chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Tracheostomy, Walking aid user, Wean from ventilator
Clinical narrative: Patient received the 1st dose of Shingrix on November 25th, 2019 at a pharmacy. On the following Sunday (December 1, 2019) patient suddenly lost usage of her arms and legs, resulting in being transported to hospital for emergency care. After multiple tests were performed, it was determined by Dr. (neurologist) that Guillian Barre Syndrome was suspected. Patient underwent IVIG treatment and was transferred to the Medical Center on December 7th. She was placed in the Neuroscience Critical Care Unit for further analysis and treatment. During her two week stay there, GBS was confirmed as the diagnosis. Ventilation was required throughout this time period, and a tracheotomy and feeding tube installation were performed. On December 21st, patient was transferred to a third Hospital- Select floor for initial therapy while gradually being weaned from ventilation. On January 21st, she was transferred to medical facility for rehabilitation and therapy. She was there for three months before being transferred to another location for further rehabilitation and therapy. On May 20, 2019, patient came home. Therapy continued at home until September 2019. Patient is still experiencing numbness in her feet presently (August 2021) and uses a walker or cane to walk.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was exposed to room temperature from 10:28 am on 17-Aug-2022 until 18-Aug-2022 at 12:42 pm; No adverse event; Patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine), PRODUCT STORAGE ERROR (The vial was exposed to room temperature from 10:28 am on 17-Aug-2022 until 18-Aug-2022 at 12:42 pm) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.    On 18-Aug-2022 at 12:42 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Aug-2022 at 12:42 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to room temperature from 10:28 am on 17-Aug-2022 until 18-Aug-2022 at 12:42 pm) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine), PRODUCT STORAGE ERROR (The vial was exposed to room temperature from 10:28 am on 17-Aug-2022 until 18-Aug-2022 at 12:42 pm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature from 10:28 am on 17-Aug-2022 until 18-Aug-2022 at 12:42 pm).    The patient had received first dose and second dose from unknown manufacturer. The Patient was taking other medication. The patient didn't receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient received vaccine after 12 hours in which the vial was open on (17-Aug-2022) at 10:28 am and was administered on 18-Aug-2022 at 12:42 pm. The vial was initially stored in the refrigerator on 11-Aug-2022. The vial stored post puncture at Room Temperature. The vial did not undergo any temperature excursion. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) from 10:28 am on 17Aug2022 until 18Aug2022 at 12:42 pm. HCP was not aware patient received an expired vaccine. Patient did not report having side effects. No treatment medication was provided.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: The Hib portion was reconstituted with 0.4% NACL saline but the DTAP portion was not yet administered with no reported adverse event; Initial information on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old female patient who was administered the hib portion which was reconstituted with 0.4% nacl saline but the dtap portion was not yet administered with no reported adverse event while receiving vaccine diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 12-Aug-2022, the patient received 0.5 mL dose of suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (formulation, strength not reported; lot UJ674AA, U7136AA expiry date: 04-Jun-2023) via intramuscular route in the left thigh for immunization.  On 12-Aug-2022, the patient was administered the hib portion which was reconstituted with 0.4% nacl saline but the dtap portion was not yet administered with no reported adverse event (product preparation error) following the administration of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  It was reported, "they have administered PENTACEL separately. The Hib portion was reconstituted with 0.4% NACL saline but the DTAP portion was not yet administered as they stop vaccination after they realized they are not doing the right thing".   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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: 32.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: reporting an expired dose of ACTHIB was inadvertently administered with no reported adverse event; Initial information received on 16-Aug-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 32-year-old female patient who reports an expired dose of acthib was inadvertently administered with no reported adverse event while receiving vaccine hib (prp/t) vaccine [act-hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine b rfhbp/nada/nhba omv (bexsero) for Prophylactic vaccination; and meningococcal vaccine a/c/y/w (meningococcal vaccine a/c/y/w) for Prophylactic vaccination.  On 16-Aug-2022, the patient received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection of dose 0.5 ml total (lot no.- UJ456AAA) via intramuscular route in the right deltoid region (expiry date: 03-May-2022 and 13-May-2022) for Immunization (Immunisation).  On 16-AUG-2022 the patient reports an expired dose of acthib was inadvertently administered with no reported adverse event (expired product administered) (one day latency) following the administration of HIB (PRP/T) VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: 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: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose being administered with no reported adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 years old male patient to whom expired dose was being administered with no reported adverse event , it involved vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2022, the patient received a  0.5ml dose (once) of suspect IPV (VERO) , with an unknown formulation and strength, (lot: T1D482M ; expiry date: 25-Jul-2022 ) via subcutaneous route in the left arm. for immunization  On 15-Aug-2022 , an expired dose was administered to the patient with no reported adverse event (expired product administered) (latency: same day) following the administration of IPV (VERO). It was administered by licensed practitioner nurse (LPN)  Action taken : not applicable.  Outcome: 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: U
Vaccine: MNQ
Symptoms: Accidental exposure to product
Clinical narrative: drop of the vaccine flew out and landed in the patients eye with no reported adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender who had Accidental exposure to product (drop of the vaccine flew out and landed in the patient's eye with no reported adverse event ), and it involved vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date ,nurse pulled off the safety needle cover and as she did  a  drop of the vaccine flew out and landed in the patient's eye with no reported adverse event (accidental exposure to product) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. Information in batch number has been requested. The product was used for immunization  Action taken : not applicable.  Outcome: 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 guidelines. 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Audiogram abnormal, Blood test normal, Condition aggravated, Pyrexia
Clinical narrative: 24hrs after the vaccine was administered, I experienced the usual mild body weakness and perhaps a slight temperature.  It was not concerning to me and I rested that evening early,  However, after a few days, I noticed an increase in my tinnitus.  I initially thought it was due to the cold weather and perhaps some underlying cold developing.  But this was not the case and the tinnitus has persisted ever since to become a hissing sound in both ears, put perhaps more so in my left ear.  The original underlying tinnitus hum has increased in volume but it is the new hissing sound that particularly disturbs me to the point that I have found sleep very difficult.  The tinnitus has varied in type and volume, but hardly ever ceased at all.  I have never experienced it for this length of time at this volume.  Sometimes the noise has been steady, at other times pulsating.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: 24hrs after the vaccine was administered, I experienced the usual mild body weakness and perhaps a slight temperature.  It was not concerning to me and I rested that evening early,  However, after a few days, I noticed an increase in my tinnitus.  I initially thought it was due to the cold weather and perhaps some underlying cold developing.  But this was not the case and the tinnitus has persisted ever since to become a hissing sound in both ears, put perhaps more so in my left ear.  The original underlying tinnitus hum has increased in volume but it is the new hissing sound that particularly disturbs me to the point that I have found sleep very difficult.  The tinnitus has varied in type and volume, but hardly ever ceased at all.  I have never experienced it for this length of time at this volume.  Sometimes the noise has been steady, at other times pulsating.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Chills, Diarrhoea, Full blood count, Myalgia
Clinical narrative: Persistent for 5 days Nausea, Vomiting, diarrhea, Fever, Chills, and muscle pain (Back)
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Persistent for 5 days Nausea, Vomiting, diarrhea, Fever, Chills, and muscle pain (Back)
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: Fever, chills, headache, body aches, sore throat and occasional cough. Takes Tylenol.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, body aches, sore throat and occasional cough. Takes Tylenol.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Secondary amenorrhea. Only had 3 periods since receiving shot. Directly after receiving vaccine it was 4 months before my first menstrual period, 12/22. Then 1month later, 1/22, I received the second. I got the Pfizer booster shot on 1/11/22.  After that it took 3 months for my next menstruation, 4/22. Currently have had a period since April. 4 months.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses/ Incorrectly drawled up the doses; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses/ Incorrectly drawled up the doses ) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .15 milliliter. On 16-Aug-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses/ Incorrectly drawled up the doses ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses/ Incorrectly drawled up the doses ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses/ Incorrectly drawled up the doses ).    No concomitant medications were reported.  The patient received lower than authorized doses and received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml dose. The reporter had an issue and they incorrectly drawled up the doses.  No treatment information was provided by the reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Bone pain, Chills, Vaccination site pain
Clinical narrative: Bone aches from the waist down; Bad chills; Sore left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of BONE PAIN (Bone aches from the waist down), CHILLS (Bad chills) and VACCINATION SITE PAIN (Sore left arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced BONE PAIN (Bone aches from the waist down), CHILLS (Bad chills) and VACCINATION SITE PAIN (Sore left arm). At the time of the report, BONE PAIN (Bone aches from the waist down), CHILLS (Bad chills) and VACCINATION SITE PAIN (Sore left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, Antibody test: 800 antibody level returned at 800 5 months after his first booster dose. In May 2022, Antibody test: 800 800 ELU/ml.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  In March of 2021 after his Primary Series the patient had an antibody dose of 1800 ELU/ml.  The patient reported that after his third booster dose his antibody level returned at 800 5 months after his first booster dose.  The patient had a sore left arm, bone aches from the waist down, and bad chills after his first Moderna Covid-19 vaccine booster dose on 12-NOV-2021.   This case was linked to MOD-2022-630007 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: history of woman having problems with her menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (history of woman having problems with her menstrual cycle) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (history of woman having problems with her menstrual cycle). At the time of the report, MENSTRUAL DISORDER (history of woman having problems with her menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, swelling, itching  at injection site
Age: 76.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Immunisation reaction, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Weakness-Severe, Additional Details: Patient called pharmacy on 8/18/22 to reports adverse effects post vaccination. Patient reports limited arm mobility (only able to lift arm half way up, very painful to move) and arm pain. Reports this started after receiving Bexsero vaccine at pharmacy on 8/3/22. She reports seeing her primary care provider for this issue. She reports being referred to physical therapy to help with issue. Reports seeing phyiscal therapist on 8/15/22. See attached for additional details.
Age: 76.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Weakness-Severe, Additional Details: Patient called pharmacy on 8/18/22 to reports adverse effects post vaccination. Patient reports limited arm mobility (only able to lift arm half way up, very painful to move) and arm pain. Reports this started after receiving Bexsero vaccine at pharmacy on 8/3/22. She reports seeing her primary care provider for this issue. She reports being referred to physical therapy to help with issue. Reports seeing phyiscal therapist on 8/15/22. See attached for additional details.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong vaccine/Product administered.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Limb injury, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Systemic: Joint Pain-Mild, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.). Additional details: Patient's wife reported his shoulder is stiff/muscles tight. Denied pain but unable to move above 90 degrees.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Systemic: Joint Pain-Mild, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.). Additional details: Patient's wife reported his shoulder is stiff/muscles tight. Denied pain but unable to move above 90 degrees.
Age: 46.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Dizziness, Fall, Hyperhidrosis, Malaise, Pallor
Clinical narrative: Client not feeling well, stated he was dizzy.   He was pale and sweaty.  Administering nurse said he was a little nervous to get his second dose.  Client was fanned, given water and advised to take deep breaths.  Client alert and responsive.  His partner came over,  Client asked to go to bathroom to have bowel movement but was advised against getting up.  Client's partner was talking to him and he suddenly slumped over in the chair.  Staff called 911.  Ammonia tab was popped, restrictive clothing was loosened and client given chest rub.  Nurse told client to look at her and he moved his head but eyes were unresponsive, fixed and dilated.  Ammonia tablet under his nose the whole time.  After thirty sec., started blinking and pushing the tablet away.  Partner told him to open his mouth and his jaw locked for 10 sec.  Client stated "I got the vaccine and then all this."  Client was fanned, kept talking and cold water bottle placed on his neck.  He said he had breakfast and lunch.  Paramedics arrived.  Client's bp 107/70, heart rate 103.  Client is an avid runner, running 9 miles this morning.  Paramedics considered his blood pressure normal.  Client refused any other treatment and decided not to go to the hospital.  He stated he takes antidepressants and blood pressure medication but cannot remember their names.  After 5 min. left with partner on his own power.
Age: 46.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Pupil fixed, Trismus
Clinical narrative: Client not feeling well, stated he was dizzy.   He was pale and sweaty.  Administering nurse said he was a little nervous to get his second dose.  Client was fanned, given water and advised to take deep breaths.  Client alert and responsive.  His partner came over,  Client asked to go to bathroom to have bowel movement but was advised against getting up.  Client's partner was talking to him and he suddenly slumped over in the chair.  Staff called 911.  Ammonia tab was popped, restrictive clothing was loosened and client given chest rub.  Nurse told client to look at her and he moved his head but eyes were unresponsive, fixed and dilated.  Ammonia tablet under his nose the whole time.  After thirty sec., started blinking and pushing the tablet away.  Partner told him to open his mouth and his jaw locked for 10 sec.  Client stated "I got the vaccine and then all this."  Client was fanned, kept talking and cold water bottle placed on his neck.  He said he had breakfast and lunch.  Paramedics arrived.  Client's bp 107/70, heart rate 103.  Client is an avid runner, running 9 miles this morning.  Paramedics considered his blood pressure normal.  Client refused any other treatment and decided not to go to the hospital.  He stated he takes antidepressants and blood pressure medication but cannot remember their names.  After 5 min. left with partner on his own power.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second COVID-19 booster given too early. First booster 5/12/2022.
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Swollen upper and lower arm
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Artificial insemination, Maternal exposure before pregnancy, Mechanical urticaria, Pregnancy
Clinical narrative: I completed a cycle of IUI on 12/22/21 and found out I was pregnant on 1/3/22.  Miscarriage occurred during week 8.  On December 27. 2021 I developed chronic urticaria and dermatographia.  I continually suffer symptoms of chronic urticaria and dermatographia.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: I completed a cycle of IUI on 12/22/21 and found out I was pregnant on 1/3/22.  Miscarriage occurred during week 8.  On December 27. 2021 I developed chronic urticaria and dermatographia.  I continually suffer symptoms of chronic urticaria and dermatographia.
Age: 34.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient describes had swelling, hot and redness to injection site and was see at Emergency Room at Medical Center on 8/05/22. Per patient was discharged with Keflex 500mg and advised to take 1 every 8 hours, and states had noticed improvement since started but felt had reached a "roadblock in the healing process". Patient stated continued with some mild swelling injection site appears to be looking like a bruise and there was pain to the touch, pain described as a 5/10 in pain scale.
Age: 34.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Swelling, Tenderness
Clinical narrative: Patient describes had swelling, hot and redness to injection site and was see at Emergency Room at Medical Center on 8/05/22. Per patient was discharged with Keflex 500mg and advised to take 1 every 8 hours, and states had noticed improvement since started but felt had reached a "roadblock in the healing process". Patient stated continued with some mild swelling injection site appears to be looking like a bruise and there was pain to the touch, pain described as a 5/10 in pain scale.
Age: 36.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Urticaria
Clinical narrative: Pt was given 0.1 mL intradermal however wheal was not produced. Pt was given 0.1 ML intradermal again which produced wheal. Pt left in no distress
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, MMRV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: rash to left Deltoid. Redness and swelling
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea, Respiratory tract congestion
Clinical narrative: SOB, weakness, congestion, cough
Age: 34.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Raised, red, itchy area around the injection site (~1? in total diameter) starting about 12-16 hours after administration
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Contusion, Dizziness, Headache, Irregular breathing, Nausea
Clinical narrative: Pt received Tdap vaccine to LD at 1054 and was advised to remain in the store for 15-minutes following administration to monitor for adverse effects.  Pt was standing next to his father in the aisle when his father reports he collapsed without warning.  Father carried the pt to the clinic exam room and he was noted to be unresponsive with irregular breathing; he maintained a pulse.  A contusion was noted to his right forehead, right lip, and right chin.  EMS was activated by a bystander and AED was brought into the exam room by the LVN.  Within 10-seconds of lying supine, pt was arousable to tactile stimuli and able to make eye contact.  BP 140/80, HR 64, Sp02 98% on RA, RR 20.  Pt's breathing pattern normalized and he became more alert over the next 2-3 minutes.  EMS arrived and was given a detailed report by the clinic FNP.  Pt reported he had a headache and felt dizzy; he did not recall these symptoms prior to collapsing.  EMS recommended evaluation at the ER but the family declined. When pt was assisted to a seated position for reassessment, pt became acutely dizzy, nauseated and vomited twice into a wastebasket.  BP 116/62, HR 68.  Pt was provided cool, damp towels and he reported symptom improvement after vomiting.  Pt was monitored for an additional 30-minutes before he independently ambulated from the clinic room to his care with his mother and father.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Oral contusion, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Pt received Tdap vaccine to LD at 1054 and was advised to remain in the store for 15-minutes following administration to monitor for adverse effects.  Pt was standing next to his father in the aisle when his father reports he collapsed without warning.  Father carried the pt to the clinic exam room and he was noted to be unresponsive with irregular breathing; he maintained a pulse.  A contusion was noted to his right forehead, right lip, and right chin.  EMS was activated by a bystander and AED was brought into the exam room by the LVN.  Within 10-seconds of lying supine, pt was arousable to tactile stimuli and able to make eye contact.  BP 140/80, HR 64, Sp02 98% on RA, RR 20.  Pt's breathing pattern normalized and he became more alert over the next 2-3 minutes.  EMS arrived and was given a detailed report by the clinic FNP.  Pt reported he had a headache and felt dizzy; he did not recall these symptoms prior to collapsing.  EMS recommended evaluation at the ER but the family declined. When pt was assisted to a seated position for reassessment, pt became acutely dizzy, nauseated and vomited twice into a wastebasket.  BP 116/62, HR 68.  Pt was provided cool, damp towels and he reported symptom improvement after vomiting.  Pt was monitored for an additional 30-minutes before he independently ambulated from the clinic room to his care with his mother and father.
Age: 61.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Erythema, Pain
Clinical narrative: continued soreness, redness in upper arm (after 1 week)
Age: 28.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Urticaria
Clinical narrative: Started experiencing hives on both arms just over 48 hours after receiving monkeypox vaccine. No issues breathing or other signs of serious reaction, just hives which appear to be getting better/going away just under 72 hours post- vaccine/just under 24 hours of noticing hives. Unsure if hives were caused by vaccine or unrelated factor but was advised to report.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough event
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Pt admitted to Hospital for COVID-19
Age: 103.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 1/6/21 Moderna 012L20A dose 2 2/3/21 Moderan 025J20A
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Chills, Computerised tomogram, Disability
Clinical narrative: 1 month after: got sick with colds weekly 2 months after: sick + insomnia 3 months (Nov): sinusitis, sick, insomnia, shakes, night sweats Jan: Sinus surgery April: still sick, docs cant figure it out April: Find Lab enter into clinical study. Am diagnosed with adverse covid vaccine reaction. Was put on maraviroc and pravastatin August. Slowly improving, but I have 5.5% of spike proteins in my system
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Immunisation reaction, Impaired work ability
Clinical narrative: 1 month after: got sick with colds weekly 2 months after: sick + insomnia 3 months (Nov): sinusitis, sick, insomnia, shakes, night sweats Jan: Sinus surgery April: still sick, docs cant figure it out April: Find Lab enter into clinical study. Am diagnosed with adverse covid vaccine reaction. Was put on maraviroc and pravastatin August. Slowly improving, but I have 5.5% of spike proteins in my system
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Laboratory test, Malaise, Myalgia, Nasopharyngitis
Clinical narrative: 1 month after: got sick with colds weekly 2 months after: sick + insomnia 3 months (Nov): sinusitis, sick, insomnia, shakes, night sweats Jan: Sinus surgery April: still sick, docs cant figure it out April: Find Lab enter into clinical study. Am diagnosed with adverse covid vaccine reaction. Was put on maraviroc and pravastatin August. Slowly improving, but I have 5.5% of spike proteins in my system
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Sinus operation, Sinusitis, Tremor
Clinical narrative: 1 month after: got sick with colds weekly 2 months after: sick + insomnia 3 months (Nov): sinusitis, sick, insomnia, shakes, night sweats Jan: Sinus surgery April: still sick, docs cant figure it out April: Find Lab enter into clinical study. Am diagnosed with adverse covid vaccine reaction. Was put on maraviroc and pravastatin August. Slowly improving, but I have 5.5% of spike proteins in my system
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: Started experiencing shortness of breath on Tuesday evening-- on Wednesday afternoon she started to develop a rash on her face, neck , chest, and arms along with itching. Patient went to the ED at Hospital last night for SOB and was given a breathing treatment and steroids. Denies any changes to routine or soaps lotions or detergents.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Dyspnoea, Pruritus, Urticaria
Clinical narrative: Started experiencing shortness of breath on Tuesday evening-- on Wednesday afternoon she started to develop a rash on her face, neck , chest, and arms along with itching. Patient went to the ED at Hospital last night for SOB and was given a breathing treatment and steroids. Denies any changes to routine or soaps lotions or detergents.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chronic obstructive pulmonary disease, Cough, Diabetes mellitus inadequate control
Clinical narrative: Pt complained of worsening cough, weakness and shortness of breath over the last 10 days. Pt has uncontrolled diabetes mellitus and COPD with a history of renal cell cancer. Pt was found to be COVID positive.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Pt complained of worsening cough, weakness and shortness of breath over the last 10 days. Pt has uncontrolled diabetes mellitus and COPD with a history of renal cell cancer. Pt was found to be COVID positive.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case COVID-19 after fully vaccinated (2 doses mRNA )
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site warmth, Pyrexia
Clinical narrative: Fever and tiredness hours after the short that lasted for approx 12-18 hours; Very Hot Arm Around the Injection Site for over 5 days post shot
Age: 49.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Cellulitis, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 8/15/2022 Discharge Date: Aug 18, 2022  PRESENTING PROBLEM: Cellulitis of left lower extremity [L03.116] COVID-19 [U07.1] Cellulitis [L03.90]   HOSPITAL COURSE: Patient is a 49-year-old woman with a past medical history significant for developmental delay who presented to the emergency department with concern for bilateral lower extremity cellulitis.  Was found to have a positive COVID-19 PCR.  Slowly became hypoxic requiring up to 4 L during her hospitalization.  Initially was given 1 dose of IV Decadron and started on oral Decadron and remdesivir.  Hypoxia quickly resolved and patient was not having any respiratory symptoms.  Decadron and remdesivir were discontinued.  Patient was treated with IV cefazolin for bilateral lower extremity cellulitis which improved during hospitalization.  Subsequently discharged on oral Decadron to complete 10 days of total therapy.  Patient was discharged in medically stable condition.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, Dyspnoea, Osteomyelitis
Clinical narrative: Pt arrived with increased shortness of breath and acute hypoxic respiratory failure. He was recently hospitalized and discharged on 7/26 for osteomyelitis status post bilateral toe amputation, and his hospital course was complicated by AKI. Pt was found to be tachypneic and required BIPAP and was COVID positive.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Positive airway pressure therapy, SARS-CoV-2 test positive, Tachypnoea, Toe amputation
Clinical narrative: Pt arrived with increased shortness of breath and acute hypoxic respiratory failure. He was recently hospitalized and discharged on 7/26 for osteomyelitis status post bilateral toe amputation, and his hospital course was complicated by AKI. Pt was found to be tachypneic and required BIPAP and was COVID positive.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was brought to health center by parent for COVID booster. Patient had previously had 2 Pfizer doses. Moderna 0.25mL dose was given to patient. It was later realized that Moderna is not yet approved by CDC for booster in patients under the age of 18. Patient parent was notified and voiced no concerns at this time. Additional training, education and information sheets were provided to all staff at health center to prevent future errors.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Purulent discharge, Scab
Clinical narrative: Nothing happened for a few weeks after vaccine. Started noticing itchiness, swelling around hands and arms. Continuous itchiness, scabs, puss, healing, and repeat.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Pain radiating down arm and numb fingers
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypoacusis, Pain in extremity, Pallor, Tinnitus
Clinical narrative: Patient become pale, complaint of ears ringing and trouble hearing, and arm pain.
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feber
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Patient noticed bald spots after receiving COVID vaccine in June.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Decreased appetite, Diarrhoea, Lacrimation increased
Clinical narrative: I experienced a breakthrough case of COVID-19  with the following symptoms, diarrhea, sore throat, watery eyes, fever, loss of appetite, post nasal drip and coughing.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Upper-airway cough syndrome, Vaccine breakthrough infection
Clinical narrative: I experienced a breakthrough case of COVID-19  with the following symptoms, diarrhea, sore throat, watery eyes, fever, loss of appetite, post nasal drip and coughing.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Area around injection is bright red, hard knot to area, tenderness. Redness extends out in circular pattern from injection site.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The vaccine that was administer was Covid-19 moderna vaccine booster doses (NDC 80777-275-05)and it suppose to be toddler.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Polyarthritis
Clinical narrative: inflammatory polyarthritis
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, COVID-19, Cardiac arrest, Chest X-ray abnormal, Death
Clinical narrative: Patient presented to hospital on 06/12/2022 with c/o SOB.  Patient was placed on BiPAP via EMS.  On arrival to ED patient was intubated for continued hypoxia and distress.  CXR showed hyperdensity in left lung.  EKG showed atrial flutter with QTc 523.  Patient was admitted to the ICU.  Patient tested positive for Covid-19.  Patient was started on antibiotics and steroids.  Patient ultimately went into PEA arrest and full ACLS protocol was initiated.  Patient expired on 06/12/2022.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram QT interval, Electrocardiogram abnormal, Endotracheal intubation, Hypoxia
Clinical narrative: Patient presented to hospital on 06/12/2022 with c/o SOB.  Patient was placed on BiPAP via EMS.  On arrival to ED patient was intubated for continued hypoxia and distress.  CXR showed hyperdensity in left lung.  EKG showed atrial flutter with QTc 523.  Patient was admitted to the ICU.  Patient tested positive for Covid-19.  Patient was started on antibiotics and steroids.  Patient ultimately went into PEA arrest and full ACLS protocol was initiated.  Patient expired on 06/12/2022.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Life support, Lung disorder, Positive airway pressure therapy, Pulseless electrical activity
Clinical narrative: Patient presented to hospital on 06/12/2022 with c/o SOB.  Patient was placed on BiPAP via EMS.  On arrival to ED patient was intubated for continued hypoxia and distress.  CXR showed hyperdensity in left lung.  EKG showed atrial flutter with QTc 523.  Patient was admitted to the ICU.  Patient tested positive for Covid-19.  Patient was started on antibiotics and steroids.  Patient ultimately went into PEA arrest and full ACLS protocol was initiated.  Patient expired on 06/12/2022.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory distress, SARS-CoV-2 test positive
Clinical narrative: Patient presented to hospital on 06/12/2022 with c/o SOB.  Patient was placed on BiPAP via EMS.  On arrival to ED patient was intubated for continued hypoxia and distress.  CXR showed hyperdensity in left lung.  EKG showed atrial flutter with QTc 523.  Patient was admitted to the ICU.  Patient tested positive for Covid-19.  Patient was started on antibiotics and steroids.  Patient ultimately went into PEA arrest and full ACLS protocol was initiated.  Patient expired on 06/12/2022.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Throat irritation
Clinical narrative: After the patient received her second COVID vaccine she stated that she felt dizzy. Student pharmacist alerted pharmacist, who immediately went to evaluate the patient. Patient then stated her throat was itchy. Pharmacist made the decision to administer IM epipen per protocol. Patient was then wheeled to the ER for further evaulation.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: R back rash starting about the size of a soft ball and has spread to entire back with redness, itching, and hives.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasopharyngitis, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I thought I had a cold because I was in a hotel and felt it was drafty. In the morning I had a cough and congestion. I traveled out of state and felt an oncoming head cold while driving. On the 7th I got home and it was a little worse but not real bad so I started taking cold medication. I took the test on the 16th and by then it was mostly past but like a mild cold and tested positive that day. I had a tele med appointment on the 17th and was already past the day since I think I got it on the 8th.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Coordination abnormal, Death, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Patient was a resident of a facility.  Patient was admitted for rehabilitation d/t lack of coordination.  Patient tested positive for Covid-19 on 02/11/2022 and was placed in isolation.  Patient expired at facility on 02/24/2022.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITAL
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITAL
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anaplastic thyroid cancer, Biopsy, Chemotherapy, Computerised tomogram abnormal, Lymphadenectomy
Clinical narrative: Contracted STAGE IV ANAPLASTIC THYROID CANCER.  Found small tumor in neck in September 2021. Diagnosed in October 2021. Continuous cancer treatments from November 2021 to present.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Metastases to lung, Neoplasm, Positron emission tomogram, Radiotherapy, Surgery
Clinical narrative: Contracted STAGE IV ANAPLASTIC THYROID CANCER.  Found small tumor in neck in September 2021. Diagnosed in October 2021. Continuous cancer treatments from November 2021 to present.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroidectomy, Tumour excision, Ultrasound scan
Clinical narrative: Contracted STAGE IV ANAPLASTIC THYROID CANCER.  Found small tumor in neck in September 2021. Diagnosed in October 2021. Continuous cancer treatments from November 2021 to present.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITAL
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Loss of consciousness
Clinical narrative: PATIENT PASSED OUT FOR A COUPLE OF SECONDS.  DAD MENTIONED BEFORE PATIENT PASSED OUT GIVING HER ASPIRIN.  TOOK PATIENT BACK TO THE ROOM AND ELEVATED LEGS, CHECKED VITALS PATIENT RESPONDED IMMEDIATELY.  GAVE ORANGE JUICE, PEANUT BUTTER CRACKERS. DR EVALUATED PATIENT AND WAS DISCHARGED WITHOUT DIFFICULTIES.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Occipital Stroke
Age: 23.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Limb mass
Clinical narrative: The lump in my arm grew from little to small over the past two weeks of the original injection date
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Coxsackie viral infection, Pharyngeal swelling, Screaming
Clinical narrative: She received the vaccine on 08/15/2022. We waited about 15 minuets before leaving and as I was putting her in the car I felt her temperature rising. I gave her a TYLENOL when we got home. She took a nap and temperature went down a little.  After medicine wore off about 6 hours later her temperature raised again. Two days later she started constantly screaming and I took her to the doctor. The doctor checked her and found white small bumps in back of throat with an elevated temperature of 102.9. Daughter was then diagnosed with Coxsackie. Was told to continue giving her TYLENOL to ease pain. Symptoms still continuing however fever has subsided.