chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Act-HIB for which cold chain break is reported with no reported adverse event; excursion vaccine was administered with no reported adverse; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA124713:Master Case
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: Poor quality vaccine administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received via physician.  This case involves Infant and unknown gender patient who was administered  with poor quality vaccine hib (prp/t) vaccine [Act-Hib] with no reported adverse event  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date the patient was administered with poor quality vaccine of hib (prp/t) (poor quality product administered) (same day latency) no reported adverse event  Action taken was not applicable.  At time of reporting, the outcome was Unknown .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: excursion vaccine was administered with no adverse event; vaccine Act-HIB for which cold chain break is reported with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA124713:master case
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: products should not be used because they were delivered beyond the acceptable shipping time,3 patients received MenQuadfi from this shipment with no reported adverse event; products should not be used because they were delivered beyond the acceptable shipping time with no reported adverse event; Initial information received on 20-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 3 patients of unknown age and demographics who were administered Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] which were delivered beyond the acceptable shipping time 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 patients received 0.5ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On 30-Mar-2023, it was reported that the products (Meningococcal A-C-Y-W135 (T CONJ) vaccine) should not be used because they were delivered beyond the acceptable shipping time with no reported adverse event (product storage error) (unknown latency).  On an unknown date, the patient developed a non-serious event products should not be used because they were delivered beyond the acceptable shipping time,3 patients received menquadfi from this shipment with no reported adverse event (poor quality product administered) (same day latency) following the administration of Meningococcal A-C-Y-W135 (T CONJ) vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (products should not be used because they were delivered beyond the acceptable shipping time,3 patients received MenQuadfi from this shipment with no reported adverse event).  At time of reporting, the outcome was Unknown for the event products should not be used because they were delivered beyond the acceptable shipping time with no reported adverse event and products should not be used because they were delivered beyond the acceptable shipping time,3 patients received menquadfi from this shipment 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event, Product preparation error
Clinical narrative: patient administered acthib with expired sterile diluent with no reported adverse events; patient administered acthib with expired sterile diluent with no reported adverse events; Initial information received on 20-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had patient administered acthib with expired sterile diluent with no reported adverse events after receiving vaccine hib (prp/t) vaccine [act-hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection, strength, dose, expiration date and lot number not reported via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious patient administered acthib with expired sterile diluent with no reported adverse events (expired product administered) and (product preparation error) ( (unknown latency).  Lab data was not reported.  Action taken was not applicable.  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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TYP
Symptoms: Fatigue, Muscular weakness, Oropharyngeal pain
Clinical narrative: sore throat; muscle weakness; fatigue; Initial information received on 20-Apr-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who experienced sore throat, muscle weakness and fatigue while receiving vaccine typhoid VI polysaccharide vaccine [Typhim VI].  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 typhoid VI polysaccharide vaccine Solution for injection strength, dose not reported lot V2A556V expiry date: 31-Oct-2024 via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious event "sore throat" (oropharyngeal pain), "muscle weakness" (muscular weakness) and fatigue (unknown latency) following the administration of typhoid VI polysaccharide vaccine.  It was reported "Patient who is working received a Typhim Vi vaccine from overseas. Label states it is imported by Sanofi. She asked on whether Typhim Vi is an inactive vaccine and states that it is an inactivated vaccine. She concurred. Caller also mentioned that she experienced sore throat, muscle weakness and fatigue after being administered of this product".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events sore throat, muscle weakness, fatigue.  At time of reporting, the outcome was Unknown for the events sore throat, muscle weakness, fatigue.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired daptacel vaccine, with no reported adverse event; Initial information received on 21-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 1 years old female patient who was administered an expired daptacel vaccine, diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination.  On 20-Apr-2023, the patient received suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection, dose number 4 at dose of 0.5 ml (lot C5828AA, Expiry date: 30-Mar-2023) via intramuscular route in Right thigh for prophylactic vaccination (immunization).  On 20-Apr-2023, patient was administered an expired daptacel vaccine(expired product administered) (same day latency) with no reported adverse event  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: a few drops dripped out between the needle and the syringe; it was like four drops that ran down the patient's arm with no reported adverse event; Initial information was received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 24 years old female patient who experienced a few drops dripped out between the needle and the syringe; it was like four drops that ran down the patient's arm with no reported adverse event after receiving rabies (hdc) vaccine [Imovax Rabies].  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 unknown dose of suspect rabies (hdc) vaccine(Powder and solvent for suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event of a few drops dripped out between the needle and the syringe; it was like four drops that ran down the patient's arm with no reported adverse event (accidental exposure to product) (unknown latency) following the administration of rabies (hdc) vaccine.  No lab data reported.  Action taken with rabies vaccine (Imovax Rabies) was not applicable.  At time of reporting, the outcome was Unknown for the event a few drops dripped out between the needle and the syringe; it was like four drops that ran down the patient's arm 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.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received a yellow fever vaccine intramuscularly instead of the recommended route of administration which is subcutaneously with no reported adverse event; Initial information was received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age/gender patient who received a yellow fever vaccine [YF-vax] intramuscularly instead of the recommended route of administration which is subcutaneously with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect yellow fever vaccine Solution for injection (dose, strength, lot number, batch number, expiration date and administration site: Unknown) via intramuscular route instead of the recommended route of administration which is subcutaneously with no reported adverse event (incorrect route of product administration) (latency: same day)  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event patient received a yellow fever vaccine intramuscularly instead of the recommended route of administration which is subcutaneously 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired diluent of the vaccine was administered to a patient with no reported adverse event; Initial information received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who experienced expired diluent of the vaccine was administered with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Apr-2023, the patient received a 0.5 ml (total) (dose 2) dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of lot UJ667ABA (diluent expiry: 07-Apr-2023) via intramuscular route in unknown administration site as immunization.  On 20-Apr-2023, the patient developed a non-serious event expired diluent of the vaccine was administered to a patient with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired diluent of the vaccine was administered to a patient 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: 12.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient received their first dose of MENQUADFI in October 2022, and then inadvertently received another dose of MENQUADFI early with no reported adverse event; the patient was supposed to receive the HPV vaccine, but she was inadvertently administered a second dose of MENQUADFI with no reported adverse event; Initial information received on 21-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 12 years old female patient who received their first dose of menquadfi in october 2022, and then inadvertently received another dose of menquadfi early and the patient was supposed to receive the hpv vaccine, but she was inadvertently administered a second dose of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On 17-Apr-2023, the patient received  suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot dose number 2 at dose of 0.25 ml (batch number: U7449AA, Expiry date: 23-Sep-2024) via intramuscular route in the left arm for prophylactic vaccination (immunization) and TB skin test (skin test)  On 17-Apr-2023 , patient received their first dose of menquadfi in october 2022, and then inadvertently received another dose of menquadfi early (incorrect dose administered) , patient was supposed to receive the hpv vaccine, but she was inadvertently administered a second dose of menquadfi (wrong product administered) (same day latency) with no reported adverse event.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for both 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: 10.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of QUADRACEL to a patient that is 10 years old (with no reported adverse event); Initial information received on 24-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 10 years old male patient who was administred  quadracel (with no reported adverse event)  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.    On 06-Apr-2023, the patient received suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection at dose of 0.5 ml (lot U756AA, Expiry date: 08-Nov-2024) (strength: unknown) via intramuscular route in the right deltoid for prophylactic vaccination (immunization).  On 06-Apr-2023 the patient was given quadracel to a patient that is 10 years old (product administered to patient of inappropriate age) (same day latency) (with no reported adverse event)  Action taken was not applicable.  At time of reporting, the outcome was 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: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently received a dose of Pentacel and VAXELIS instead of Vaxneuvance with no reported AE; Initial information received on 25-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 1 years old male patient who inadvertently received a dose of pentacel and vaxelis instead of vaxneuvance with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) for Prophylactic vaccination.  On 25-Apr-2023, the patient received suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at dose of 0.5 ml (lot UJ804AA, Expiry date: 07-Oct-2023) via intramuscular route in the right thigh for prophylactic vaccination (immunization).  On 25-Apr-2023 the patient inadvertently received a dose of pentacel and vaxelis instead of vaxneuvance (wrong product administered) (same day latency) with no reported adverse event.  Action taken was not applicable.  At time of reporting, the outcome was unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLUC3
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Rash; Hives; Slight fever; This spontaneous case was received on 14-Nov-2022 from other healthcare professional (reference number: SEQW22-05776) with additional information received on 15-Nov-2022 (being processed together) and concerned a male patient of unknown age.  The patient's concurrent condition included flu. The patient's concomitant medications were not reported.  On 11-Nov-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration: intramuscular, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 942444.  On the same date, after receiving Flucelvax Quadrivalent the patient experienced a rash and hives. The patient also had a slight fever.  On an unspecified date in Nov-2022, the patient visited a physicians office, the patient presented a rash and hives, and also had a slight fever. The physician stated that probably the patient was infected with flu at the time he received the vaccine.  Outcome of the events was unknown.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The event of rash, hives and fever are assessed as possible related to Flucelvax Quadrivalent due to plausible temporal relationship.; Sender's Comments: The event of rash, hives and fever are assessed as possible related to Flucelvax Quadrivalent due to plausible temporal relationship.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Carbuncle
Clinical narrative: carbuncle of skin one week after vaccine
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthrogram abnormal, Bone marrow oedema, Humerus fracture, Immediate post-injection reaction, Immunisation reaction
Clinical narrative: I felt pain as soon as the flu vaccine needle was inserted into my left arm, she inserted the needle too high and too deep. I immediately had range of motion issues and excruciating pain. The pain and ROM issues did not subside so a week later I returned to the work health clinic to report, they told me to see my primary care doctor so I went to urgent care. The urgent care told me I need to see an orthopedist so I returned to the work clinic and they sent me out to be evaluated at clinic. I received 19 sessions of physical therapy that had little results because they did not know how to treat my injury properly. I got an MRI that showed fraying of the infraspinatus tendon and bone marrow edema. I received a stem cell injection that my family paid for out of pocket which had 0 results. I went to another clinic and was referred to Dr. at Orthopedic clinic where I got an MRI Arthrogram that showed a labral tear. I received better physical therapy at orthopedic clinic to regain active motion in my left arm/shoulder 10 sessions total. I then underwent shoulder surgery to fix the labral tear but they determined no Labral Tear but cleaned out scar tissue and added fractures to the humoral head to promote healing. Dr. said this was from the vaccine. I am now recovering and off work for 8 weeks for now and could be more. I have been in pain every day since 11/13/2021 and it has not gotten better.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Impaired work ability, Injection site pain, Injury, Joint range of motion decreased, Magnetic resonance imaging abnormal
Clinical narrative: I felt pain as soon as the flu vaccine needle was inserted into my left arm, she inserted the needle too high and too deep. I immediately had range of motion issues and excruciating pain. The pain and ROM issues did not subside so a week later I returned to the work health clinic to report, they told me to see my primary care doctor so I went to urgent care. The urgent care told me I need to see an orthopedist so I returned to the work clinic and they sent me out to be evaluated at clinic. I received 19 sessions of physical therapy that had little results because they did not know how to treat my injury properly. I got an MRI that showed fraying of the infraspinatus tendon and bone marrow edema. I received a stem cell injection that my family paid for out of pocket which had 0 results. I went to another clinic and was referred to Dr. at Orthopedic clinic where I got an MRI Arthrogram that showed a labral tear. I received better physical therapy at orthopedic clinic to regain active motion in my left arm/shoulder 10 sessions total. I then underwent shoulder surgery to fix the labral tear but they determined no Labral Tear but cleaned out scar tissue and added fractures to the humoral head to promote healing. Dr. said this was from the vaccine. I am now recovering and off work for 8 weeks for now and could be more. I have been in pain every day since 11/13/2021 and it has not gotten better.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Product administered at inappropriate site, Scar, Shoulder operation, Stem cell therapy
Clinical narrative: I felt pain as soon as the flu vaccine needle was inserted into my left arm, she inserted the needle too high and too deep. I immediately had range of motion issues and excruciating pain. The pain and ROM issues did not subside so a week later I returned to the work health clinic to report, they told me to see my primary care doctor so I went to urgent care. The urgent care told me I need to see an orthopedist so I returned to the work clinic and they sent me out to be evaluated at clinic. I received 19 sessions of physical therapy that had little results because they did not know how to treat my injury properly. I got an MRI that showed fraying of the infraspinatus tendon and bone marrow edema. I received a stem cell injection that my family paid for out of pocket which had 0 results. I went to another clinic and was referred to Dr. at Orthopedic clinic where I got an MRI Arthrogram that showed a labral tear. I received better physical therapy at orthopedic clinic to regain active motion in my left arm/shoulder 10 sessions total. I then underwent shoulder surgery to fix the labral tear but they determined no Labral Tear but cleaned out scar tissue and added fractures to the humoral head to promote healing. Dr. said this was from the vaccine. I am now recovering and off work for 8 weeks for now and could be more. I have been in pain every day since 11/13/2021 and it has not gotten better.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Tendon disorder, Therapeutic product ineffective, Wrong technique in product usage process
Clinical narrative: I felt pain as soon as the flu vaccine needle was inserted into my left arm, she inserted the needle too high and too deep. I immediately had range of motion issues and excruciating pain. The pain and ROM issues did not subside so a week later I returned to the work health clinic to report, they told me to see my primary care doctor so I went to urgent care. The urgent care told me I need to see an orthopedist so I returned to the work clinic and they sent me out to be evaluated at clinic. I received 19 sessions of physical therapy that had little results because they did not know how to treat my injury properly. I got an MRI that showed fraying of the infraspinatus tendon and bone marrow edema. I received a stem cell injection that my family paid for out of pocket which had 0 results. I went to another clinic and was referred to Dr. at Orthopedic clinic where I got an MRI Arthrogram that showed a labral tear. I received better physical therapy at orthopedic clinic to regain active motion in my left arm/shoulder 10 sessions total. I then underwent shoulder surgery to fix the labral tear but they determined no Labral Tear but cleaned out scar tissue and added fractures to the humoral head to promote healing. Dr. said this was from the vaccine. I am now recovering and off work for 8 weeks for now and could be more. I have been in pain every day since 11/13/2021 and it has not gotten better.
Age: 37.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Hypoaesthesia, Nerve conduction studies, Pain, Pain in extremity
Clinical narrative: Lingering pain--unlike previous COVID shots or any other vaccines, which typically didn't last beyond the first day or so. The pain  radiated down my entire arm and nothing soothed it--every position I placed my arm in, hurt. There was also numbness felt throughout my arm, into my fingers, especially when my arm was in a specific position. Any normal activity (driving, cleaning, working, etc.) led to pain and numbness--I constantly had to shake the numbness out or reposition my arm.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptomatic adverse event reported; nurse reporting administration of expired PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-MAR-2023, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter once, lot #U030591, expiration date: 29-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No temperature excursions were reported. No additional adverse events were reported.
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Illness
Clinical narrative: Moderna shot got him sick; within 24 hours everything is fuzzy, and 2 years later he is still brainfogged.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Moderna shot got him sick) and FEELING ABNORMAL (within 24 hours everything is fuzzy, and 2 years later he is still brainfogged.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Moderna shot got him sick) and FEELING ABNORMAL (within 24 hours everything is fuzzy, and 2 years later he is still brainfogged.). At the time of the report, ILLNESS (Moderna shot got him sick) outcome was unknown and FEELING ABNORMAL (within 24 hours everything is fuzzy, and 2 years later he is still brainfogged.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications details were reported. It was reported that, patient took the vaccine 2 years ago. No treatment medications details were reported.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Stomach ache, nauseated, headache, mild fever, feeling tired. All of this started on 04.28.2023 and has lasted for hours.
Age: 99.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 102.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 97.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 95.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 93.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: mild arm soreness, severe myalgias, headache, chills; took naproxen 440 mg with minimal relief; just took acetaminophen 975 mg and no relief yet
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Pain, Tinnitus
Clinical narrative: After about a week after receiving the covid vaccine Moderna i had hip bursitis and a lot of pain to stand up once sitting. I never had bursitis in my life nor any other joint pain. The pain was so bad I was crying as I stood up and started walking. The pain mostly resolved about 6 months after my second vaccine shot. In addition, I have tinnitus that started shortly after my first vaccine shot. this has not resolved even after 2 years post vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: I took the Pfizer Covid-19 vaccine (March 27, 2021) and booster (April 17, 2021). I have been struggling with sever tinnitus, daily, all of the day, and I have suffered hearing loss. I'm making an appointment to see a doctor after reading possible links to the vaccine and tinnitus as that triggered my thinking and realized I never had these issue until after the vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  TRANSIENT CEREBRAL ISCHEMIA
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye swelling, Fatigue, Injection site pain, Pain, Vision blurred
Clinical narrative: Undereye swelling.  On the day of the vaccination, I only felt sore at the injection site (left arm).  The following morning, however, I awoke and noticed significant swelling in the undereye area.  I had some body aches and fatigue, but was able to run some errands and do some chores.  This morning, two days after the injection, my undereye area is still swollen, and possibly slightly more so, than yesterday.  My vision seems unaffected except possibly a very slight blurriness.  I have had no such side effect after the prior Covid vaccinations; I received all possible vaccinations including one prior bivalent booster, all by Moderna.  I plan to see my PCP today if possible. Please feel free to contact me by phone or by email if you have any questions.  Thank you.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, INIT ALLERGIC REACTION, SEQUELA
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Headache
Clinical narrative: I had terrible ringing in my ears and my whole head, postnasal drip, cough, chills, and exhaustion. I had a fever of 101. For one day I had a headache. The symptoms came and went. The ringing has not gone completely. On 09/14/2022 I got a COVID-19 test and it was positive within five seconds. I took Advil.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Tinnitus, Upper-airway cough syndrome
Clinical narrative: I had terrible ringing in my ears and my whole head, postnasal drip, cough, chills, and exhaustion. I had a fever of 101. For one day I had a headache. The symptoms came and went. The ringing has not gone completely. On 09/14/2022 I got a COVID-19 test and it was positive within five seconds. I took Advil.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Other complications following immunization, not elsewhere classified, initial encounter on 2022-04-14.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  HYPOTENSION
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 51.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site pruritus, Injection site reaction, Nerve compression, Pain in extremity, Paraesthesia
Clinical narrative: On 10/27/2022, I noticed itchiness at the injection site and redness. It was a red rash. I took 200 mg ibuprofen for a couple of days. In December, I noticed tingling in my fingertips and pain down my forearm. I went to my primary doctor for my annual visit in February of 2023. She said it sounded like nerve entrapment, so I started physical therapy on March 8, 2023.
Age: 51.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Rash erythematous
Clinical narrative: On 10/27/2022, I noticed itchiness at the injection site and redness. It was a red rash. I took 200 mg ibuprofen for a couple of days. In December, I noticed tingling in my fingertips and pain down my forearm. I went to my primary doctor for my annual visit in February of 2023. She said it sounded like nerve entrapment, so I started physical therapy on March 8, 2023.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Pain
Clinical narrative: On 19APR2023 in the evening I had chills and fever that never reached over 99.4 but very bad chills and aches. Fatigue hit me hard that night. I slept well and the next morning I felt better and went to a funeral as an Usher which I was committed to do I stayed away from people and hugged nobody. I slept eleven hours total that Thursday fatigue was gone by Friday but coughing started and remained terrible through 24APR2023 but has been getting better since then. I am still testing positive as of this date 28APR2023.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On 19APR2023 in the evening I had chills and fever that never reached over 99.4 but very bad chills and aches. Fatigue hit me hard that night. I slept well and the next morning I felt better and went to a funeral as an Usher which I was committed to do I stayed away from people and hugged nobody. I slept eleven hours total that Thursday fatigue was gone by Friday but coughing started and remained terrible through 24APR2023 but has been getting better since then. I am still testing positive as of this date 28APR2023.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Cough, Fall, Joint injury, Oropharyngeal pain
Clinical narrative: I started having a severe sore throat that lasted for a couple days.  I started then to have a cough that lasted for about 3 in half weeks.  I did take a home COVID test and it was negative.  The sore throat went away.  The cough did not go away. I contacted my PCP and had a telehealth visit on December 7th.  She prescribed a steroid.  After a 7-day course of the steroid the cough was better, but it still took about a week to full go away.  On December 21, 2022, I had another health event.  I was jumping over some lawn equipment, and I caught my foot on the equipment and landed on my hands and knees.  I immediately had knee pain.  I put ice on it and took a extra medicine of my anti-inflammatory medication.  My knee still hurt with walking and everything.  On February 6th I went to the orthopedic doctor for their opinion due to not feeling any better after several weeks.  They discovered I had a broken patella.  She told me to keep doing what I had been doing.  She said it would heal on it own.  On March 28th and my patella was almost completely healed.  Today I very minimal pain in my knee cap.