chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: U
Vaccine: HIBV, UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: staff member gave the liquid portion of PENTACEL to a 4 month old with no reported AE; Initial information received on 16-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old patient of unknown gender to whom staff member gave the liquid portion of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine [Pentacle] portion and not HIB (PRP/T) Vaccine[ACT-HIB] portion 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 a staff member gave DTAP/IPV portion of the vaccine (lot - U7130AA) (strength, dose, route, formulation, expiry date not reported) via unknown route at  unknown administration site for Immunization and not the ACTHIB portion to a 4 month old with no reported adverse event (Product preparation error) (unknown latency).  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: 11.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Incorrect dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: one of them was given bexsero instead of menquadfi,with no reported adverse event; inappropriate dose of vaccine administered with no reportedadverse event; Initial information received on 16-Nov-2022 regarding an unsolicited valid non serious case received from a other health professional.  This case involves a 11 years old and unknown gender patient who had given bexsero instead of(Meningococcal)A-C-Y-W135 (T CONJ) vaccine) MENQUAFDI with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a  dose of Meningococcal)A-C-Y-W135 (T CONJ) vaccine, Solution for injection(lot no- U7576AB, expiry date-28-Feb-2025 ) (with unknown , frequency, strength, dose, route and administration site) for prophylactic vaccination(immunization).  On an unknown date, Patient had given bexsero instead of (Meningococcal)A-C-Y-W135 (T CONJ) vaccine menquadfi(latency:same day),with no reported adverse event (wrong product administered) and Inappropriate dose of vaccine administered(Incorrect dose administered).  It was also reported that nurse said they have two (2) patients, both 11 years old.As per nurse they are not sure at this time which of the two patients were given Bexsero instead of MENQUAFI and needs to look into it.   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 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: 71.0
Sex: F
Vaccine: FLUR3
Symptoms: Depressed mood, Erythema, Feeling hot, Injection site pain, Pruritus
Clinical narrative: needle hit her arm it was painful;; arm has become itchy; arm has become red; arm has become hot; she was very upset about a reaction that occurred while she was on the product.; Initial information received on 18-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer.  This case is linked to case 2022SA480609(CLUSTER).  This case involves a 71 years old female patient who experienced pain in arm during injecting  vaccine,arm has become itchy, arm has become red, arm has become hot and she was  upset about a reaction that occurred while she was on the product. after receiving  influenza quadrivalent recombinant vaccine [flublok].  The patient's past vaccination(s) included fluzone high-dose quadrivalent for immunization.  patient had history of Cancer (NOS).  The patient's past medical treatment and family history were not provided.  On 15-Nov-2022, the patient received a dose of 0.5 ml(milligram) influenza quadrivalent recombinant vaccine (with unknown formulation, strength, route, lot number and expiration) in the armNOS. for immunization.  On 15-Nov-2022 the patient developed needle hit her arm it was painful;(injection site pain)arm has become itchy (pruritus)  arm has become red (erythema)arm has become hot (feeling hot)she was very upset about a reaction that occurred while she was on the product(depressed mood) following (latency: same day)the administration of influenza quadrivalent recombinant vaccine.  It was also reported that she known that she would have a reaction like this to the product she would have continued using the Fluzone HD QIV and dealt with the arm swelling. She is frustrated and concerned as well about potentially not receiving enough antigen content. She states she read online from the CDC that the flu products all provide the same coverage, but feels she was misled. Apparently there was a remark from a 2020 article that the FLUZONE HD has four time she antigen of the FLUBLOK and FLUAD, and she doesn't understand why that was written. Because of this publication she feels like she was misled to receiving the wrong product due to the difference in antigen content and believes she may have to be revaccinated. Agent went over multiple vaccines per season standard as well as the antigen strain per dose for all three Sanofi flu products.  No lab data were reported.  Action taken: not applicable.  The patient was treated with paracetamol,  diclofenac and diphenhydramine hydrochloride for all treatments.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events; Sender's Comments:  01372459:
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event, Product preparation error
Clinical narrative: was administered a dose of ACTHIB with an expired diluent with no reported adverse events; administered a dose of ACTHIB with an expired diluent with no reported adverse event; Initial information received on 21-Nov-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 1 years old male patient who was administered a dose of ACTHIB with an expired 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.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE)and FLUORESCEIN SODIUM  for Prophylactic vaccination.  On 19-Nov-2022, the patient received a Series 4 of suspect HIB (PRP/T) VACCINE(Dose- 0.5 mL, Frequency-Total, Lot Number- UJ60RAAA (HIB), U7172AB (DILUENT) Route- intramuscular route in the left deltoid for Immunization, Expiry date-  23MAR2023 (HIB), 29OCT2022 (DILUENT)(strength-standard) (form : unknown).  On 19-Nov-2022 the patient developed a non-serious events was administered a dose of ACTHIB with an expired diluent with no reported adverse events (product preparation error),(expired product administered) following the administration of HIB (PRP/T) VACCINE.(latency-same day).  Action taken : Not applicable.  At time of reporting, the outcome was Unknown for all 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: 16.0
Sex: U
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: flublok was administered to a patient under the age of 18/ was 16 years (with no reported adverse event); Initial information received on 21-Nov-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 16 years old and unknown gender patient to whom  flublok was administered  (with no reported adverse event) after receiving influenza quadrivalent recombinant vaccine[flublok].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On 06-Nov-2022, the patient received a 1 dosage form  of influenza quadrivalent recombinant vaccine (lot QFAA2238, expiration date:30-Jun-2023) (with unknown formulation, frequency, strength, route and  in unknown administration site) for influenza.   On 06-Nov-2022, 16 years old patient who received vaccine which was indicated for 18 and older people( Drug use in unapproved age group ) (with no reported adverse event) (product use issue) (latency: same day)following the administration of influenza quadrivalent recombinant vaccine  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.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of FLUZONE HD QIV with no adverse event; Initial information received on 21-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient who received an expired dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Nov-2022, the patient received an unknown dose of expired suspect influenza quadrival A-B high dose hv vaccine (lot: UJ764AA; expiry date: 30-Jun-2022) (strength, form unknown) via unknown route in unknown administration site for prophylactic vaccination with no adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event received an expired dose of fluzone hd qiv with no 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: 60.0
Sex: M
Vaccine: YF
Symptoms: Muscular weakness
Clinical narrative: he is experiencing weakness of the arm; Initial information received on 22-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 60 years old male patient who experienced weakness of the arm after receiving vaccine yellow fever vaccine -  [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A vaccine, Hepatitis B vaccine and influenza vaccine, all for Immunization.  On 19-Nov-2022, the patient received 0.5 milliliter (ml) dose of suspect yellow fever vaccine -  solution for injection with standard strength (lot: UJ683AA, expiry date: 15-Nov-2023) via subcutaneous route in the left arm for Immunization.  On an unknown date the patient experienced weakness of the arm (muscular weakness) (unknown latency).  It was reported that "he is experiencing weakness of the arm where the vaccine was administered. Upon further confirmation, it is not pain but weakness, "locking up and feels dead" on certain range of motion".  Action taken: not applicable.  No corrective treatment was received for the event.  Outcome: Unknown.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain migrated to the shoulder and now I feel a lot of pain in that area; Can't even get it lift my arm more than a certain point and therefore have low mobility in my shoulder; Arm started to hurt in the injection area; This spontaneous case was received on 14-Nov-2022 from other non-healthcare professional(consumer) (reference number SEQW22-0579) with additional information received on 16-Nov-2022 (being processed together) and concerned a 64-years-old, female patient.  The patient's concurrent condition included anxiety.The patient's concomitant medications included Cymbalta (duloxetine hydrochloride), mirtazapine and clonazepam, all used for unrepotrted indication.   On 29-Sep-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: 0,5 ml, route of administration: intramuscular and anatomical location: not reported), for influenza prophylaxis. The batch number was AS3614B and expiry date: 30-Apr-2023.   On the same date, after receiving Afluria Quadrivalent, the patient's arm started to hurt in the injection area. The pain migrated to the shoulder and the patient felt a lot of pain in that area. The patient didn't lift her arm more than a certain point and therefore have low mobility in shoulder.   On unspecified date, the patient started treatment with prednisolone and Celebrex (celecoxib).  On unspecified date, the patient stopped treatment with prednisolone. The patient was planning to make X-ray and if nothing appears to do a Magnetic resonance imaging (MRI).  At the time of initial report on 14-Nov-2022, the patient had not recovered from all events. The patient still had the pain in the shoulder and arm and was not able to lift her arm.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: The events of shoulder pain, injected limb mobility decreased and vaccination site pain are assessed as possibly related to Afluria Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of shoulder pain, injected limb mobility decreased and vaccination site pain are assessed as possibly related to Afluria Quadrivalent due to plausible temporal relationship.
Sex: F
Vaccine: FLUC3
Symptoms: Influenza, Influenza A virus test positive, Malaise
Clinical narrative: She has tested positive for influenza A; This spontaneous case was received on 14-Nov-2022 from physician (reference number: SEQW22-05790) with additional information received on 15-Nov-2022 (being processed together) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in 2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in 2022, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient become sick and tested positive for influenza A.   The outcome of the event 'influenza A virus infection' was not reported.   The reporter did not provide a causality assessment.   The event of 'influenza A virus infection' was considered medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A female patient of unreported age was vaccinated with Flucelvax Quadrivalent. An unknown amount of time after vaccination, the patient become sick and tested positive for influenza A. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is unassessable, due to lack of information provided and unclear chronology.; Sender's Comments: A female patient of unreported age was vaccinated with Flucelvax Quadrivalent. An unknown amount of time after vaccination, the patient become sick and tested positive for influenza A. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is unassessable, due to lack of information provided and unclear chronology.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Bell's palsy, Condition aggravated
Clinical narrative: Patient with bells palsey history experienced flare up after receiving Fluad vaccine; Patient with bells palsey history experienced flare up after receiving Fluad vaccine; This spontaneous case was received on 16-Nov-2022 from a pharmacist (reference number: SEQW22-05861) and concerned a 66-year-old, male patient.  The patient's current condition included Bell's palsy. The patient's concomitant medication included lisinopril used for an unreported indication.  On 10-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration: intramuscular, anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in Sep-2022, a couple of days after receiving Fluad Quadrivalent, the patient experienced flare up of Bell's palsy. The patient did not receive any treatment.   At the time of initial reporting on 16-Nov-2022, the patient had not recovered from the event.   The reporter did not provide causality assessment.  The event of Bell's palsy and 'condition aggravated' was considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 66-year-old patient was vaccinated with Fluad Quadrivalent. A couple of days after receiving Fluad Quadrivalent, the patient experienced flare up of Bell's palsy. The patient did not receive any treatment. The patient's current condition included Bell's palsy. No more relevant information was provided. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A 66-year-old patient was vaccinated with Fluad Quadrivalent. A couple of days after receiving Fluad Quadrivalent, the patient experienced flare up of Bell's palsy. The patient did not receive any treatment. The patient's current condition included Bell's palsy. No more relevant information was provided. Causal role of the suspect vaccine is assessed as possibly related.
Sex: M
Vaccine: COVID19
Symptoms: Death, Illness
Clinical narrative: DIED; GOT REAL SICK; This spontaneous report received from a consumer via social media (J&J corporate) via a company representative concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient also received booster of covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced real sickness after his first booster and died (Dose number in series 2). The date of death and cause of death was not reported. It was unknown if an autopsy was performed or not. The reporter stated that "My Son in Laws Dad got real sick after his first booster and died. No wonder they call it the death jab." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of got real sick was not reported. This report was serious (Death). This case, from the same reporter is linked to 20221147290.; Sender's Comments: V0: 20221149115- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD; This spontaneous report received from a consumer (patient's son/daughter) via a company representative via social media (J and J Corporate) concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: mastectomy, chemotherapy, radiation, and cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown ) dose was not reported, 01 total, administered on 12-MAY-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 17-MAY-2021, the patient died from unknown cause of death. It was unknown whether autopsy performed. Reporter reported that, "J&J killed my mom with their vaccine. She went through A mastectomy, chemo and radiation during COVID. The day she was cleared of cancer 5/12/21 (my birthday), she got vaccinated so she could fly back home with me but she was dead 5 days later. Thanks J and J". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221149992- dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the site of injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness in the site of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A, 048A21A, 014F21A and 056A22A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine) and Drug allergy (Vicodin).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the site of injection). On 06-May-2022, VACCINATION SITE PAIN (Soreness in the site of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was not under any concomitant or regular medication.  Patient did not have any medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not have any COVID positive test or diagnosis.  Patient only felt soreness in the site of injection during 1 day after each vaccine i.e. on 12 Feb 2021, 12 Mar 2021, 17 Nov 2021 and 06 May 2022.  No treatment medication was provided.   This case was linked to MOD-2022-676047 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site erythema, Vaccination site mass
Clinical narrative: Felt far worse the next day; Arm had a big raised red lump where I got the shot; Arm had a big raised red lump where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt far worse the next day), VACCINATION SITE MASS (Arm had a big raised red lump where I got the shot) and VACCINATION SITE ERYTHEMA (Arm had a big raised red lump where I got the shot) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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 FEELING ABNORMAL (Felt far worse the next day), VACCINATION SITE MASS (Arm had a big raised red lump where I got the shot) and VACCINATION SITE ERYTHEMA (Arm had a big raised red lump where I got the shot). At the time of the report, FEELING ABNORMAL (Felt far worse the next day), VACCINATION SITE MASS (Arm had a big raised red lump where I got the shot) and VACCINATION SITE ERYTHEMA (Arm had a big raised red lump where I got the shot) outcome was unknown.            No Concomitant medication were provided. Patient felt far worse the next day than the patient did with any of the other Moderna COVID shots. No Treatment Medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2022: Live Follow-up received with No New Information
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A monovalent vaccine was administered instead of a bivalent booster dose to one patient; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (A monovalent vaccine was administered instead of a bivalent booster dose to one patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (A monovalent vaccine was administered instead of a bivalent booster dose to one patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A monovalent vaccine was administered instead of a bivalent booster dose to one patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A monovalent vaccine was administered instead of a bivalent booster dose to one patient).    No concomitant medication information was provided. No treatment medication was provided.   Reporter did not allow further contact
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Sick as hell; Initial information received on 18-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.   This case involves a patient of unknown age and unknown gender who was sick as hell after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past 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, route, formulation, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date, the patient became sick as hell (illness) (latency: unknown) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (Sick as heck).  At time of reporting, the outcome was Unknown for the event sick as heck.
Age: 21.0
Sex: M
Vaccine: UNK
Symptoms: Chest discomfort, Throat tightness, Urticaria
Clinical narrative: An hour after receiving the shot, I began to break out into hives. About four hours later, I went to the ER because they were getting much worse and I had tightness in the chest and throat. They began to subside on their own after about 12 hours.
Age: 44.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hyperhidrosis, Hypotension, Nausea, Oxygen saturation decreased, Pallor
Clinical narrative: Pallor, profuse sweating, nausea, low blood pressure, low oxygen saturation Unsure of duration Symptoms occurred then color returned to skin, sweating and nausea stopped, blood pressure and oxygen saturation returned to normal levels.
Age: 44.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Cold sweat, Flushing, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: Pallor, profuse sweating, nausea, low blood pressure, low oxygen saturation Unsure of duration Symptoms occurred then color returned to skin, sweating and nausea stopped, blood pressure and oxygen saturation returned to normal levels.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Nausea, Pyrexia, Tremor
Clinical narrative: Systemic: Chills-Medium, Systemic: Fever-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patuent began to feel nauseaus and began shaking several hours after recieving vaccine.  He vomited several times and spiked a fever of 104 degrees.  He took ibuprofen for symptoms - he did not seek medical care.  Symptoms began to subside after 12 pm.  He still had a fever but that went away by morning.  He continued to feel weak and nauseaus for a couple of days.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Systemic: Chills-Medium, Systemic: Fever-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patuent began to feel nauseaus and began shaking several hours after recieving vaccine.  He vomited several times and spiked a fever of 104 degrees.  He took ibuprofen for symptoms - he did not seek medical care.  Symptoms began to subside after 12 pm.  He still had a fever but that went away by morning.  He continued to feel weak and nauseaus for a couple of days.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: 2 shots were administered..moderna bivalent and flucelvax, pt started to fell dizzy and started to have skin rash, emt were contacted immediately, Emt advised not to give any food,drinks or medications, emt arrived checked vitals and vitals were ok per emt, paretns were given option to for the pt to go to hospital by ambulance or with them, parents decided to go on their on their own.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: Error: Diluent Administered Instead of Vaccine-
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Confusional state, Dizziness, Dyspnoea, Flushing
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: we called 911 for pt after he had all these symptoms.he laid down on the floor and we elevated his legs.it took hom up to 25 mon to feel bettwe and go home.he did not go urgent care after that .he went home.
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Hypotension, Nausea, Tremor, Visual impairment
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: we called 911 for pt after he had all these symptoms.he laid down on the floor and we elevated his legs.it took hom up to 25 mon to feel bettwe and go home.he did not go urgent care after that .he went home.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Injection site pain, Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Vomiting-Mild, Additional Details: pt parent reported child was feeling faint and dizzy, and threw up in bathroom after drinking gatorade. paramedics were called and cleared child to go home.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: Patient received her 1st Moderna booster on 11/19. 1 min after the shot, she fainted and lost her consciousness. RPh ran to get Epipen and instructed the tech to call 911. She regained her consciousness after 10-15 sec of fainting and was laid on the floor to monitor breathing. Mom said patient has history of faiting/passing out after getting shot but had not informed RPh when being asked/before administration. EMS came to take her vitals then sent pt home with her mom
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: The patient came to the pharmacy to receive a flu and HPV vaccine. After receiveing her HPV vaccine, patient complained of lightheadedness. I gave her a bottle of water and sat with her in the vaccine room. After about 30 seconds, patient fainted. She quickly regained consciousness and I helped her to the floor to lay down and recover. We checked her blood pressure and listened to her heart. We also gave her a glucose tablet incase her blood sugar was low since patient stated she had not eaten.
Age: 33.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Head injury, Headache, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Additional Details: During the 15 minute period after the vaccine patient was sitting down and felt nausea and diziness. He leaned forward to rest his head on his knees. This is when he fainted and fell forward hitting his head on the ground. He woke up just about 5-10 seconds later and his wife called EMS. Patient felt fine at that point and wanted to go home but wife wanted to be safe and wait for first responders to have him check out. First repsonders arrived and determined the patient was good to go home
Age: 33.0
Sex: M
Vaccine: FLUC4
Symptoms: Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Additional Details: During the 15 minute period after the vaccine patient was sitting down and felt nausea and diziness. He leaned forward to rest his head on his knees. This is when he fainted and fell forward hitting his head on the ground. He woke up just about 5-10 seconds later and his wife called EMS. Patient felt fine at that point and wanted to go home but wife wanted to be safe and wait for first responders to have him check out. First repsonders arrived and determined the patient was good to go home
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered, No adverse event, Product administration error
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose normal, Dizziness, Somnolence
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient was giving Covid vaccine bivalent 1st booster. Patient was asked to wait 15 minutes. During this time, patient started feeling drowsy/lightheaded. Patient lie down on bed, feet up, vitals checked, blood sugar checked, which were all normal. NP gave patient Gatorade to drink. Purse lip breathing and smelling of alchol swab to patient directed. Patient started to feel better and was able to go home with husband after event. she denies SOB or chest pain.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Hyperhidrosis, Influenza virus test negative, Mobility decreased, Nausea
Clinical narrative: 10/7/2022 The night after my vaccine I had sweats, headache, nausea and vomiting into the next morning. I was in bed for three days with these symptoms. I called the doctor on 10/8/2022 and my COVID and Flu tests were both negative. I was told to drink a lot of fluids, rest and TYLENOL for headaches. I felt better by 11/13/2022.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: 10/7/2022 The night after my vaccine I had sweats, headache, nausea and vomiting into the next morning. I was in bed for three days with these symptoms. I called the doctor on 10/8/2022 and my COVID and Flu tests were both negative. I was told to drink a lot of fluids, rest and TYLENOL for headaches. I felt better by 11/13/2022.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Mobility decreased, Pain in extremity, Rash
Clinical narrative: Patient describe strong pain in arm making it very difficult to lift the arm for a couple of days. She also developed a rash very close to the elbow area that spread to the anterior part of the arm but not close at all to the the administration site. When she reported these adverse reactions; the pain had subsided enough for her to be able to lift her arm again  but the rash was still visible. She mentioned just using cold and hot compresses to relieve the pain and swelling.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle twitching
Clinical narrative: muscle twitches
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: I had headache, sore throat, feeling fatigue; I wasn't sure if it was a fibromyalgia flare-up, but I realized my significant other was recovering from COVID-19 so I knew I probably had just contracted it from him. My doctor told me I didn't need to take a test to confirm since my partner had already taken an at-home test and PCR tests, which both came back positive. I'm disabled so I don't work, and having fibromyalgia only worsened the pain of my symptoms. I was in so much physical pain. I took MOTRIN, TYLENOL, and MUCINEX to help subside my symptoms.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer bivalent was administered instead of the first dose pfizer vaccine
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Antibody test negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody positive, Biopsy kidney abnormal, Blood albumin decreased
Clinical narrative: New onset nephrotic syndrome. Symptoms of lower extremity edema started approx 7-10 days after vaccine. Followed by new onset hypertension, proteinuria and hypoalbuminemia, noted about 14 days after vaccine. Required renal biopsy (completed 11/22/22), which demonstrated active focal segmental glomerulosclerosis (FSGS).
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Double stranded DNA antibody, Focal segmental glomerulosclerosis, Haematuria, Hypertension, Hypoalbuminaemia
Clinical narrative: New onset nephrotic syndrome. Symptoms of lower extremity edema started approx 7-10 days after vaccine. Followed by new onset hypertension, proteinuria and hypoalbuminemia, noted about 14 days after vaccine. Required renal biopsy (completed 11/22/22), which demonstrated active focal segmental glomerulosclerosis (FSGS).
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Light chain analysis abnormal, Nephrotic syndrome, Oedema peripheral, Proteinuria, Red blood cell sedimentation rate increased
Clinical narrative: New onset nephrotic syndrome. Symptoms of lower extremity edema started approx 7-10 days after vaccine. Followed by new onset hypertension, proteinuria and hypoalbuminemia, noted about 14 days after vaccine. Required renal biopsy (completed 11/22/22), which demonstrated active focal segmental glomerulosclerosis (FSGS).
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urine protein/creatinine ratio increased
Clinical narrative: New onset nephrotic syndrome. Symptoms of lower extremity edema started approx 7-10 days after vaccine. Followed by new onset hypertension, proteinuria and hypoalbuminemia, noted about 14 days after vaccine. Required renal biopsy (completed 11/22/22), which demonstrated active focal segmental glomerulosclerosis (FSGS).
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Nausea, Pyrexia, Vaccine breakthrough infection
Clinical narrative: Participant had a breakthrough case of Covid had fever, chills and nausea.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vision blurred
Clinical narrative: Within a month of this vaccine my vision got kind of blurry within a few weeks. It would clear up but then it would go back to being blurry. It's a steady on/off routine of when it comes and goes. I called my doctor told me to drink plenty of fluids and take TYLENOL if I develop a fever.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo, Vomiting
Clinical narrative: I woke up and the room was spinning. I had help getting out of bed. I started vomiting severely. This lasted for about 3 days. I went to the doctor and was prescribed an anti-dizzy and anti-nausea medicine called meclizine. It took about 3 days for the symptoms to subside. I was good until I woke up with it again on November 18, 2022. This happened after I had dose 4 on 10/13/2022 Moderna Bivalent left arm GH9702). This time it lasted much longer. I was not able to go into the doctor, so we did over the phone consult. She prescribed the medication again. I'm on day 7 and I am still having to take them. It has improved but there is still some dizziness when I wake up in the morning.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I had a holiday with my family and friends without any problems. After a camping trip with my family in July 2022, I tested positive for COVID-19 on 07/30/2022. I contacted my doctor's office in an email and in database. I had difficulty breathing and congestion. I did not receive a prescription, but I took over the counter medication.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: I had a terrible sore throat, fever, body aches and pains, and a very bad, dry cough that wouldn't go away. I had digestive issues, I vomited for two days. I called and told my doctor about my symptoms. I took several at-home COVID-19 tests which all came back positive. My doctor prescribed me PAXLOVID half-dose. It took a couple of days, but it helped reduce the symptoms. At this moment, it's been over two weeks and I'm starting to feel better. I finally got a negative COVID-19 test as of two days ago (11/23/2022).
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: I had a terrible sore throat, fever, body aches and pains, and a very bad, dry cough that wouldn't go away. I had digestive issues, I vomited for two days. I called and told my doctor about my symptoms. I took several at-home COVID-19 tests which all came back positive. My doctor prescribed me PAXLOVID half-dose. It took a couple of days, but it helped reduce the symptoms. At this moment, it's been over two weeks and I'm starting to feel better. I finally got a negative COVID-19 test as of two days ago (11/23/2022).
Age: 1.08
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID infection