chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administration error because he received the Moderna bivalent booster dose instead of the first dose of primary series; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (administration error because he received the Moderna bivalent booster dose instead of the first dose of primary series) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first 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 WRONG PRODUCT ADMINISTERED (administration error because he received the Moderna bivalent booster dose instead of the first dose of primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administration error because he received the Moderna bivalent booster dose instead of the first dose of primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.       No concomitant medications was reported. It was reported that patient should go back to receive the first dose of primary series but mentioned there are some risks when it happens. No treatment drug details was reported.   Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Dysphonia
Clinical narrative: Patient woke up with goofy voice and can hardly talk; Patient woke up with goofy voice and can hardly talk; This spontaneous case was reported by a patient and describes the occurrence of DYSPHONIA (Patient woke up with goofy voice and can hardly talk) and DYSARTHRIA (Patient woke up with goofy voice and can hardly talk) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced DYSPHONIA (Patient woke up with goofy voice and can hardly talk) and DYSARTHRIA (Patient woke up with goofy voice and can hardly talk). At the time of the report, DYSPHONIA (Patient woke up with goofy voice and can hardly talk) and DYSARTHRIA (Patient woke up with goofy voice and can hardly talk) outcome was unknown.            No concomitant medication information was provided.  Patient had previous doses of Moderna covid-19 vaccine -1st dose on 02-Feb-2021 (lot 007M20A and expiry date unknown), 2nd dose on 02-Mar-2021 (lot 010A21A and expiry date unknown), first monovalent booster dose on 16-Nov-2021 (lot 058F21A and expiry date unknown) and second monovalent booster dose on 16-Jun-2022 (lot 059A22A and expiry date unknown).  No treatment medication was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: severe tinnitus; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (severe tinnitus) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067f21a, 017b21a and 027a21a) for COVID-19 vaccination.     Patient not had COVID + test or diagnosis. No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (severe tinnitus). At the time of the report, TINNITUS (severe tinnitus) had not resolved.            It was reported that vaccination about 2-3 weeks after the first booster patient started to experience severe tinnitus. No similar event was experienced by the patient in the past. The patient symptoms had worsened. No treatment medication details was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling a little bad after the first primary dose; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feeling a little bad after the first primary dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00J20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Drug allergy (allergic to Sulfa).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling a little bad after the first primary dose). On 15-Jan-2021, FEELING ABNORMAL (Feeling a little bad after the first primary dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-667374 (Patient Link).
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Appetite disorder, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: being lightheaded; not feeling well, not feeling too good; having chills; being weak, being exhaustion; Feeling Funny; hives; having a change in appetite; having severe daily headaches; body aches, having pain in the jaw; suspecting a really bad infection; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 69-year-old female patient who experienced being lightheaded, not feeling well, not feeling too good, having chills, being weak, being exhaustion, feeling funny, hives, having a change in appetite, having severe daily headaches, body aches, having pain in the jaw, suspecting a really bad infection while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT).   The patient's past medical history included CSF leakage and Bronchitis. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concurrent condition includes ongoing Sinus disorder.  This case is linked to cases 2022SA447408 and 2022SA445722.    On 11-Oct-2022, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via intramuscular route in the left arm.  On 11-Oct-2022, few hours after vaccination in evening, the patient developed a non-serious being lightheaded (dizziness), not feeling well, not feeling too good (malaise), having chills (chills), being weak, being exhaustion (fatigue), feeling funny (feeling abnormal), hives (urticaria), having a change in appetite (appetite disorder), having severe daily headaches (headache) and body ache, having pain in the jaw (pain). After 5 days of vaccination, dentist due to the pain in the jaw and the daily headaches, that the Keflex was prescribed due to suspecting a bad infection (infection) at onset Oct-2022, latency unknown  Action taken: Not applicable.  Corrective treatment: treated with keflex for Infection, Headache and Pain.  At time of reporting, the outcome was Not Recovered for all events.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Headache, Infection, Malaise, Pain
Clinical narrative: being lightheaded; not feeling well, not feeling too good; having chills; being weak, being exhaustion; Feeling Funny; hives; having a change in appetite; having severe daily headaches; body aches, having pain in the jaw; suspecting a really bad infection; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 69-year-old female patient who experienced being lightheaded, not feeling well, not feeling too good, having chills, being weak, being exhaustion, feeling funny, hives, having a change in appetite, having severe daily headaches, body aches, having pain in the jaw, suspecting a really bad infection while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT).   The patient's past medical history included CSF leakage and Bronchitis. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concurrent condition includes ongoing Sinus disorder.  This case is linked to cases 2022SA447408 and 2022SA445722.    On 11-Oct-2022, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via intramuscular route in the left arm.  On 11-Oct-2022, few hours after vaccination in evening, the patient developed a non-serious being lightheaded (dizziness), not feeling well, not feeling too good (malaise), having chills (chills), being weak, being exhaustion (fatigue), feeling funny (feeling abnormal), hives (urticaria), having a change in appetite (appetite disorder), having severe daily headaches (headache) and body ache, having pain in the jaw (pain). After 5 days of vaccination, dentist due to the pain in the jaw and the daily headaches, that the Keflex was prescribed due to suspecting a bad infection (infection) at onset Oct-2022, latency unknown  Action taken: Not applicable.  Corrective treatment: treated with keflex for Infection, Headache and Pain.  At time of reporting, the outcome was Not Recovered for all events.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in jaw, Urticaria
Clinical narrative: being lightheaded; not feeling well, not feeling too good; having chills; being weak, being exhaustion; Feeling Funny; hives; having a change in appetite; having severe daily headaches; body aches, having pain in the jaw; suspecting a really bad infection; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 69-year-old female patient who experienced being lightheaded, not feeling well, not feeling too good, having chills, being weak, being exhaustion, feeling funny, hives, having a change in appetite, having severe daily headaches, body aches, having pain in the jaw, suspecting a really bad infection while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT).   The patient's past medical history included CSF leakage and Bronchitis. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concurrent condition includes ongoing Sinus disorder.  This case is linked to cases 2022SA447408 and 2022SA445722.    On 11-Oct-2022, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via intramuscular route in the left arm.  On 11-Oct-2022, few hours after vaccination in evening, the patient developed a non-serious being lightheaded (dizziness), not feeling well, not feeling too good (malaise), having chills (chills), being weak, being exhaustion (fatigue), feeling funny (feeling abnormal), hives (urticaria), having a change in appetite (appetite disorder), having severe daily headaches (headache) and body ache, having pain in the jaw (pain). After 5 days of vaccination, dentist due to the pain in the jaw and the daily headaches, that the Keflex was prescribed due to suspecting a bad infection (infection) at onset Oct-2022, latency unknown  Action taken: Not applicable.  Corrective treatment: treated with keflex for Infection, Headache and Pain.  At time of reporting, the outcome was Not Recovered for all events.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Feeling abnormal, Headache
Clinical narrative: having headaches; still-- bundled in a blanket, feeling punky; feeling funny; Initial information received on 25-Oct-2022 regarding an unsolicited validnon-serious case from a consumer/non-hcp.  This case is linked to case 2022SA447771(CLUSTER).  This case involves a 70 years old male patient who experienced having headaches, still-- bundled in a blanket, feeling punky and feeling funny while receiving vaccine influenza vaccine (quadrivalent).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 11-Oct-2022, the patient received suspect influenza vaccine (quadrivalent) produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination(immunisation).  On an unknown date the patient developed a non-serious having headaches (headache), still-- bundled in a blanket, feeling punky (malaise), feeling funny (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Not Recovered / Not Resolved for all the events.
Age: 9.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone hd qiv was accidentally given to a 9 year old with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old and unknown gender patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was accidentally given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (dose, strength, formulation, and lot number: unknown) via unknown route in unknown administration site for prophylactic vaccination at inappropriate age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered, Injection site discharge, Injection site haemorrhage
Clinical narrative: Some of the vaccine came out of the injection site after administration/she noticed the fluid coming out of the injection site, which was followed by blood; Some of the vaccine came out of the injection site after administration/she noticed the fluid coming out of the injection site; This spontaneous case was received on 18-Oct-2022 from Communications (reference number: SEQW22-04698), reported by other healthcare professional and concerned a 65-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 18-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: not reported, route of administration: intramuscular, anatomical location: reported as 'right deltoid', and indication: influenza prophylaxis). The batch number was not reported. During administration of the Fluad Quadrivalent, the patient's arm was tense and firm. When pharmacist delivered the dose and removed the needle, she noticed the fluid coming out of the injection site, which was followed by blood (Explicitly coded as 'Incorrect dose administered'). Additionally, the pharmacist confirmed that there was no issue with the pre-filled syringe.  The outcome of the event of 'vaccination site bleeding' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 65-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. As reported, when pharmacist delivered the dose and removed the needle, fluid was coming out of the injection site, which was followed by blood (Explicitly coded as 'Incorrect dose administered'). Causality for vaccination site haemorrhage is assessed as possibly related. Causality for incorrect dose administered is assessed as not related based on company specific guidelines.; Sender's Comments: A 65-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. As reported, when pharmacist delivered the dose and removed the needle, fluid was coming out of the injection site, which was followed by blood (Explicitly coded as 'Incorrect dose administered'). Causality for vaccination site haemorrhage is assessed as possibly related. Causality for incorrect dose administered is assessed as not related based on company specific guidelines.
Age: 51.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Arthralgia, Eructation, Headache
Clinical narrative: Influenza and Shingles vaccines.   Severa epigastric pain, bloating, belching, nausea continuing for 3 days (ongoing) 24 hours significant malaise, headache and severe muscle and joint pain
Age: 51.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: Influenza and Shingles vaccines.   Severa epigastric pain, bloating, belching, nausea continuing for 3 days (ongoing) 24 hours significant malaise, headache and severe muscle and joint pain
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise, Tremor
Clinical narrative: headache, dizziness,trebling,malaise
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received dose 1 or Shingrix on 01/23/2020. Patient is now requesting second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: The patient was now requesting for second dose. The consent to follow-up was granted. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case has been linked to the case US2020049336 reported by the same reporter.; Sender's Comments:  US-GSK-US2020049336:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 shingles vaccinations 7 months apart; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment:  The patient reported that he/she received both the Shingles vaccine 7 months apart. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received dose 14 days past expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 13th October 2022) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: The clinic manager reported that the patient received a dose of Havrix 14 days past the expiration date.  The clinic manager reported the expiration date for the dose given was 13 Oct 2022.  The reporter consent to follow up. The reporter did not consent to account creation.  The reporter contact information for follow up would be sent mailbox. Additional supportive information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Condition aggravated, Inappropriate schedule of product administration, Palpitations
Clinical narrative: FLARES; HEART PALPITATIONS; Stomach pain; DELTA VARIANT OF COVID; First dose on 18-Dec-2020 and second dose on 08-Jan-2021; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARES), PALPITATIONS (HEART PALPITATIONS), ABDOMINAL PAIN UPPER (Stomach pain), COVID-19 (DELTA VARIANT OF COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Dec-2020 and second dose on 08-Jan-2021) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products PANCREATIN (CREON) capsule for an unknown indication and ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 18-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started PANCREATIN (CREON) (Oral) UNK, Delayed Release Pellets and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a week. On 08-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Dec-2020 and second dose on 08-Jan-2021). On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARES), PALPITATIONS (HEART PALPITATIONS), ABDOMINAL PAIN UPPER (Stomach pain) and COVID-19 (DELTA VARIANT OF COVID). At the time of the report, CONDITION AGGRAVATED (FLARES), PALPITATIONS (HEART PALPITATIONS), ABDOMINAL PAIN UPPER (Stomach pain), COVID-19 (DELTA VARIANT OF COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Dec-2020 and second dose on 08-Jan-2021) outcome was unknown.            It was reported the patient was on Humira and had been switched to weekly due to flares. Patient was taking Creon and still not well. She had heart palpitation after second vaccine. She got delta variant of COVID of 2021. The reporter's causality for the event(s) of DELTA VARIANT OF COVID, FLARES, HEART PALPITATIONS and STOMACH PAIN with Humira was Not Provided. The reporter's causality for the event(s) of DELTA VARIANT OF COVID, FLARES, HEART PALPITATIONS and STOMACH PAIN with Pancrelipase Capsule, Delayed Release Pellets was No Reasonable Possibility It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  No treatment medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as the first primary dose).    No concomitant medications was provided. No treatment medications was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-666604 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666604:67-year old female patient
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pyrexia
Clinical narrative: Felt unwell; pretty out of it; fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt unwell), FEELING ABNORMAL (pretty out of it) and PYREXIA (fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Epilepsy and Immunocompromised (Immunocompromised with neutropenia low white blood cell count.). Concomitant products included LEVETIRACETAM and ZONISAMIDE for Epilepsy.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt unwell), FEELING ABNORMAL (pretty out of it) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, MALAISE (Felt unwell), FEELING ABNORMAL (pretty out of it) and PYREXIA (fever) outcome was unknown.            This case was linked to MOD-2022-667347 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received a monovalent Moderna COVID19 vaccine as a booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a monovalent Moderna COVID19 vaccine as a booster) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received a monovalent Moderna COVID19 vaccine as a booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received a monovalent Moderna COVID19 vaccine as a booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received a monovalent Moderna COVID19 vaccine as a booster).    No concomitant information was reported. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cough, Fatigue, Headache
Clinical narrative: Very sick; Patient clearing throat; Cough; Weakness; Headache; Joints aching; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Very sick), THROAT CLEARING (Patient clearing throat), COUGH (Cough), ASTHENIA (Weakness) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0760217, 024m20a and 041l20a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Hormone replacement therapy: Femhrt. Past adverse reactions to the above products included TIA with Femhrt. Concurrent medical conditions included Arthritis (The patient had problems with inflammation in the joints and pain with other shot.) and Drug allergy (to some medications not true allergy but side effects.).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ILLNESS (Very sick), THROAT CLEARING (Patient clearing throat), COUGH (Cough), ASTHENIA (Weakness), HEADACHE (Headache), ARTHRALGIA (Joints aching) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Very sick), THROAT CLEARING (Patient clearing throat), COUGH (Cough), ASTHENIA (Weakness), HEADACHE (Headache), ARTHRALGIA (Joints aching) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Oxygen saturation: oxygen level was 93 and 91 percent.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other patient medical history information included spine issues. The patient did not experience a similar event in the past only achy joints.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-667363, MOD-2022-667365 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Oxygen saturation, Throat clearing
Clinical narrative: Very sick; Patient clearing throat; Cough; Weakness; Headache; Joints aching; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Very sick), THROAT CLEARING (Patient clearing throat), COUGH (Cough), ASTHENIA (Weakness) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0760217, 024m20a and 041l20a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Hormone replacement therapy: Femhrt. Past adverse reactions to the above products included TIA with Femhrt. Concurrent medical conditions included Arthritis (The patient had problems with inflammation in the joints and pain with other shot.) and Drug allergy (to some medications not true allergy but side effects.).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ILLNESS (Very sick), THROAT CLEARING (Patient clearing throat), COUGH (Cough), ASTHENIA (Weakness), HEADACHE (Headache), ARTHRALGIA (Joints aching) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Very sick), THROAT CLEARING (Patient clearing throat), COUGH (Cough), ASTHENIA (Weakness), HEADACHE (Headache), ARTHRALGIA (Joints aching) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Oxygen saturation: oxygen level was 93 and 91 percent.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other patient medical history information included spine issues. The patient did not experience a similar event in the past only achy joints.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-667363, MOD-2022-667365 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Mobility decreased, Muscle discomfort, Vaccination site pain
Clinical narrative: Lost his muscle control again 24 Hours after the 2nd monovalent booster; Could not get out of the chair 24 Hours after the 2nd monovalent booster/Could not roll over in bed 24 Hours after the 2nd monovalent booster; Fell a couple of times 24 Hours after the 2nd monovalent booster; Sore left arm injection site  24 Hours after the 2nd monovalent booster; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE DISCOMFORT (Lost his muscle control again 24 Hours after the 2nd monovalent booster), MOBILITY DECREASED (Could not get out of the chair 24 Hours after the 2nd monovalent booster/Could not roll over in bed 24 Hours after the 2nd monovalent booster), FALL (Fell a couple of times 24 Hours after the 2nd monovalent booster) and VACCINATION SITE PAIN (Sore left arm injection site  24 Hours after the 2nd monovalent booster) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22-2A, 012F21A, 030M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis (under control) since 1996.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, the patient experienced MUSCLE DISCOMFORT (Lost his muscle control again 24 Hours after the 2nd monovalent booster), MOBILITY DECREASED (Could not get out of the chair 24 Hours after the 2nd monovalent booster/Could not roll over in bed 24 Hours after the 2nd monovalent booster) and FALL (Fell a couple of times 24 Hours after the 2nd monovalent booster). 12-Jul-2022, the patient experienced VACCINATION SITE PAIN (Sore left arm injection site  24 Hours after the 2nd monovalent booster). On 14-Jul-2022, MUSCLE DISCOMFORT (Lost his muscle control again 24 Hours after the 2nd monovalent booster), MOBILITY DECREASED (Could not get out of the chair 24 Hours after the 2nd monovalent booster/Could not roll over in bed 24 Hours after the 2nd monovalent booster), FALL (Fell a couple of times 24 Hours after the 2nd monovalent booster) and VACCINATION SITE PAIN (Sore left arm injection site  24 Hours after the 2nd monovalent booster) had resolved.            No concomitant medications were reported.  On 01-Nov-2021, the patient received the 1st booster dose of Moderna COVID-19 vaccine. On 11-Jul-2022, the patient received the 2nd booster dose Moderna COVID-19 vaccine.  No treatment medications were reported.   This case was linked to MOD-2021-016707, MOD-2022-667351 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Patient felt "shivery stuff" during the day after receiving the first dose of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (Patient felt "shivery stuff" during the day after receiving the first dose of the vaccine) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Patient felt "shivery stuff" during the day after receiving the first dose of the vaccine). At the time of the report, CHILLS (Patient felt "shivery stuff" during the day after receiving the first dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Slight headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Blood pressure high and Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder, METFORMIN and BISOPROLOL FUMARATE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient had no allergies. Patient did not had COVID positive test or diagnosis. No treatment information was provided.   This case was linked to MOD-2022-667382 (Patient Link).   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, body aches, arm and corresponding under arm very sore, thirsty by 1:00 11/1/22. Later, coughing, nausea
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Thirst
Clinical narrative: Fever, body aches, arm and corresponding under arm very sore, thirsty by 1:00 11/1/22. Later, coughing, nausea
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: Localized redness at injection site. warm to the touch with mild swelling. Soreness after 2 hours.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oral herpes
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: no redness at ijection site. pateint called after went home saying he had fever bilster came up after vaccines in his lower lips.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: PATIENT SAYS SHE HAS BEEN EXPERIENCING SORENESS IN RIGHT ARM THAT HAS NOT GONE AWAY SINCE RECIEVING VACCINE
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered.
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site haemorrhage, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient Bled with both shots. First the Fluzone had a long drop of blood running down his arm about 5 inches, with the Pfizer Bivalent COVID shot hes had drop of blood about a 1/2 inch. After receiving both shot the patient passout briefly and was unresponsive for brief period of time. We then had him lay on the floor with his feet up on a chair. we called 911, ems came and evaluated the patient. no further action was necessary. pt was given water and apple juice to drink and the left the pharmac
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fainted while being given flu shot and was unconscious for ~5 seconds before coming to. Patient was lowered to ground level and had feet elevated above head. Patient waited at the pharmacy for ~20 minutes and was responsive and lucid at time of leaving.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: RPh asked technician to call 911 and bring Epinephrine. Patient quickly recovered and asked us to cancel and NOT to call 911. After she recovered, she stated she had a similiar previous reaction and should have told me. She was given water and laid on the floor until she felt fine. I asked her to stay in pharmacy for 30 minutes. Her mother can inside the store and stayed with her until that time. She checked in with me before leaving. She said she was fine and apologized a number of times.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Fall, Heart rate decreased, Hypopnoea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient recvd vaccine about 5pm, then was talking to wife as she was about to recv her vaccine, when he fainted and fell backwards onto the moveable privacy screen, helped into a chair then fainted again, low pulse, shallow breathing, called 911, then he was taken to emergency dept.  called his number at 7PM but not reached for followup.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Site: Swelling at Injection Site-Medium, Additional Details: The patient noticed vesicles, blisters at the site.  No swelling noted. He took bandage off.  He denied itch.
Age: 5.0
Sex: M
Vaccine: FLUN4, MMR, VARCEL
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse event. Flumist given on 10/28/2022, MMR and Varicella given 10/31/2022. Live/Live rule. Reporting for vaccine error only.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe, Additional Details: Patient states she developed redness and swelling at injection site for which she was given antibiotics from a physician. Then 1-2 days later she developed pain in the shoulder and had difficulty lifting arm. Doctor advised the patient that the flu shot was administered "too far back on the arm." Patient states she has been diagnosed with bursitis.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Product administered at inappropriate site
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe, Additional Details: Patient states she developed redness and swelling at injection site for which she was given antibiotics from a physician. Then 1-2 days later she developed pain in the shoulder and had difficulty lifting arm. Doctor advised the patient that the flu shot was administered "too far back on the arm." Patient states she has been diagnosed with bursitis.
Age: 48.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Ageusia, Chills, Decreased appetite, Depression, Diarrhoea
Clinical narrative: Chill, Feverish, headache, vertigo, loss of taste, poor appetite, diarrhea, fatigue, depression.  Treatment includes rest, drink fluid, Advil hospitalization for ten days, currently in half day hospitalization for mental health treatment.
Age: 48.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Fatigue, Headache, Pyrexia, SARS-CoV-2 test negative, Vertigo
Clinical narrative: Chill, Feverish, headache, vertigo, loss of taste, poor appetite, diarrhea, fatigue, depression.  Treatment includes rest, drink fluid, Advil hospitalization for ten days, currently in half day hospitalization for mental health treatment.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse event, Injection site discomfort, Injection site erythema, Injection site warmth, Reaction to previous exposure to any vaccine
Clinical narrative: Noticed a lg. area where injection was injected 24 hrs. later. Area was 3"x3". Very red, hot to touch and uncomfortable to touch. Sent to ER, told to apply ice to the area and take Benadryl. The adverse event lasted 36 hours, approximately.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Dizziness, Electrocardiogram abnormal, Palpitations
Clinical narrative: experienced random heart palpitations 3 days after injection and have yet to go away as of today's date experienced dizziness approximately 3 weeks after injection.  Treatment - none Outcome - diagnosed with A-Fib and following up with a cardiologist for further analysis and review
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Pyrexia
Clinical narrative: Area on arm very red and swollen Headache Fever
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Sever pain in injection arm, fever, muscle ache, headache, fatigue.  Started 8 hours after injection.  Bed ridden for 36 hours.  2 days after injection feeling better, fever broke, still fatigued.  No longer have headache
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sever pain in injection arm, fever, muscle ache, headache, fatigue.  Started 8 hours after injection.  Bed ridden for 36 hours.  2 days after injection feeling better, fever broke, still fatigued.  No longer have headache