chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient whose medical assistant did not mix the two vials together, so the patient only received the Dtap-Ipv portion and not the Hib portion with no reported adverse event , it involved vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 15-Sep-2022, the patient received dose of 0.5m once of  suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE , with an unknown formulation and strength, (lot: U7311AA ; expiry date: 09-Sep-2023) via intramuscular route in the right thigh for immunization.  It was reported that on 15-Sep-2022, the medical assistant did not mix the two vials together, so the patient only received the Dtap-Ipv portion and not the Hib portion with no reported adverse event ,  (single component of a two-component product administered, product preparation error) (latency: same day).   Action taken: not applicable for both the events.  Outcome: unknown for both the events.   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: 0.42
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 5-month-old female patient who experienced medical assistant did not mix the two vials together, so the patients only received the dtap-ipv portion and not the hib portion with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA418088.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination.  On 15-Sep-2022, the patient received suspect Pentacel (VERO) Vaccine at dose 0.5 ml once (lot: U7311AA, 09-Sep-2022) via intramuscular route in the right thigh for prophylactic vaccination.  On 15-SEP-2022, the medical assistant did not mix the two vials together, so the patients only received the dtap-ipv portion and not the hib portion with no reported adverse event (single component of a two-component product administered)(Product preparation error) at same day latency following the administration of Pentacel (VERO).  Action taken: Not applicable for both events.  At time of reporting, the outcome was Unknown for both 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: 4.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: patient administered open IPOL post excursion with no adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA419841(CLUSTER), 2022SA422655(CLUSTER), 2022SA422419(CLUSTER), 2022SA422653(CLUSTER), 2022SA422151(CLUSTER), 2022SA421782(CLUSTER) and 2022SA422846(CLUSTER).  This case involves a 4 years old male patient who was administered open IPV (VERO) [IPOL] post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR)  and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 26-Sep-2022, the patient received 0.5 ml dose of suspect open  IPV (VERO), suspension for injection (lot V1A022M; Exp.date: 17-FEB-2024) via intramuscular route in the left thigh for Immunisation post excursion with no adverse event (poor quality product administered) (latency on same day).  Action taken : not applicable.  Outcome :  Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Illness, Influenza, Influenza like illness, Malaise, Muscle discomfort
Clinical narrative: got violently ill; sick for 3 weeks afterwards with flu symptoms; lose all of his muscular ability; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA422349(CLUSTER) and 2022SA425046(CLUSTER).  This case involves a 78 years old male patient who got violently ill, lose all of his muscular ability and sick for 3 weeks afterwards with flu symptoms 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 (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of got violently ill (illness) and sick for 3 weeks afterwards with flu symptoms (influenza) (latency: unknown) following the administration of INFLUENZA VACCINE.  On 15-OCT-2021 the patient developed a non-serious event of lose all of his muscular ability (muscle discomfort) (latency: unknown) following the administration of INFLUENZA VACCINE.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: Recovered / Resolved on an unknown date for all events.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Influenza, Malaise
Clinical narrative: sick for 3 weeks afterwards with flu symptoms; flu symptoms; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA424503(CLUSTER), 2022SA425041(CLUSTER), 2022SA424529(CLUSTER) and 2022SA425046(CLUSTER).  This case involves an elderly female patient who was sick for 3 weeks afterwards with flu symptoms and flu symptoms while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine once produced by unknown manufacturer (lot number: not reported; dose, strength, formulation and expiry date unknown) via unknown route in unknown administration site for immunization.  On an unknown date the patient got sick for 3 weeks afterwards with flu symptoms (illness)  and symptoms (influenza) (unknown latency) following the administration of influenza vaccine .  It was reported Three years ago, she received a "senior" flu shot from pharmacy. The caller does not know which senior flu shot his wife received. She got sick for 3 weeks afterwards with flu symptoms. She now says that she will never get another flu shot, after what she experienced 3 years ago.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (sick for 3 weeks afterwards with flu symptoms, flu symptoms).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for both the events.
Age: 34.0
Sex: U
Vaccine: FLU4, TD
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event; administered to patients after tempearature excursion with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 34 years old and unknown gender patient and reporter reported temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event and was administered to patients after tempearature excursion with no reported adverse event while receiving vaccines diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] and 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 23-Sep-2022, the patient received a dose of suspect influenza quadrival a-b vaccine (lot UJ899AA and expiry date 30-Jun-2023) Suspension for injection (with an unknown strength, dose, frequency, route, administration site) for immunization.  On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (with an unknown strength, dose, frequency, route, lot number, expiry date administration site) for prophylactic vaccination.  On an unknown date the temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event (Product storage error) and On 23-SEP-2022 the patient was administered with vaccineinfluenza quadrival a-b vaccine and on unknown date administered with diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult with no reported adverse event (poor quality product administered).  No lab data reported.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for both the events.  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: 42.0
Sex: U
Vaccine: FLU4, TD
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: medication error due to temperature excursion that exceeded the stability data  and administered to patient with no reported adverse event; medication error due to temperature excursion that exceeded the stability data  and administered to patient with no reported adverse event; Initial information received from on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 42 years old and unknown gender patient and reporter stated that there was a medication error due to temperature excursion that exceeded the stability data  and administered to patient with no reported adverse involving 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.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC). It was reported regarding a medication error due to temperature excursion that exceeded the stability data and administered to patient with no reported adverse event (product storage error) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation was unknown, lot UJ899AA and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Immunization.  On 22-Sep-2022 the patient developed a non-serious event of medication error due to temperature excursion that exceeded the stability data and administered to patient with no reported adverse event (poor quality product administered) (Latency: same day)following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: U
Vaccine: FLU4, TD
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion with no reported adverse event; temperature excursion / administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 36 years old and unknown gender patient who had temperature excursion with no reported adverse event and temperature excursion / administered to patient with no reported adverse event involving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC).  On 29-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation was unknown, lot UJ899AA and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Immunization.  On 29-Sep-2022 the patient developed a non-serious event of temperature excursion with no reported adverse event (product temperature excursion issue) involving INFLUENZA QUADRIVAL A-B VACCINE. On 29-Sep-2022 the patient developed a non-serious event of temperature excursion / administered to patients with no reported adverse event (poor quality product administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken:  not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 46.0
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; administered to patients after temperature excursion with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 46 years old and unknown gender patient and reporter reported temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event and was administered to patients after tempearature excursion 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 22-Sep-2022, the patient received a dose of suspect influenza quadrival a-b vaccine (lot UJ899AA) Suspension for injection (with an unknown strength, dose, frequency, route, expiry date, administration site) for immunization.   On an unknown date the temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data with no adverse event (Product storage error) (latency unknown) and On 22-SEP-2022 the patient was administered with the vaccine influenza quadrival a-b vaccine with no reported adverse event (poor quality product administered) (latency same day).  No lab data reported.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: patient did not receive the full dose with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received via health professional. number: 01318866.  This case involves a patient of unspecified demographics who did not receive the full dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA425199.   On an unknown date, one of the nurses was administering suspect PENTACEL (VERO) vaccine to patient at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination, patient did not receive the full dose with no adverse event (incorrect dose administered) at unknown latency. The caller reported the needle was displaced and the medication squirted out. The caller inquired does the patient need to be revaccinated.   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.
Age: 26.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Vaccination site joint swelling
Clinical narrative: injection site is swollen to about the size of a half dollar; Initial information regarding an unsolicited valid non-serious case received via patient husband on 12-Oct-2022. GMI number: 01318954.  This case involves a 26-year-old female patient who experienced injection site is swollen to about the size of a half dollar after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant vaccination includes Bivalent COVID.    On 11-Oct-2022, the patient received a dose of suspect Fluzone Quadrivalent vaccine flu shot at dose 0.5 ml total (lot: UT7689NA, expiry date: Jun-2023) via unknown route in unknown administration site for immunization.  On 12-OCT-2022 the patient developed a non-serious injection site is swollen to about the size of a half dollar (vaccination site joint swelling) at 1 day following the administration of Fluzone Quadrivalent vaccine.  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Not Recovered for the event Vaccination site joint swelling.
Age: 21.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received a tenivac immunization that was later noted to have expired with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 21 years old male patient who received a -2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] immunization that was later noted to have expired with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Oct-2022, the patient received expired 0.5 ml, dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength: standard, formulation: unknown) (lot U6831AA, expiry date: 08-Oct-2022) via intramuscular route in the deltoid NOS (not otherwise specified) with no adverse event (expired product administered) (latency: same day).  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-2022SA422490:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Biopsy lymph gland, Blood test, Computerised tomogram, Electrophoresis protein
Clinical narrative: Approximately 10 days after the 2nd booster (4th shot) I developed enlarged lymph nodes in my neck followed by severe red, scaly, flat rash. This progressed to lymphadenopathy and an enlarged spleen,. Although it is beginning to resolve (rash went away 6 months after vaccine) many of the symptoms mimicked lymphoma and therefore I underwent extensive testing to determine the cause.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Exfoliative rash, Flow cytometry, Full blood count, Laboratory test, Lymphadenopathy
Clinical narrative: Approximately 10 days after the 2nd booster (4th shot) I developed enlarged lymph nodes in my neck followed by severe red, scaly, flat rash. This progressed to lymphadenopathy and an enlarged spleen,. Although it is beginning to resolve (rash went away 6 months after vaccine) many of the symptoms mimicked lymphoma and therefore I underwent extensive testing to determine the cause.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoid tissue hyperplasia, Metabolic function test, Positron emission tomogram, Rash erythematous, Splenomegaly
Clinical narrative: Approximately 10 days after the 2nd booster (4th shot) I developed enlarged lymph nodes in my neck followed by severe red, scaly, flat rash. This progressed to lymphadenopathy and an enlarged spleen,. Although it is beginning to resolve (rash went away 6 months after vaccine) many of the symptoms mimicked lymphoma and therefore I underwent extensive testing to determine the cause.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Approximately 10 days after the 2nd booster (4th shot) I developed enlarged lymph nodes in my neck followed by severe red, scaly, flat rash. This progressed to lymphadenopathy and an enlarged spleen,. Although it is beginning to resolve (rash went away 6 months after vaccine) many of the symptoms mimicked lymphoma and therefore I underwent extensive testing to determine the cause.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Urticaria
Clinical narrative: Broke out in hives on right hand
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blister, Colitis, Computerised tomogram abdomen abnormal, Diarrhoea
Clinical narrative: On September 24, 2022, I developed a huge cold sore / shingle on my face below my lip.  - this was day after the vaccine, I know this was from vaccine.  I started to feel kind of sick then the sore broke out on my face.  Very itchy and multiple blisters.   On October 9, 2022, I became severely ill with nausea/vomiting/diarrhea and had to go to the ER for treatment. As I told the representative, I do not know if this was directly related to the vaccine.  The diagnosis from tests given at ER was abdominal pain and colitis.   The representative wanted me to report my illness to have it on record.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Nausea, Oral herpes, Pruritus
Clinical narrative: On September 24, 2022, I developed a huge cold sore / shingle on my face below my lip.  - this was day after the vaccine, I know this was from vaccine.  I started to feel kind of sick then the sore broke out on my face.  Very itchy and multiple blisters.   On October 9, 2022, I became severely ill with nausea/vomiting/diarrhea and had to go to the ER for treatment. As I told the representative, I do not know if this was directly related to the vaccine.  The diagnosis from tests given at ER was abdominal pain and colitis.   The representative wanted me to report my illness to have it on record.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion, Vomiting
Clinical narrative: On September 24, 2022, I developed a huge cold sore / shingle on my face below my lip.  - this was day after the vaccine, I know this was from vaccine.  I started to feel kind of sick then the sore broke out on my face.  Very itchy and multiple blisters.   On October 9, 2022, I became severely ill with nausea/vomiting/diarrhea and had to go to the ER for treatment. As I told the representative, I do not know if this was directly related to the vaccine.  The diagnosis from tests given at ER was abdominal pain and colitis.   The representative wanted me to report my illness to have it on record.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus - ringing in both ears.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Sepsis
Clinical narrative: Became septic and was hospitalized/It was reported the patient had a 104F fever; This spontaneous case was reported by a physician and describes the occurrence of SEPSIS (Became septic and was hospitalized/It was reported the patient had a 104F fever) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In September 2022, the patient experienced SEPSIS (Became septic and was hospitalized/It was reported the patient had a 104F fever) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from sometime in September 2022 to sometime in September 2022 due to SEPSIS. At the time of the report, SEPSIS (Became septic and was hospitalized/It was reported the patient had a 104F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, Body temperature: 104 F.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  Patient got the vaccine, dose number not specified. It was reported the patient had a 104F fever and was hospitalized and became septic and was hospitalized 48 hours after taking the vaccine.  No treatment information mentioned.  Company Comment: This is a Spontaneous case reported by a physician, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Sepsis, which occurred 2 days after an unspecified dose of mRNA-1273 vaccine. Patient had a 104 F fever and was hospitalized. He became septic. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a physician, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Sepsis, which occurred 2 days after an unspecified dose of mRNA-1273 vaccine. Patient had a 104 F fever and was hospitalized. He became septic. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he is fully vaccinated and boosted and still get the virus; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he is fully vaccinated and boosted and still get the virus) in a male 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.     No Medical History information was reported.    On an unknown date, the patient received 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 COVID-19 (he is fully vaccinated and boosted and still get the virus). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (he is fully vaccinated and boosted and still get the virus) outcome was unknown.            No concomitant drug information was provided.  It was reported that patient was fully vaccinated and boosted with Moderna vaccine, however patient still got virus. Patient had already finished the Paxlovid therapy and was enquiring when to take a covid-19 test.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: Sick; felt under the weather; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Sick) and MALAISE (felt under the weather) 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.     No Medical History information was reported.    On an unknown date, the patient received 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 (Sick) and MALAISE (felt under the weather). At the time of the report, ILLNESS (Sick) and MALAISE (felt under the weather) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660539 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660539:case for another patient-male
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Itchy painful rash all over body
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood test, Cardiac flutter, Electrocardiogram, Erythema, Extrasystoles
Clinical narrative: The day after my vaccines I started experiencing a fluttering feeling in my chest and, when checking my pulse manually, could feel my heart skipping beats. Several blood pressure checks showed elevated pulse and pressure throughout the following weekend. My right arm (Moderna) swelled significantly and developed a large, hot, itchy red patch that lasted about 5 days.
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Peripheral swelling, Pruritus, Pulse pressure increased, Skin warm
Clinical narrative: The day after my vaccines I started experiencing a fluttering feeling in my chest and, when checking my pulse manually, could feel my heart skipping beats. Several blood pressure checks showed elevated pulse and pressure throughout the following weekend. My right arm (Moderna) swelled significantly and developed a large, hot, itchy red patch that lasted about 5 days.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Joint injury, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Mobility decreased, Paralysis
Clinical narrative: Systemic: temporary paralysis-Severe, Additional Details: Abdel went to bed at 11:00 PM that night after receiving vaccine at 11:01 AM that day. He woke up 4 hours later at 3:00 AM and could not move. He eventually went back to sleep and when he woke up several hours later he had enough movement to roll himself off of the bed. He eventually regained full mobility. Says he feels normal now.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Vomiting-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Mild
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Tremor, Vomiting
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Vomiting-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Mild
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient presenting 8 days post vaccination with decreased ROM in injection site shoulder/arm with tingling down extremity.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Joint range of motion decreased, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient presenting 8 days post vaccination with decreased ROM in injection site shoulder/arm with tingling down extremity.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Flushing, Hyperhidrosis, Paraesthesia, Paraesthesia oral
Clinical narrative: Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported a metallic taste in his mouth and also a tingling in his tongue
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: Pain and swelling under right arm. Large swollen lymph node, red skin, duration 48 hours.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Neck pain, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: patient recieved vaccine two vaccines in left arm around 11:39AM - called pharmacy at 5:30pm saying shes in excrutiation pain radaiting from neck to arm - hurts to lift arm perform normal functions
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Tinnitus, Tympanometry
Clinical narrative: Tinnitus noticed shortly after receipt of first dose.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 36.0
Sex: M
Vaccine: COVID19-2, COVID19, FLUC3
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Starting approximately at around 5:00 AM on October 19, I am experiencing a severe headache, fatigue, severe muscle and joint pain.
Age: 36.0
Sex: M
Vaccine: COVID19-2, COVID19, FLUC3
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Off label use
Clinical narrative: Starting approximately at around 5:00 AM on October 19, I am experiencing a severe headache, fatigue, severe muscle and joint pain.
Age: 36.0
Sex: M
Vaccine: COVID19-2, COVID19, FLUC3
Symptoms: Product use issue
Clinical narrative: Starting approximately at around 5:00 AM on October 19, I am experiencing a severe headache, fatigue, severe muscle and joint pain.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Mild, Additional Details: Noticed immediate swelling at injection site after needle was removed. It appeared to be localized to around the injection site. Patient reported no other symptoms or signs of systemic anaphylaxis. Photos taken for documentation. Patient left with my contact information if he has any further problems.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Confusional state, Dizziness, Fatigue
Clinical narrative: Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: Pt received COVID Bivalent moderna booster in left delt, Fluad in right delt. felt fine for around 2 minutes before head tilted back and pt lost consciousness, excessive sweating.  pt still felt bad when he woke up. blood pressure 145/84, pulse 54. shaky, weak. water and orange juice did not resolve symptoms. wife drove pt to local urgent care. will follow up with pt tomorrow.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Flushing, Hyperhidrosis, Hypertension, Lethargy
Clinical narrative: Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: Pt received COVID Bivalent moderna booster in left delt, Fluad in right delt. felt fine for around 2 minutes before head tilted back and pt lost consciousness, excessive sweating.  pt still felt bad when he woke up. blood pressure 145/84, pulse 54. shaky, weak. water and orange juice did not resolve symptoms. wife drove pt to local urgent care. will follow up with pt tomorrow.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Loss of consciousness, Nervousness, Posture abnormal, Syncope, Tremor
Clinical narrative: Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: Pt received COVID Bivalent moderna booster in left delt, Fluad in right delt. felt fine for around 2 minutes before head tilted back and pt lost consciousness, excessive sweating.  pt still felt bad when he woke up. blood pressure 145/84, pulse 54. shaky, weak. water and orange juice did not resolve symptoms. wife drove pt to local urgent care. will follow up with pt tomorrow.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: Pt received COVID Bivalent moderna booster in left delt, Fluad in right delt. felt fine for around 2 minutes before head tilted back and pt lost consciousness, excessive sweating.  pt still felt bad when he woke up. blood pressure 145/84, pulse 54. shaky, weak. water and orange juice did not resolve symptoms. wife drove pt to local urgent care. will follow up with pt tomorrow.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Pain started from arm and now moved to elbow-Severe
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Diarrhoea, Dizziness, Fatigue, Hypersomnia
Clinical narrative: In the evening of the second day following the vaccine dizziness and nausea began abruptly at 7pm. The injection site was sore and had been since the time of the vaccine. By 8:30pm dizziness and nausea worsened and I went to bed. At midnight I woke up with diarrhea and experiencing extreme fatigue and muscle soreness over the entire body.  A headache was intense almost like a migraine. Neck and back were sore and stiff. At 1am I returned to bed after taking two extra strength ibuprofen capsules. I did not get up from bed again until afternoon Wednesday to urinate then went immediately back to bed with zero improvement in symptoms except diarrhea was gone. Remained in bed throughout the rest of Tuesday sleeping all but 2 hours total. This remained the case through Thursday morning. I went to the urgent care/ER to get tested for COVID and other viral panel to determine if this was a vaccine reaction or something else. Friday morning following all symptoms were gone completely. No feeling of residual illness of any type persisted into Friday at all. Since I?ve never ?recovered? completely from any illness so suddenly, it seemed to further indicate the symptoms were a response to the vaccine and not any actual viral or bacterial source. This was my 5th COVID vaccine injection and I?ve never had a reaction to any of them other than temporary injection site soreness.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Injection site pain, Migraine, Musculoskeletal stiffness, Myalgia
Clinical narrative: In the evening of the second day following the vaccine dizziness and nausea began abruptly at 7pm. The injection site was sore and had been since the time of the vaccine. By 8:30pm dizziness and nausea worsened and I went to bed. At midnight I woke up with diarrhea and experiencing extreme fatigue and muscle soreness over the entire body.  A headache was intense almost like a migraine. Neck and back were sore and stiff. At 1am I returned to bed after taking two extra strength ibuprofen capsules. I did not get up from bed again until afternoon Wednesday to urinate then went immediately back to bed with zero improvement in symptoms except diarrhea was gone. Remained in bed throughout the rest of Tuesday sleeping all but 2 hours total. This remained the case through Thursday morning. I went to the urgent care/ER to get tested for COVID and other viral panel to determine if this was a vaccine reaction or something else. Friday morning following all symptoms were gone completely. No feeling of residual illness of any type persisted into Friday at all. Since I?ve never ?recovered? completely from any illness so suddenly, it seemed to further indicate the symptoms were a response to the vaccine and not any actual viral or bacterial source. This was my 5th COVID vaccine injection and I?ve never had a reaction to any of them other than temporary injection site soreness.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Neck pain, Respiratory viral panel, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: In the evening of the second day following the vaccine dizziness and nausea began abruptly at 7pm. The injection site was sore and had been since the time of the vaccine. By 8:30pm dizziness and nausea worsened and I went to bed. At midnight I woke up with diarrhea and experiencing extreme fatigue and muscle soreness over the entire body.  A headache was intense almost like a migraine. Neck and back were sore and stiff. At 1am I returned to bed after taking two extra strength ibuprofen capsules. I did not get up from bed again until afternoon Wednesday to urinate then went immediately back to bed with zero improvement in symptoms except diarrhea was gone. Remained in bed throughout the rest of Tuesday sleeping all but 2 hours total. This remained the case through Thursday morning. I went to the urgent care/ER to get tested for COVID and other viral panel to determine if this was a vaccine reaction or something else. Friday morning following all symptoms were gone completely. No feeling of residual illness of any type persisted into Friday at all. Since I?ve never ?recovered? completely from any illness so suddenly, it seemed to further indicate the symptoms were a response to the vaccine and not any actual viral or bacterial source. This was my 5th COVID vaccine injection and I?ve never had a reaction to any of them other than temporary injection site soreness.