chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received fluzone high dose quadrivalent shots in a time frame of 2 weeks with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 93 years old female patient who had received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] shots in a time frame of 2 weeks with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received a 2 (0.7ml) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ937AA and expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for Immunization.  On 17-Oct-2022 the patient developed a non-serious event of patient received fluzone high dose quadrivalent shots in a time frame of 2 weeks with no reported adverse event (extra dose administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: flublok administered to 12 years old with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2022SA432188(CLUSTER).  This case involves a 12 years old male patient to whom vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] administered with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 15-Oct-2022 the patient developed a non-serious event of flublok administered (dose: 0.5ml, route: intramuscular in the left arm, batch number: UJ893AA and expiry date: 09-Jun-2023) to 12 years old with no reported adverse event (off label use) for Immunization (Latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken : not applicable.  Outcome: Unknown
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: arm pain that started after 4 days of vaccination and the pain is radiating down to their arm, going into their hand; gets achy/pain is radiating down to their arm, going into their hand; injection site is itchy; injection site got extremely swollen to about 4 inches and turned brown like a baseball; feverish; injection site got extremely swollen to about 4 inches and turned brown like a baseball; Initial information received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional via pharmacy.  This case involves a 75 years old female patient who was feverish, injection site got extremely swollen to about 4 inches and turned brown like a baseball, arm pain that started after 4 days of vaccination, gets achy/pain is radiating down to their arm, going into their hand after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Oct-2022 at 04:00 clock, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported  at a dose of 0.7ml via unknown route in unknown administration site for immunization.  On 14-Oct-2022, the patient reported that she relates that she gets it every year and each time, she gets achy(pain) (latency: same day)and feverish (Pyrexia) (latency: same day). This time, the injection site got extremely swollen to about 4 inches and turned brown like a baseball(injection site swelling) (injection site discoloration).(latency: same day) The swelling calmed down but they still have arm pain that started after 4 days of vaccination (pain in extremity)(latency: 4 days) and the pain is radiating down to their arm, going into their hand and the injection site is itchy(injection site pruritus) (latency: same day)and wanted to know if they should be concerned regarding the side effects they are experiencing and if they can take antihistamine since they still feel uncomfortable.   Action taken :not applicable  It was not reported if the patient received a corrective treatment for the events  Outcome: recovered for injection site swelling and Recovering / Resolving for all other events
Age: 0.33
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received FLUZONE QIV at 4 months old with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who experienced patient received fluzone qiv at 4 months old with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2022, the patient received 0.5 mL total of dose 1 of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ878AB and expiry date: 30-Jun-2023) via intramuscular route in the right thigh for prophylactic vaccination.  On 11-Oct-2022, (latency: same day) the patient received fluzone qiv at 4 months old with no reported adverse event (product administered to patient of inappropriate age) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was 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: 36.0
Sex: F
Vaccine: FLUR3
Symptoms: Exposure during pregnancy
Clinical narrative: 12 weeks pregnant got flublok with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2022SA435259(CLUSTER).  This case involves a 36 years old female patient who was exposed to vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] in context of 12 weeks pregnant got flublok with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported 12 weeks pregnant got flublok with no reported adverse event occurred at 13 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at 13 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  The date of last menstrual period was reported as 27-Jul-2022. The estimated due date is 03-May-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 18-Oct-2022, the patient received 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation was unknown, lot UJ888AA and expiry date: 08-Jun-2023) via unknown route in the left deltoid for Immunization.  On 18-Oct-2022 the patient developed a non-serious event of 12 weeks pregnant got flublok with no reported adverse event (exposure during pregnancy) (Latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken : not applicable.  Outcome: Unknown Additionally, at time of reporting, the pregnancy was still ongoing.
Age: 54.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pain, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Stiffness in right shoulder/ stiffness at the location of the injection; Tightness in her shoulder; Tenderness at the injection site but not painful; This spontaneous case was received on 05-Sep-2022 from other non-health care professional (consumer) via Agency (reference numbers: SEQW22-04055, with additional information received on the same day from other non-health professional via Agency (reference number: SEQW22-04070) (being processed together) and concerned a 54-year-old, female patient.   The patient's medical history was not reported. The patient was not taking any concomitant medications.   On 04-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose 0.5 mL; route of administration: intramuscular (IM); anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Flucelvax Quadrivalent, the patient experienced stiffness in her right shoulder. There was no pain, redness, or inflammation around the site, only general stiffness at the location of the injection. No treatment measures were made associated with the event.  On an unspecified date in Oct-2022, the patient experienced tightness in her shoulder and tenderness at the injection site which was not painful.    At the time of initial reporting, the patient was recovering from the event of 'stiffness shoulder'. As reported, it was still ongoing but resolving as the day went on and she was using her arm.  The outcome of the events 'joint tightness' and 'vaccination site tenderness' was not reported.  The reporter did not provide causality assessment.   This case was assessed as non-serious.  Company comment: A 54-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving the vaccine, the patient experienced stiffness in her right shoulder. There was no pain, redness, or inflammation around the site, only general stiffness at the location of the injection. The patient also reported tenderness at the injection site which was not painful. Causal role of the suspect vaccine is assessed as possibly related, due to plausible temporal relationship and no alternative aetiology reported.; Sender's Comments: A 54-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, after receiving the vaccine, the patient experienced stiffness in her right shoulder. There was no pain, redness, or inflammation around the site, only general stiffness at the location of the injection. The patient also reported tenderness at the injection site which was not painful. Causal role of the suspect vaccine is assessed as possibly related, due to plausible temporal relationship and no alternative aetiology reported.
Age: 32.0
Sex: F
Vaccine: FLUC3
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Regurgitation
Clinical narrative: Blurry vision; Regurgitation; Loose bowel movements; Nausea; Headache; Felt fatigued; This spontaneous case was received on 05-Oct-2022 from other non-health care professional (consumer) with additional information received on the same day (reference number: SEQW22-04094) and on 18-Oct-2022 (reference number: SEQW22-04661) (being processed together) via Communications, and concerned a 32-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications were not reported.  On 04-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 348368 and the expiry date was 30-Jun-2023.  On 05-Oct-2022, in the morning, one day after receiving Flucelvax Quadrivalent, the patient experienced blurry vision coupled with nausea. Later in the morning, the patient experienced regurgitation and loose bowel movements. The patient also experienced headache and felt fatigued. Reset and increased fluids eased symptoms.  On the same date, the patient recovered from the events.  The case was assessed as non-serious.  Company comment: A 32-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient experienced blurry vision, nausea, regurgitation and loose bowel movements. The patient also experienced headache and felt fatigued. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.; Sender's Comments: A 32-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient experienced blurry vision, nausea, regurgitation and loose bowel movements. The patient also experienced headache and felt fatigued. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.
Age: 32.0
Sex: F
Vaccine: FLUC3
Symptoms: Vision blurred
Clinical narrative: Blurry vision; Regurgitation; Loose bowel movements; Nausea; Headache; Felt fatigued; This spontaneous case was received on 05-Oct-2022 from other non-health care professional (consumer) with additional information received on the same day (reference number: SEQW22-04094) and on 18-Oct-2022 (reference number: SEQW22-04661) (being processed together) via Communications, and concerned a 32-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications were not reported.  On 04-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 348368 and the expiry date was 30-Jun-2023.  On 05-Oct-2022, in the morning, one day after receiving Flucelvax Quadrivalent, the patient experienced blurry vision coupled with nausea. Later in the morning, the patient experienced regurgitation and loose bowel movements. The patient also experienced headache and felt fatigued. Reset and increased fluids eased symptoms.  On the same date, the patient recovered from the events.  The case was assessed as non-serious.  Company comment: A 32-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient experienced blurry vision, nausea, regurgitation and loose bowel movements. The patient also experienced headache and felt fatigued. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.; Sender's Comments: A 32-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient experienced blurry vision, nausea, regurgitation and loose bowel movements. The patient also experienced headache and felt fatigued. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.
Age: 31.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body aches; Chills; Fatigue; This spontaneous case was received on 07-Oct-2022 from other healthcare professional via Communications (reference number: SEQW22-04209) with additional information received on 10-Oct-2022 from other healthcare professional via Communications (reference number: SEQW22-04247) (being processed together) and concerned a 31-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 06-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration: intramuscular (IM), anatomical location: not reported) for influenza prophylaxis. The batch number reported was 348368 and expiry date 30-Jun-2023.   On the same day, about eight hours after receiving Flucelvax Quadrivalent, the patient started experiencing chills, fatigue and body aches.  On an unspecified date in Oct-2022, the patient recovered from all events.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 31-year-old patient was vaccinated with Flucelvax Quadrivalent. About eight hours after receiving Flucelvax Quadrivalent, the patient started experiencing chills, fatigue and body aches. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.; Sender's Comments: A 31-year-old patient was vaccinated with Flucelvax Quadrivalent. About eight hours after receiving Flucelvax Quadrivalent, the patient started experiencing chills, fatigue and body aches. Causal role of the suspect vaccine is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.
Sex: F
Vaccine: FLUC3
Symptoms: Flushing, Skin irritation, Skin warm
Clinical narrative: Cheeks started flushing, became hot, and irritated; Cheeks started flushing, became hot, and irritated; This spontaneous case was received on 07-Oct-2022 from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-04164), with additional information received on 11-Oct-2022 (reference number SEQW22-04340) (being processed together) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medication were not reported.  On 06-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location: not reported) for influenza virus vaccine indicated for active immunization against influenza caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 348368 and expiry date 30-Jun-2023.   On the same date, at 11 am, about an hour after receiving Flucelvax Quadrivalent, the patient's cheeks started flushing, became hot, and irritated. The patient reported it to the nurse.  The outcome of the events was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. About an hour after receiving Flucelvax Quadrivalent, the patient's cheeks started flushing, became hot, and irritated. Causal role of the suspect vaccine is assessed as probably related, due to suggestive time relationship and no alternative aetiology provided.; Sender's Comments: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. About an hour after receiving Flucelvax Quadrivalent, the patient's cheeks started flushing, became hot, and irritated. Causal role of the suspect vaccine is assessed as probably related, due to suggestive time relationship and no alternative aetiology provided.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Confusional state, Memory impairment
Clinical narrative: Mental confusion/ difficult to remember numbers; Mental confusion/ difficult to remember numbers; This spontaneous case was received on 07-Oct-2022 from pharmacist via Communications (reference number: SEQW22-04179) and concerned an 85-year-old, female patient.  The patient had no relevant medical history. The patient was using concomitant medications, however it was not reported which one.   On 01-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, dose: 0.5 ml, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 346361 and expiry date: 19-May-2023.  On 02-Oct-2022, one day after receiving Fluad Quadrivalent, the patient experienced mental confusion and it was difficult to remember numbers for about six days. No treatment was associated with the event.  At the time of initial report on 07-Oct-2022, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: An 85-year-old, female patient of unknown age and gender was vaccinated with the suspect product influenza vaccine. One day after vaccination the patient experienced mental confusion and it was difficult to remember numbers for about six days. Information regarding the related diagnostic findings and concomitant medications has not been provided. Advanced age confounds causality. Causality is assessed as not related based on biological implausibility.; Sender's Comments: An 85-year-old, female patient of unknown age and gender was vaccinated with the suspect product influenza vaccine. One day after vaccination the patient experienced mental confusion and it was difficult to remember numbers for about six days. Information regarding the related diagnostic findings and concomitant medications has not been provided. Advanced age confounds causality. Causality is assessed as not related based on biological implausibility.
Sex: F
Vaccine: FLUC3
Symptoms: Death, Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This spontaneous case was received on 06-Oct-2022 from other healthcare professional (nurse) via agency (reference number: SEQW22-04040) with additional information received on 12-Oct-2022 and 13-Oct-2022 via agency (reference number: SEQW22-03395) (being processed together) and concerned a female patient of unspecified age.  The patient's medical history and concomitant medications were not reported. As reported on an unspecified date, the patient had passed and that was not related to the flu injection but to her on going medical condition.  On unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On unspecified date, an unknown time after receiving Flucelvax Quadrivalent, the patient experienced diarrhea and nausea.   The outcome of the events diarrhea and nausea was not reported.  The reporter assessed the events of diarrhea and nausea to be related to Flucelvax Quadrivalent. As reported, both were related to the vaccine as not one else had these symptoms prior to vaccine administration and these only occurred in the patients that received the vaccine.  This case is linked with cases 202204733, 202204734, 202204735, 202204736, 202204737, 202204738, 202204739, 202204740 and 202205483 (the same reporter).  Company comment: The events of diarrhea and nausea are assessed as unassessable to Flucelvax Quadrivalent due to unclear temporal relationship.; Reporter's Comments: As reported, diarrhea and nausea, both were related to the vaccine as not one else had these symptoms prior to vaccine administration and these only occurred in the patients that received the vaccine.; Sender's Comments: The events of diarrhea and nausea are assessed as unassessable to Flucelvax Quadrivalent due to unclear temporal relationship.; Reported Cause(s) of Death: One- has passed and that was NOT related to the flu injection but to her on going medical condition
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Noticed red itchy, hive like area on right arm below the injection site.  Warm and itchy.  I'm not sure the vaccine was administered correctly.  Didn't feel like it went into the deltoid.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cold sweat, Dizziness, Hypoaesthesia, Migraine
Clinical narrative: nasuea/vomitting migraine limb numbness weakness visual disturbances dizziness hands  blotchy and clamy
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Rash macular, Visual impairment, Vomiting
Clinical narrative: nasuea/vomitting migraine limb numbness weakness visual disturbances dizziness hands  blotchy and clamy
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient 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 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) 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 ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster).    No concomitant medications were provided. No adverse events were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662391, US-MODERNATX, INC.-MOD-2022-662390, US-MODERNATX, INC.-MOD-2022-662385 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662391:same reporter US-MODERNATX, INC.-MOD-2022-662385:Same reporter US-MODERNATX, INC.-MOD-2022-662390:same reporter
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test, Tremor
Clinical narrative: Muscle spasm; Shaking; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Muscle spasm) and TREMOR (Shaking) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 012F21A, 039A21A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Date of positive COVID-19 test: 20/21Nov2020) on 20-Nov-2020.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient experienced MUSCLE SPASMS (Muscle spasm) and TREMOR (Shaking). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In April 2022, MUSCLE SPASMS (Muscle spasm) and TREMOR (Shaking) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2020, SARS-CoV-2 test: Positive. In November 2020, SARS-CoV-2 test: Positive.         No concomitant medication was reported.   No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not felt cold, patient used a blanket. She would go through it for half hour on and off. The muscle spasm lasted for 3 hours. Patient was nervous about receiving another booster. Patient was not taking other medication. Patient had COVID-19 positive on 09-Mar-2020. Symptoms was began on 09-Mar-2020. patient felt woozy, Cough for 3 hours straight, Phlegm in the throat. Patient received treatment medication as Claritin and Tylenol. Hospitalization was not required. On 20/21 Nov-2020 Patient had COVID-19 positive test. Symptoms was began on 20-Nov-2020. No treatment medication was received. Hospitalization was not required.   This case was linked to MOD-2022-662409 (Patient Link).
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patient was accidentally administered an expired Fluzone Quadrivalent with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 37 years old female patient was accidentally administered an expired Influenza quadrival A-B vaccine [Fluzone Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2022, the patient was accidentally administered an expired 0.5ml (total)  dose of suspect Influenza quadrival A-B vaccine (lot UT7356NA;Expiration Date :30-Jun-2022) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product administered).  Action taken: not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Asthenia, Blood glucose normal, Confusional state, Dizziness
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT'S FAMILY REPORTED THAT PATIENT FAINTED 3-5 MINUTES AFTER THE TWO IMMUNIZATIONS. WHEN PHARMACY  SAW THE PATIENT, SHE WAS AWAKE WITH IMPAIRED RESPONSIVENESS TO QUESTIONS. PATIENT ALSO HAD PALENESS IN HER FACE. EMERGENCY LINE CALLED IMMEDIATELY AND ARRIVED TO TAKE HER TO NEARBY HOSPITAL (NAME OF HOSPITAL UNKNOWN). RESPONDERS REPORTED NORMAL BLOOD GLUCOSE IN PATIENT BUT LOW BLOOD PRESSURE (APPROX 70/55).
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Hypotension, Lethargy, Nausea, Pallor
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT'S FAMILY REPORTED THAT PATIENT FAINTED 3-5 MINUTES AFTER THE TWO IMMUNIZATIONS. WHEN PHARMACY  SAW THE PATIENT, SHE WAS AWAKE WITH IMPAIRED RESPONSIVENESS TO QUESTIONS. PATIENT ALSO HAD PALENESS IN HER FACE. EMERGENCY LINE CALLED IMMEDIATELY AND ARRIVED TO TAKE HER TO NEARBY HOSPITAL (NAME OF HOSPITAL UNKNOWN). RESPONDERS REPORTED NORMAL BLOOD GLUCOSE IN PATIENT BUT LOW BLOOD PRESSURE (APPROX 70/55).
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT'S FAMILY REPORTED THAT PATIENT FAINTED 3-5 MINUTES AFTER THE TWO IMMUNIZATIONS. WHEN PHARMACY  SAW THE PATIENT, SHE WAS AWAKE WITH IMPAIRED RESPONSIVENESS TO QUESTIONS. PATIENT ALSO HAD PALENESS IN HER FACE. EMERGENCY LINE CALLED IMMEDIATELY AND ARRIVED TO TAKE HER TO NEARBY HOSPITAL (NAME OF HOSPITAL UNKNOWN). RESPONDERS REPORTED NORMAL BLOOD GLUCOSE IN PATIENT BUT LOW BLOOD PRESSURE (APPROX 70/55).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Hypoaesthesia, Injection site bruising, Injection site indentation, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient has pain, severe sensitivity, and tenderness at the injection site. Arm becomes numb during physical activity, like exercise, then becomes sore afterwards. There's a dip/pit in her arm at the injection area which has gotten bigger over time. Her PCP described it as it seems to be "eating away at the muscle & the tissue is disappearing." Her blood work & x-ray came back normal so PCP recommended she see an orthopedic specializing in bone & tissue.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: X-ray normal
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient has pain, severe sensitivity, and tenderness at the injection site. Arm becomes numb during physical activity, like exercise, then becomes sore afterwards. There's a dip/pit in her arm at the injection area which has gotten bigger over time. Her PCP described it as it seems to be "eating away at the muscle & the tissue is disappearing." Her blood work & x-ray came back normal so PCP recommended she see an orthopedic specializing in bone & tissue.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient has history of fainting upon seeing needles/injection. Patient became light headed and fell on the floor, bruising her buttocks. Patient was felt better after raising feet while lying down, drinking water and eating candy bars. Patient was able to leave on her own power after 30 to 40 minutes. Patient's spouse was with her.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Apologized to patient about her experience and advised patient to see her physician
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal, Vision blurred, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: told mom she felt funny and her eyes were blurry-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Mom stated she had an adverse reaction to another vaccination given in Dr Office, and since then gets very nervous about vaccines.  They had been getting them at the Doctor since the reaction , but they wanted to try here for the flu shot.  She states they will probably just get them at the Dr from now on and have her lay down when getting vaccine.  She did walk out on her own with no issue.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Wrong Age for Vaccine Given-
Age: 65.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Body temperature increased, Cellulitis
Clinical narrative: Provider states low grade temperature (101F) the weekend following injections. Cellulitis roughly the size of palm with no abscess.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Erythema multiforme, Rash
Clinical narrative: Patient developed erythema multiforme rash beginning on 10/13/2022 (6 days after immunizations given).  Called office and initially advised that full body rash would be consistent with reaction to MMR vaccine.  However, later sent pictures consistent with EM.  Rash continued to progress peaking on 10/19 and beginning to resolve 10/20/2022.  Patient did not take any medications at any time, did not have any fever or other signs of illness.  Had not recently taken any medications prescribed or over the counter.  No tylenol, motrin, etc.  Only can be attributed to immunizations and would assume that this would be due to MMR vaccine due to the delay in reaction.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Body temperature increased, Injection site pain, Myalgia
Clinical narrative: pain at the site of injection;  Overall  body aches in muscles and joints  an elevated temp but not critical
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expiration was 10/31/2022 for the 10 week expiration but  stated 9/30/2022 for this lot
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hot flush, Hyperhidrosis, Menopause
Clinical narrative: I had the initial Moderna COVID vaccines in Jan/Feb 2021. Menopause, specifically hot flashes several times a day, started shortly thereafter. Prior to the vaccines I was not showing signs of being perimenopausal. I began taking OTC supplement to help get some relief from the hot flashes. First booster Moderna in Nov 2021. Hot flashes continued and perhaps worsened. But consistent use of the supplements for the past year seemed be helping get them under control and I wasn't experiencing them nearly as often or as strongly. Another booster in September 2022. Hot flashes have returned WITH A VENEGENCE and now they're to the point that I'm breaking out in a sweat, in particular on my forehead, upper lip, nose. Since the onset of hot flashes in the winter of 2021, I would experience the rising flush of internal heat, but I never got sweaty. But following this most recent booster I am definitely noticing a marked difference in the strength of the hot flashes. I recently saw a news article about the study that did show a link between COVID vaccines and changes in young women's menstrual cycles. I had suspected that the initial vaccine had kick-started menopause for me (currently 49, nearly 50 years old) back in the winter of 2021, but this most recent booster has DEFINITELY affected the severity of the hot flashes and confirmed my suspicions. I do not regret getting the vaccine. If there are additional boosters, I will probably get them as well. I haven't heard anyone else talking about a link between kickstarting or worsening symptoms of menopause with the vaccine and I felt I should attempt to bring it to someone's attention.
Age: 21.0
Sex: M
Vaccine: FLUR4
Symptoms: Device malfunction, Incorrect dose administered
Clinical narrative: When administering a PFS of flublok to patient, the fluid would not expel from the syringe. Placement and needle patency were reviewed, unable to determine cause of issue.
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Inflammation, Vomiting
Clinical narrative: Chest pain, vomitting, and inflammation. Inflammation persisted following the acute event on 05OCT2022.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Soreness, chills, fever, headache, nauseated
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Nightmare, Rash, Rash pruritic
Clinical narrative: Scheduled and received Covid booster shot (bivalent) and flu shot for the 27th of September 2022 and the 30th of September 2022, respectively. Notice itchiness and rash on the upper back on the 8th of October 2022. Started Benedryl (25mg) by mouth on the 10th of October 2022. Visited urgent care (virtual) on the 14th of October 2022. A prescription of prednisone (20mg, two tablets daily for 5 days) was given and recommendation of OTC Allegra (180mg, one tablet per day) and Benedryl. stopped taking the Benadryl after the 14th of October 2022. Prednisone alleviated rash and itchiness. After the completion of prednisone, I initiated Allegra on the 18th of October 2022 and through the 19th of October 2022. Allegra alleviated the rash and itchiness but I experienced nightmares both nights. Stopped taking Allegra on the third day, the 20th of October 2022. Attempted another dose on the 22nd of October 2022. Nightmares returned.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Immunisation reaction
Clinical narrative: Annual flu shot. Had serious adverse reaction to shot. Did not seek medical help but did call my physician and report. Held off on going to emergency room and felt ok after 48 hours.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the 10 week expiration on the pediatric vaccine was 10/31/2022 but the mfg expiration was 09/30/2022--   vaccine was expired
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered on 10/7/22 when it expired 09/30/22. According to manufacturer there is data to support extended stability thru 10/19/2022 for this LOT.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Fatigue, Oropharyngeal pain
Clinical narrative: On and off fatigue, sore throat and restricted breathing  beginning 5 hours after inoculation and continuing through to present (3+ weeks).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture negative, Blood sodium decreased, Brain natriuretic peptide increased, COVID-19, Chest X-ray abnormal
Clinical narrative: Patient presented to the ER  due to cough and fatigue she experienced over the past 5 days  without shortness of breath. The patient was on room air.  Sodium was 129.  She was admitted to the hospital.  She did well during her stay. She refused monoclonal antibodies.  Discussed risks and benefits with her. She verbalized understanding.  We discontinued her hydrochlorothiazide because of hyponatremia.  Sodium improved to 134.  Procalcitonin was 0.1.  BNP 104. Blood culture was negative.  The patient continued to be on room air.  Two- dimensional echo showed EF 60%, diastolic dysfunction.  Chest x-ray showed possible left lower lobe infiltrate.  Clinically, unlikely pneumonia, probably secondary to COVID-19.  The patient did well, and she was discharged in stable Condition with covid kit The patient received Zithromax and Rocephin during her stay.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diastolic dysfunction, Echocardiogram abnormal, Fatigue, Hyponatraemia
Clinical narrative: Patient presented to the ER  due to cough and fatigue she experienced over the past 5 days  without shortness of breath. The patient was on room air.  Sodium was 129.  She was admitted to the hospital.  She did well during her stay. She refused monoclonal antibodies.  Discussed risks and benefits with her. She verbalized understanding.  We discontinued her hydrochlorothiazide because of hyponatremia.  Sodium improved to 134.  Procalcitonin was 0.1.  BNP 104. Blood culture was negative.  The patient continued to be on room air.  Two- dimensional echo showed EF 60%, diastolic dysfunction.  Chest x-ray showed possible left lower lobe infiltrate.  Clinically, unlikely pneumonia, probably secondary to COVID-19.  The patient did well, and she was discharged in stable Condition with covid kit The patient received Zithromax and Rocephin during her stay.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Procalcitonin, SARS-CoV-2 test positive
Clinical narrative: Patient presented to the ER  due to cough and fatigue she experienced over the past 5 days  without shortness of breath. The patient was on room air.  Sodium was 129.  She was admitted to the hospital.  She did well during her stay. She refused monoclonal antibodies.  Discussed risks and benefits with her. She verbalized understanding.  We discontinued her hydrochlorothiazide because of hyponatremia.  Sodium improved to 134.  Procalcitonin was 0.1.  BNP 104. Blood culture was negative.  The patient continued to be on room air.  Two- dimensional echo showed EF 60%, diastolic dysfunction.  Chest x-ray showed possible left lower lobe infiltrate.  Clinically, unlikely pneumonia, probably secondary to COVID-19.  The patient did well, and she was discharged in stable Condition with covid kit The patient received Zithromax and Rocephin during her stay.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered 10/8/22 when it expired 09/30/22. Per manufacturer, extended stability data shows stability through 10/19/2022.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccination administered on 10/8/22, when it expired 09/30/22. Per manufacturer, extended stability data supports stability thru 10/19/22.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 10/22/21, 12/15/21. Positive on 10/24/22
Age: 25.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: None- Expired vaccine administered
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Cold sweat, Fall, Fatigue, Gait inability, Headache
Clinical narrative: Beyond Horrible Fatigue, Could not wallk without falling over, sever cold sweats, severe headaches
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine's actual expiry date was 09/30/2022. The vaccine was administered to the patient on 10/02/2022. Upon, enquiring with the manufacturer (pfizer),the stability data supported the use of the product through 10/19/2022.  Since the vaccine was administered before 10/19/2022 re-vaccination of the dose was not required.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT WAS GIVEN MODERNA COVID BIVALENT VACCINE 2 WEEKS POST GETTING THE SAME VACCINE.  PHYSICIAN WAS INFORMED IMMEDIATELY
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Delivery, Exposure during pregnancy, Induced labour
Clinical narrative: I was 24 weeks pregnant via IVF with no  complications at the time of the COVID vaccine,  my daughter was born 8lbs 7oz  at 41 weeks gestation. After an uneventful induction by my OBGYN baby started having seizures 4 hours after birth. She was take to the ICU where they found Via MRI she had a Infarct of the right MCA with hemorrhage. Baby spent 2 weeks in the ICU and at this time is still on medication to control seizures and revived physical therapy for possible left sided deficits.