27 hours 2. Fever - 99.5 - 100F, treated with OTC meds, lasting 27 hours 3. Muscle aches/fatigue- treated with OTC meds, rest, lasting 30 hours 4. Lymphadenopathy- left armpit, same side as injection.  Not resolved at  42 hours 5. Injection site swelling/pain - treated with OTC meds, not resolved at 42 hours
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: 8-10 hours post-dose: 1. Headache - treated with OTC meds, lasting  27 hours 2. Fever - 99.5 - 100F, treated with OTC meds, lasting 27 hours 3. Muscle aches/fatigue- treated with OTC meds, rest, lasting 30 hours 4. Lymphadenopathy- left armpit, same side as injection.  Not resolved at  42 hours 5. Injection site swelling/pain - treated with OTC meds, not resolved at 42 hours
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Irregular menstrual cycle. Since the booster shot (I had J&J as my original vax), my periods have been arriving 7 to 10 days late, after 7 to 10 days of pre-period sever cramping. The periods themselves are heavier and more painful than before as well.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Lymphadenopathy, Muscular weakness
Clinical narrative: Headache, muscle weakness, injection site pain, and enlarged lymph nodes under armpit. Same arm the injection was given.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Significant fatigue (could not get out of bed all day), Significant joint pain, chills, fever, headache
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Urticaria
Clinical narrative: Fever, hives, aches, chills, nausea  Tylenol PM taken  Started day with aches and chills, at night it became a fever and the nausea and hives started
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac telemetry abnormal, Dyspnoea, Fatigue, Headache, Insomnia
Clinical narrative: Onset of headache and neck pain 10/10 over 1 minute which resolved after 2 days  After 4 days developed myocarditis with SVT with several bouts of heart rate to 140's and SVT on ECG telemetry.     Palpitations, insomnia, Dyspnea, shortness of breath,  fatigue, headaches.    Gradually resolving over last few months.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Neck pain, Palpitations, Supraventricular tachycardia
Clinical narrative: Onset of headache and neck pain 10/10 over 1 minute which resolved after 2 days  After 4 days developed myocarditis with SVT with several bouts of heart rate to 140's and SVT on ECG telemetry.     Palpitations, insomnia, Dyspnea, shortness of breath,  fatigue, headaches.    Gradually resolving over last few months.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Contusion, Pain
Clinical narrative: Besides chills and body aches, which was expected, Bruising around ankles, along inside of left leg.  Bruising disappeared in several hours.  Chest pain began 2 days later and lasted for 48 hours.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Fatigue, Hypoaesthesia, Injection site erythema, Malaise
Clinical narrative: Woke up with uncontrollable urge to move my arms along with tingling and numbness in the arm. Red streaks on the arm at the objection site that lasted several days. The Red streaks have subsided but the tingling and numbness and urge to move my arm has not. Overall feeling of malaise fatigue and buddy aches
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: Woke up with uncontrollable urge to move my arms along with tingling and numbness in the arm. Red streaks on the arm at the objection site that lasted several days. The Red streaks have subsided but the tingling and numbness and urge to move my arm has not. Overall feeling of malaise fatigue and buddy aches
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Eye discharge, Eye pruritus, Eye swelling
Clinical narrative: Itchy, swollen eyes with discharge still after 30 days.  The days immediately following the injection, extreme chills (wearing a winter coat with blanket in a heated home), racing heart (like I was jogging but was not) exhaustion and migraine.  Those subsided within 4 days but the eye swelling and itching has continued.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Palpitations
Clinical narrative: Itchy, swollen eyes with discharge still after 30 days.  The days immediately following the injection, extreme chills (wearing a winter coat with blanket in a heated home), racing heart (like I was jogging but was not) exhaustion and migraine.  Those subsided within 4 days but the eye swelling and itching has continued.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Rash, Rash pruritic, Urticaria
Clinical narrative: Dermatographia all over my body. Rashes welts started on chest and ears. Moved to legs stomach back. Everywhere. Taking antihistamines multiple times a day to keep itching away. Red welts still appearing. Itching still happening when not taking antihistamine.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Chest pain, Cough, Dizziness, Headache
Clinical narrative: 101f Fever, full body severe aches and pains, cough, Headache , severe pain radiating from injection sure to under arm, back and chest and neck, dizzy
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: 101f Fever, full body severe aches and pains, cough, Headache , severe pain radiating from injection sure to under arm, back and chest and neck, dizzy
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: Bells Palsy on side of face; facial numbness x 7 days
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Extreme weakness
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Arrhythmia, Chest X-ray, Chest pain, Computerised tomogram thorax
Clinical narrative: AFTER TWO DAYS, I STARTED HAVING CHEST PAIN, SHORTNESS OF BREATH, SEVERE DYSPNEA ON EXERTION, IRREGULAR HEART RATES, HEART ARRYTHMIAS AND SYNCOPE.  I WENT TO THE EMERGENCY ROOM ON 11/24. I HAD EKGS, CTA OF CHEST, CHEST XRAY AND CARDIAC/BLOOD PRESSURE MONITORING . I FOLLOWED UP WITH MY PCP. FOLLOWED UP WITH CARDIOLOGIST AND HAD ECHOCARDIOGRAM, CT OF CHEST, PULMONARY FUNCTION TESTS AND A 24 HOUR HOLTER MONITOR. FOLLOWED UP WITH PULMONOLOGIST AND WILL HAVING REPEAT CATSCAN WITHIN THREE MONTHS
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: AFTER TWO DAYS, I STARTED HAVING CHEST PAIN, SHORTNESS OF BREATH, SEVERE DYSPNEA ON EXERTION, IRREGULAR HEART RATES, HEART ARRYTHMIAS AND SYNCOPE.  I WENT TO THE EMERGENCY ROOM ON 11/24. I HAD EKGS, CTA OF CHEST, CHEST XRAY AND CARDIAC/BLOOD PRESSURE MONITORING . I FOLLOWED UP WITH MY PCP. FOLLOWED UP WITH CARDIOLOGIST AND HAD ECHOCARDIOGRAM, CT OF CHEST, PULMONARY FUNCTION TESTS AND A 24 HOUR HOLTER MONITOR. FOLLOWED UP WITH PULMONOLOGIST AND WILL HAVING REPEAT CATSCAN WITHIN THREE MONTHS
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Pulmonary function test, Syncope
Clinical narrative: AFTER TWO DAYS, I STARTED HAVING CHEST PAIN, SHORTNESS OF BREATH, SEVERE DYSPNEA ON EXERTION, IRREGULAR HEART RATES, HEART ARRYTHMIAS AND SYNCOPE.  I WENT TO THE EMERGENCY ROOM ON 11/24. I HAD EKGS, CTA OF CHEST, CHEST XRAY AND CARDIAC/BLOOD PRESSURE MONITORING . I FOLLOWED UP WITH MY PCP. FOLLOWED UP WITH CARDIOLOGIST AND HAD ECHOCARDIOGRAM, CT OF CHEST, PULMONARY FUNCTION TESTS AND A 24 HOUR HOLTER MONITOR. FOLLOWED UP WITH PULMONOLOGIST AND WILL HAVING REPEAT CATSCAN WITHIN THREE MONTHS
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain, Injection site pruritus, Injection site vesicles, Nausea
Clinical narrative: Fever - next day for approximately 5 hours aches - next day onset for 36 hours diarrhea - next day 7 hours nausea - next day 24 hours vomiting - next day, 2 incidents blistering at injection site that hurts and itches - began approximately 48 hours after injection, came on suddenly and grew in size, is still occuring
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling, Vomiting
Clinical narrative: Fever - next day for approximately 5 hours aches - next day onset for 36 hours diarrhea - next day 7 hours nausea - next day 24 hours vomiting - next day, 2 incidents blistering at injection site that hurts and itches - began approximately 48 hours after injection, came on suddenly and grew in size, is still occuring
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Headache, Injection site pain, Musculoskeletal chest pain, Nausea
Clinical narrative: Fever, full body aches and pains, headache, radiating pain from injection site to throat neck ribs, Diarrhea, nausea
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever, full body aches and pains, headache, radiating pain from injection site to throat neck ribs, Diarrhea, nausea
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: Injection site pain, body aches , nausea