chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardiac failure acute, Dyspnoea, Infection
Clinical narrative: The patient has a history of COPD, CHF, and chronic kidney disease. She was seen in the ED on 5/10 with gradually worsening shortness of breath over the past several days. In the ED, her O2 sats were at 88%; she was placed on 2L supplemental O2 with improvement. A COVID PCR test done in the ED resulted positive. Of note, the patient previously tested positive on 2/28, however had resolution of symptoms in early March. Ultimately, the patient was admitted 5/10/23 - 5/13/23. Discharge diagnoses include acute hypoxic respiratory failure, acute on chronic diastolic heart failure, suspect pneumonia likely hospital-acquired secondary to strep pneumoniae, and COVID-19 infection, among other diagnoses.  Of note, during admission she was able to be weaned off supplemental oxygen.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Left ventricular failure, Pneumonia, Pneumonia pneumococcal, SARS-CoV-2 test positive
Clinical narrative: The patient has a history of COPD, CHF, and chronic kidney disease. She was seen in the ED on 5/10 with gradually worsening shortness of breath over the past several days. In the ED, her O2 sats were at 88%; she was placed on 2L supplemental O2 with improvement. A COVID PCR test done in the ED resulted positive. Of note, the patient previously tested positive on 2/28, however had resolution of symptoms in early March. Ultimately, the patient was admitted 5/10/23 - 5/13/23. Discharge diagnoses include acute hypoxic respiratory failure, acute on chronic diastolic heart failure, suspect pneumonia likely hospital-acquired secondary to strep pneumoniae, and COVID-19 infection, among other diagnoses.  Of note, during admission she was able to be weaned off supplemental oxygen.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site became red, mildly swollen and mildly itchy. No dizziness, no shortness of breath, no nausea no vomiting. Skin intact, no pealing no rash. Reported mild pain at site of injection. No other body system involvement. The symptom started within a day of the injection and peaked the evening of 7/22/23 (about 30 hours after injection). The symptoms have reportedly improved 7/24/23 but are still present.   Patient has followup appt on 7/27/23
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: red area on shoulder red, hot and slightly raised.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient Deceased
Age: 13.0
Sex: F
Vaccine: HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: NO ADVERSE EVENT NOTED OR REPORTED. PT MISTAKENLY GIVEN COMBINATION MMRV VACCINE INSTEAD OF SEPARATE MMR AND VARICELLA VACCINES
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, COVID-19, Cerebrovascular accident, Cough, Dyspnoea
Clinical narrative: The patient has a history of chronic atrial fibrillation and COPD. Notably, he was recently hospitalized 4/22/23 - 5/3/23 for recurrent right MCA CVA. On 5/14 the patient presented to the ED due to increased weakness, shortness of breath, and palpitations. A COVID PCR test performed in the ED resulted positive. Ultimately, he was admitted 5/14/23 - 5/16/23 for cough and generalized weakness likely secondary to COVID-19 infection, among other discharge diagnoses. Of note, the patient remained on room air throughout his admission. He has received the primary COVID vaccine series and three boosters.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Palpitations, SARS-CoV-2 test positive, Symptom recurrence
Clinical narrative: The patient has a history of chronic atrial fibrillation and COPD. Notably, he was recently hospitalized 4/22/23 - 5/3/23 for recurrent right MCA CVA. On 5/14 the patient presented to the ED due to increased weakness, shortness of breath, and palpitations. A COVID PCR test performed in the ED resulted positive. Ultimately, he was admitted 5/14/23 - 5/16/23 for cough and generalized weakness likely secondary to COVID-19 infection, among other discharge diagnoses. Of note, the patient remained on room air throughout his admission. He has received the primary COVID vaccine series and three boosters.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Cold sweat, Dizziness, Vomiting
Clinical narrative: Patient started to have reactions minutes after MMR vaccine was administered to her at family medicine on 7/24/2023. She became dizzy, clammy and proceeded to vomit.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Differential white blood cell count normal, Full blood count normal, Headache, Immunisation reaction, Impaired work ability
Clinical narrative: developed fever and headache 2 days after injection of Rabies pre-exposure. Diagnosed with adverse effect of vaccine. Out of work for 1 day.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: developed fever and headache 2 days after injection of Rabies pre-exposure. Diagnosed with adverse effect of vaccine. Out of work for 1 day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Eye pain, Headache, Muscle spasms, Myalgia
Clinical narrative: Fever of 102 noted the next day, however pt felt fever approx 3-4 hours after dose.  Had fever for up to 4 days post vaccine.  Pt had HA approx 4 hours after vaccine and described as severe, continued for several weeks.  Pt reports peri-ocular pain that started in conjunction with generalized myalgia.  Then developed polyarthraglia 4-5 days post vaccine.  Pt has had muscle cramping as well.  Symptoms have been prolonged and are still present today (7/24/2023).  Pt has also had itching on extremities, no rash.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Fever of 102 noted the next day, however pt felt fever approx 3-4 hours after dose.  Had fever for up to 4 days post vaccine.  Pt had HA approx 4 hours after vaccine and described as severe, continued for several weeks.  Pt reports peri-ocular pain that started in conjunction with generalized myalgia.  Then developed polyarthraglia 4-5 days post vaccine.  Pt has had muscle cramping as well.  Symptoms have been prolonged and are still present today (7/24/2023).  Pt has also had itching on extremities, no rash.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: N/A.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, Aspiration, Barium swallow abnormal, Bifascicular block
Clinical narrative: Patient is a 79 y.o. male with a history of CVA with left hemiplegia, prostate cancer and recent admission 5/12/235/15/23 for acute CVA who presented to RMH 6/2/2023 with progressive shortness of breath and positive COVID at facility.    1. COVID-19 Infection: Symptom onset 5/29/23 with headache, tested positive 6/2/23 at SNF. Decadron x 10 days continued; weaned off O2. Isolation per protocol.  2. Acute on Chronic Respiratory Failure: ABG on admit showed pH 7.33 and CO2 56.9 indicative of chronic retention. SaO2 88% on admit due to COVID; weaned off O2 gradually.  3. Elevated Troponin: Prior troponin 24, 25 noted in 2019. Troponin 25 on 6/2/23. Suspected demand. EKG 6/2/23 showed bifascicular block without ST changes noted. No further evaluation necessary. 4. Bifascicular Block: Noted on EKGs prior to admission with RBBB and LAFB. s/p loop recorder 2016 and 2019. Follows with Dr. (EP)TTE 5/14/23 with slightly abnormal septal wall motion, EF 55%.  5. Dysphagia: Due to CVA in 5/2023. MBS 5/13/23 showed aspiration and patient placed on nectar thick liquids. SLP followed. 6. CVA: Multiple with residual left hemiplegia (requiring wheelchair) and residual dysphagia. Follows with Dr. (PMR) and, CNP (Neuro). Home ASA, Plavix and statin resumed. 7. Hypothyroidism: S/p thyroidectomy in 1995. Home medications resumed. 8. Prostate Adenocarcinoma: Per history. Follows with Dr.  9. Code status: Full code, patient transitioned to DNR-CCA prior admission but was uncertain this admit.  10. DVT Prophylaxis: Lovenox
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood gases abnormal, Blood pH decreased, COVID-19, Carbon dioxide increased, Cerebrovascular accident
Clinical narrative: Patient is a 79 y.o. male with a history of CVA with left hemiplegia, prostate cancer and recent admission 5/12/235/15/23 for acute CVA who presented to RMH 6/2/2023 with progressive shortness of breath and positive COVID at facility.    1. COVID-19 Infection: Symptom onset 5/29/23 with headache, tested positive 6/2/23 at SNF. Decadron x 10 days continued; weaned off O2. Isolation per protocol.  2. Acute on Chronic Respiratory Failure: ABG on admit showed pH 7.33 and CO2 56.9 indicative of chronic retention. SaO2 88% on admit due to COVID; weaned off O2 gradually.  3. Elevated Troponin: Prior troponin 24, 25 noted in 2019. Troponin 25 on 6/2/23. Suspected demand. EKG 6/2/23 showed bifascicular block without ST changes noted. No further evaluation necessary. 4. Bifascicular Block: Noted on EKGs prior to admission with RBBB and LAFB. s/p loop recorder 2016 and 2019. Follows with Dr. (EP)TTE 5/14/23 with slightly abnormal septal wall motion, EF 55%.  5. Dysphagia: Due to CVA in 5/2023. MBS 5/13/23 showed aspiration and patient placed on nectar thick liquids. SLP followed. 6. CVA: Multiple with residual left hemiplegia (requiring wheelchair) and residual dysphagia. Follows with Dr. (PMR) and, CNP (Neuro). Home ASA, Plavix and statin resumed. 7. Hypothyroidism: S/p thyroidectomy in 1995. Home medications resumed. 8. Prostate Adenocarcinoma: Per history. Follows with Dr.  9. Code status: Full code, patient transitioned to DNR-CCA prior admission but was uncertain this admit.  10. DVT Prophylaxis: Lovenox
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Echocardiogram abnormal, Ejection fraction normal, Electrocardiogram abnormal
Clinical narrative: Patient is a 79 y.o. male with a history of CVA with left hemiplegia, prostate cancer and recent admission 5/12/235/15/23 for acute CVA who presented to RMH 6/2/2023 with progressive shortness of breath and positive COVID at facility.    1. COVID-19 Infection: Symptom onset 5/29/23 with headache, tested positive 6/2/23 at SNF. Decadron x 10 days continued; weaned off O2. Isolation per protocol.  2. Acute on Chronic Respiratory Failure: ABG on admit showed pH 7.33 and CO2 56.9 indicative of chronic retention. SaO2 88% on admit due to COVID; weaned off O2 gradually.  3. Elevated Troponin: Prior troponin 24, 25 noted in 2019. Troponin 25 on 6/2/23. Suspected demand. EKG 6/2/23 showed bifascicular block without ST changes noted. No further evaluation necessary. 4. Bifascicular Block: Noted on EKGs prior to admission with RBBB and LAFB. s/p loop recorder 2016 and 2019. Follows with Dr. (EP)TTE 5/14/23 with slightly abnormal septal wall motion, EF 55%.  5. Dysphagia: Due to CVA in 5/2023. MBS 5/13/23 showed aspiration and patient placed on nectar thick liquids. SLP followed. 6. CVA: Multiple with residual left hemiplegia (requiring wheelchair) and residual dysphagia. Follows with Dr. (PMR) and, CNP (Neuro). Home ASA, Plavix and statin resumed. 7. Hypothyroidism: S/p thyroidectomy in 1995. Home medications resumed. 8. Prostate Adenocarcinoma: Per history. Follows with Dr.  9. Code status: Full code, patient transitioned to DNR-CCA prior admission but was uncertain this admit.  10. DVT Prophylaxis: Lovenox
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test positive, Troponin increased
Clinical narrative: Patient is a 79 y.o. male with a history of CVA with left hemiplegia, prostate cancer and recent admission 5/12/235/15/23 for acute CVA who presented to RMH 6/2/2023 with progressive shortness of breath and positive COVID at facility.    1. COVID-19 Infection: Symptom onset 5/29/23 with headache, tested positive 6/2/23 at SNF. Decadron x 10 days continued; weaned off O2. Isolation per protocol.  2. Acute on Chronic Respiratory Failure: ABG on admit showed pH 7.33 and CO2 56.9 indicative of chronic retention. SaO2 88% on admit due to COVID; weaned off O2 gradually.  3. Elevated Troponin: Prior troponin 24, 25 noted in 2019. Troponin 25 on 6/2/23. Suspected demand. EKG 6/2/23 showed bifascicular block without ST changes noted. No further evaluation necessary. 4. Bifascicular Block: Noted on EKGs prior to admission with RBBB and LAFB. s/p loop recorder 2016 and 2019. Follows with Dr. (EP)TTE 5/14/23 with slightly abnormal septal wall motion, EF 55%.  5. Dysphagia: Due to CVA in 5/2023. MBS 5/13/23 showed aspiration and patient placed on nectar thick liquids. SLP followed. 6. CVA: Multiple with residual left hemiplegia (requiring wheelchair) and residual dysphagia. Follows with Dr. (PMR) and, CNP (Neuro). Home ASA, Plavix and statin resumed. 7. Hypothyroidism: S/p thyroidectomy in 1995. Home medications resumed. 8. Prostate Adenocarcinoma: Per history. Follows with Dr.  9. Code status: Full code, patient transitioned to DNR-CCA prior admission but was uncertain this admit.  10. DVT Prophylaxis: Lovenox
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: The day after the administration, patient reported joint pain, low grade fever, arm soreness and redness.  Systemic symptoms abated over the next 2 days but patient called the pharmacy on 7/24 to report persistent arm redness, swelling and the fact that it was hot to touch still. Patient did not report seeking any medical attention for these symptoms as of the date of this report and stated her symptoms were improving.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: The day after the administration, patient reported joint pain, low grade fever, arm soreness and redness.  Systemic symptoms abated over the next 2 days but patient called the pharmacy on 7/24 to report persistent arm redness, swelling and the fact that it was hot to touch still. Patient did not report seeking any medical attention for these symptoms as of the date of this report and stated her symptoms were improving.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Laboratory test, Syncope
Clinical narrative: Syncopal episode over 24 hours after the vaccination. Still feeling tired after 5 days.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Rash
Clinical narrative: On Saturday, July 22nd, customer reports seeing redness behind her ear.  Sunday she went to an urgent care because she then saw a rash behind her ear and felt pain.  She was prescribed Valtrex.   Monday she went to her PCP, she was prescribed gabapentin and lidocaine topical.  PCP told her that she had shingles.
Age: 1.5
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects. Patient received incorrect dose.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthritis
Clinical narrative: Beginning in the end of 2022, (Current hand Ahtritis got worst)/Since Feb 2023, both hands are gradually getting worse and feeling more pain; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (Beginning in the end of 2022, (Current hand Ahtritis got worst)/Since Feb 2023, both hands are gradually getting worse and feeling more pain) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A, 011A21A and 066F21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Hand arthritis.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2022, the patient experienced ARTHRITIS (Beginning in the end of 2022, (Current hand Ahtritis got worst)/Since Feb 2023, both hands are gradually getting worse and feeling more pain). At the time of the report, ARTHRITIS (Beginning in the end of 2022, (Current hand Ahtritis got worst)/Since Feb 2023, both hands are gradually getting worse and feeling more pain) had not resolved.            Concomitant product use was not provided by the reporter.  It was reported that in the end of 2022, Current hand Arthritis got worst, and needed to visit physician. Since prior to 2022 right hand exhibited no symptoms. Since Feb-2023, both hands are gradually getting worse and feeling more pain. Inquiring if other vaccine recipients had exhibited same symptoms. Needs to know if Moderna is working on this same issue using MRNA technology.  Treatment information was not provided.   Company Comment: This is a spontaneous case concerning an elderly female patient with current condition of hand arthritis, who experienced the non-serious unexpected AESI of Arthritis, reported as Arthritis aggravated. The event occurred approximately from year 10 months to almost 2 years after the first and third booster dose of mRNA-1273 vaccine, respectively, received as part of COVID-19 vaccination schedule. The patient also received a fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) almost 7 months prior to the event. Clinical course, supportive diagnostic procedures, circumstances leading to the event, were not provided. The outcome of the event was reported as not recovered. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-733401 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733401:Bivalent
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination Adverse Reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination Adverse Reaction) in a 21-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jun-2023, the patient experienced IMMUNISATION REACTION (Vaccination Adverse Reaction). At the time of the report, IMMUNISATION REACTION (Vaccination Adverse Reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pyrexia
Clinical narrative: little redness; chills; slight fever; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (little redness), CHILLS (chills) and PYREXIA (slight fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A, 011L20A, 939904 and 014B22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Sleep apnea (on CPAP- diagnosed even before she had the 1st dose of the Moderna Covid-19 vaccine).   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced ERYTHEMA (little redness). 03-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (slight fever). On 04-Feb-2021, ERYTHEMA (little redness), CHILLS (chills) and PYREXIA (slight fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient have received fifth dose of MODERNA COVID-19 VACCINE, BIVALENT in the past, the last one of which was in 11-OCT-2022 (Batch: 053D22A ). and she did not have any serious side effects. No treatment information was reported.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anaemia, Asthenia, Blood creatine, Blood test, Chest X-ray
Clinical narrative: discomfort in arm; Another blood test said they were anemic; feeling uncomfortable; They are in bed everyday with no energy at all; Started to get tired; started to get nauseous; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all) and FATIGUE (Started to get tired) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy.    On 20-Jun-2023, the patient received fourth 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 LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all), FATIGUE (Started to get tired) and NAUSEA (started to get nauseous). At the time of the report, LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all), FATIGUE (Started to get tired) and NAUSEA (started to get nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatine: creatine was off the scale. On an unknown date, Blood test: Anemic. On an unknown date, Chest X-ray: everything was okay. On an unknown date, Red blood cell count: Decreased. On an unknown date, Weight: loss.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had an oral contrast of their abdomen and everything was relatively okay.Doctor has not prescribed any medications to them. Patient also reported losing weight like mad.  No treatment information was reported.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Feeling abnormal, Limb discomfort, Nausea, Red blood cell count
Clinical narrative: discomfort in arm; Another blood test said they were anemic; feeling uncomfortable; They are in bed everyday with no energy at all; Started to get tired; started to get nauseous; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all) and FATIGUE (Started to get tired) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy.    On 20-Jun-2023, the patient received fourth 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 LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all), FATIGUE (Started to get tired) and NAUSEA (started to get nauseous). At the time of the report, LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all), FATIGUE (Started to get tired) and NAUSEA (started to get nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatine: creatine was off the scale. On an unknown date, Blood test: Anemic. On an unknown date, Chest X-ray: everything was okay. On an unknown date, Red blood cell count: Decreased. On an unknown date, Weight: loss.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had an oral contrast of their abdomen and everything was relatively okay.Doctor has not prescribed any medications to them. Patient also reported losing weight like mad.  No treatment information was reported.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Weight
Clinical narrative: discomfort in arm; Another blood test said they were anemic; feeling uncomfortable; They are in bed everyday with no energy at all; Started to get tired; started to get nauseous; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all) and FATIGUE (Started to get tired) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy.    On 20-Jun-2023, the patient received fourth 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 LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all), FATIGUE (Started to get tired) and NAUSEA (started to get nauseous). At the time of the report, LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all), FATIGUE (Started to get tired) and NAUSEA (started to get nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatine: creatine was off the scale. On an unknown date, Blood test: Anemic. On an unknown date, Chest X-ray: everything was okay. On an unknown date, Red blood cell count: Decreased. On an unknown date, Weight: loss.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had an oral contrast of their abdomen and everything was relatively okay.Doctor has not prescribed any medications to them. Patient also reported losing weight like mad.  No treatment information was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Caller stated he received the bivalent Moderna COVID19 vaccine 7 times in the time; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Caller stated he received the bivalent Moderna COVID19 vaccine 7 times in the time) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Kidney transplant. Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Caller stated he received the bivalent Moderna COVID19 vaccine 7 times in the time) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Caller stated he received the bivalent Moderna COVID19 vaccine 7 times in the time) 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 EXTRA DOSE ADMINISTERED (Caller stated he received the bivalent Moderna COVID19 vaccine 7 times in the time).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient responded well to the majority of vaccines in the past. No treatment information was provided.   Reporter did not allow further contact
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; Patient was supposed to get the 3rd dose of the Moderna vaccine but was administer the Pfizer vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was supposed to get the 3rd dose of the Moderna vaccine but was administer the Pfizer vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Patient parents did not describe any medical History or Condition.    On 30-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2023, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 19-Jul-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was supposed to get the 3rd dose of the Moderna vaccine but was administer the Pfizer vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was supposed to get the 3rd dose of the Moderna vaccine but was administer the Pfizer vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was supposed to get the 3rd dose of the Moderna vaccine but was administer the Pfizer vaccine).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Although it was refrigerated, it has been out of the freezer 41 days; No adverse event; Vial was taken out of the freezer June 8th and placed in refrigerator. Vaccine was administered 19-Jul-2023; Patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) as first dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was taken out of the freezer June 8th and placed in refrigerator. Vaccine was administered 19-Jul-2023), WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) as first dose), PRODUCT STORAGE ERROR (Although it was refrigerated, it has been out of the freezer 41 days) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2023, 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 19-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was taken out of the freezer June 8th and placed in refrigerator. Vaccine was administered 19-Jul-2023) and WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) as first dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Although it was refrigerated, it has been out of the freezer 41 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was taken out of the freezer June 8th and placed in refrigerator. Vaccine was administered 19-Jul-2023), WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) as first dose), PRODUCT STORAGE ERROR (Although it was refrigerated, it has been out of the freezer 41 days) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vial was taken out of the freezer June 8th and placed in refrigerator. Vaccine was administered 19-Jul-2023), WRONG PRODUCT ADMINISTERED (Patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) as first dose) and PRODUCT STORAGE ERROR (Although it was refrigerated, it has been out of the freezer 41 days).    No concomitant information was reported. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: She broke out in hives all over her body and continues to have hives/hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (She broke out in hives all over her body and continues to have hives/hives) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension (Taking Amlodipine.). Concomitant products included AMLODIPINE for Hypertension.    On 04-Jan-2023, the patient received fourth 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 URTICARIA (She broke out in hives all over her body and continues to have hives/hives). The patient was treated with FEXOFENADINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE (ALLEGRA F) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (She broke out in hives all over her body and continues to have hives/hives) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported by patient that she received 4 doses of Moderna COVID-19 vaccine.  First dose, Shot #1: First Primary monovalent dose on 13MAR2021 (Lot# 036A21A & Exp. Date: unknown).  Second dose, Shot #2: 2nd Primary monovalent dose on 10APR2021 (Lot# 042B21A & Exp. Date: unknown). Third dose, Shot #3: First Monovalent Booster dose on 09NOV2021 (Lot# 037C21A & Exp. Date unknown).  Patient stated that she did not receive another vaccine within 4 months of the Bivalent booster. Patient stated that she did not had any reactions with the first 3 vaccines. Two weeks after the Bivalent booster, she broke out in hives all over her body and continued to had hives. At first it was not going away. She spoke to her doctor and started taking Allegra. If she took the Allegra every day the hives (called it Line Hives) disappear. If she missed the Allegra for just one day, the hives came back. Her doctor told her that she was not the first to get hives from Moderna Vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2023: Follow up received and had no new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Patient received dose 1 on 21-Sep-2021 and second dose on 21-Mar-2022; Five months after being vaccinated she contracted mild covid symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Five months after being vaccinated she contracted mild covid symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 21-Sep-2021 and second dose on 21-Mar-2022) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 048L21A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Mar-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 21-Sep-2021 and second dose on 21-Mar-2022). In 2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Five months after being vaccinated she contracted mild covid symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for Symptomatic COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Five months after being vaccinated she contracted mild covid symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 21-Sep-2021 and second dose on 21-Mar-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive and Negative.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient had no fever or sore throat. The patient took Paxlovid and three days later, the patient was tested negative. The patient was sneezing around her husband and gave covid to him..   This case was linked to US-MODERNATX, INC.-MOD-2023-734152 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734152:husband case
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: He had covid for a whole week, felt tired, sneezing; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He had covid for a whole week, felt tired, sneezing) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Mar-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (He had covid for a whole week, felt tired, sneezing). On 16-Jul-2023, COVID-19 (He had covid for a whole week, felt tired, sneezing) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734135 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734135:Wife case
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: She states that after the first shot, she started having pain in the left arm. After the 2nd shot the other arm started hurting. The arm was sore./ pain in both arms, and shoulders. /arm started hurting.; headaches / The pain shoots up to her neck and head from both sides of her body.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (She states that after the first shot, she started having pain in the left arm. After the 2nd shot the other arm started hurting. The arm was sore./ pain in both arms, and shoulders. /arm started hurting.) and HEADACHE (headaches / The pain shoots up to her neck and head from both sides of her body.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 017B21A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL SUCCINATE for Blood pressure high.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (She states that after the first shot, she started having pain in the left arm. After the 2nd shot the other arm started hurting. The arm was sore./ pain in both arms, and shoulders. /arm started hurting.) and HEADACHE (headaches / The pain shoots up to her neck and head from both sides of her body.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (She states that after the first shot, she started having pain in the left arm. After the 2nd shot the other arm started hurting. The arm was sore./ pain in both arms, and shoulders. /arm started hurting.) and HEADACHE (headaches / The pain shoots up to her neck and head from both sides of her body.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. On 20-Jul-2023 patient had pain in both arms and shoulders. It was reported that since the COVID-19 vaccination, patient had not received a flu shot or any other shots. Patient stated that even Tylenol does not help and she can not sleep at nights because of the pain.
Sex: F
Vaccine: PNC20
Symptoms: Heart rate increased, Incorrect dose administered by device, Needle issue, Nervousness, Palpitations
Clinical narrative: Patient jumped while administering Prevnar 20 and needle bent; Patient received half of the dose; racing heart rate; had a vagal response; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 70-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (intervention required), outcome "unknown", described as "racing heart rate"; PRESYNCOPE (intervention required), outcome "unknown", described as "had a vagal response"; INCORRECT DOSE ADMINISTERED BY DEVICE (intervention required), outcome "unknown", described as "Patient received half of the dose"; NEEDLE ISSUE (intervention required), outcome "unknown", described as "Patient jumped while administering Prevnar 20 and needle bent". The event "racing heart rate" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: racing. Therapeutic measures were taken as a result of heart rate increased, presyncope.  Clinical course: Patient jumped while administering Prevnar 20 and needle bent. Patient received half of the dose and had a vagal response which she was treated for. 2 hours later was seen and treated in ER for racing heart rate.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Presyncope
Clinical narrative: Patient jumped while administering Prevnar 20 and needle bent; Patient received half of the dose; racing heart rate; had a vagal response; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 70-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (intervention required), outcome "unknown", described as "racing heart rate"; PRESYNCOPE (intervention required), outcome "unknown", described as "had a vagal response"; INCORRECT DOSE ADMINISTERED BY DEVICE (intervention required), outcome "unknown", described as "Patient received half of the dose"; NEEDLE ISSUE (intervention required), outcome "unknown", described as "Patient jumped while administering Prevnar 20 and needle bent". The event "racing heart rate" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: racing. Therapeutic measures were taken as a result of heart rate increased, presyncope.  Clinical course: Patient jumped while administering Prevnar 20 and needle bent. Patient received half of the dose and had a vagal response which she was treated for. 2 hours later was seen and treated in ER for racing heart rate.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.