chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: A 2 year old patient received a Quadracel vaccine instead of a Pentacel vaccine with no reported adverse event; Initial information was received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old and unknown gender patient who received a diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] instead of a pentacel vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine suspension for injection (lot U7526AA, expiry date - 07-Sep-2024) (dose, frequency and strength: unknown) via unknown route in unknown administration site for immunization.  On an unknown date 2 year old patient received a diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine instead of a pentacel vaccine with no reported adverse event (interchange of vaccine products) (unknown latency) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event
Age: 4.0
Sex: F
Vaccine: FLUC3
Symptoms: Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: She tested positive for influenza A; Fever; This spontaneous case was received on 04-Oct-2022 from other non-healthcare professional (patient's mother) (reference number: SEQW22-03964) with additional documents received on the same date (reference numbers: SEQW22-03958) (being processed together), reported by other non-healthcare professional and concerned a 5-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 09-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for prevention of influenza. The batch number reported was 308432.  On 01-Oct-2022, 11 months and 22 days after receiving Flucelvax Quadrivalent, the patient was tested positive for influenza A. The patient was prescribed generic Tamiflu (oseltamivir) from her Pediatrician.  On an unspecified date in Oct-2022, the patient experienced fever.   Since 02-Oct-2022, the patient had been fever free.   At the time of initial reporting on 04-Oct-2022, the patient was recovering from the event of 'influenza A virus infection' since she was better now.   The reporter did not provide a causality assessment.  The event of 'Influenza A virus infection' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 5-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Eleven months and 22 days following vaccination, the patient tested positive for influenza A. In addition, the patient developed fever. Causal role of the suspect vaccine is assessed as not related, due to chronological implausibility.; Sender's Comments: A 5-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Eleven months and 22 days following vaccination, the patient tested positive for influenza A. In addition, the patient developed fever. Causal role of the suspect vaccine is assessed as not related, due to chronological implausibility.
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: PERICARDITIS; This 65-year-old, Male, subject was participating in study.  The subject's medical history, as provided by the investigator, included intraocular lens implant (bilateral), skin cancer- squamous cell (left tonsil), tonsillectomy (left tonsil), and cataracts (bilateral). Concomitant medications reported included naproxen and naproxen sodium.  Prior to event onset, the subject received intramuscular mRNA-1273 (Dose 3) for SARS-CoV-2 vaccination on 04 Oct 2021, approximately 11 months, 29 days before onset of the event.  On 02 Oct 2022, the subject experienced pericarditis. It was reported that the subject was admitted and diagnosed with pericarditis. Per reporter, the diagnosis was not secondary to receiving the Moderna covid-19 vaccine. Treatment information was not provided.  The subject received all scheduled doses of study drug prior to the event; therefore, action taken with study drug in response to the event was not applicable.   The event, pericarditis, was reported as resolved on 04 Oct 2022.  The investigator assessed the event, pericarditis, as not related to study drug and not related to study procedure.  Company Comment: This case concerns a 65-year-old, Male, subject with medical history of intraocular lens implant (bilateral), skin cancer- squamous cell (left tonsil), tonsillectomy (left tonsil), and cataracts (bilateral), who experienced the expected serious adverse event of special interest (AESI) pericarditis. The event occurred 2 years 1 month 19 days after the first dose of mRNA-1273 and 11 months 29 days after the third (booster) dose. The event was reported as resolved and was assessed as not related with study drug in accordance with the investigator´s assessment noting the long latency to onset. Further information was requested.
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient received 2 doses of Bivalent booster, 1 in each arm; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received 2 doses of Bivalent booster, 1 in each arm) and NO ADVERSE EVENT (No adverse event) in a 93-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7163B and AS7163B) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Oct-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 11-Oct-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 11-Oct-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient received 2 doses of Bivalent booster, 1 in each arm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received 2 doses of Bivalent booster, 1 in each arm) 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 assessment was provided for EXTRA DOSE ADMINISTERED (Patient received 2 doses of Bivalent booster, 1 in each arm).    No concomitant medications was reported. It was reported that patient scheduled to receive bivalent booster and flu shot but inadvertently received 2 doses of bivalent booster 1 in each arm. No treatment drug details was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; most recent dose of the vaccine she received was a pediatric presentation of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (most recent dose of the vaccine she received was a pediatric presentation of the vaccine) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS7164B, 038A22A, 004F21A, 040A21A and 039K20-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Oct-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (most recent dose of the vaccine she received was a pediatric presentation of the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (most recent dose of the vaccine she received was a pediatric presentation of the vaccine) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (most recent dose of the vaccine she received was a pediatric presentation of the vaccine).    Concomitant medications details were not reported by the reporter.  Reporter stated that has not reported any symptoms with those most recent dose. No additional doses, medications or treatments have been administered in response to the event.
Sex: U
Vaccine: COVID19-2
Symptoms: Illness
Clinical narrative: still got sick but not quite as badly; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (still got sick but not quite as badly) in a  patient of an unknown age and gender 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 COVID-19 vaccination: COVID-19 VACCINE (Booster dose) in October 2021, COVID-19 VACCINE (Booster dose) in October 2021, COVID-19 VACCINE (Dose 2 (Original Vaccination)), COVID-19 VACCINE (Dose 1 (Original Vaccination)), COVID-19 VACCINE (Dose 2 (Original Vaccination)) and COVID-19 VACCINE (Dose 1 (Original Vaccination)). Past adverse reactions to the above products included Nausea with COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE; and Vomiting with COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    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, the patient experienced ILLNESS (still got sick but not quite as badly). At the time of the report, ILLNESS (still got sick but not quite as badly) outcome was unknown.            No concomitant medication was reported.  The patient had the two original vaccinations and one booster for Covid, the last one being October 2021. The patient experienced nausea and vomiting for all three and really took about three days to recover from each shot. The patient tried the Moderna shot last week (Oct 2022) and still got sick but not quite as badly. The patient was wondering if patient had suffered an allergic reaction. The patient did not knewanyone else who got hit from the shots in this way.   No treatment information was provided.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  Linked to case- 2022SA409871.   This case involves Adult and unknown gender patient who was administered expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2022, the patient received a expired dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation. dose, strength: unknown) (lot UT7325MA, exp: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) (latency: same day)  No lab data provided.   Action taken: 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 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.; Sender's Comments:  US-SA-2022SA409871:
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: instead of asking them for the pneumonia shot he asked for a flu shot so they gave him the Adjuvanted Flu with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 66 years old male patient who experienced instead of asking them for the pneumonia shot he asked for a flu shot so they gave him the adjuvanted flu with no reported adverse event while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received a  dose of suspect influenza quadrival a-b high dose hv vaccine at dose of 0.7ml  lot UJ882AB expiration date:30-Jun-2023 via intramuscular route in Left Deltoid site for Immunization.  On 07-Oct-2022 the patient developed a non-serious instead of asking them for the pneumonia shot he asked for a flu shot so they gave him the adjuvanted flu with no reported adverse event (wrong product administered) following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported "Medical Assistant says the consumer received the FLUZONE HIGH DOSE QUADRIVALENT at their office and wanted to get the pneumonia 20 but they do not carry that. He went to the pharmacy next door to them and instead of asking them for the pneumonia shot he asked for a flu shot so they gave him the Adjuvanted Flu  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event instead of asking them for the pneumonia shot he asked for a flu shot so they gave him the adjuvanted flu with no reported adverse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: got Fluzone QIV, instead of Fluzone HD (with no reported adverse event); Initial information received on 08-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 65 years old and unknown gender patient who experienced got fluzone qiv, instead of fluzone hd (with no reported adverse event) while receiving vaccine influenza quadrival a-b vaccine [fluzone qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza quadrival a-b vaccine [fluzone qiv] lot number not reported via unknown route in unknown administration site for Immunisation.  On an unknown date the patient developed a non-serious got fluzone qiv, instead of fluzone hd (with no reported adverse event) (wrong product administered) (unknown latency) following the administration of influenza quadrival a-b vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event got fluzone qiv, instead of fluzone hd (with no reported adverse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus; no treatment; still experiencing one week after vaccination
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Abdominal pain lower, Appendicitis, Blood test abnormal, Computerised tomogram abnormal
Clinical narrative: PATIENT BEGAN HAVING ABDOMINAL PAIN THEN  NAUSEA AND VOMITING ON 10.11.2022. ON 10.12.2022 IT PROGRESSED TO HER RIGHT LOWER QUADRANT. PATIENT DEVELOPED APPENDICITIS. APPENDECTOMY SCHEDULED FOR 10.13.2022.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Vomiting
Clinical narrative: PATIENT BEGAN HAVING ABDOMINAL PAIN THEN  NAUSEA AND VOMITING ON 10.11.2022. ON 10.12.2022 IT PROGRESSED TO HER RIGHT LOWER QUADRANT. PATIENT DEVELOPED APPENDICITIS. APPENDECTOMY SCHEDULED FOR 10.13.2022.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Aortic aneurysm, Aortic aneurysm rupture, Blood test abnormal, Computerised tomogram abnormal
Clinical narrative: ON 10.12.2022 PATIENT STARTING HAVING RIGHT FLANK PAIN AND THEN NAUSEA AND VOMITTING. HE PRESENTED TO THE ER ON 10.13.2022 VERY EARLY.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Flank pain, Haematoma, Nausea, Vomiting
Clinical narrative: ON 10.12.2022 PATIENT STARTING HAVING RIGHT FLANK PAIN AND THEN NAUSEA AND VOMITTING. HE PRESENTED TO THE ER ON 10.13.2022 VERY EARLY.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Dizziness, Feeling abnormal, Gait disturbance, Tachycardia
Clinical narrative: Tachycardia (135 bpm) Brain Fog Trouble walking (dizzy)
Age: 64.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Blood test normal, Pain in extremity, Paraesthesia, Peripheral swelling, Ultrasound scan normal
Clinical narrative: I had the new COVID BOOSTER October 4, 2022, and the Monkeypox intradermally on October6, 2022.  3 days ago I realized my left  hand ( monkeypox vaccination shot arm) swelled up and became quite boated. Very scary. It tingled and hurt. This never happened before.  Yesterday, Urgency care sent me to ER. After X-ray, sonogram and blood draws, concussion that there was no blood cots.  It was probably reaction from having the two vaccine just days apart. I had the new COVID BOOSTER October 4, 2022, and the Monkeypox intradermally on October 6, 2022.
Age: 64.0
Sex: M
Vaccine: SMALLMNK
Symptoms: X-ray normal
Clinical narrative: I had the new COVID BOOSTER October 4, 2022, and the Monkeypox intradermally on October6, 2022.  3 days ago I realized my left  hand ( monkeypox vaccination shot arm) swelled up and became quite boated. Very scary. It tingled and hurt. This never happened before.  Yesterday, Urgency care sent me to ER. After X-ray, sonogram and blood draws, concussion that there was no blood cots.  It was probably reaction from having the two vaccine just days apart. I had the new COVID BOOSTER October 4, 2022, and the Monkeypox intradermally on October 6, 2022.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia
Clinical narrative: Extreme insomnia from time of dose
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Chest pain, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: patient expierenced a redness, rash that burned and itched all the way around her arm and was about 3 inches wide. patinet also complained of have chest pains-Medium
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: patient expierenced a redness, rash that burned and itched all the way around her arm and was about 3 inches wide. patinet also complained of have chest pains-Medium
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Medium, Additional Details: Patient has no history of seizures or other neurological disorders. Patient had a seizure lasting approximately 45 seconds within 2-3 minutes after receiving these vaccinations.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 90.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium, Systemic: dark bruising from bicep to below elbow, area spreading-Medium, Additional Details: patient presented to the pharmacy on 10/9/22, stating he has had bruising/blood under skin since he received the flu shot on 9/23/22. There was older yellow bruising in the deltoid area and dark skin areas extending from bicep toward elbow and below and patient said the area had been growing since receiving the flu shot. Patient stated he is on eliquis, blood thinner. I advised him to go to ER to have it looked at as he seemed concerned.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: Systemic: swelling of feet-Medium
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 42.0
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: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Confusional state, Dizziness, Pallor, Tremor
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT TURNED PALE AND FALLING TO ONE SIDE, SO WE STABILIZED HIM. WHEN THE EMS ARRIVED AFTER 15 MINUTES , HE SEEM LIKE HE WAS RECOVERING AND THEY TOOK AWAY ON A GURNEY. HE NEVER LOST HIS CONSCIOUSNESS.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Systemic: Pt reported mild numbness in mouth, described sensation similar to after dental anesthesia and similar senstation in righ arm 30 mins after. pt was monitored for 30 minutes and left without following up with pharmacist.-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Pt received 2 vaccinations,moderna bi-valent on L arm and flucelvax on R arm.Pt reported feeling mild numbness around mouth;described sensation similar to after dental anesthesia.Pt was monitored for 30 mins, after initial 15 mins he described similar sensation in R arm but can still feel his arm.Pt denies anaphylaxis,SOB,or light headedness.Pt was alert and oriented.Pt was advised to stay additional 15 mins for monitoring and report numbness to md however pt left without f/u with pharmacist.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia
Clinical narrative: Systemic: Joint Pain-Severe
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chills, Headache, Nausea, Neck pain
Clinical narrative: Fever 103 with chills, headache, neck and back pain including nerve pain, nausea all symptoms lasted for about 8 hours and started approximately 10 hours after dose was given.  Took ibuprofen around 11pm when my fever got up to 103. Woke up the next morning still with headache and low grade fever.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Pyrexia
Clinical narrative: Fever 103 with chills, headache, neck and back pain including nerve pain, nausea all symptoms lasted for about 8 hours and started approximately 10 hours after dose was given.  Took ibuprofen around 11pm when my fever got up to 103. Woke up the next morning still with headache and low grade fever.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Ear discomfort, Injection site pain, Oropharyngeal pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Additional Details: Pt reports chest congestion, cough, bad sore throat, ear clogged, chills, no fever. started 3 days after and it has been 7 days and still ongoing.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory tract congestion
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Additional Details: Pt reports chest congestion, cough, bad sore throat, ear clogged, chills, no fever. started 3 days after and it has been 7 days and still ongoing.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cardiac disorder, SARS-CoV-2 test positive
Clinical narrative: Sudden cardiac event, COVID-19 positive
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Ultrasound scan, Vaginal haemorrhage, Vulvovaginal pruritus
Clinical narrative: 9/27/22 Got annual flu shot manuf sequirus lot as1594B exp 6/30/2023 0.5ml right arm. influenza vaccine flucelvax quadrivalent 2022-2023 formula. normal arm itch and redness incur for a week plus normal. but 5 days later on 10/1/22 i use a ointment triamcinolone acetonide 0.25% usp ointment ndc 00168-0005-80 for vaginal itch as prescribe by skin dr. been using this ointment for a long time. at about 915pm 10/1/22 at bathroom tissue wipe after ointment apply find vaginal bleeding its been about 7 days now current tiny spotting to nothing at bathroom wipe. reported triam to medwatch 10/6/2022 now i am reporting in the flu shot to go with the problem. victim is female 66. unknown what cause the bleeding. i still have box to triam i uploaded wtih my fda complain yesterday. as to the flu shot i only have printout dr gave me about the rx no box no bottle no anything on it.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Needle issue
Clinical narrative: Nurse was administering a Covid booster to patient in his right deltoid. Just as she was finishing, there was a very clear snap sound and as I pulled back, the needle had broken clean off of the syringe. It was far enough into his arm that the provider decided to send him to the ED for further evaluation. The syringe used was VanishPoint Lot# G210415.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: I received what I thought was a Covid vaccination but upon looking back at the documentation my vaccination is listed as other and has the identifier of 043A21A. I received this at Clinic Pharmacy. Maybe it is coincidental but the identifier happens to match an unsecure public wireless network on my computer and cellular phone that I am unable to get rid of.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Lot FL2757 Expiration Date: 9/30/2022 administered to patient by staff on 10/06/2022 07:06 pm
Age: 80.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Balance disorder
Clinical narrative: Made an appointment at local Pharmacy to obtain COVID booster (Pfizer) and Shingrix. Within a few days. Experienced extreme issues with balance. Two months later I am beginning to feel better. Have had appointments with my cardiologist and neuologist.
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10/06/2022 at 7:06 am PFIZER PEDI Orange Cap lot: FL2757. Expired vaccine administered. Expiration Date: 9/30/2022. 0.2 ml administered to patient
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Electrocardiogram abnormal
Clinical narrative: AFib 19 day after bivalent booster
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Asthenia, Chest pain, Dyspnoea, Malaise
Clinical narrative: Pfiser booster lastest one 2022 taken nearly 3 weeks ago. I have been sick ever since. Nausea general weakness as well as shoulder neck and chest pain combined w shortness of breath. Fine beforehand no significant issues. Modana inoculations previously w no significant adverse effects. Every single one w never feeling ill afterwards. First tome w pfiser and dick as hell ever since
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Neck pain
Clinical narrative: Pfiser booster lastest one 2022 taken nearly 3 weeks ago. I have been sick ever since. Nausea general weakness as well as shoulder neck and chest pain combined w shortness of breath. Fine beforehand no significant issues. Modana inoculations previously w no significant adverse effects. Every single one w never feeling ill afterwards. First tome w pfiser and dick as hell ever since
Sex: M
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Vertigo after flu shot
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient came to the pharmacy for the COVID-19 bivalent vaccine and received the regular vaccine.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Bell's palsy, Influenza virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: 4 days after receiving bexsero vaccination patient developed right-sided Bell's Palsy
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Syringe issue
Clinical narrative: Nurse went to administer flu vaccine and states she pushed on plunger to express drop of vaccine to ensure no air would be in injection.  She then states she inserted needle in patient's arm and started to depress it but it would not depress any further.  She then removed from patient arm and informed patient that there was no flu vaccine in that syringe and would have to give patient another shot, which she did.  Upon inspection of the syringe, it did appear the syringe/needle area was crooked so may have been an error in manufacturing process.  No other syringes in that box had any issues.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Brain natriuretic peptide increased, COVID-19, Chest X-ray normal, Echocardiogram
Clinical narrative: "Provider d/c note:  79 YO female with h/o  HLD, HTN, CKD, hypertrophic cardiomyopathy, short term memory loss. She tested positive for COVID on 10/5 with initial Sx onset 2-3 days prior to being positive.  Had reached out to her PCP and Paxlovid was set to be initiated.  But was brought to the hospital due to worsening weakness.  In the emergency department she was found to be hemodynamically stable, labs within normal limits except for elevated BNP > 3000, and tested positive for COVID-19.  Patient was not requiring any oxygen throughout her stay.  Chest x-ray within normal limits.  Given her prior history of cardiomyopathy repeat echocardiogram was ordered which is pending to be read but initial report with EF > 60%. Patient given IV lasix  40 mg with improvement of symptoms.   She was evaluated with Physical therapy who recommended home with assist.  Patient remains stable, she tolerated oral intake. She will be discharged today back to home.  Will recommend patient to discuss with PCP again regarding Paxlovid."
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ejection fraction, Malaise, SARS-CoV-2 test positive
Clinical narrative: "Provider d/c note:  79 YO female with h/o  HLD, HTN, CKD, hypertrophic cardiomyopathy, short term memory loss. She tested positive for COVID on 10/5 with initial Sx onset 2-3 days prior to being positive.  Had reached out to her PCP and Paxlovid was set to be initiated.  But was brought to the hospital due to worsening weakness.  In the emergency department she was found to be hemodynamically stable, labs within normal limits except for elevated BNP > 3000, and tested positive for COVID-19.  Patient was not requiring any oxygen throughout her stay.  Chest x-ray within normal limits.  Given her prior history of cardiomyopathy repeat echocardiogram was ordered which is pending to be read but initial report with EF > 60%. Patient given IV lasix  40 mg with improvement of symptoms.   She was evaluated with Physical therapy who recommended home with assist.  Patient remains stable, she tolerated oral intake. She will be discharged today back to home.  Will recommend patient to discuss with PCP again regarding Paxlovid."
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lethargy, Myalgia
Clinical narrative: Muscle aches / Joint pain and soreness. Headache  Fatigue/ lethargic
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Myalgia, Pain
Clinical narrative: headache, all body soreness, muscle ache
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received vaccine via IM injection at hospital immunizations clinic and within 15 minutes began to display hives on that arm which spread across her chest and up her neck. Patient denied trouble breathing or chest pain. Patient was treated in emergency room with diphenhydramine IM injection. Hives resolved after approximately 40 minutes from diphenhydramine injection. Patient reported continued itching as of the next day.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose, Dizziness, Hypotension, Vision blurred
Clinical narrative: Low blood pressure, feeling like fainting, blurred vision
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Was to get the Bivalent, but received Monovalent  Spoke to patient, no adverse side effect she was advised that she can have the Bivalent in 2 months by the report on the CDC website.  Attending notified in the clinic of event, filing report and time frame that she can get the next booster by the CDC website Guidelines
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pallor, Syncope
Clinical narrative: Patient fainted approximately 10-15 minutes after receiving vaccine.  Patient was told to stay on the ground. He was sitting and was told to put his head between his knees, after about 10 minutes some sips of water  patient was feeling better and his color came back to his face.
Age: 6.0
Sex: F
Vaccine: COVID19, FLU4, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient given an expired dose of the COVID19 Pfizer Biontech vaccine. Vaccine expiration date was 9/30/2022 and vaccine administered on 10/6/2022. No adverse reactions.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Condition aggravated, Tachycardia
Clinical narrative: onset of rapid atrial fibrillation vs wide complex tachycardia, hospitalization
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Imaging procedure, Lip erythema, Peripheral swelling, Skin warm
Clinical narrative: My left arm got red, hot, and swollen on Sunday morning after receiving the booster shot, my left eye lid on the corner also got red and swollen. Plus my lips got beat red.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling of eyelid
Clinical narrative: My left arm got red, hot, and swollen on Sunday morning after receiving the booster shot, my left eye lid on the corner also got red and swollen. Plus my lips got beat red.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Muscle disorder, Pain
Clinical narrative: soreness in injection site, slight pain  when raising left arm.  feel muscle stretching.
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Client was mistakenly vaccinated with a vial of vaccine that had expired the day before. Medical director and manufacturer were contacted, and the recommendation is to revaccinate the client. Client was called and made aware of the issue, and he will call us back to make an appointment for his next dose.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Pain, Skin lesion, Skin swelling
Clinical narrative: On October 12th, red raised lesion appeared on lower right arm/wrist area.  Another smaller red raised lesion appeared on the pinky finger of the left hand.  Both lesions painful.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest discomfort, Cough, Fatigue, Injection site erythema
Clinical narrative: Two days after receiving the vaccine I had a red, itchy spot at the injection site which lasted a day or two. I tested positive for COVID-19 on 09/29/2022 via a home test. I had a sore throat, terrible cough and fatigue. I contacted my doctor, and they did not prescribe PAXLOVID due to side effects. I took MUCINEX and TYLENOL as needed. I continue to have trouble with swelling in throat, chest tightness and fatigue. My doctor put me on a steroid medication to help me with my symptoms. I'm not fully recovered but I am feeling better after starting the steroid.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus, Oropharyngeal pain, Pharyngeal swelling, SARS-CoV-2 test positive
Clinical narrative: Two days after receiving the vaccine I had a red, itchy spot at the injection site which lasted a day or two. I tested positive for COVID-19 on 09/29/2022 via a home test. I had a sore throat, terrible cough and fatigue. I contacted my doctor, and they did not prescribe PAXLOVID due to side effects. I took MUCINEX and TYLENOL as needed. I continue to have trouble with swelling in throat, chest tightness and fatigue. My doctor put me on a steroid medication to help me with my symptoms. I'm not fully recovered but I am feeling better after starting the steroid.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bronchitis, Nasopharyngitis, Rash, Rash pruritic
Clinical narrative: Itchy rash appeared on inside of left thigh and left side of torso Sept. 27, 2022. The rash stays for 12-24 hours and then changes locations on the body, which includes feet, legs, hands, arms, torso (front, back and side), neck and crotch. I stopped doxycycline 100mg after two doses and began generic Zyrtec in the morning and generic Benadryl at night, then was prescribed steroids. I have finished all of that and the rash has not dissipated. Nurse suspected possibility of stress rash (I appeared partway through the toughest three weeks of my work each year).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient indicated for bivalent booster. Received monovalent booster instead.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Eye pain, Headache, Ocular hyperaemia, Ophthalmological examination abnormal, UV light therapy
Clinical narrative: Right eye pain, blurry vision, eye injected (red), mild headache, increased eye pain in bright light Treatment: steroid eye drops Prednisolone Acetate One drop to right eye 4 times a day
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vision blurred
Clinical narrative: Right eye pain, blurry vision, eye injected (red), mild headache, increased eye pain in bright light Treatment: steroid eye drops Prednisolone Acetate One drop to right eye 4 times a day
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Culture urine, Lower urinary tract symptoms, Urine analysis
Clinical narrative: I developed classic UTI symptoms on 10OCT2022,  approximately 3.5 weeks after bivalent vaccine. Treating with TMP/SMX and symptoms are improving. Not related to vaccine but within reporting window
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Wrong technique in product usage process
Clinical narrative: Significant Shoulder soreness.  Patient also claims that this has never happened before and also confirmed that he believes the injection was done correctly.  Proper placement and depth.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Burning sensation, Erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: He got his vaccine, at first a couple of hours later he had swelling on Sunday morning.  Then about a day later he noticed that the swelling was still there on Monday, and had red spots on the arm.  When he came home Monday night it looked like the red spots got bigger like they were going to pop and something else was going to happen.  On Tuesday morning he has a really bad burning sensation in it, and also blisters that popped at the injection site only.  It likes a big circle, he can see where the injection was given, and it's probably about 3" wide around it.  It is hot to touch, very painful, it burns, and does not know what to do or put on it.  He has an appointment with his old doctors associate on Friday.  He has not seen anybody for this yet.   He called the pharmacy when he got his vaccine and they told him to call us.  He noticed that yesterday that the blisters popped, there is about 25 of them.  It's like a bunch of little dots all around the area.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Swelling
Clinical narrative: He got his vaccine, at first a couple of hours later he had swelling on Sunday morning.  Then about a day later he noticed that the swelling was still there on Monday, and had red spots on the arm.  When he came home Monday night it looked like the red spots got bigger like they were going to pop and something else was going to happen.  On Tuesday morning he has a really bad burning sensation in it, and also blisters that popped at the injection site only.  It likes a big circle, he can see where the injection was given, and it's probably about 3" wide around it.  It is hot to touch, very painful, it burns, and does not know what to do or put on it.  He has an appointment with his old doctors associate on Friday.  He has not seen anybody for this yet.   He called the pharmacy when he got his vaccine and they told him to call us.  He noticed that yesterday that the blisters popped, there is about 25 of them.  It's like a bunch of little dots all around the area.
Age: 26.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: CELLUTLITIS REQUIRING ANTIBIOTIC
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: Patient only received the suspension, of the Shringrix vaccine the full dose was not given.  Patient was contacted and notified of the error. Instructed to return in 4 weeks for the full dose.  The patient denied any complications at the time of notification.
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Chest discomfort, Extra dose administered, Pain, Pain in extremity
Clinical narrative: Patient inadvertently received a second dose of high-dose quad influenza vaccine within 28 days of her first annual dose.  At time of follow-up from pharmacy, patient was said to have body aches (including mild chest tightness) and a sore arm.  This information was given to us by the daughter and not able to be confirmed with the patient.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Electric shock sensation, Lymphadenopathy, Pain, SARS-CoV-2 test negative
Clinical narrative: When stretching hands over head felt burning electrical pain in right arm throughout the body doctored confirmed swollen lymph node. Blood pressure was elevated 140/90.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy intestine abnormal, Colitis microscopic, Colonoscopy abnormal
Clinical narrative: I now have lymphomatic colitus which can have a stealth approach to starting. It was unstoppable by July 2022 and confirmed by a recent biopsy in Sep 2022, but could have been there earlier. I read in a study that although it is a possibly inherited autoimmune disease that the vaccine has set some cases off so wanted to report my case so you know. I'm not expecting any further action. Just figured you might like the data. The acute onset was closer to dose 4 but there were subtler signs throughout 2022 and 2021 that could have been the actual onset so it could have started after dose 3 or even dose 2. There's no real way of proving that. Dose 5 was AFTER this started.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 via a home test on 10/08/2022. I had a cough and felt congested. I was given the prescription for PAXLOVID lower dose. I had my last dose today, so I'm not fully recovered but I am feeling better.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was under-dosed and given 0.25 ml rather than 0.5 ml
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was under-dosed and given 0.25 ml rather than 0.5 ml
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy kidney, Cardiac function test, Computerised tomogram abnormal, Dialysis, Hypotonia
Clinical narrative: I started with a 190 heart beat, I went to the doctor, and she put me right in the hospital. With that I was in the ER and they decided to do a catscan, and that's when they found something wrong with my renal, and they admitted me, and not only did they do test on my heart, they did a test on my kidneys - a renal biopsy. And that is where they found I had Vasculitis, and that is when they put me on Dialysis. I lost my muscle tone, and now I have to have a live in aid, and physical therapy. Before, I was walking 3.5 miles. If this is from the injection, I do not want this to happen to someone else.   2 mths in With hospital and at Rehab
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Renal disorder, Vasculitis
Clinical narrative: I started with a 190 heart beat, I went to the doctor, and she put me right in the hospital. With that I was in the ER and they decided to do a catscan, and that's when they found something wrong with my renal, and they admitted me, and not only did they do test on my heart, they did a test on my kidneys - a renal biopsy. And that is where they found I had Vasculitis, and that is when they put me on Dialysis. I lost my muscle tone, and now I have to have a live in aid, and physical therapy. Before, I was walking 3.5 miles. If this is from the injection, I do not want this to happen to someone else.   2 mths in With hospital and at Rehab
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given red cap moderna at age 17 years old.  Red cap moderna is not approved for those under age 18
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Became COVID positive while in hospital despite 3 Moderna vaccines
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was under-dosed and given 0.25 ml rather than 0.5 ml
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Mother of the minor, by phone call refers that minor presents redness and hot to the touch in the area of vaccination the next day. 10/12/2022.