chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got her second dose about a year or a lil bit more after the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date, about one or more than 1 year prior to the 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than recommended interval, which led to lengthening of vaccination schedule. The reporter mentioned that, patient received 2nd dose about a year or little bit more after the 1st dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient was administered only the adjuvant portion of Shingrix; patient was administered only the adjuvant portion of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Healthcare professional did not had time to give details about adverse event, and agreed to email follow up. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: If the patient received/ first dose over a year ago do they have to start the series over?; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date, over a year prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patients did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The Healthcare professional was later asked by medical information agent that what product the person received and the reporter answered that it was Shingrix. No more information was available.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Dependence on respirator, Gait inability, Impaired work ability, Oxygen saturation decreased
Clinical narrative: COVID-19 PNEUMONIA; DEPENDENCE ON VENTILATOR; NOT ABLE TO WALK; COULD NOT WORK; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol user (not often), and non-smoker, and he had no chronic medical history. He did not have any drug abuse/illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. After vaccination on 10-APR-2021 (Saturday), he was feeling bad and 11-APR-2021 (Sunday) and 8 days later went to the hospital. He did a polymerase chain reaction (PCR) covid-19 test at the hospital on 16-April-2021 and result was positive. He went back home but on 28-APR-2021, because his oxygen levels dropped and had trouble breathing. He was ventilated for 18 days. He was hospitalized for Covid-19 pneumonia (pneumonia, feeling bad and lost 45 pounds) for 36 days. He was discharged from hospital on 03-JUN-2021. On an unspecified date, he was not able to walk. He had home therapy and nursing therapy to be able to walk again and he lost 45 pounds. Since unspecified date, he could not work for 3 months.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia on 03-JUN-2021, and dependence on ventilator, and could not work, and had not recovered from not able to walk. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000182426. The suspected product quality complaint has been confirmed to be not voided. The patient received the vaccine on 09-APR-2021 and had a positive Covid-19 test on 16-APR-2021 with 7 days elapsed between vaccination and test. There was not sufficient time elapsed for the patient to achieve immunity; therefore this report was not considered a lack of effect for Janssen COVID-19 vaccine.; Sender's Comments: V0: 20210622074-covid-19 vaccine ad26.cov2. s-Covid 19 Pneumonia, Dependence on Ventilator. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Weight decreased
Clinical narrative: COVID-19 PNEUMONIA; DEPENDENCE ON VENTILATOR; NOT ABLE TO WALK; COULD NOT WORK; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol user (not often), and non-smoker, and he had no chronic medical history. He did not have any drug abuse/illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. After vaccination on 10-APR-2021 (Saturday), he was feeling bad and 11-APR-2021 (Sunday) and 8 days later went to the hospital. He did a polymerase chain reaction (PCR) covid-19 test at the hospital on 16-April-2021 and result was positive. He went back home but on 28-APR-2021, because his oxygen levels dropped and had trouble breathing. He was ventilated for 18 days. He was hospitalized for Covid-19 pneumonia (pneumonia, feeling bad and lost 45 pounds) for 36 days. He was discharged from hospital on 03-JUN-2021. On an unspecified date, he was not able to walk. He had home therapy and nursing therapy to be able to walk again and he lost 45 pounds. Since unspecified date, he could not work for 3 months.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia on 03-JUN-2021, and dependence on ventilator, and could not work, and had not recovered from not able to walk. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000182426. The suspected product quality complaint has been confirmed to be not voided. The patient received the vaccine on 09-APR-2021 and had a positive Covid-19 test on 16-APR-2021 with 7 days elapsed between vaccination and test. There was not sufficient time elapsed for the patient to achieve immunity; therefore this report was not considered a lack of effect for Janssen COVID-19 vaccine.; Sender's Comments: V0: 20210622074-covid-19 vaccine ad26.cov2. s-Covid 19 Pneumonia, Dependence on Ventilator. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED PRODUCT ADMINISTERED TO UNKNOWN NUMBER OF RESIDENTS; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced expired product administered to unknown number of residents. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered to unknown number of residents was not reported. This report was non-serious.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; INCORRECT STORAGE OF DRUG; This spontaneous report received from a health care professional concerned a 68 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 11-JUN-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced administration of expired vaccine. On 11-JUN-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and incorrect storage of drug was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoacusis, Nausea, Tinnitus
Clinical narrative: SOME HEARING LOSS IN LEFT EAR; HUMMING IN BOTH EARS; BRAIN FOG; NAUSEA; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up was requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced some hearing loss in left ear, humming in both ears, brain fog, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the humming in both ears, nausea, brain fog and some hearing loss in left ear was not reported. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Initial insomnia, Magnetic resonance imaging, Pain
Clinical narrative: PAIN IN BACK AND FRONT OF HEAD RADIATING DOWN THE NECK; TROUBLE SLEEPING; This spontaneous report received from a consumer concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 01-JUL-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced pain in back and front of head radiating down the neck. On 12-JUN-2021, the subject experienced trouble sleeping. Laboratory data included: Blood test (NR: not provided) no problem found, Computerised tomogram (NR: not provided) normal, and Magnetic resonance imaging (NR: not provided) no problem found. Treatment medications included: morphine. Additional treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in back and front of head radiating down the neck, and trouble sleeping. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURES; This spontaneous report received from a pharmacist concerned a 49-year-old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, pharmacist called for a follow up on a precious case, from which one of the patient had experienced seizures.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210629430- covid-19 vaccine ad26.cov2. s-seizures. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: EXTREME NAUSEA; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gastroparesis, non smoker, non alcohol user, and sulfa allergy, and patient had no known drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 11-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the patient experienced nausea and have had extreme nausea every day. Patients doctor (Gastroenterologist) was aware of the adverse effect. Patient was currently taking ondansetron for nausea but it was not working. Patients husband described her as deathly sick.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme nausea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case was assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISING OVER ARMS AND LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced bruising over arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising over arms and legs. This report was non-serious. This case, from the same reporter is linked to 20210632493.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: MUCUS IN NOSE/RUNNY NOSE; STUFFINESS/CONGESTION; SORE THROAT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-JUN-2021, the subject experienced sore throat. On 14-JUN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On an unspecified date, the subject experienced mucus in nose/runny nose, and stuffiness/congestion. Treatment medications (dates unspecified) included: chlorphenamine maleate/dextromethorphan hydrobromide/paracetamol/pseudoephedrine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, mucus in nose/runny nose and stuffiness/congestion was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: LETHARGY; FEVER; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced lethargy, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, fever, and headache. This report was non-serious.
Sex: U
Vaccine: FLUR4
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of Flublok Quadrivalent/ No AE; Initial information received on 08-Jun-2021 regarding an unsolicited valid non-serious case received from nurse via call center via Medical Information (Reference number- 00632994).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  Potential Product Technique Complain: Nurse asked that if this was counted as a valid dose and if there are adverse reactions they should look out for. The nurse said she will ask her manager. She said her manager did not answer her and she preferred not to provide the information. Opening hours: 8 am to 6 pm from Monday to Wednesday; 8 am to 8 pm on Thursday and 8 am to 5 pm on Friday.  At the time of reporting, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Client verbalized feeling a sudden rush of warmth from her stomach to her chest. Onsite paramedics evaluated client.  Client was observed for 15 additional minutes.  Vital signs BP 124/2, O2Sat 100%, HR 96.  Per paramedics client will not need any further evaluation.  Client exited facility at 12:40pm.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Communication disorder, Fatigue, Flat affect, Hallucination, tactile, Hallucination, visual
Clinical narrative: Headache, extreme fatigue, disconnect with reality.   Stopped communicating; developed paranoia, began to have self neglect, not caring for self ir doing normal Hygiene   Within days had visual and tactile hallucinations, flat affect, began cutting self.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Indifference, Intentional self-injury, Neglect of personal appearance, Paranoia
Clinical narrative: Headache, extreme fatigue, disconnect with reality.   Stopped communicating; developed paranoia, began to have self neglect, not caring for self ir doing normal Hygiene   Within days had visual and tactile hallucinations, flat affect, began cutting self.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Poor personal hygiene
Clinical narrative: Headache, extreme fatigue, disconnect with reality.   Stopped communicating; developed paranoia, began to have self neglect, not caring for self ir doing normal Hygiene   Within days had visual and tactile hallucinations, flat affect, began cutting self.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Electrocardiogram, Hyperhidrosis, Nausea
Clinical narrative: Patient is a 12 year old female arrived to observation area complaining of nausea, weakness, noted to be diaphoretic.  Instructed patient to remain calm, relax.   arrived to scene for further evaluation.  Vital signs rendered EKG rendered.  Pt. denies any pain, discomfort.  Pt. refused hospitalization.   Pt. recovered from adverse event and left via personal vehicle with mother at 4:10pm.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness/Lightheadness-Mild, Systemic: Fainting/Unresponsive-Mild, Systemic: Weakness-Mild.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Systemic: Nausea-Medium, Systemic: Vomiting-Mild
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: facial urticaria - eyelids and cheeks.  lasting 3 weeks.  tx with topical steroids and oral antihistamines
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reported hx of previous fainting with other vaccines and within 2 minutes of receiving this vaccine if fainted and quickly came to.  We continued to monitor him for 30 additional minutes with no further complications.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Hyperhidrosis, Lethargy, Syncope
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Additional Details: ambulance was called. pt felt better eventually, per paramedics: pt went home with friend, did not want to go to hospital.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Additional Details: ambulance was called. pt felt better eventually, per paramedics: pt went home with friend, did not want to go to hospital.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, chills, headache   Used Advil, fluids and rest
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: A week after receiving the first dose of the vaccine I began to see hives after two years of no hives.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Feeling abnormal, Nausea
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: 3 minutes after admin patient was weak, light headed and confused, then became unresponsive. called 911. he sat forward and began vomiting on the floor. then slowly became more coherent - he said he felt like his blood pressure was very low. EMTs came, checked him out, and he refused treatment. after about 30 minutes he walked out on his own.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: 3 minutes after admin patient was weak, light headed and confused, then became unresponsive. called 911. he sat forward and began vomiting on the floor. then slowly became more coherent - he said he felt like his blood pressure was very low. EMTs came, checked him out, and he refused treatment. after about 30 minutes he walked out on his own.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted but did not remember. She stated that she has fainted due to vaccine and blood being drawn (due to needle involving situations). When I came to patient, she became conscious when I tapped her. Pulse was fine. 911 response team came and took her to hospital since she was still stable even though pt felt she was okay.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Biopsy artery, Blood test abnormal, Giant cell arteritis
Clinical narrative: In usual state of health prior to Moderna vaccine, golfing 2-4x/wk, walking neighborhood, maintaining our apt, walking up 2 flights of stairs w/o difficulty. I had No reservations re: Covid vaccine.  1st Vaccine 2/13/21-pain started around 2/19/21 in right shoulder area. 1st seemed localized but then progressed to a larger area(neck, l shoulder) . Sought out orthopedic, and was prescribed pysical therapy for shoulder-without resolve ( 18 visits) pain spread down the back, hamstrings to knees.  2nd vaccine-3/1/3/21, pain in r arm shoulder area intensified and spread immediately and making normal activies of bathing, getting out of bed , self care and sleeping difficult, necessitating help from my partner.  Cortisone shot R shoulder  3/26/21 Bloodwork 4/26 showed high inflammatory markers. MRI-4/21/21 Med Center, no tear-severe inflammation along entire arm.   6/1/21 xrays and cortisone shot r shoulder.  Blood work shows elevated markers of inflammation.  6/8-seen on semi urgent appt-for evaluation. Dx -PMR-polymyalgia rheumatica rheumatica and progressed into GCA Giant sell Arteritis.  I am now on high dose steroids, had temporal biopsy 6/15/21 and unable to do normal activities of daily living as before.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, Mobility decreased, Neck pain
Clinical narrative: In usual state of health prior to Moderna vaccine, golfing 2-4x/wk, walking neighborhood, maintaining our apt, walking up 2 flights of stairs w/o difficulty. I had No reservations re: Covid vaccine.  1st Vaccine 2/13/21-pain started around 2/19/21 in right shoulder area. 1st seemed localized but then progressed to a larger area(neck, l shoulder) . Sought out orthopedic, and was prescribed pysical therapy for shoulder-without resolve ( 18 visits) pain spread down the back, hamstrings to knees.  2nd vaccine-3/1/3/21, pain in r arm shoulder area intensified and spread immediately and making normal activies of bathing, getting out of bed , self care and sleeping difficult, necessitating help from my partner.  Cortisone shot R shoulder  3/26/21 Bloodwork 4/26 showed high inflammatory markers. MRI-4/21/21 Med Center, no tear-severe inflammation along entire arm.   6/1/21 xrays and cortisone shot r shoulder.  Blood work shows elevated markers of inflammation.  6/8-seen on semi urgent appt-for evaluation. Dx -PMR-polymyalgia rheumatica rheumatica and progressed into GCA Giant sell Arteritis.  I am now on high dose steroids, had temporal biopsy 6/15/21 and unable to do normal activities of daily living as before.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Polymyalgia rheumatica, Sleep disorder, X-ray limb
Clinical narrative: In usual state of health prior to Moderna vaccine, golfing 2-4x/wk, walking neighborhood, maintaining our apt, walking up 2 flights of stairs w/o difficulty. I had No reservations re: Covid vaccine.  1st Vaccine 2/13/21-pain started around 2/19/21 in right shoulder area. 1st seemed localized but then progressed to a larger area(neck, l shoulder) . Sought out orthopedic, and was prescribed pysical therapy for shoulder-without resolve ( 18 visits) pain spread down the back, hamstrings to knees.  2nd vaccine-3/1/3/21, pain in r arm shoulder area intensified and spread immediately and making normal activies of bathing, getting out of bed , self care and sleeping difficult, necessitating help from my partner.  Cortisone shot R shoulder  3/26/21 Bloodwork 4/26 showed high inflammatory markers. MRI-4/21/21 Med Center, no tear-severe inflammation along entire arm.   6/1/21 xrays and cortisone shot r shoulder.  Blood work shows elevated markers of inflammation.  6/8-seen on semi urgent appt-for evaluation. Dx -PMR-polymyalgia rheumatica rheumatica and progressed into GCA Giant sell Arteritis.  I am now on high dose steroids, had temporal biopsy 6/15/21 and unable to do normal activities of daily living as before.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Rash
Clinical narrative: Fever, chills, severe nausea, rash on left arm, hand and face.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Headache, Nausea
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Fever-Medium, Systemic: Lymph Node Swelling-Medium
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: WHEN HE CAME BACK FOR HIS 2ND DOSE IT WAS REALIZED THAT HE RECEIVED MODERNA FOR THE 1ST DOSE. THE SERIES WAS COMPLETED WITH MODERNA. THE FAMILY UNDERSTOOD
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient received Menctra in his right arm. Then Tdap was administered in his left arm. He became unconscious after Tdap was given for approximately 10-15 seconds. He aroused and was stable following incident. He has a history of vasovagal events.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Pain in extremity, Paraesthesia
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Arm pain going down to palm of hand developed 2 days after shot, accompanied by numbness and tingling of fingers
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging normal, Musculoskeletal stiffness
Clinical narrative: Woke the next morning with severe headache (9/10) and stiff neck.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Wrong Route (SC, IM, etc.)
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus, ongoing and no cure. Saw ear doctor on May 13. Will be going back as issue has not gone away. Was not aware this could be a Covid vaccine side effect so did not initially report.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dermatitis allergic, Diarrhoea, Fatigue, Headache
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Diarrhea-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: The patient reports that adverse effects were noticed on the night of 5/20/21 and then checked into hospital
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pain, Pyrexia, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Diarrhea-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: The patient reports that adverse effects were noticed on the night of 5/20/21 and then checked into hospital
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Diarrhea-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: The patient reports that adverse effects were noticed on the night of 5/20/21 and then checked into hospital
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Disorientation, Dizziness
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: patient lost consciousness within few minutes post injection; came to soon after but was disoriented asking for help, saying her kids are calling after her; she appeared very pale; rph helped her to the floor; she rested for about 10 minutes; an attempt to sit up was unsuccessful at that point as nausea, dizziness, visual changes came right back; at that point technician called 911; paramedics assessed the pt -bp & hr were normal. however, 40 mins post-injection pt still had all above symptoms
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Nausea, Pallor, Syncope
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: patient lost consciousness within few minutes post injection; came to soon after but was disoriented asking for help, saying her kids are calling after her; she appeared very pale; rph helped her to the floor; she rested for about 10 minutes; an attempt to sit up was unsuccessful at that point as nausea, dizziness, visual changes came right back; at that point technician called 911; paramedics assessed the pt -bp & hr were normal. however, 40 mins post-injection pt still had all above symptoms
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: patient lost consciousness within few minutes post injection; came to soon after but was disoriented asking for help, saying her kids are calling after her; she appeared very pale; rph helped her to the floor; she rested for about 10 minutes; an attempt to sit up was unsuccessful at that point as nausea, dizziness, visual changes came right back; at that point technician called 911; paramedics assessed the pt -bp & hr were normal. however, 40 mins post-injection pt still had all above symptoms
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Chills, Soreness, muscle aches, slight fever
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Condition aggravated, Fatigue, Pyrexia
Clinical narrative: Fatigue, fever, chills starting ~12 hours after vaccination to ~36hours after vaccination  But more importantly (which is my motivation to fill out this form): Debilitating worsening of chest pain (associated with my chronic conditions mentioned before), starting with the onset of the other symptoms but gradual worsening for at least 4 days.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Headache, Nausea, Pyrexia
Clinical narrative: Both doses first 2 days no fever but feeling very cold and mild headache. Following 4 days nausea ,unsteadiness and headache . Gradually reducing after 9 days
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid, Blood glucose, Brain stem stroke, Computerised tomogram head abnormal
Clinical narrative: STROKE TO THE STEM OF THE BRAIN, RIGHT SIDE AFFECTED, SPEECH AND SWALLOWING.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Echocardiogram, Electrocardiogram, Lipids, Scan with contrast
Clinical narrative: STROKE TO THE STEM OF THE BRAIN, RIGHT SIDE AFFECTED, SPEECH AND SWALLOWING.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder, Swallow study abnormal, Ultrasound Doppler abnormal
Clinical narrative: STROKE TO THE STEM OF THE BRAIN, RIGHT SIDE AFFECTED, SPEECH AND SWALLOWING.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Breast pain, Breast swelling, Computerised tomogram abnormal, Diarrhoea
Clinical narrative: Began my yearly physical two days after the vaccine, as did my husband. Both of our urine tests showed blood in our urine. Had a second urine test a month later. Still had blood in urine. Also had 3 weeks of diarrhea. That was followed by a vaginal yeast infection. Given a prescription to clear that up. Then my breasts became swollen and painful. It has been ten weeks since the vaccination. Saw a urologist  this week there is still blood in my urine. The amount of blood has decreased, but still showing up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan vagina, Vulvovaginal mycotic infection
Clinical narrative: Began my yearly physical two days after the vaccine, as did my husband. Both of our urine tests showed blood in our urine. Had a second urine test a month later. Still had blood in urine. Also had 3 weeks of diarrhea. That was followed by a vaginal yeast infection. Given a prescription to clear that up. Then my breasts became swollen and painful. It has been ten weeks since the vaccination. Saw a urologist  this week there is still blood in my urine. The amount of blood has decreased, but still showing up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation
Clinical narrative: acute inflammation - both knees
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Insomnia, Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling
Clinical narrative: About 2-3 days after my second COVID-19 Pfizer vaccine shot, the middle finger of my right had began to swell, turn slightly purple, and become painful, and this pain and swelling worsened as the week progressed. I also experienced unusual redness and itching on both my hands, especially the palms and writsts, but this has been only mild, and occasional. The pain in my fingers, however, seems to wax and wane, sometimes spreading to my pointer finger and most of my third finger, and other times receding just to the top inch or two of my middle finger. Everything I do with my hand--write, type, wash, etc.--has been hampered by the pain and swelling, and the discomfort has occasionally kept me awake at night. It has now been about a week since this symptom became noticeable. It is slightly less painful than it was in the first 2-3 after the onset of symptoms, and the swelling is mainly restricted to the top inch of my middle finger (approximately up to the first joint) but it is still painful enough to hamper my everyday life. I hope and pray sincerely that it will resolve soon.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration
Clinical narrative: About 2-3 days after my second COVID-19 Pfizer vaccine shot, the middle finger of my right had began to swell, turn slightly purple, and become painful, and this pain and swelling worsened as the week progressed. I also experienced unusual redness and itching on both my hands, especially the palms and writsts, but this has been only mild, and occasional. The pain in my fingers, however, seems to wax and wane, sometimes spreading to my pointer finger and most of my third finger, and other times receding just to the top inch or two of my middle finger. Everything I do with my hand--write, type, wash, etc.--has been hampered by the pain and swelling, and the discomfort has occasionally kept me awake at night. It has now been about a week since this symptom became noticeable. It is slightly less painful than it was in the first 2-3 after the onset of symptoms, and the swelling is mainly restricted to the top inch of my middle finger (approximately up to the first joint) but it is still painful enough to hamper my everyday life. I hope and pray sincerely that it will resolve soon.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose was administered outside of the recommended time window after first vial puncture. Dose determined invalid.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: Headache, body aches, joint pain, feeling hot and cold, sweaty, feeling tired, insomnia, congestion with cough, nausea and vomiting, on and off since March
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Nausea, Pain, Pulmonary congestion
Clinical narrative: Headache, body aches, joint pain, feeling hot and cold, sweaty, feeling tired, insomnia, congestion with cough, nausea and vomiting, on and off since March
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, body aches, joint pain, feeling hot and cold, sweaty, feeling tired, insomnia, congestion with cough, nausea and vomiting, on and off since March
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Blood thyroid stimulating hormone normal, Chest pain, Erectile dysfunction, Full blood count abnormal
Clinical narrative: starting that evening of the vaccine, pt developed tremors, paresthesias, erectile dysfunction, nausea, vision changes, chest pain, insomnia, and palpitations. The chest pain resolved with tylenol. The other symptoms have not remitted.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Metabolic function test, Nausea, Palpitations, Paraesthesia
Clinical narrative: starting that evening of the vaccine, pt developed tremors, paresthesias, erectile dysfunction, nausea, vision changes, chest pain, insomnia, and palpitations. The chest pain resolved with tylenol. The other symptoms have not remitted.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Polycythaemia, Tremor, Visual impairment
Clinical narrative: starting that evening of the vaccine, pt developed tremors, paresthesias, erectile dysfunction, nausea, vision changes, chest pain, insomnia, and palpitations. The chest pain resolved with tylenol. The other symptoms have not remitted.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Experiencing tinnitus, constant hissing loud sound.  Reported to both naturopath and to Dr.  Will see an audiologist.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I have soreness and sharp pain in the left arm- this is the arm that the shot was given
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph node in right armpit
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A rash has developed around the body which progressively got worse after the second dose. Rash has continue to spread one week after the second dose.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Dizziness, Dyspnoea, Pain in extremity
Clinical narrative: That day, light headed ness and heart palpitations.  Heart palpitations for short time only but felt periodically over the next few days.  June 11, lower left led swelled and painful and shortness of breath.  June 14, went to ER.  They found multiple blood clots in upper thigh, behind knee and lower left leg.  They also found approximately 20 clots in the lungs and administered Heparin drip and I was impatient.  They put me on Eliquis and released me the next day.  Now convalescing at my daughter?s house.  Diagnosis. Acute Deep Vein Thromboses and Pulmonary Embolism bilateral.