chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Office would draw up all COVID booster vaccines at the beginning of the day and discard vial. They kept a sticky note with bivalent  NDC, lot and expiration date and used that data to enter into the EMR. At some point the realized that on some days they had pulled and administered monovalent instead of the bivalent booster as intended. Office is unable to say with certainty who received monovalent or bivalent.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Office would draw up all COVID booster vaccines at the beginning of the day and discard vial. They kept a sticky note with bivalent  NDC, lot and expiration date and used that data to enter into the EMR. At some point the realized that on some days they had pulled and administered monovalent instead of the bivalent booster as intended. Office is unable to say with certainty who received monovalent or bivalent.
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site pain, X-ray limb
Clinical narrative: Persistent pain to left deltoid
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: Developed IBS and continue to have trouble. Went to primary care doctor and gastroentorolgist. They said wait and see if gets better.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Urticaria
Clinical narrative: Patient had the J and J vaccine offered at her college in 2020 and had no reaction to that vaccine. In Jan 2021 she had to get a booster even though there wasn?t one for J&J and J&J was pulled from market. Had to be boosted with Moderna  Jan 2021 in order to return to college. Difficulty breathing, within 15 minutes of injection,  irregular border hives all over trunk of body at 45 minutes which continued over the next couple hours. Pharmacy staff had no idea how to address adverse reaction, Just said it was rare and go to ER.  Pt only had the Moderna vaccine that day, even though pharmacy staff tried to push her to get flu shot as well. Our allergist was across the street and able to see Pt within 1.5 hours of reaction. Diagnosis of real allergic reaction to the Moderna vaccine. Due to this reaction our allergist stated it is not recommended for Pt to get any other mRNA boosters. Benedryl and albuterol inhaler administered. Was fine by the next day.
Age: 58.0
Sex: U
Vaccine: COVID19-2
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives over entire body, even eye lids. Fever
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth, Product administered to patient of inappropriate age
Clinical narrative: Patient (age 56) was accidentally given Fluzone HD while not indicated for it.  The pharmacy contacted the patient to communicate that an error had occurred. The only issue the patient described was that of a dry mouth at the time of call on October 19th, 2022 but feeling fine, otherwise.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dysphonia, Erythema, Swelling
Clinical narrative: Redness, swelling, hoarseness, weakness
Age: 65.0
Sex: M
Vaccine: COVID19-2, FLU4, PNC20
Symptoms: Injection site swelling, Neuralgia, Pain
Clinical narrative: Swollen arm for three weeks( vaccination given at the same site). Patient experiencing shooting nerve pain
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: child was given 0.5ml of adult moderna bivalent
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: PT RECEIVED PFIZER PEDIATRIC BIVALENT BUT HAD NOT RECEIVED THE PRIMARY SERIES YET (OUTSIDE OF CDC GUIDELINES)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Limb discomfort, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: I developed a very painful swollen lymph node in my left armpit, the evening after the shot.  This continued to be painful for weeks. Now almost a year later, the pain comes and goes. It flares up before my period (never had this before the shot) and I can feel it in my armpit. Sometimes it causes discomfort shooting down my arm.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan normal
Clinical narrative: I developed a very painful swollen lymph node in my left armpit, the evening after the shot.  This continued to be painful for weeks. Now almost a year later, the pain comes and goes. It flares up before my period (never had this before the shot) and I can feel it in my armpit. Sometimes it causes discomfort shooting down my arm.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Swollen tongue
Clinical narrative: felt tongue swelling very soon after injection, starting under and to one side of tongue then all of tongue.  light headedness a few minutes later.  Subsided within 30 minutes.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary arterial stent insertion, Myocardial infarction
Clinical narrative: Heart Attack
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: injected expired vaccine, no symptoms
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Just discovered that the immunization the patient recieved had expired on 9/30/2022
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Just discovered that the immunization that the patient recieved had actually expired on 9/30/2022
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Just discovered that the immunization the patient recieved had expired on 9/30/2022
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Just discovered that the immunization that the patient recieved had actually expired on 9/30/2022
Age: 1.92
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: On 10/14/2022 HPV vaccine was administered inadvertently to this client (child) 1 yr and 11 month old.  On 10/17/2022 spoke with childs father he states his daughter is doing well, playing well, No Red, No swelling to injection site and No fever has occurred.
Sex: U
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Overnight after receiving covid-19 updated Moderna vaccine, on left arm, had swelling and redness on the upper arm.
Age: 49.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Bell's palsy
Clinical narrative: Pt developed facial numbness on 8/4/2022 that progressed to unilateral upper and lower facial numbness and weakness on 8/9/2022.
Age: 49.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Asthenia, Bell's palsy, Hypoaesthesia
Clinical narrative: Pt developed facial numbness on 8/4/2022 that progressed to unilateral upper and lower facial numbness and weakness on 8/9/2022.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Pyrexia
Clinical narrative: The caller stated the patient developed a rash/palmar lesions; The caller stated the patient developed a rash, cold like symptoms, and a fever; The caller stated, "Maybethe brother transmitted it to him."; had palmar lesions and that the lesions resemble hand, foot, mouth disease.; This spontaneous report has been received from a physician concerning to a 2-year-old child male patient.The patient's medical history, concurrent conditions, previous drug reactions or allergies were not provided. Concomitant therapies included sterile diluent.  On an unknown date (also reported as "when he was one year old"),the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, vaccination scheme frequency, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was mentioned that the patient did not experience any symptoms at that time.  Then, on an unknown date, it was reported that the patient developed rash, cold like symptoms (nasopharyngitis) and fever at an unspecified time after his brother received both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) concomitantly. The caller stated, "Maybe the brother transmitted it to him" (secondary transmission); the patient also experienced palmar lesions and that lessions resemble had, foot and mouth disease (hand-foot-and-mouth disease).  The outcome of the events was reported as recovering.  The causality assessment between the suspect therapy regarding the events, were not provided.   This is one of two reports referring to siblings.; Sender's Comments:  US-009507513-2209USA005673:case from his brother
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Hand-foot-and-mouth disease, Nasopharyngitis, Pyrexia, Rash, Secondary transmission
Clinical narrative: The caller stated the patient developed a rash/palmar lesions; The caller stated the patient developed a rash, cold like symptoms, and a fever; The caller stated, "Maybethe brother transmitted it to him."; had palmar lesions and that the lesions resemble hand, foot, mouth disease.; This spontaneous report has been received from a physician concerning to a 2-year-old child male patient.The patient's medical history, concurrent conditions, previous drug reactions or allergies were not provided. Concomitant therapies included sterile diluent.  On an unknown date (also reported as "when he was one year old"),the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, vaccination scheme frequency, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was mentioned that the patient did not experience any symptoms at that time.  Then, on an unknown date, it was reported that the patient developed rash, cold like symptoms (nasopharyngitis) and fever at an unspecified time after his brother received both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) concomitantly. The caller stated, "Maybe the brother transmitted it to him" (secondary transmission); the patient also experienced palmar lesions and that lessions resemble had, foot and mouth disease (hand-foot-and-mouth disease).  The outcome of the events was reported as recovering.  The causality assessment between the suspect therapy regarding the events, were not provided.   This is one of two reports referring to siblings.; Sender's Comments:  US-009507513-2209USA005673:case from his brother
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Cough, Decreased appetite, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: The caller stated the patient developed a rash/palmar lesions; The caller stated the patient developed a rash, cold like symptoms, and a fever; The caller stated, "Maybethe brother transmitted it to him."; had palmar lesions and that the lesions resemble hand, foot, mouth disease.; This spontaneous report has been received from a physician concerning to a 2-year-old child male patient.The patient's medical history, concurrent conditions, previous drug reactions or allergies were not provided. Concomitant therapies included sterile diluent.  On an unknown date (also reported as "when he was one year old"),the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, vaccination scheme frequency, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was mentioned that the patient did not experience any symptoms at that time.  Then, on an unknown date, it was reported that the patient developed rash, cold like symptoms (nasopharyngitis) and fever at an unspecified time after his brother received both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) concomitantly. The caller stated, "Maybe the brother transmitted it to him" (secondary transmission); the patient also experienced palmar lesions and that lessions resemble had, foot and mouth disease (hand-foot-and-mouth disease).  The outcome of the events was reported as recovering.  The causality assessment between the suspect therapy regarding the events, were not provided.   This is one of two reports referring to siblings.; Sender's Comments:  US-009507513-2209USA005673:case from his brother
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Secretion discharge, Vomiting, Wrong product administered
Clinical narrative: The caller stated the patient developed a rash/palmar lesions; The caller stated the patient developed a rash, cold like symptoms, and a fever; The caller stated, "Maybethe brother transmitted it to him."; had palmar lesions and that the lesions resemble hand, foot, mouth disease.; This spontaneous report has been received from a physician concerning to a 2-year-old child male patient.The patient's medical history, concurrent conditions, previous drug reactions or allergies were not provided. Concomitant therapies included sterile diluent.  On an unknown date (also reported as "when he was one year old"),the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, vaccination scheme frequency, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was mentioned that the patient did not experience any symptoms at that time.  Then, on an unknown date, it was reported that the patient developed rash, cold like symptoms (nasopharyngitis) and fever at an unspecified time after his brother received both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) concomitantly. The caller stated, "Maybe the brother transmitted it to him" (secondary transmission); the patient also experienced palmar lesions and that lessions resemble had, foot and mouth disease (hand-foot-and-mouth disease).  The outcome of the events was reported as recovering.  The causality assessment between the suspect therapy regarding the events, were not provided.   This is one of two reports referring to siblings.; Sender's Comments:  US-009507513-2209USA005673:case from his brother
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: at-home COVID test was positive; at-home COVID test was positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GJ5342, Expiration Date: Apr2023) at the age of 75 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), in arm, on 18Mar2021 as dose 2, single (Lot number: EN6208), in arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 8841), in arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FK9894), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT oral taken for depression (ongoing); CONCERTA oral taken for attention deficit hyperactivity disorder (ongoing); MIRTAZAPINE oral taken for depression (ongoing); OMEPRAZOLE oral taken for flatulence (ongoing). It was reported that on 15Sep2022, patient received the latest Pfizer booster and also the most recent iteration of the seasonal flu shot. On 18Sep2022, patient started having "cold-like" symptoms. On 19Sep2022, patient did one of the at-home Covid tests and it was positive. One half hour later a doctor called the patient to clarify a couple of points and shortly thereafter patient  had a prescription for Paxlovid. Patient reported that his experience with Covid was similar to that of a mild head cold so it seems the vaccination and boosters did what they were designed to do. On 01Oct2022, patient tested Negative for Covid. On 03Oct2022, patient did two additional tests both of which were strong Negatives. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient recovered from the events.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201182172 same patient and suspect drug/different dose;
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: at-home COVID test was positive; at-home COVID test was positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GJ5342, Expiration Date: Apr2023) at the age of 75 years, in arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), in arm, on 18Mar2021 as dose 2, single (Lot number: EN6208), in arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 8841), in arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FK9894), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT oral taken for depression (ongoing); CONCERTA oral taken for attention deficit hyperactivity disorder (ongoing); MIRTAZAPINE oral taken for depression (ongoing); OMEPRAZOLE oral taken for flatulence (ongoing). It was reported that on 15Sep2022, patient received the latest Pfizer booster and also the most recent iteration of the seasonal flu shot. On 18Sep2022, patient started having "cold-like" symptoms. On 19Sep2022, patient did one of the at-home Covid tests and it was positive. One half hour later a doctor called the patient to clarify a couple of points and shortly thereafter patient  had a prescription for Paxlovid. Patient reported that his experience with Covid was similar to that of a mild head cold so it seems the vaccination and boosters did what they were designed to do. On 01Oct2022, patient tested Negative for Covid. On 03Oct2022, patient did two additional tests both of which were strong Negatives. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient recovered from the events.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201182172 same patient and suspect drug/different dose;
Age: 18.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Anxiety, Incorrect product formulation administered
Clinical narrative: Monovalent vaccine given rather than desired bivalent.
Age: 18.0
Sex: F
Vaccine: COVID19, FLU4, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine given rather than desired bivalent.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: covid symptoms included the coughing, fever and not much respiratory involvement; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid symptoms included the coughing, fever and not much respiratory involvement) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F2114 and 039K20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (covid symptoms included the coughing, fever and not much respiratory involvement) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to COVID-19. At the time of the report, COVID-19 (covid symptoms included the coughing, fever and not much respiratory involvement) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication was not provided.  Patient were treated with Medicines.  The covid symptoms included the coughing, fever, not much respiratory involvement, being hospitalized for three days.  Company comment- This spontaneous case concerns a 78-year-old male patient, with no medical history reported, who experienced the serious (hospitalization) unexpected event of COVID-19 approximately 11 months after receiving a booster dose of mRNA-1273 vaccine. First and second doses of mRNA-1273 vaccine were administered in an inappropriate schedule of vaccination (39 days interval). Patient´s COVID symptoms included coughing, fever with not much respiratory involvement. He was hospitalized for three days. The event might be explained by current pandemic outbreak. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-658647 (Patient Link).; Sender's Comments: This spontaneous case concerns a 78-year-old male patient, with no medical history reported, who experienced the serious (hospitalization) unexpected event of COVID-19 approximately 11 months after receiving a booster dose of mRNA-1273 vaccine. First and second doses of mRNA-1273 vaccine were administered in an inappropriate schedule of vaccination (39 days interval). Patient´s COVID symptoms included coughing, fever with not much respiratory involvement. He was hospitalized for three days. The event might be explained by current pandemic outbreak. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid symptoms included the coughing, fever and not much respiratory involvement; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid symptoms included the coughing, fever and not much respiratory involvement) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F2114 and 039K20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (covid symptoms included the coughing, fever and not much respiratory involvement) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to COVID-19. At the time of the report, COVID-19 (covid symptoms included the coughing, fever and not much respiratory involvement) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication was not provided.  Patient were treated with Medicines.  The covid symptoms included the coughing, fever, not much respiratory involvement, being hospitalized for three days.  Company comment- This spontaneous case concerns a 78-year-old male patient, with no medical history reported, who experienced the serious (hospitalization) unexpected event of COVID-19 approximately 11 months after receiving a booster dose of mRNA-1273 vaccine. First and second doses of mRNA-1273 vaccine were administered in an inappropriate schedule of vaccination (39 days interval). Patient´s COVID symptoms included coughing, fever with not much respiratory involvement. He was hospitalized for three days. The event might be explained by current pandemic outbreak. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-658647 (Patient Link).; Sender's Comments: This spontaneous case concerns a 78-year-old male patient, with no medical history reported, who experienced the serious (hospitalization) unexpected event of COVID-19 approximately 11 months after receiving a booster dose of mRNA-1273 vaccine. First and second doses of mRNA-1273 vaccine were administered in an inappropriate schedule of vaccination (39 days interval). Patient´s COVID symptoms included coughing, fever with not much respiratory involvement. He was hospitalized for three days. The event might be explained by current pandemic outbreak. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Blindness unilateral, Retinal vascular occlusion, Vision blurred, Visual impairment
Clinical narrative: Patient reports feeling well after vaccination.  Patient reports he woke up at 5:45am the morning after vaccination (9/30/22) and could not see anything with his left eye.  Patient reports his vision was completely black in the left eye with normal vision in the right.  Patient denied any pain or pressure to the eye.  Patient states his vision had improved by 8:00am and he could see light and shadows but no details.  Patient states he saw the ARNP at his doctors office who referred him to the eye doctor.  Patient was seen OD on 9/30/22 and was diagnosed with a left central retina vascular occlusion with diffuse retinal hemorrhaging, optic disc edema and macular edema.  Patient was referred to an MD.
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Activated partial thromboplastin time, Blindness unilateral, C-reactive protein, Differential white blood cell count, Full blood count
Clinical narrative: Patient reports feeling well after vaccination.  Patient reports he woke up at 5:45am the morning after vaccination (9/30/22) and could not see anything with his left eye.  Patient reports his vision was completely black in the left eye with normal vision in the right.  Patient denied any pain or pressure to the eye.  Patient states his vision had improved by 8:00am and he could see light and shadows but no details.  Patient states he saw the ARNP at his doctors office who referred him to the eye doctor.  Patient was seen OD on 9/30/22 and was diagnosed with a left central retina vascular occlusion with diffuse retinal hemorrhaging, optic disc edema and macular edema.  Patient was referred to an MD.
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Macular oedema, Optic disc disorder, Platelet count, Prothrombin time, Red blood cell sedimentation rate
Clinical narrative: Patient reports feeling well after vaccination.  Patient reports he woke up at 5:45am the morning after vaccination (9/30/22) and could not see anything with his left eye.  Patient reports his vision was completely black in the left eye with normal vision in the right.  Patient denied any pain or pressure to the eye.  Patient states his vision had improved by 8:00am and he could see light and shadows but no details.  Patient states he saw the ARNP at his doctors office who referred him to the eye doctor.  Patient was seen OD on 9/30/22 and was diagnosed with a left central retina vascular occlusion with diffuse retinal hemorrhaging, optic disc edema and macular edema.  Patient was referred to an MD.
Age: 76.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Retinal haemorrhage, Retinal vein occlusion
Clinical narrative: Patient reports feeling well after vaccination.  Patient reports he woke up at 5:45am the morning after vaccination (9/30/22) and could not see anything with his left eye.  Patient reports his vision was completely black in the left eye with normal vision in the right.  Patient denied any pain or pressure to the eye.  Patient states his vision had improved by 8:00am and he could see light and shadows but no details.  Patient states he saw the ARNP at his doctors office who referred him to the eye doctor.  Patient was seen OD on 9/30/22 and was diagnosed with a left central retina vascular occlusion with diffuse retinal hemorrhaging, optic disc edema and macular edema.  Patient was referred to an MD.
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea
Clinical narrative: Patient was falling asleep several times during the day; Chills; Fatigue; Body aches; Joint aches; Some nausea; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Patient was falling asleep several times during the day), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches) and ARTHRALGIA (Joint aches) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient never had COVID positive test or diagnosis and history related to mentioned AE and both acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: Flu vaccine (3 weeks ago) in September 2022. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Allergy to NSAIDs. Concomitant products included CLOPIDOGREL for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL), LOSARTAN, OMEPRAZOLE, ATORVASTATIN, AMLODIPINE BESYLATE and METFORMIN for an unknown indication.    On 14-Oct-2022, 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 14-Oct-2022, the patient experienced SOMNOLENCE (Patient was falling asleep several times during the day), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches), ARTHRALGIA (Joint aches) and NAUSEA (Some nausea). At the time of the report, SOMNOLENCE (Patient was falling asleep several times during the day), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches), ARTHRALGIA (Joint aches) and NAUSEA (Some nausea) had not resolved.            On Mar 2021, the patient received the first dose of Moderna vaccine. In end of Apr 2021, the patient received the second dose of Moderna vaccine . On 10 Nov 2021, the patient received the first booster dose of Moderna vaccine.  The AE cause patient to call the doctor that morning. The patient did not experienced a similar event in the past. It was reported that symptoms were still ongoing and improving a little bit.  No treatment had been given for the symptoms.   This case was linked to MOD-2022-660151 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Patient was falling asleep several times during the day; Chills; Fatigue; Body aches; Joint aches; Some nausea; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Patient was falling asleep several times during the day), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches) and ARTHRALGIA (Joint aches) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient never had COVID positive test or diagnosis and history related to mentioned AE and both acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: Flu vaccine (3 weeks ago) in September 2022. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Allergy to NSAIDs. Concomitant products included CLOPIDOGREL for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL), LOSARTAN, OMEPRAZOLE, ATORVASTATIN, AMLODIPINE BESYLATE and METFORMIN for an unknown indication.    On 14-Oct-2022, 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 14-Oct-2022, the patient experienced SOMNOLENCE (Patient was falling asleep several times during the day), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches), ARTHRALGIA (Joint aches) and NAUSEA (Some nausea). At the time of the report, SOMNOLENCE (Patient was falling asleep several times during the day), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches), ARTHRALGIA (Joint aches) and NAUSEA (Some nausea) had not resolved.            On Mar 2021, the patient received the first dose of Moderna vaccine. In end of Apr 2021, the patient received the second dose of Moderna vaccine . On 10 Nov 2021, the patient received the first booster dose of Moderna vaccine.  The AE cause patient to call the doctor that morning. The patient did not experienced a similar event in the past. It was reported that symptoms were still ongoing and improving a little bit.  No treatment had been given for the symptoms.   This case was linked to MOD-2022-660151 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Somnolence
Clinical narrative: Patient was falling asleep several times during the day; Chills; Fatigue; Body aches; Joint aches; Some nausea; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Patient was falling asleep several times during the day), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches) and ARTHRALGIA (Joint aches) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient never had COVID positive test or diagnosis and history related to mentioned AE and both acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: Flu vaccine (3 weeks ago) in September 2022. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Allergy to NSAIDs. Concomitant products included CLOPIDOGREL for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL), LOSARTAN, OMEPRAZOLE, ATORVASTATIN, AMLODIPINE BESYLATE and METFORMIN for an unknown indication.    On 14-Oct-2022, 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 14-Oct-2022, the patient experienced SOMNOLENCE (Patient was falling asleep several times during the day), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches), ARTHRALGIA (Joint aches) and NAUSEA (Some nausea). At the time of the report, SOMNOLENCE (Patient was falling asleep several times during the day), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches), ARTHRALGIA (Joint aches) and NAUSEA (Some nausea) had not resolved.            On Mar 2021, the patient received the first dose of Moderna vaccine. In end of Apr 2021, the patient received the second dose of Moderna vaccine . On 10 Nov 2021, the patient received the first booster dose of Moderna vaccine.  The AE cause patient to call the doctor that morning. The patient did not experienced a similar event in the past. It was reported that symptoms were still ongoing and improving a little bit.  No treatment had been given for the symptoms.   This case was linked to MOD-2022-660151 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Rhinorrhoea
Clinical narrative: Felt Achy after first primary shot/Felt Achy after  2nd  primary shot; Flu like symptoms after first primary shot/Flu like symptoms after 2nd primary shot; Runny nose after first primary shot/Runny nose after 2nd primary shot; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Felt Achy after first primary shot/Felt Achy after  2nd  primary shot), INFLUENZA LIKE ILLNESS (Flu like symptoms after first primary shot/Flu like symptoms after 2nd primary shot) and RHINORRHOEA (Runny nose after first primary shot/Runny nose after 2nd primary shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Felt Achy after first primary shot/Felt Achy after  2nd  primary shot), INFLUENZA LIKE ILLNESS (Flu like symptoms after first primary shot/Flu like symptoms after 2nd primary shot) and RHINORRHOEA (Runny nose after first primary shot/Runny nose after 2nd primary shot). On 26-Feb-2021, PAIN (Felt Achy after first primary shot/Felt Achy after  2nd  primary shot), INFLUENZA LIKE ILLNESS (Flu like symptoms after first primary shot/Flu like symptoms after 2nd primary shot) and RHINORRHOEA (Runny nose after first primary shot/Runny nose after 2nd primary shot) had resolved.            The concomitant and treatment medication was not reported. The patient had another episode of events achy, flu like symptoms and runny nose after second shot on 23-Mar-2021 and resolved on 26-Mar-2021.   This case was linked to MOD-2021-374714, MOD-2022-660546 (Patient Link).
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: shot at 10:20 am by 12:30 pm I started having severe pain in my upper part of my shoulder.I said to my husband this is strange I am getting very sore and it is not at the injection site it is my arm! By 1:30PM I was in excrutiating  pain.My entire arm to my finger tips. I did have chills no fever.My daughter is a nurse came home that evening checked me out asked me if I could move my arm. I couldnt even move my arm! I tried so hard but the pain was unbearable and I got to lift it off my leg a few inches but was trembling. I tried to reach out to several of my doctors but they all thought it was from the injection site and no one understood the pain I was in even after telling 2 different nurses No your not understanding!! Tuesday 10/18/2022 my daughter took me to the Urgent care where the doctor there confirmed that the shot was given too high up which in turn may have caused inflamation and my nerves to be affected. She did put me on gabapentin and advised me to reach out to a neurologist if not fully recovered in 2 days.I just reached out to one today but can only get there by 11/01/2022.  I do want to clarify that when the pharmacist injected me I said to her WOW I can really feel that going into my body that hurts! Being a lay person I dont know any better. I have had 4 days of Hell and have no intentions of ever getting vaccinated again!! Each day I hope to get better and am slowly but what a horrible experience this is!
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: shot at 10:20 am by 12:30 pm I started having severe pain in my upper part of my shoulder.I said to my husband this is strange I am getting very sore and it is not at the injection site it is my arm! By 1:30PM I was in excrutiating  pain.My entire arm to my finger tips. I did have chills no fever.My daughter is a nurse came home that evening checked me out asked me if I could move my arm. I couldnt even move my arm! I tried so hard but the pain was unbearable and I got to lift it off my leg a few inches but was trembling. I tried to reach out to several of my doctors but they all thought it was from the injection site and no one understood the pain I was in even after telling 2 different nurses No your not understanding!! Tuesday 10/18/2022 my daughter took me to the Urgent care where the doctor there confirmed that the shot was given too high up which in turn may have caused inflamation and my nerves to be affected. She did put me on gabapentin and advised me to reach out to a neurologist if not fully recovered in 2 days.I just reached out to one today but can only get there by 11/01/2022.  I do want to clarify that when the pharmacist injected me I said to her WOW I can really feel that going into my body that hurts! Being a lay person I dont know any better. I have had 4 days of Hell and have no intentions of ever getting vaccinated again!! Each day I hope to get better and am slowly but what a horrible experience this is!
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product administered at inappropriate site, Tremor
Clinical narrative: shot at 10:20 am by 12:30 pm I started having severe pain in my upper part of my shoulder.I said to my husband this is strange I am getting very sore and it is not at the injection site it is my arm! By 1:30PM I was in excrutiating  pain.My entire arm to my finger tips. I did have chills no fever.My daughter is a nurse came home that evening checked me out asked me if I could move my arm. I couldnt even move my arm! I tried so hard but the pain was unbearable and I got to lift it off my leg a few inches but was trembling. I tried to reach out to several of my doctors but they all thought it was from the injection site and no one understood the pain I was in even after telling 2 different nurses No your not understanding!! Tuesday 10/18/2022 my daughter took me to the Urgent care where the doctor there confirmed that the shot was given too high up which in turn may have caused inflamation and my nerves to be affected. She did put me on gabapentin and advised me to reach out to a neurologist if not fully recovered in 2 days.I just reached out to one today but can only get there by 11/01/2022.  I do want to clarify that when the pharmacist injected me I said to her WOW I can really feel that going into my body that hurts! Being a lay person I dont know any better. I have had 4 days of Hell and have no intentions of ever getting vaccinated again!! Each day I hope to get better and am slowly but what a horrible experience this is!
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 antibody test positive
Clinical narrative: Tested positive for Covid
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cardiac flutter, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Headache  Tingling in hands  Numbness in hands and legs  Pain in legs Tired  Pain in back and neck  Blurry vision  Heart flutter
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Paraesthesia, Vision blurred
Clinical narrative: Headache  Tingling in hands  Numbness in hands and legs  Pain in legs Tired  Pain in back and neck  Blurry vision  Heart flutter
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Hyperaesthesia, Lip swelling, Muscular weakness, Pain in extremity
Clinical narrative: Swelling on hands, lower lip and jaw area. Weakness in left arm and very sensitive hands. Pain when there is pressure on hands or joints. Itchiness on the palm of hands. over 1 week since symptoms and still slight swelling.
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Pruritus, Swelling face
Clinical narrative: Swelling on hands, lower lip and jaw area. Weakness in left arm and very sensitive hands. Pain when there is pressure on hands or joints. Itchiness on the palm of hands. over 1 week since symptoms and still slight swelling.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia, Vasculitic rash
Clinical narrative: Vasculitis of nose for about 30 minutes.  No pain nor discharge.  Minor tingling.  No longterm side affect
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Impaired work ability, Metamorphopsia, Vision blurred, Visual acuity reduced, Visual field defect
Clinical narrative: I  received the Pfizer vaccine (2nd booster) on 10/11/2022 @1500, and developed sudden onset of  darkening of visual field , reduction of visual acuity with accompanied visual distortion, I could not see the computer screen at work and became quite blurry.  The incident occured same day at 2115 . I did sit down for 20 minutes and it gradually cleared.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Electrocardiogram
Clinical narrative: Suspected pericarditis; flu shot at 3pm and feeling fine until 2 am that night about waking up with chest tightness and feeling wide awake; as the day progressed tightness worsened and became painful; pain with deep breathing; pain with lieing down in the center of chest or when bending over; went to urgent care around 4pm and they sent me to ED given my symptoms; was in ED until about 9pm and was diagnosised with pericarditis and to take nsaids
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Painful respiration, Pericarditis, Sleep disorder
Clinical narrative: Suspected pericarditis; flu shot at 3pm and feeling fine until 2 am that night about waking up with chest tightness and feeling wide awake; as the day progressed tightness worsened and became painful; pain with deep breathing; pain with lieing down in the center of chest or when bending over; went to urgent care around 4pm and they sent me to ED given my symptoms; was in ED until about 9pm and was diagnosised with pericarditis and to take nsaids
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; administration of expired PROQUAD vaccine to 2 patients; This spontaneous report was received from a registered nurse and refers to a 6-year-old female patient.  The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported.  On 29-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose of 0.5ml, lot number: U009260, which was determined to be valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD), with an expiration date reported as: 19-SEP-2022 (route of administration, and anatomical site of injection were not reported) as prophylaxis (expired product administered). No additional adverse event was reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2209USA009292:
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient had not manifested any side effects; administered the VARIVAX that had expired on 22Sep2022; This spontaneous report was received from a nurse and refers to a 34-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II).  On 24-SEP-2022, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #T032322, expiration date: 22-SEP-2022, route: subdermic, for prophylaxis (anatomical location, and dose were not provided) (expired product administered). The reporter stated that varicella virus vaccine live (oka/merck) (VARIVAX), hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II) were administered by medical assistant (MA) to the patient. When the patient's vaccine record card was printed, the MA discovered the varicella virus vaccine live (oka/merck) (VARIVAX) had expired on 22-SEP-2022. As of the time of the call, the patient had not manifested any side effects. There were no adverse events reported (no adverse event).