chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: COULD NOT SLEEP; HANDS HURT SO BAD; 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. The patient's concurrent conditions included: arthritis. 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 covid-19 prophylaxis. 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 patient experienced could not sleep, and hands hurt so bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hands hurt so bad and could not sleep was not reported. This report was non-serious. This case, from the same reporter is linked to 20221222529.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions; We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H11A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions), PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions) and PRODUCT STORAGE ERROR (We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions).    No relevant concomitant medications were reported.   We had an excursion where Moderna product was stored in the fridge and experienced multiple warm and cold excursions. Data shows the vaccine was below 36F for a total of 166 hours. The minimum temperature reached was 31.658 F. The vaccine was above 46F for a total of 67 hours. The maximum temperature reached was 50.234 F. Lot 023H22A was delivered on 11/10/22, 11/14/22, and 11/15/22. Lot 041h11a was delivered on 11/22/22. Product was not used after 12/6/22. This is for a fridge excursion only.  No treatment information was provided.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Got Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got Covid) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Pfizer, dose 2), Pfizer (Pfizer and dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got Covid). At the time of the report, COVID-19 (Got Covid) outcome was unknown.            No concomitant medication was reported. Patient got boosted twice with Moderna. Patient not had any side effects nor did get very ill, although got Covid, it was mild. No treatment medication was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    Concurrent medical conditions included Panuveitis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.            No concomitant medications were reported. The reporter's causality for the event of Headaches with co-suspect humira was not provided. No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Conjunctivitis, Cough, Fatigue, Neck pain, Ocular hyperaemia
Clinical narrative: I had ocular respiratory syndrome within two to three hours of receiving the vaccine. Both is my eyes reddened and had mild conjunctivitis. I had a deep chest cough and severe exhaustion.  Of course, my arm and neck are still sore.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Oculorespiratory syndrome, Pain in extremity
Clinical narrative: I had ocular respiratory syndrome within two to three hours of receiving the vaccine. Both is my eyes reddened and had mild conjunctivitis. I had a deep chest cough and severe exhaustion.  Of course, my arm and neck are still sore.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ear infection
Clinical narrative: Ear infection
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: Narrative:  42-year-old female received first dose of COVID-19 Moderna vaccine on 4/08/21 and developed shaking, sweating, and fever on 4/20/21. Recommended to stay hydrated and take either acetaminophen or ibuprofen at home for fever. Patient was called for follow up later on 4/20/21 and was felling much better.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctival haemorrhage
Clinical narrative: Subconjunctival hemorrhage; This case was reported by a pharmacist via call center representative and described the occurrence of subconjunctival hemorrhage in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number HE4P7, expiry date unknown) for prophylaxis.   On 2nd December 2022, the patient received the 2nd dose of Shingrix. On 6th December 2022, 4 days after receiving Shingrix, the patient experienced subconjunctival hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the subconjunctival hemorrhage was unknown.   It was unknown if the reporter considered the subconjunctival hemorrhage to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comment: The patient informed that subconjunctival hemorrhage was experienced after receiving the Shingrix vaccine. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD; This spontaneous report received from a consumer via a company representative through social media (J and J Corporate) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in perfect health. The patient previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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, after 3 days of receiving booster the patient died from an unknown cause of death (Dose number in series 2). It was unknown if an autopsy was performed or not. It was reported as "I think this vaccine is from hell. Recently knew someone in perfect health got booster and about three days later was dead".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221222480.; Sender's Comments: V0-20221222470-Dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIE; This spontaneous report received from a consumer via a company representative via concerned multiple (two) patients. The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry dates were not reported) dose was not reported, 1 total administered, start therapy dates were not reported for covid-19 prophylaxis. 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 patients died from unknown cause of death. It was unknown whether the autopsy was performed or not. As per reporter, "when full disclosure is not required you can believe what you want. When two friends die from the shot and they change the definition of "vaccine" I explore further for the hidden data." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20221223314-Die. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: FLUX
Symptoms: Gastroenteritis viral
Clinical narrative: stomach flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who was having stomach flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route as prophylactic vaccination.  On an unknown date the patient had stomach flu (gastroenteritis viral) (unknown latency) following the administration of INFLUENZA VACCINE..  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per authorization  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (stomach flu).  At time of reporting, the outcome was Unknown for the event stomach flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 06-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who had flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had a serious event flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   No lab data reported.  Action taken: not applicable.  An unknown corrective treatment was received for the event (Flu).  Outcome was Unknown for the event flu.  Seriousness Criteria: The patient was hospitalized for this event.; Sender's Comments: Sanofi company comment dated 12-Dec-2022: This case involves a patient of unknown demographics who had flu after receiving vaccine INFLUENZA VACCINE. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Hypertension, Injection site erythema, Injection site injury, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: needle broke off into arm-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: Upon removing the needle from the arm of the patient the needle broke off and remained in the patient's arm. Staff were unable to remove the needle as it had gone below the surface of the skin. Patient was taken by ambulance to the nearest emergency room for further evaluation and treatment.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site swelling, Musculoskeletal foreign body, Needle issue, Tremor
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: needle broke off into arm-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: Upon removing the needle from the arm of the patient the needle broke off and remained in the patient's arm. Staff were unable to remove the needle as it had gone below the surface of the skin. Patient was taken by ambulance to the nearest emergency room for further evaluation and treatment.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case   dose 1 Moderna  6/3/21  005C21A dose 2 Moderna  7/1/21  043B21A
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Pfizer  1/30/21  EL9261 dose 2 Pfizer 2/20/21  EM9810 dose 3 Pfizer 11/4/21 no lot number dose 4 Pfizer 2/1/22 no lot number
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: see pt written statement attached.  pt complained of site too high above normal injection area.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging abnormal, Palpitations
Clinical narrative: Heart palpitations  starting 3 days after vaccine. Off and on until Sunday November 13th.   Suffered a stroke on the 13th. Admitted to local Hospital on the 14th. MRI showed  Stroke.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, MENB, MENB, MENB, MENB, MENB, MENB, MNQ, MNQ, MNQ, MNQ, MNQ, MNQ
Symptoms: Erythema, Face injury, Fall, Feeling hot, Nausea
Clinical narrative: 1640 male here to receive school vaccines Bexsero, HPV and Menquafi. Child was accompanied  by his mother. Patient was very anxious prior to vaccine administration. RN gave child phycological reassurance. After child received 3rd vaccine (HPV), without warning  he fell to the floor, hitting his face forward  to the floor. The chair fell  on top of the child. After the child hit the floor, he convulsed for 5 secs. RN and mother attempted to raise his head of off the floor. RN and mother held the  child and yelled out for assistance. Tech took child's vitals. 106/64 - 78 RN and  mother was able to get child in sitting position.  Child vomited x2 C/O nausea. Cool wet compress applied to child's head, along with ice pack to back of his Neck. Clerk called emergency services. Fan turned on to cool child due to C/O feeling hot. Observed a reddened area about  a half dollar sized circle to child's forehead.  0 hematoma or lump noted. Child was alert and talkative after in sitting position. Patient stated his Name, date, day of week and  location correctly. Child denied dizziness or  any weakness or headaches. EMT arrived @ 1:50pm. Vital Signs taken by EMT staff.  EMT assisted child off of floor to standing  position where his BP was taken again.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, MENB, MENB, MENB, MENB, MENB, MENB, MNQ, MNQ, MNQ, MNQ, MNQ, MNQ
Symptoms: Seizure, Vomiting
Clinical narrative: 1640 male here to receive school vaccines Bexsero, HPV and Menquafi. Child was accompanied  by his mother. Patient was very anxious prior to vaccine administration. RN gave child phycological reassurance. After child received 3rd vaccine (HPV), without warning  he fell to the floor, hitting his face forward  to the floor. The chair fell  on top of the child. After the child hit the floor, he convulsed for 5 secs. RN and mother attempted to raise his head of off the floor. RN and mother held the  child and yelled out for assistance. Tech took child's vitals. 106/64 - 78 RN and  mother was able to get child in sitting position.  Child vomited x2 C/O nausea. Cool wet compress applied to child's head, along with ice pack to back of his Neck. Clerk called emergency services. Fan turned on to cool child due to C/O feeling hot. Observed a reddened area about  a half dollar sized circle to child's forehead.  0 hematoma or lump noted. Child was alert and talkative after in sitting position. Patient stated his Name, date, day of week and  location correctly. Child denied dizziness or  any weakness or headaches. EMT arrived @ 1:50pm. Vital Signs taken by EMT staff.  EMT assisted child off of floor to standing  position where his BP was taken again.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Sinus disorder
Clinical narrative: SORE THROAT, SINUS ISSUES
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Lot number was expired. Patient tolerated well. Per Moderna, the vaccine administered maintained its activity necessary to protect against the COVID 19 virus at the time of administration.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Confusional state, Cough, Fatigue, Headache
Clinical narrative: 12/4/22 I woke up with just a small cough. Went through most of the day. Around 4:00, the cough began getting stronger. Between 4:00 and 6:00 I went to chills, body ache and headache. I went to bed and stayed in bed until I had to go to the doctor on 12/5/22. My COVID test was negative, Flu A was positive. I was prescribed TAMIFLU and started taking it that evening, 12/5/22. I was in bed on the 5th and 6th. My fever broke on the night of 12/6/22. I got up mid-morning 12/7/22 and worked from home the rest of the week. On 12/8/22 early in the morning, I woke up with a very bad panic and confusion feeling. I ended up video calling my wife to calm me down. My family doctor suggested that unless I still need the TAMIFLU, I should stop it, this could have caused those symptoms. I still have a cough and nasal congestion and have been tired since then. I have not completely recovered.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Influenza A virus test positive, Influenza B virus test, Mobility decreased, Nasal congestion, Pain
Clinical narrative: 12/4/22 I woke up with just a small cough. Went through most of the day. Around 4:00, the cough began getting stronger. Between 4:00 and 6:00 I went to chills, body ache and headache. I went to bed and stayed in bed until I had to go to the doctor on 12/5/22. My COVID test was negative, Flu A was positive. I was prescribed TAMIFLU and started taking it that evening, 12/5/22. I was in bed on the 5th and 6th. My fever broke on the night of 12/6/22. I got up mid-morning 12/7/22 and worked from home the rest of the week. On 12/8/22 early in the morning, I woke up with a very bad panic and confusion feeling. I ended up video calling my wife to calm me down. My family doctor suggested that unless I still need the TAMIFLU, I should stop it, this could have caused those symptoms. I still have a cough and nasal congestion and have been tired since then. I have not completely recovered.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Panic reaction, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 12/4/22 I woke up with just a small cough. Went through most of the day. Around 4:00, the cough began getting stronger. Between 4:00 and 6:00 I went to chills, body ache and headache. I went to bed and stayed in bed until I had to go to the doctor on 12/5/22. My COVID test was negative, Flu A was positive. I was prescribed TAMIFLU and started taking it that evening, 12/5/22. I was in bed on the 5th and 6th. My fever broke on the night of 12/6/22. I got up mid-morning 12/7/22 and worked from home the rest of the week. On 12/8/22 early in the morning, I woke up with a very bad panic and confusion feeling. I ended up video calling my wife to calm me down. My family doctor suggested that unless I still need the TAMIFLU, I should stop it, this could have caused those symptoms. I still have a cough and nasal congestion and have been tired since then. I have not completely recovered.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus ringing in left ear prominent
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Pt reports swelling, a "hard knot" at injection site that causes intense itching
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Pt reports swelling, a "hard knot" at injection site that causes intense itching
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient reports swelling, a "hard knot" at injection site that causes intense itching
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Hypersensitivity, Lacrimation increased, Ocular hyperaemia, Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Watery eyes, redness in right eye-Medium, Additional Details: Pt's Wife reported pt took Benadryl and felt better. Pt began experiencing swelling and watering in left eye 3 hours after the vaccine was administered. He will continue to take Benadryl and will see his primary care doctor for a yearly physical and inquire about continuing the second dose in the Shingrix series
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angina pectoris, Cardiac disorder, Cardiac monitoring, Chest discomfort, Chest pain
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hypotension-Medium, Additional Details: hardness redness lump heat on arm lasting 5 days, covid type symptoms , heart pain mild following this , preexisting congested heart failure, followed with cardiologist, low blood pressure during this time, under testing, left bundle monitoring, advising no other covid products
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hypotension-Medium, Additional Details: hardness redness lump heat on arm lasting 5 days, covid type symptoms , heart pain mild following this , preexisting congested heart failure, followed with cardiologist, low blood pressure during this time, under testing, left bundle monitoring, advising no other covid products
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site warmth, Malaise
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hypotension-Medium, Additional Details: hardness redness lump heat on arm lasting 5 days, covid type symptoms , heart pain mild following this , preexisting congested heart failure, followed with cardiologist, low blood pressure during this time, under testing, left bundle monitoring, advising no other covid products
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Incorrect flu vaccine given to patient.  Patient given FluBlok for 18 and up only.  Patient is 15 years of age at time of vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Laboratory test, Seizure
Clinical narrative: Injection site-red, raised, warm, size of half dollar    36 hr post vaccination had seizure-gave injection of ativan, next day had another seizure and had to be sent out to hospital
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, COVID-19, Chest X-ray, Dyspnoea, Fatigue
Clinical narrative: I experienced shortness of breath that is getting progressively worse, fatigue and a breakthrough case of COVID-19.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: I experienced shortness of breath that is getting progressively worse, fatigue and a breakthrough case of COVID-19.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was administered a vaccine from the primary Moderna series rather than the bivalent vial. Notified patient of error. Patient denied experiencing adverse effects after vaccine administration and is currently doing well. He will notify this provider if any issues arise later.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: Bump in left arm
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anaemia, Gastrointestinal haemorrhage, Pain in extremity
Clinical narrative: After receiving the vaccine, I had a sore arm for a day. On 12/03/2022 I went to the emergency room for a gastrointestinal bleed. I had no prior pain or symptoms. I was in the hospital for six days. As of today, I continue to be anemic.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood creatinine increased
Clinical narrative: Patient admitted with multiple comorbidities and caregiving needs with positive COVID test.  Discharged from hospital on 12/05/22 to hospice care services for end stage alzheimers with subsequent death on 12/07/22.  Provider d/c note:  "Per HPI, a 87 YO male with h/o Alzheimer's dementia, HTN presenting to the ED for evaluation of AMS   Patient unable to provide any history due to mental status. History obtained from chart review and speaking with sons at bedside. Patient was seen in the ED on 11/26 with similar symptoms, was sent home due to hemodynamical stability however patient was exhibiting generalized weakness and family was unable to support him. Patient is nonverbal at baseline, though able to ambulate without difficulty. He lives with his wife who is also COVID+ and is unable to take care of him.    In the ED, pt febrile to 39.1c, otherwise hemodynamically stable. Lab work significant for Cr 1.3, AST 188, ALT 73.    Hospital Course: 1. Alzheimer's dementia: end stage. Wife POA is agreeable to switch code status to DNR/DNI CC at this time. Family signed for hospice - Home memantine    2. COVID: febrile to 39.1c, maintaining adequate saturation on RA.  - Antipyretics PRN   3. Generalized weakness: suspect due to above - PT/OT   4. Acute renal insufficiency: likely due to dehydration. Received 500ml bolus in the ED   5. LFT elevation: as above. Trend while on remdesivir    6. HTN - D/c 'dantihypertensives "
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Death, Dehydration, Dementia Alzheimer's type
Clinical narrative: Patient admitted with multiple comorbidities and caregiving needs with positive COVID test.  Discharged from hospital on 12/05/22 to hospice care services for end stage alzheimers with subsequent death on 12/07/22.  Provider d/c note:  "Per HPI, a 87 YO male with h/o Alzheimer's dementia, HTN presenting to the ED for evaluation of AMS   Patient unable to provide any history due to mental status. History obtained from chart review and speaking with sons at bedside. Patient was seen in the ED on 11/26 with similar symptoms, was sent home due to hemodynamical stability however patient was exhibiting generalized weakness and family was unable to support him. Patient is nonverbal at baseline, though able to ambulate without difficulty. He lives with his wife who is also COVID+ and is unable to take care of him.    In the ED, pt febrile to 39.1c, otherwise hemodynamically stable. Lab work significant for Cr 1.3, AST 188, ALT 73.    Hospital Course: 1. Alzheimer's dementia: end stage. Wife POA is agreeable to switch code status to DNR/DNI CC at this time. Family signed for hospice - Home memantine    2. COVID: febrile to 39.1c, maintaining adequate saturation on RA.  - Antipyretics PRN   3. Generalized weakness: suspect due to above - PT/OT   4. Acute renal insufficiency: likely due to dehydration. Received 500ml bolus in the ED   5. LFT elevation: as above. Trend while on remdesivir    6. HTN - D/c 'dantihypertensives "
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Laboratory test abnormal, Liver function test increased, Mental status changes, Pyrexia
Clinical narrative: Patient admitted with multiple comorbidities and caregiving needs with positive COVID test.  Discharged from hospital on 12/05/22 to hospice care services for end stage alzheimers with subsequent death on 12/07/22.  Provider d/c note:  "Per HPI, a 87 YO male with h/o Alzheimer's dementia, HTN presenting to the ED for evaluation of AMS   Patient unable to provide any history due to mental status. History obtained from chart review and speaking with sons at bedside. Patient was seen in the ED on 11/26 with similar symptoms, was sent home due to hemodynamical stability however patient was exhibiting generalized weakness and family was unable to support him. Patient is nonverbal at baseline, though able to ambulate without difficulty. He lives with his wife who is also COVID+ and is unable to take care of him.    In the ED, pt febrile to 39.1c, otherwise hemodynamically stable. Lab work significant for Cr 1.3, AST 188, ALT 73.    Hospital Course: 1. Alzheimer's dementia: end stage. Wife POA is agreeable to switch code status to DNR/DNI CC at this time. Family signed for hospice - Home memantine    2. COVID: febrile to 39.1c, maintaining adequate saturation on RA.  - Antipyretics PRN   3. Generalized weakness: suspect due to above - PT/OT   4. Acute renal insufficiency: likely due to dehydration. Received 500ml bolus in the ED   5. LFT elevation: as above. Trend while on remdesivir    6. HTN - D/c 'dantihypertensives "
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient admitted with multiple comorbidities and caregiving needs with positive COVID test.  Discharged from hospital on 12/05/22 to hospice care services for end stage alzheimers with subsequent death on 12/07/22.  Provider d/c note:  "Per HPI, a 87 YO male with h/o Alzheimer's dementia, HTN presenting to the ED for evaluation of AMS   Patient unable to provide any history due to mental status. History obtained from chart review and speaking with sons at bedside. Patient was seen in the ED on 11/26 with similar symptoms, was sent home due to hemodynamical stability however patient was exhibiting generalized weakness and family was unable to support him. Patient is nonverbal at baseline, though able to ambulate without difficulty. He lives with his wife who is also COVID+ and is unable to take care of him.    In the ED, pt febrile to 39.1c, otherwise hemodynamically stable. Lab work significant for Cr 1.3, AST 188, ALT 73.    Hospital Course: 1. Alzheimer's dementia: end stage. Wife POA is agreeable to switch code status to DNR/DNI CC at this time. Family signed for hospice - Home memantine    2. COVID: febrile to 39.1c, maintaining adequate saturation on RA.  - Antipyretics PRN   3. Generalized weakness: suspect due to above - PT/OT   4. Acute renal insufficiency: likely due to dehydration. Received 500ml bolus in the ED   5. LFT elevation: as above. Trend while on remdesivir    6. HTN - D/c 'dantihypertensives "
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PATIENT HAD ASKED FOR  MODERNA AND I GAVE  HER PFIZER.  SHE WAS HERE WITH HER HUSBAND WHO WAS GETTING PFIZER. I USUALLY SAY THE NAME OF VACCINE BEFORE INJECTING BUT DID NOT DO  IT THIS TIME. I SAID IT TO HER HUSBAND AND THIS  IS WHEN I REALIZED I HAD GIVEN HER PFIZER.  SHE DID  NOT HAVE  AN ADVERSE REACTION AND WAS NOT EVEN UPSET  THAT THIS  HAD OCCURED.
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FluBlok given to 16 yo patient.  This vaccination intended for 18  and up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood test normal, COVID-19, Fatigue
Clinical narrative: 09/28/22 I had cold symptoms for a couple of days and they started to clear up. I took COVID home tests for 3 days that were negative. About four days later, I lost my sense of taste and smell. I went to the doctor and tested positive. I felt fine then. The cold symptoms were gone and I only had the loss of sense of taste and smell. I am still very tired and sleep more than normal. Blood work was done and everything was normal. My doctor feels I have long haul COVID.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Post-acute COVID-19 syndrome, SARS-CoV-2 test positive, Somnolence
Clinical narrative: 09/28/22 I had cold symptoms for a couple of days and they started to clear up. I took COVID home tests for 3 days that were negative. About four days later, I lost my sense of taste and smell. I went to the doctor and tested positive. I felt fine then. The cold symptoms were gone and I only had the loss of sense of taste and smell. I am still very tired and sleep more than normal. Blood work was done and everything was normal. My doctor feels I have long haul COVID.
Age: 14.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FluBlok given to 14 yo patient.  Vaccine intended for 18 and up only.
Age: 97.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Hypervolaemia, Polyuria, SARS-CoV-2 test positive
Clinical narrative: COVID vaccinated patient who admitted to hospital with COVID detected PCR.  Provider d/c note:  "98 y/o male with a past medical history significant for HFrEF, TIA, Afib, heart block s/p pacemaker, RAS who presented to the ED on 12/4/2022 due to weakness. On arrival he was diagnosed with COVID. He did not require any supplemental O2 and was treated with supportive care. He did also have symptoms of fluid overload which responded to diuresis. He was seen by PT/OT who recommended return to assisted living facility with assistance, he will be discharged back there today. He was given strict return precautions to which he verbalized understanding. "
Age: 67.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Administered vaccine from primary Moderna series instead of bivalent. This provider attempted to reach patient to notify them of the medical error that occurred but was unsuccessful. At the time of administration, patient tolerated the vaccine well and denied any immediate adverse effects.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 17 yo female given Flublok instead of Fluzone Quad
Age: 35.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: COVID-19, Chills, Cough, Decreased appetite, Dyspnoea
Clinical narrative: Starting 11/07/2022 in the evening, I felt like I needed my inhaler but didn't feel like I was having a true asthma attack. I just felt slightly short of breath and within half an hour I had body aches. By the time I went to bed, I could tell I had a fever. The next day (11/08/2022) I tested positive for COVID-19. I contacted my doctor who recommended PAXLOVID; however, due to my daily use of KLONOPIN, my pharmacist did not recommend me using PAXLOVID. I had the fever for about 3 days along with chills, body aches and loss of appetite. Once the fever dissipated my appetite returned but I developed a cough. On 11/10/2022 I spoke to my regular doctor and they said that since I was getting better to just continue treating the symptoms. The entire time I also had head congestion. Since the cough started, I have been more frequently short of breath. I have had to use my inhaler more often than usual and that has continued to this day.
Age: 35.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Starting 11/07/2022 in the evening, I felt like I needed my inhaler but didn't feel like I was having a true asthma attack. I just felt slightly short of breath and within half an hour I had body aches. By the time I went to bed, I could tell I had a fever. The next day (11/08/2022) I tested positive for COVID-19. I contacted my doctor who recommended PAXLOVID; however, due to my daily use of KLONOPIN, my pharmacist did not recommend me using PAXLOVID. I had the fever for about 3 days along with chills, body aches and loss of appetite. Once the fever dissipated my appetite returned but I developed a cough. On 11/10/2022 I spoke to my regular doctor and they said that since I was getting better to just continue treating the symptoms. The entire time I also had head congestion. Since the cough started, I have been more frequently short of breath. I have had to use my inhaler more often than usual and that has continued to this day.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: we gave the patient a 4 days old  expired vaccine but patinet is fine have no symptoms
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chemotherapy, Cough, Gastrointestinal tube insertion, Medical device change
Clinical narrative: Patient with history of 2 COVID vaccines who admitted with COVID detected test.  Provider d/c note:  "48 year old woman with past medical history of anaplastic thyroid carcinoma s/p tracheal stent undergoing chemo/radiatoin, multiple PE on eliquis, hypothyroidism presents to the emergency department with NG tube removed likely 2/2 to intractable nausea and vomiting from chemotherapy and cough 2/2 +Covid 19. GI consulted and successfully replaced NG tube 12/2 however due to coughing spells it was expelled. Bed side 12F NG tube successful. Patient continues to have upper respiratory symptoms however discussed that this can be managed at home. Patient hemodynamically stable for discharge and will follow up with oncology to reschedule missed chemo apt 12/6."
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Respiratory symptom, SARS-CoV-2 test positive, Therapy interrupted, Unintentional medical device removal
Clinical narrative: Patient with history of 2 COVID vaccines who admitted with COVID detected test.  Provider d/c note:  "48 year old woman with past medical history of anaplastic thyroid carcinoma s/p tracheal stent undergoing chemo/radiatoin, multiple PE on eliquis, hypothyroidism presents to the emergency department with NG tube removed likely 2/2 to intractable nausea and vomiting from chemotherapy and cough 2/2 +Covid 19. GI consulted and successfully replaced NG tube 12/2 however due to coughing spells it was expelled. Bed side 12F NG tube successful. Patient continues to have upper respiratory symptoms however discussed that this can be managed at home. Patient hemodynamically stable for discharge and will follow up with oncology to reschedule missed chemo apt 12/6."
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Patient with history of 2 COVID vaccines who admitted with COVID detected test.  Provider d/c note:  "48 year old woman with past medical history of anaplastic thyroid carcinoma s/p tracheal stent undergoing chemo/radiatoin, multiple PE on eliquis, hypothyroidism presents to the emergency department with NG tube removed likely 2/2 to intractable nausea and vomiting from chemotherapy and cough 2/2 +Covid 19. GI consulted and successfully replaced NG tube 12/2 however due to coughing spells it was expelled. Bed side 12F NG tube successful. Patient continues to have upper respiratory symptoms however discussed that this can be managed at home. Patient hemodynamically stable for discharge and will follow up with oncology to reschedule missed chemo apt 12/6."
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, SARS-CoV-2 test negative, Secretion discharge, Sinusitis
Clinical narrative: She started with a runny stuffy nose on about December 1st. Then started a cough approximately 5 days later. Tested multiple times for COVID but all negative. Her mucus turned green over the weekend and the doctor treated her with antibiotics for a sinus infection.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Syncope
Clinical narrative: 10/31/22 presents to ED for "syncope". PMHx of "CABG, CHF, AF, DM, HTN, and CVA"
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Pain at injection site, headache, fatigue, muscle ache, nausea  As of 12/13/2022 still experiencing pain at injection site.