chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal mass, Alanine aminotransferase normal, Albumin globulin ratio normal, Anion gap, Antinuclear antibody negative
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Aspartate aminotransferase normal, Basophil count normal, Basophil percentage decreased, Blood albumin normal, Blood alkaline phosphatase increased
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Blood bilirubin normal, Blood calcium normal, Blood chloride increased, Blood creatinine normal, Blood glucose normal
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Blood osmolarity decreased, Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: C-reactive protein normal, Carbon dioxide normal, Cytomegalovirus test negative, Eosinophil count normal, Eosinophil percentage
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Epstein-Barr virus test negative, Fatigue, Full blood count normal, General symptom, Globulin
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Granulocyte percentage, Haematocrit normal, Haemoglobin normal, Hypoaesthesia, Immature granulocyte count
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Laboratory test, Lymphocyte count, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Mean cell volume normal, Mean platelet volume normal, Metabolic function test normal, Monocyte count, Monocyte percentage
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Mononucleosis heterophile test negative, Muscular weakness, Neutrophil count, Neutrophil percentage, Paraesthesia
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Platelet count decreased, Protein total normal, Pyrexia, Red blood cell count normal, Red blood cell nucleated morphology
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Red cell distribution width normal, Rheumatoid factor negative, SARS-CoV-2 test negative, Streptococcus test negative, White blood cell count decreased
Clinical narrative: Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Age: 43.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a RSV vaccine on accident even though the patient was not over the recommended age of 60 years old. Currently, the patient does not have an adverse symptom and is monitoring.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: ligh headed,fainted
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Nausea, Pyrexia
Clinical narrative: fever and nausea and weakness
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Pt started having headaches, nausea/vomiting, diarrhea, and very bad stomach cramps in the middle of the night after taking vaccine the previous day.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Significant injection site related adverse effects -- particularly a rash including redness/tenderness spreading along entirety of upper left arm (shoulder to elbow). Receding after 24+ hours.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Pain in extremity, Wrong product administered
Clinical narrative: Patient was billed for, filled for, dispensed as, and verified, and was told receiving SpikeVax, however, pharmacist administered Comirnaty vaccine instead.  Pt had normal adverse effects associated with Comirnaty (sore arm and headache on day of administration, no other side effects reported by patient).  Updated patient's record infomation 9/28/23 to state she received Comirnaty and the lot and expiration of the vaccine, as well as the prescribing information was provided to patient 9/28/23.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Mobility decreased, Neuralgia, Pain in extremity, Paraesthesia, Paralysis
Clinical narrative: Patient had nerve pain in right leg and tingling in feet. Over the last 12 days it has progressed to "partial paralysis", hard time with mobility
Age: 34.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: Employee noticed local itching and some redness and developed a small clear fluid blister with a few smaller raised blisters in area. Determined was around the Heplisav B site. Had used three different bandaids to differentiate which one was which. Applied coolness to site and told to not scratch/open blister.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Vaccination site erythema, Vaccination site pain
Clinical narrative: Per pt's report: after receiving the vaccine, the vaccination site started to get sore, red, and warm to the touch. The soreness and warmth increased into next day and persisted, and she came in to pharmacy to consult with us what OTC remedies can/should be taken to help control pain. Pt reported warmth and redness just locally (area about the size of her palm around injection site and lower) and pain "from shoulder to elbow".
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination site warmth
Clinical narrative: Per pt's report: after receiving the vaccine, the vaccination site started to get sore, red, and warm to the touch. The soreness and warmth increased into next day and persisted, and she came in to pharmacy to consult with us what OTC remedies can/should be taken to help control pain. Pt reported warmth and redness just locally (area about the size of her palm around injection site and lower) and pain "from shoulder to elbow".
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Monoplegia, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: patient reported nerve pain in right leg and tingling in feet that started after receiving a vaccine 10 days prior. After this vaccine it progressed to "partial paralysis" causing a hard time with mobility.
Age: 67.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: patient presented to pharmacy and had red round area that he states is itchy.  it is in the location the imz were given
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: SWELLING, REDNESS, ITCHING, WARMTH.  PATIENT STATES SHE TOOK BENADRYL AND IT GOT BETTER.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Patients mother brought him into clinic for left arm swelling  after receiving  flulaval. Patient seen by Provider prescribed CEPHALEXIN 250/5 SUS 100ML 250 SUSP. and DIPHENHYDRAMINE 12.5/5 118M 12.5 Liquid.
Age: 1.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Abnormal behaviour, Irritability, Lethargy, Vomiting
Clinical narrative: Received his flu and covid-booster shot at the same appointment.  Within 30 minutes he was lethargic, fussy and vomited twice.  He seemed to return to normal behavior by an hour post-vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was inadvertently administer 2 dose of Covid Vaccine Lot number 8057658 on 09/28/2023.
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: After 6 days the injection site was very tender to touch and bruise.
Age: 19.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: An hour after vaccine swelling and redness started and by 9.27.23 Swelling and redness remained in addition to being warm to touch and very itchy. No hives or SOB noted. Had swelling last year but not this bad and did not have warmth or itching. Had reaction years ago with severe flu like symptoms so had not had another flu vaccine until last year when required by work.
Age: 19.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Pain, Pruritus, Skin warm, Swelling
Clinical narrative: An hour after vaccine swelling and redness started and by 9.27.23 Swelling and redness remained in addition to being warm to touch and very itchy. No hives or SOB noted. Had swelling last year but not this bad and did not have warmth or itching. Had reaction years ago with severe flu like symptoms so had not had another flu vaccine until last year when required by work.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Retching, Seizure like phenomena, Syncope
Clinical narrative: A few moments  after vaccination patient  fainted was lowered to floor by Mom and Pharmacist legs elevated, some red spots on vaccinated arm, begin a seizure type activity.  Gaged but no vomiting, heavy breathing.  Patient came back around after a few minutes.  The mother and patient stayed about 20 more minutes.  Patient  returned to normal had some cold water and snack.  The Mom mentioned the patient had fainted before with vaccination however on the consent answered that question as No.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor, Vomiting
Clinical narrative: Flushot was administered (Fluzone quad) for patient 10 years of age, approximately 5 minutes after administration patient began to vomit. She had 2 episodes and was pale, patient sat down and took deep breaths. Oddly, patient's brother also began vomitting 5 minutes after vaccine administration of fluzone quad as well.  After about 15 minutes patient was able to leave with family.  I called patients mother 3 hours later to check in and patient was doing 100% better, appetite was back and she had eaten dinner. No other concerns at this time.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor, Vomiting
Clinical narrative: Patient recieved flu shot and approximately 5 minutes later he began to vomit.  His sister had received a flu shot prior to him and was vomitting as well. Patient was pale and sat down for 15 minutes and took deep breaths.  He was able to leave with family after 15 minutes.  I called patient's parents to check in 3 hours later and patient was feeling 100% back to normal with an appetite and had eaten dinner with no problems.  No further concerns at this time.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Feeling hot, Flushing, Rash, Rash erythematous
Clinical narrative: feeling hot (flushing) red rashes on face.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Electrocardiogram, Headache, Hypoaesthesia, Injection site erythema
Clinical narrative: Approx 8-12 hours post shot I had a blinding, pounding headache, muscle and joint pain, joint swelling, numbness and tingling. The left arm of injection was red, swollen and hot in a circle surrounding the injection site. The muscle pain and headache subsided a day or two later. The injection site issues also subsided after a few days.  The joint pain and swelling, as well as numbness and tingling, got increasingly worse for the coming weeks and didn't start to subside until 6 months or so post injection. Those symptoms persist, but at a more tolerable daily level. There are occasional flares. I have also had one or two occasions of the left arm redness, swelling and heat returning as if I just got the injection. That lasts a few hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Joint swelling, Myalgia, Nerve conduction studies
Clinical narrative: Approx 8-12 hours post shot I had a blinding, pounding headache, muscle and joint pain, joint swelling, numbness and tingling. The left arm of injection was red, swollen and hot in a circle surrounding the injection site. The muscle pain and headache subsided a day or two later. The injection site issues also subsided after a few days.  The joint pain and swelling, as well as numbness and tingling, got increasingly worse for the coming weeks and didn't start to subside until 6 months or so post injection. Those symptoms persist, but at a more tolerable daily level. There are occasional flares. I have also had one or two occasions of the left arm redness, swelling and heat returning as if I just got the injection. That lasts a few hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Approx 8-12 hours post shot I had a blinding, pounding headache, muscle and joint pain, joint swelling, numbness and tingling. The left arm of injection was red, swollen and hot in a circle surrounding the injection site. The muscle pain and headache subsided a day or two later. The injection site issues also subsided after a few days.  The joint pain and swelling, as well as numbness and tingling, got increasingly worse for the coming weeks and didn't start to subside until 6 months or so post injection. Those symptoms persist, but at a more tolerable daily level. There are occasional flares. I have also had one or two occasions of the left arm redness, swelling and heat returning as if I just got the injection. That lasts a few hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dysstasia, Erythema, Gait disturbance, Peripheral swelling
Clinical narrative: Patient with a large local reaction on right thigh.  Started 1 day post vaccination and he didn't want to stand on the leg  day one.  There was also swelling and redness.  Day two increased swelling and redness.  It was so large the patient was sent home from school for it.  He was able to walk but continued to have a limp.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Dyspnoea, Headache, Heart rate increased, Nausea
Clinical narrative: Headache, shortness of breath, nausea the first day. Fever, chills, rapid heart rate the second day and continued headache.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Headache, shortness of breath, nausea the first day. Fever, chills, rapid heart rate the second day and continued headache.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: red patch on arm at site of injection
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Agency staff administering  flu and covid vaccines. Father was to receive covid vaccine and daughter was being fussy so wanted her to receive flu vaccine first. Agency staff grabbed covid vaccine and gave to 4 yr old in leg instead of giving the flu vaccine. Covid vaccine is for 12 + years of age.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Fatigue, diarrhea
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pt accidentally received fluzone HD instead of the age appropriate fluzone quadrivalent.  pt seems to be doing fine so far.
Age: 78.0
Sex: M
Vaccine: COVID19-2, FLU4, RSV
Symptoms: Chills, Dyspnoea, Fatigue, Fear, Tremor
Clinical narrative: I had the chills to the points that I could not stop shaking. Became very tired and could not stay awake so I had to get into bed at 9:30 whereas I normally retire at 1200 a.m. I could not get my breath and was panting and gasping for air. This lasted until 1100a.m. the next morning and I gradually regained my breath back. It  was a very scary , horrible experience.
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue, soreness in extremities
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Accidental 2nd dose given (first dose 9/20, second 9/27)
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: WOKE NEXT MORNING WITH EXTRMELY LOUD TINNITUS. HAD MILD TINNITUS PREEXISTING. REMAINED VERY LOUD FOR ABOUT 2 HOURS THEN STARTED GOING DOWN BUT HAS NOT RETURNED TO BASE LINE AND IS MUCH WORSE THAN BEFORE
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Wrong product administered
Clinical narrative: Pediarix (Dtap Hep B Polio), Prevnar (pneumococcal) vaccines given in error.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Flu vaccine administered by mistake, not ordered.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: malaise; Body aches/Leg aches; fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise), PAIN (Body aches/Leg aches) and PYREXIA (fever) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 30371) for COVID-19 prophylaxis.     No known allergies.  The patient's past medical history included COVID-19 (lasted 6 days, very mild, no symptoms) on 15-Apr-2022. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1, Lot # 007M20A) on 29-Jan-2021, Moderna COVID-19 vaccine (Dose 2, Lot # 023M20A) on 25-Feb-2021, Moderna COVID-19 vaccine (Dose 2, Lot # 023M20A) on 25-Feb-2021, Moderna COVID-19 vaccine (Dose 2, Lot # 023M20A) on 25-Feb-2021, Moderna COVID-19 vaccine (Dose 3, Lot # 012F21A) on 24-Oct-2021, Moderna COVID-19 vaccine (Dose 4, Lot # 065K21A) on 01-Apr-2022, Moderna COVID-19 bivalent (Dose 5, Lot # C0S9860) on 06-Sep-2022, Moderna COVID-19 bivalent (Dose 6 and Lot # 7180B) on 20-Apr-2023. Past adverse reactions to the above products included Aches & pains in legs with Moderna COVID-19 vaccine; Fever with Moderna COVID-19 vaccine; General body pain with Moderna COVID-19 bivalent and Moderna COVID-19 bivalent; Malaise with Moderna COVID-19 vaccine; and No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 22-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced MALAISE (malaise), PAIN (Body aches/Leg aches) and PYREXIA (fever). On 26-Sep-2023, MALAISE (malaise), PAIN (Body aches/Leg aches) and PYREXIA (fever) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742300, US-MODERNATX, INC.-MOD-2023-742321 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742300:Monovalent case US-MODERNATX, INC.-MOD-2023-742321:Bivalent case
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: I developed a rash on my chest which has since been confirmed as shingles; I developed a rash on my chest; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash.   On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced shingles (Verbatim: I developed a rash on my chest which has since been confirmed as shingles) and rash (Verbatim: I developed a rash on my chest).The outcome of the shingles and rash were not reported.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     It was unknown if the company considered the shingles and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-SEP-2023 The reporter wanted to know what was the danger in taking the shingles shot when one had active shingles. The reporter showed an arm rash to his/her doctor and she said that he/she did not have shingles and said he/she could receive the Shingrix vaccine. The patient got vaccinated and within four days, he/she developed a rash on his/her chest which had since been confirmed as shingles. The patient's doctor had so far refused to confirm whether the rash on his /her arm was the start of shingles.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: I developed a rash on my chest which has since been confirmed as shingles; I developed a rash on my chest; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash.   On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced shingles (Verbatim: I developed a rash on my chest which has since been confirmed as shingles) and rash (Verbatim: I developed a rash on my chest).The outcome of the shingles and rash were not reported.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     It was unknown if the company considered the shingles and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-SEP-2023 The reporter wanted to know what was the danger in taking the shingles shot when one had active shingles. The reporter showed an arm rash to his/her doctor and she said that he/she did not have shingles and said he/she could receive the Shingrix vaccine. The patient got vaccinated and within four days, he/she developed a rash on his/her chest which had since been confirmed as shingles. The patient's doctor had so far refused to confirm whether the rash on his /her arm was the start of shingles.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The healthcare worker is reporting that a patient received improperly stored vaccine.; No adverse event; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown day, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (1 dosage form, lot #X0006983 (lot number X0006983 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX)), expiration date 07-MAR-2025 or lot #x000999, expiration date 09-JAN-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). It was unknown which of the two lots was given to the patient.   On unknown dates, the vaccines experienced temperature excursion of 6 degrees Fahrenheit (F) up to 14 F for 10 hours and 14 F up to 46 F for 3 hours 30 minutes. No additional adverse events (AEs) were reported (No adverse event). No further information was provided. No previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA005860:linked case
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 78-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 as dose 5 (booster), single (Lot number: GJ3268) at the age of 77 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Sep2023 to 18Sep2023.  Additional information: The patient had no known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
Age: 19.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: swelling, paimn, warm to touch and itching
Age: 19.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Pain, Pruritus, Skin warm, Swelling
Clinical narrative: swelling, paimn, warm to touch and itching
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Electrocardiogram normal, Extrasystoles, Fatigue, Heart rate increased
Clinical narrative: Started having  skipped heart beats & high resting heart rate April of 2023. Have been to several physicians and was diagnosed with PVCs/PACs. Resting heart rates of 110-140. Extreme fatigue and exhaustion, working as a registered nurse . Never had issues before, had an echocardiogram years ago that was normal.Now seeing cardiologist for further investigation. Also on 9/28/23 diagnosed with pityriadis rosea.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pityriasis rosea, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: Started having  skipped heart beats & high resting heart rate April of 2023. Have been to several physicians and was diagnosed with PVCs/PACs. Resting heart rates of 110-140. Extreme fatigue and exhaustion, working as a registered nurse . Never had issues before, had an echocardiogram years ago that was normal.Now seeing cardiologist for further investigation. Also on 9/28/23 diagnosed with pityriadis rosea.
Age: 82.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Product preparation issue
Clinical narrative: RSV Arexvy diluent only given
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Catheterisation cardiac, Chest pain, Myocarditis
Clinical narrative: On 09/13/2023 I woke up with chest pain.  thought it was indigestion.  However, after eating 6 minutes it got worse.  I then called 911 and within 45 minutes I was at the Emergency Room.  I tested my blood twice and saw abnormality and catheterized my heart and found out I had Myocarditis, when at first, they thought it was a heart attack.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Chills, headache, no appetite, nausea, chills, dizziness, fatigue
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea
Clinical narrative: Chills, headache, no appetite, nausea, chills, dizziness, fatigue
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Sleep disorder, Tremor
Clinical narrative: woke during night shaking, got up at 3:20 AM checked temperature 99.8 ,  took 2 Tylenol, within 60 minutes shaking stopped and while temperature remained at 99.8 60 minutes after 1st checked.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Swollen/tingling upper Lip. Administered Benadryl + epi, and medrol.  Swelling of upper lip decreased after epinephrine. He resolved of sx with an hour.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None; Patient did not get any adverse reaction with the vaccine given
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None Patent did not give any adverse reactions with the vaccine given on 9/12/2023
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None; Patient did not get any adverse reaction with the vaccine given.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None; Patient did not get any adverse reactions from the vaccine
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Death, Ruptured cerebral aneurysm, Subarachnoid haemorrhage
Clinical narrative: RUPTURED CEREBRAL ANEURYSM AND SUBARRACHNOID HEMMORRAGE BILAT AND DEATH
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: NSTEMI
Age: 73.0
Sex: F
Vaccine: FLU4, PNC20, RSV
Symptoms: Asthenia, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: She got her vaccines, her arm was hurting after the first day, she felt a little flu-like, but nothing much.  The next morning she went for her walk and then she came back, and usually she feels good after she walks and instead she felt very weak.  She did her VS and her blood pressure was 95/71, which is normal for her.  Her pulse was 102, oxygen saturation was 92.  She kept retaking her pulse and instead it was going up, which went up to 109.  She was weak the whole morning, but the pulse ox went back up in less than an hour.  The weekness persisted for 5-6 hours.  The heart rate lasted for about 3 hours.  By the evening of that day she was feeling much better.  She was concerned as she is not one of these people people that gets weak, sleepy but not weak.  She does not get tired like most people, but that day she was so tired and extremely weak.  The only time her heart went above 90 or high 80s other than being on a treadmill, otherwise never.  Her pulse is always in the 70s.  She is suspicious of it being the RSV as this was the first time she had ever gotten it.  She did not take anything for her symptoms, other than drinking water.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child's leg at injection site became red, warm and swollen the next day. Second day after injection redness spread. Mother had applied cool compress. Took to ER when worsened
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: left arm Red, hot, swollen, and painful.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling, fever
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Heart rate increased, Pain in extremity
Clinical narrative: He got his vaccine, noticed around 9:00 PM just that his heart was beating fast, it wasn't nothing that he freaked out about but he noticed it.  His blood pressure was OK, and he took his BP medicine and was OK.  His arm was sore pretty bad, and hurt pretty bad on Tuesday and Wednesday, and yesterday it finally eased out.  He still does feel it now but minimal about a 1-2/10 in intensity.  He did not take anything for his symptoms.    A month ago on 8/5/23 he got the flu and pneumonia vaccines, but did not have any reactions.
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 62.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Dizziness, Injection site pain, Pyrexia
Clinical narrative: Experience fever of 101.7- 101.2, muscle pain at injection site, dehydration, moderate headache, elevated pulse ( 111), intermitent periods of lightheadness/dizzy for two days. Iprobufferin and Tylenol given, ice applied to injection site. By day 5 all side effects subsided.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Limb mass, Pain in extremity, Skin warm, Swelling
Clinical narrative: Red, raised, hard lump in arm, painful and warm,  First noticed on the day after the injection.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Joint swelling, Pain in extremity, Tenderness
Clinical narrative: A few days after the injection, the same side armpit was sore and tender to the touch. As the days go by, the soreness and tenderness traveled down the inside of my arm toward my forearm. Now, eight (8) days after my injection,  my armpit and the underside of my left arm is still tender and I see now that the tissue surrounding the inside of my elbow is swollen. I feel a lot of pressure in my upper arm and especially near my elbow.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Angiocardiogram, Cardiomyopathy, Catheterisation cardiac, Defect conduction intraventricular, Ejection fraction decreased
Clinical narrative: ? Left Ventricle: Left ventricle is severely dilated. Severely reduced systolic function. EF by 2D Simpson biplane is 18 %. Global hypokinesis present. Septal motion is consistent with interventricular conduction delay.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Left ventricular dysfunction
Clinical narrative: ? Left Ventricle: Left ventricle is severely dilated. Severely reduced systolic function. EF by 2D Simpson biplane is 18 %. Global hypokinesis present. Septal motion is consistent with interventricular conduction delay.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: no adverse reaction
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin warm
Clinical narrative: redness at injection site, heat in arm,
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 69.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Tremor
Clinical narrative: Patient experience shaking that occured for 3 to 4 hours after receving the vaccine. Patient stated the shaking occur for several hours. Patient stated he felt fine after the next day.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site warmth, Tenderness
Clinical narrative: patinet  has red warm area at injectio site. reports tenderness. began the day following administration. Administration date is 09/27/2023
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 63.0
Sex: M
Vaccine: COVID19-2, PNC20
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 59.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Nausea, Pyrexia
Clinical narrative: Nausea, Chills, Fever, Weakness
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: AGE INAPPROPRIATE VACCINE ADMINISTERED TO PATIENT.  MD NOTIFIED.  MOTHER STATED PATIENT HAD NO ADVERSE REACTION TO VACCINE
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 66.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 49.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 8.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: AGE INAPPROPRIATE VACCINE ADMINISTERED TO MINOR PATIENT
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 78.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine administered to inappropriate age (Patient is 16)
Age: 9.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: AGE INAPPROPRIATE VACCINE ADMINISTERED TO PATIENT.  MD NOTIFIED.  MOTHER STATED PATIENT HAD NO ADVERSE REACTION TO VACCINE
Age: 10.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: AGE INAPPROPRIATE VACCINE ADMINISTERED TO PATIENT.  MD NOTIFIED.  MOTHER STATED PATIENT HAD NO ADVERSE REACTION TO VACCINE
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Lymphadenopathy, Neck pain
Clinical narrative: Severe neck and shoulder pain above the injection site, swolen glands.  Injection site itself is OK and there is full range of motion.  Pain started to resolve after 72 hours
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: college vaccine clinic, gave Hep B instead of Men B
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: She got her vaccine, by the evening of that day her arm had a square red mark, and it was warm and it was swollen. It felt a little bruises.  She went to sleep, not hindering her.  When she woke up it was very red, warm, and still having the same reaction.  It is going away now.  It was noticeable so she did not take off her sweater last night as it was obviously swollen and red.  She was told to only get one vaccine at a time so that if she had a reaction they would know which one.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine was given outside the manufacturer's recommended window. Patient doing ok and wants revaccinated in the fall.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2, FLU4, HEP, HEP, HEP, TDAP, VARZOS
Symptoms: Liver function test increased, Urticaria
Clinical narrative: Urticaria and elevated LFTs
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Impaired work ability, Injection site pain, Injection site reaction, Malaise
Clinical narrative: On 09-28-23 the employee reported not feeling well and thought she was starting to have a migraine.  Left work early and reported having diarrhea and vomiting.  Woke up after resting for several hours and her left arm had large red splotches and pain at the injection site.  Pain continued into left upper trunk.  She is alternating tylenol and ibup for symptom relief.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rash macular, Vomiting
Clinical narrative: On 09-28-23 the employee reported not feeling well and thought she was starting to have a migraine.  Left work early and reported having diarrhea and vomiting.  Woke up after resting for several hours and her left arm had large red splotches and pain at the injection site.  Pain continued into left upper trunk.  She is alternating tylenol and ibup for symptom relief.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccine that had been stored beyond the Beyond Use Date.