chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site erythema, Wrong product administered
Clinical narrative: Patient received initial dose of 0.25 ml dose of Moderna Bivalent vaccine instead of Monovalent vaccine; 5 year old received initial dose of 0.25 ml dose of Moderna Bivalent vaccine; Redness to injection site; This spontaneous case was reported by a medical assistant and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness to injection site), WRONG PRODUCT ADMINISTERED (Patient received initial dose of 0.25 ml dose of Moderna Bivalent vaccine instead of Monovalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old received initial dose of 0.25 ml dose of Moderna Bivalent vaccine) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced VACCINATION SITE ERYTHEMA (Redness to injection site). On 04-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received initial dose of 0.25 ml dose of Moderna Bivalent vaccine instead of Monovalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old received initial dose of 0.25 ml dose of Moderna Bivalent vaccine). At the time of the report, VACCINATION SITE ERYTHEMA (Redness to injection site), WRONG PRODUCT ADMINISTERED (Patient received initial dose of 0.25 ml dose of Moderna Bivalent vaccine instead of Monovalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old received initial dose of 0.25 ml dose of Moderna Bivalent vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022).    This case was reported for patient 2.  Concomitant medications were not reported. It was reported that the monovalent vial with the beyond use date as 21-Sep-2022 was initially stored in refrigerator on 22-Aug-2022. Individual vials or unbroken cartons are 2 doses. Vial size was 5.5 ml. The vial did not undergo any temperature excursion. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-655852 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655852:same reporter, Patient 1
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; given 0.25ml of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (given 0.25ml of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 30-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (given 0.25ml of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (given 0.25ml of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (given 0.25ml of the bivalent booster).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-655875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655875:Crosslink case with same reporter
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Significant pain at the injection site during administration; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Significant pain at the injection site during administration) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Significant pain at the injection site during administration). At the time of the report, VACCINATION SITE PAIN (Significant pain at the injection site during administration) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment medication was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-025425 (Moderna).  A male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6201) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Digestion" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; SIMVASTATIN taken for blood cholesterol abnormal; SERTRALINE taken for depression; OMEPRAZOLE taken for dyspepsia; VITAMIN D3. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "mild headache".  Additional information: It was reported that the patient only experienced a mild headache after receiving the Pfizer vaccines. The patient had no allergies (medications, food and other products). The patient had never had COVID positive test or diagnosis.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200076049 same patient/event, different dose number;
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD22-025425 (Moderna).  A male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 2, single (Lot number: EN6198) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Antidepressant" (unspecified if ongoing); "digestion" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; SIMVASTATIN taken for blood cholesterol; SERTRALINE taken for depression; OMEPRAZOLE taken for dyspepsia; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6201), administration date: 10Feb2021, for COVID-19 immunization, reaction(s): "mild headache". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "mild headache".  Additional information: It was reported that the patient only experienced a mild headache after receiving the Pfizer vaccines. The patient had no allergies (medications, food and other products). The patient had never had COVID positive test or diagnosis. The patient had no history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200076049 same patient/event, differnt dose numer;
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives/red welts/Location of hive reaction: arms, especially my right arm, stomach and knee joints; itching/Itching is all over body; rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 17:30 as dose 1, single (Lot number: GH9693) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Sep2022 as dose 1, single (Lot number: GH9693) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "High cholesterol" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 19Sep2022 as dose 1, single. The following information was reported: URTICARIA (non-serious) with onset 02Oct2022 at 04:00, outcome "not recovered", described as "Hives/red welts/Location of hive reaction: arms, especially my right arm, stomach and knee joints"; PRURITUS (non-serious) with onset 02Oct2022 at 04:00, outcome "not recovered", described as "itching/Itching is all over body"; RASH (non-serious) with onset 02Oct2022 at 04:00, outcome "not recovered". Therapeutic measures were not taken as a result of urticaria, pruritus, rash.
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt. recieved th e Pfizer Bivalent booster instead of the Monovalent vaccine for her second dose in the primary series.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Oropharyngeal pain, Productive cough, Rhinorrhoea
Clinical narrative: I received my third Pfizer booster for COVID-19 on 9/13/2022. On the morning of 9/22/2022 or 9/23/2022, I woke up with a bit of a scratchy throat and a runny nose. Over the next couple of days, it progressed into a productive cough, headache, and sore throat. My husband and I were on vacation at the time. When we came home on 9/30/2022, I did a home test for COVID-19, which yielded a negative result. On the morning of 10/1/2022, I retested and got a positive result. I went to an urgent care clinic that day and was prescribed Paxlovid, which I started taking the same day. The symptoms gradually improved. I just finished the Paxlovid on the morning of 10/6/2022. I took another test this morning (10/7/2022) and got a negative result. At the time of this writing, I feel much better, though I still have a bit of a cough and runny nose.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I received my third Pfizer booster for COVID-19 on 9/13/2022. On the morning of 9/22/2022 or 9/23/2022, I woke up with a bit of a scratchy throat and a runny nose. Over the next couple of days, it progressed into a productive cough, headache, and sore throat. My husband and I were on vacation at the time. When we came home on 9/30/2022, I did a home test for COVID-19, which yielded a negative result. On the morning of 10/1/2022, I retested and got a positive result. I went to an urgent care clinic that day and was prescribed Paxlovid, which I started taking the same day. The symptoms gradually improved. I just finished the Paxlovid on the morning of 10/6/2022. I took another test this morning (10/7/2022) and got a negative result. At the time of this writing, I feel much better, though I still have a bit of a cough and runny nose.
Age: 44.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Given Moderna booster instead of booster bivalent
Age: 44.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: Given Moderna booster instead of booster bivalent
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Hypopnoea, Injection site erythema, Injection site rash
Clinical narrative: Red rash at injection site that has gotten larger in surface area as time has passed. Around midnight I started having trouble breathing. Breaths were shallow and spaced out and had chest pain. None of these symptoms have resolved but my primary care doctor was notified via telephone.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Respiration abnormal
Clinical narrative: Red rash at injection site that has gotten larger in surface area as time has passed. Around midnight I started having trouble breathing. Breaths were shallow and spaced out and had chest pain. None of these symptoms have resolved but my primary care doctor was notified via telephone.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Dyspnoea, Impaired work ability, SARS-CoV-2 test positive
Clinical narrative: Breakthrough infection - positive covid test on 9/8/22.  Emergency room visits on 9/9/22 and 9/10/22 due to breathing problems.  Received monoclonal antibodies on 9/9/22.  Did not work from 9/6/22 (first symptoms) to 9/26/22.  Then I tried to work half-days but it was too much.  Currently working half-days (as of 10/7/22)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Breakthrough infection - positive covid test on 9/8/22.  Emergency room visits on 9/9/22 and 9/10/22 due to breathing problems.  Received monoclonal antibodies on 9/9/22.  Did not work from 9/6/22 (first symptoms) to 9/26/22.  Then I tried to work half-days but it was too much.  Currently working half-days (as of 10/7/22)
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Amnesia, Confusional state, Dizziness, Loss of consciousness
Clinical narrative: Extreme confusion and dizziness beginning approx 6 hours after vaccine.  Complete loss of memory for another six hours thereafter, including two blackouts or potential seizures that were not witnessed, where I came to on the floor.  I had no prior symptoms whatsoever from four prior Pfizer COVID vaccines and have no history of blackouts or seizures.  I'm ok but still quite dizzy the next day.  No more Moderna vaccines for me!
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased
Clinical narrative: Patient reporting have a high BP with systolic values around 170. She went to the doctor where the doctor checked her out and sent her home. This happened 2 days after the vaccination. Patient called and wanted me to report this.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient did not have an adverse event. Pfizer Bivalent booster was administered 30 days earlier than CDC suggested timeline.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient received incorrect vaccine on 10/7/22. They were scheduled to receive the COVID-19 bivalent dose and instead received the Pfizer vaccine without Omicron coverage. No ADRs have occurred.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Headache
Clinical narrative: Dizzy, off balance, slight headache
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Laboratory test
Clinical narrative: cellulitis to LUE Admitted to hospital from ER for IV abx, dc on PO abx
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Wrong product administered
Clinical narrative: Patient received incorrect vaccine on 10/7/22. They were scheduled to receive the COVID-19 bivalent dose and instead received the Pfizer vaccine without Omicron coverage. No ADRs have occurred.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Dyspnoea, Ear pain, Fatigue, Headache
Clinical narrative: Within 12 hours patient had chills, lymp node swelling, body aches, headache, ear pain, nausea, shortness of breath. slowly improved over the next few days. Needed to stay home and rest. Seen by provider on day 4 of symptoms which was the best he had felt since vaccine. Still with fatigue, lymph node tenderness, and headache.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lymph node pain, Lymphadenopathy, Nausea, Pain
Clinical narrative: Within 12 hours patient had chills, lymp node swelling, body aches, headache, ear pain, nausea, shortness of breath. slowly improved over the next few days. Needed to stay home and rest. Seen by provider on day 4 of symptoms which was the best he had felt since vaccine. Still with fatigue, lymph node tenderness, and headache.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Incorrect product formulation administered, No adverse event
Clinical narrative: pt did not have an adverse event. she received 1 shot of her primary series (pfizer monovalent) and received moderna bivalent booster on 10/06/22. According to the pt she did not complete the primary series. She did not report any adverse event.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received incorrect vaccine on 10/7/22. They were scheduled to receive the COVID-19 bivalent dose and instead received the Pfizer vaccine without Omicron coverage. No ADRs have occurred.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia, Fatigue, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: 06/28/2022 I woke up with a scratchy throat,  and tiredness. I tested positive on 06/29/2022 . I did a tele health with my doctor that day. She prescribed me Paxlovid for 5 days. This was a mild case. After couple of days I started feeling better. I had a metallic taste from the medication.  On 07/08/2022 I got a scratchy throat again. I had a rebound case. I just got better by my own.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received incorrect vaccine on 10/7/22. They were scheduled to receive the COVID-19 bivalent dose and instead received the Pfizer vaccine without Omicron coverage. No ADRs have occurred.
Age: 1.83
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: 4 bumps to forehead. Family wants this even documented. not urticarial. No facial swelling. no difficulty breathing. Injection site WNL
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram head, Electroencephalogram, Generalised tonic-clonic seizure, Laboratory test, Magnetic resonance imaging head
Clinical narrative: generalized tonic clonic seizure x2
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient received incorrect vaccine on 10/7/22. They were scheduled to receive the COVID-19 bivalent dose and instead received the Pfizer vaccine without Omicron coverage. No ADRs have occurred.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received incorrect vaccine on 10/7/22. They were scheduled to receive the COVID-19 bivalent dose and instead received the Pfizer vaccine without Omicron coverage. No ADRs have occurred.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given a monovalent Pfizer vaccine instead of the bivalent vaccine for her booster.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Back pain, Impaired work ability, Spinal X-ray abnormal, Spinal stenosis
Clinical narrative: I had lower back pain and some abdomen pain in the early morning 09/30/2022. I went to my doctor on 10/04/2022 due to the pain I had an x-ray and urine test on 10/04/2022 the urine came back normal, and the x-ray of my back did show slight narrow spacing in the lower spine. The pain did cause me to miss work on Monday and Tuesday. My doctor gave me a prescription of FLEXERIL and lidocaine patches for my back. As of today, I am feeling much better than I have been, but I am unsure if that is because I am on medication or if it is getting better.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urine analysis normal
Clinical narrative: I had lower back pain and some abdomen pain in the early morning 09/30/2022. I went to my doctor on 10/04/2022 due to the pain I had an x-ray and urine test on 10/04/2022 the urine came back normal, and the x-ray of my back did show slight narrow spacing in the lower spine. The pain did cause me to miss work on Monday and Tuesday. My doctor gave me a prescription of FLEXERIL and lidocaine patches for my back. As of today, I am feeling much better than I have been, but I am unsure if that is because I am on medication or if it is getting better.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Patient fainted. She did not hit her head and recovered quickly. We offered to call 911 but Dad said daughter was fine.  Patient received water and a lollipop. Dad and daughter waited for about 15 to 20 minutes, and Dad said she was doing well before they left.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: After vaccination, patient became light headed.  Vitals obtained:  BP 89/59, pulse 69, respirations 18, pulse ox 98% on room air.  Juice, water and cookies given.  Symptoms resolved after 8 minutes at rest.  Patient aware to seek medical attention if symptoms return or new concerns.
Age: 17.0
Sex: M
Vaccine: FLU4, HEP, MENB
Symptoms: Abdominal pain upper, Diarrhoea, Injection site mass, Wrong product administered
Clinical narrative: Hepatitis B was administered as a 4th dose. Pt was supposed to receive Hepatitis A. Post vaccination symptoms included injection site lump, stomach pain, and 1 day of diarrhea.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Upon registration patient was approved as candidate for vaccination.  Consent was identified with white sticker on paper as appropriate candidate for vaccination with consent of mother as guardian per protocol. Patient identified via 6 routes of medication. Pt noted to stay for 15 minutes post vaccination with no adverse or side effects noted upon exiting.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Immediate post-injection reaction, Immunisation reaction, Injection site pruritus, Lymphadenopathy
Clinical narrative: Left/flu arm started itching immediately. Ignored it for awhile, then decided bandaid might be causing itch. Removed band aid and the itching did not improve. Now, 5 days later I still have an itchy rectangular patch on my arm approximately 1" wide & 3" long. No hives but itching still hard to resist. Shower/warm water seems to increase appearance of rectangular patch. Have tried a Benadryl itch stopping gel which gives some relief. Also have had swollen lymph nodes in left underarm for several days (which I expected). Right/COVID arm  started itching a little immediately, Removed band aid at same time as left arm. Occasional itching, but not like left arm. This is the third flu shot that has given me itching. I'm concerned I may be "becoming allergic" to something in the shots? Not sure who to consult. I have seasonal hay fever for which I take Loratadine. I had taken it that morning due to itchy eyes. I had NO OTHER allergic signs; just the itching sensation. I've been able to resist the itching.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENT, PT WAS GIVEN 0.25ML INSTEAD OF 0.5ML PER GUIDELINE, WE GAVE ANOTHER 0.25 ML LATER THAT DAY
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENT, PT WAS GIVEN 0.25ML INSTEAD OF 0.5ML PER GUIDELINE, WE GAVE ANOTHER 0.25 ML LATER THAT DAY
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENT, PT WAS GIVEN 0.25ML INSTEAD OF 0.5ML PER GUIDELINE, WE GAVE ANOTHER 0.25 ML LATER THAT DAY
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENT, PT WAS GIVEN 0.25ML INSTEAD OF 0.5ML PER GUIDELINE, WE GAVE ANOTHER 0.25 ML LATER THAT DAY
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENT, PT WAS GIVEN 0.25ML INSTEAD OF 0.5ML PER GUIDELINE, WE GAVE ANOTHER 0.25 ML LATER THAT DAY
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: NO ADVERSE EVENT, PT WAS GIVEN 0.25ML INSTEAD OF 0.5ML PER GUIDELINE, WE GAVE ANOTHER 0.25 ML LATER THAT DAY
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, COVID-19, Cough, Lymphadenopathy, Rhinorrhoea
Clinical narrative: 12/28/2021 in the afternoon I had a swollen lymph node and post nasal drip after 4 days I had sneezing, runny nose. and coughing. I didn't take any medications at all. I just stayed home for 8 days. On 08/15/2022 I was positive for COVID-19 again but I still didn't take any medication. I stayed in training for 5 days in quarantine.  After I got COVID-19 for 2 times I was diagnosed with bilateral knee arthritis which I never had it before. I was diagnosed on 05/20/2022 from my doctor.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sneezing, Upper-airway cough syndrome
Clinical narrative: 12/28/2021 in the afternoon I had a swollen lymph node and post nasal drip after 4 days I had sneezing, runny nose. and coughing. I didn't take any medications at all. I just stayed home for 8 days. On 08/15/2022 I was positive for COVID-19 again but I still didn't take any medication. I stayed in training for 5 days in quarantine.  After I got COVID-19 for 2 times I was diagnosed with bilateral knee arthritis which I never had it before. I was diagnosed on 05/20/2022 from my doctor.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: patient ordered with HEP B adult/adolescent by md and was given child dose of  engerix B  10 mcg/0.5 ml  lot CM294 exp 4/19/24 NDC 58160-826-43 No adverse effect observed . scheduled patient for the correct dose (adult)  10/19/2022  per MD  approval
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Palpitations
Clinical narrative: Chest pain and heart palpitations. Persistent chest pain after covid vaccination
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac stress test, Echocardiogram, Pain in jaw
Clinical narrative: Terrible heart pain and severe pain in my right jaw
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Ringing in my ears on the day following the vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: On 08/03/2022 I didn't feel well when I went to sleep. Then, when I woke up the next day I was sick. I had a fever, body aches, running nose, and sneezing. I took an COVID-19 test and tested positive Then, the next day my throat started hurting additional to the other symptoms. I spoke to the doctor because I wasn't getting better and she prescribed me Paxlovid.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: On 08/03/2022 I didn't feel well when I went to sleep. Then, when I woke up the next day I was sick. I had a fever, body aches, running nose, and sneezing. I took an COVID-19 test and tested positive Then, the next day my throat started hurting additional to the other symptoms. I spoke to the doctor because I wasn't getting better and she prescribed me Paxlovid.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Arthropathy, Joint range of motion decreased, Pain
Clinical narrative: Received my flu vaccine Monday and since then I?ve been experiencing some issues with my shoulder joint. Specific details include decreased ROM, sharp shooting pains, popping in the joint with pain and ?zinging? with movement. The best way I can describe it is it feels like my shoulder is subluxed and being impinged with movement.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: MMRV is supposed to be administered subcutaneously; however, my daughter had the vaccine administered intramuscularly.  About 26 hours after vaccination, the injection site is very hot to the touch, red, and swollen. This covers the top 2/3 of my daughter?s upper arm.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle spasms, Postmenopausal haemorrhage
Clinical narrative: Post-menopausal breakthrough bleeding/spotting & cramping
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy, Eyelid function disorder, Facial asymmetry, Facial paralysis
Clinical narrative: Bell's Palsy  left facial paralysis (mild) starting 1 day after vaccine.  Asymmetry of smile and closing Left eye
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: AFTER ADMINISTRATION, IT WAS DISCOVERED THAT THE VACCINE WAS BEYOND ITS BEYOND USE DATE. NO ADVERSE REACTION.
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: When administering the vaccine, it leaked out and pt did not received the appropriate dose recommended. Patient was re administered in the opposite arm per cdc guideline.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Inflammation, Injected limb mobility decreased, Lymphadenopathy, Magnetic resonance imaging abnormal
Clinical narrative: I had a severe lymph node swelling in chest, neck, breast, down to my elbow. I couldn't put my right arm down. I called my doctor to let him know. I had horrific back pain and still going to physical therapy since I had vaccine. I also had vaginal bleeding.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: I had a severe lymph node swelling in chest, neck, breast, down to my elbow. I couldn't put my right arm down. I called my doctor to let him know. I had horrific back pain and still going to physical therapy since I had vaccine. I also had vaginal bleeding.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: given this instead of bivalent
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: given this instead of bivalent
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac monitoring normal, Chest X-ray, Computerised tomogram normal, Dysgraphia, Echocardiogram normal
Clinical narrative: At the time of the vaccination, while administering the vaccine I bled profusely. I am not anemic and was not on any blood thinners. 10 days later it appears I had a TIA. I have not had COVID, I have no history of Afib, BP is good and normal, heart rate is healthy, cholesterol is normal to low. I am not overweight, have never smoked, and exercise daily for over an hour. 10 days after the vaccines, I was at my desk in the office, and felt fine except I was unable to write. I could hold the pen but I could not form letters properly as hard as I tried. I took low dose-aspirin and went to the Emergency Room. Heart echo and CT/MRI were all normal. I was kept overnight ofr observation and the symptons never returned. My ability to write returned after about 30 minutes.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Magnetic resonance imaging normal, Transient ischaemic attack
Clinical narrative: At the time of the vaccination, while administering the vaccine I bled profusely. I am not anemic and was not on any blood thinners. 10 days later it appears I had a TIA. I have not had COVID, I have no history of Afib, BP is good and normal, heart rate is healthy, cholesterol is normal to low. I am not overweight, have never smoked, and exercise daily for over an hour. 10 days after the vaccines, I was at my desk in the office, and felt fine except I was unable to write. I could hold the pen but I could not form letters properly as hard as I tried. I took low dose-aspirin and went to the Emergency Room. Heart echo and CT/MRI were all normal. I was kept overnight ofr observation and the symptons never returned. My ability to write returned after about 30 minutes.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the Pfizer Monovalent vaccine instead of the Pfizer Bivalent Vaccine.  No adverse side effect just med error.  NP informed and patient was notified of the error.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Biopsy skin abnormal, Blister, Blood test abnormal, Burning sensation
Clinical narrative: I started to have blisters that seamed like a burn at my upper back. But I ignored them because I thought that with time it will go away. Then the blisters begin to spread to my chest. Months later I had in my under arm, upper and lower back, belly and head. Sometimes it would get itchy and a burning feeling.  After approximately 6 months and after numerous biopsies doctors diagnosed me with an autoinmune diasease and it all began after my third covid-19 dose. All my live I've been healthy and never been hospilatized. Finally a blood test and a inmunofluoesent biopsy was enough to get my diagnosis. I got no family history of autoinmune diasease.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I started to have blisters that seamed like a burn at my upper back. But I ignored them because I thought that with time it will go away. Then the blisters begin to spread to my chest. Months later I had in my under arm, upper and lower back, belly and head. Sometimes it would get itchy and a burning feeling.  After approximately 6 months and after numerous biopsies doctors diagnosed me with an autoinmune diasease and it all began after my third covid-19 dose. All my live I've been healthy and never been hospilatized. Finally a blood test and a inmunofluoesent biopsy was enough to get my diagnosis. I got no family history of autoinmune diasease.
Age: 8.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Crying, Nasal congestion
Clinical narrative: Patient developed nasal congestion (but also crying reallyt at the same time) and possible itchiness/hives during 15 minute observation period following vaccination. No difficulty breathing through the mouth.
Age: 8.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nasal congestion, Pruritus, Swelling, Swelling face
Clinical narrative: Patient developed nasal congestion (but also crying reallyt at the same time) and possible itchiness/hives during 15 minute observation period following vaccination. No difficulty breathing through the mouth.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Nausea, Vomiting
Clinical narrative: Patient experienced cough, nausea and vomiting severe enough to cause patient to seek medical attention at a hospital.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Laboratory test, Ocular hyperaemia, Rash, Rash erythematous
Clinical narrative: Swollen red eyes and cheeks, red itchy rash started on left arm, red streak on left arm, rash spread over body.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Swollen red eyes and cheeks, red itchy rash started on left arm, red streak on left arm, rash spread over body.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Tinnitus ringing got louder and higher pitched
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster
Clinical narrative: Shingles
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Rash
Clinical narrative: The patient told me that she had a rash/itch after her first ever dose of moderna covid vaccine so her doctor told her to take a benadryl before each future dose.  She forgot to take one this morning so she took a tablet right before her shot.  vaccine administration was around 12:25pm and as she was waiting afterwards she said she was feeling itchy /rash on her chest and feeling a little itchy on her face at 12:51pm  .I administered 25mg of liquid diphenhydramine at 12:56pm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Histamine intolerance, Pharyngeal swelling
Clinical narrative: HISTAMINE REACTION AFTER DOSE PROVIDED. TURNED RED, STARTED TO SAY THROAT WAS SWELLING. GAVE BENadryl and issue quickly resolved.
Age: 72.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chest pain, Death
Clinical narrative: PATIENT BEGAN HAVING CHEST PAIN DAY AFTER SHOT 10/5/22 AND PRESENTED TO ER.  PATIENT PASSED AWAY AT HOSPITAL
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: The Lot had a bud of 09/22/22 and it was administered on 09/30/22.  According to our team it still maintained affective activity, but had to report this.
Age: 39.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Fever, chills, body malaise. I rested and took Tylenol which have helped.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Crying, Electric shock sensation, Hypoaesthesia, Immediate post-injection reaction, Injection site pain
Clinical narrative: Flu shot administered 10-6-22 at 1pm at place of work. Immediate intense pain in shoulder/arm. I hollered out ? ouch that hurt really bad?. The nurse said ?why are you hollering? Your the only one who has said it hurt.? Pain was sharp and my arm was very sore and weak all day . Took 2 Tylenol (no relief). Numbness/tingling down inner left arm to elbow and outside of hand and 2 fingers that started about 6 pm.  Cried all night with pain(no sleep) . Went to work 10-7-22  and told a RN what was happy to me from the shot. I also spoke with a Doctor of the practice. They recommended to take NSAIDS over the weekend and see how it is by Monday. Came home in tears with pain from tingling. Took a prescribed  muscle relaxer(for right shoulder injury) to help with flu shot side effects. By 4 pm I had tingling pain down my inner legs into feet on both sides. Rubbed Volteran cream on my shoulder , neck, and legs. Did not feel like being active at home, slept a bit but woke up in tears from the tingling electrical feeling all over my body.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Insomnia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Flu shot administered 10-6-22 at 1pm at place of work. Immediate intense pain in shoulder/arm. I hollered out ? ouch that hurt really bad?. The nurse said ?why are you hollering? Your the only one who has said it hurt.? Pain was sharp and my arm was very sore and weak all day . Took 2 Tylenol (no relief). Numbness/tingling down inner left arm to elbow and outside of hand and 2 fingers that started about 6 pm.  Cried all night with pain(no sleep) . Went to work 10-7-22  and told a RN what was happy to me from the shot. I also spoke with a Doctor of the practice. They recommended to take NSAIDS over the weekend and see how it is by Monday. Came home in tears with pain from tingling. Took a prescribed  muscle relaxer(for right shoulder injury) to help with flu shot side effects. By 4 pm I had tingling pain down my inner legs into feet on both sides. Rubbed Volteran cream on my shoulder , neck, and legs. Did not feel like being active at home, slept a bit but woke up in tears from the tingling electrical feeling all over my body.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Laryngitis, SARS-CoV-2 test negative
Clinical narrative: Laryngitis, wait for it to pass.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient thought she was receiving the Bivalent booster but the non-bivalent Pfizer vaccine was selected by mistake.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the non-bivalent Pfizer dose in error instead of the bivalent dose
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Adverse drug reaction, Asthenia, Chest discomfort, Headache, Injection site erythema
Clinical narrative: I had normal side effect symptoms starting on the evening of 10/1/22. several hours after the injection. On 10/2/22 & 10/3/22 I had low grade fever, swelling at the injection site with a red ring and warm./hot when touched. I had body aches and a severe headache. On 10/4/22 the headache and initial side effects went away and then I developed a tightness in my throat when swallowing and felt weakness in my entire body, I have high level of tinnitus and a heavy feeling in my chest. The feeling in my chest feels like as if when I was younger and stayed underwater too long and felt water logged. These symptoms from 10/4/22 were the same on 10/5/22, 10/6/22 and 10/7/22. I am ready to go to the ER, but I am hesitant for several reasons. This feeling I am having feels like an  inflammatory response to the vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia, Throat tightness
Clinical narrative: I had normal side effect symptoms starting on the evening of 10/1/22. several hours after the injection. On 10/2/22 & 10/3/22 I had low grade fever, swelling at the injection site with a red ring and warm./hot when touched. I had body aches and a severe headache. On 10/4/22 the headache and initial side effects went away and then I developed a tightness in my throat when swallowing and felt weakness in my entire body, I have high level of tinnitus and a heavy feeling in my chest. The feeling in my chest feels like as if when I was younger and stayed underwater too long and felt water logged. These symptoms from 10/4/22 were the same on 10/5/22, 10/6/22 and 10/7/22. I am ready to go to the ER, but I am hesitant for several reasons. This feeling I am having feels like an  inflammatory response to the vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: I had normal side effect symptoms starting on the evening of 10/1/22. several hours after the injection. On 10/2/22 & 10/3/22 I had low grade fever, swelling at the injection site with a red ring and warm./hot when touched. I had body aches and a severe headache. On 10/4/22 the headache and initial side effects went away and then I developed a tightness in my throat when swallowing and felt weakness in my entire body, I have high level of tinnitus and a heavy feeling in my chest. The feeling in my chest feels like as if when I was younger and stayed underwater too long and felt water logged. These symptoms from 10/4/22 were the same on 10/5/22, 10/6/22 and 10/7/22. I am ready to go to the ER, but I am hesitant for several reasons. This feeling I am having feels like an  inflammatory response to the vaccine.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Device connection issue, Incorrect dose administered, Injection site haemorrhage, Syringe issue
Clinical narrative: Patient was here for Moderna Bivalent vaccine on 10/7/22 around 330pm. During injection when needle was in patient's muscle, I saw a small amount of vaccine squirt back out from the barrel of needle (between needle and syringe).  The syringe I used for the injection already has needle attached.  Patient complained of feeling liquid dripping down his arm. I saw a few drops of blood and some clear liquids.  I wiped off them, but he complained of feeling more liquids down his elbow (which I could not see), and questioned if  he received the full vaccine dose.   I told patient that I did see some vaccine squirt back out and looked liked it was due to syringe defect, and it was likely he did not receive the full dose.  I offered to call his primary doctor. I was able to reach his PCP Dr.   and manufacturer.  I told Doctor that manufacturer recommended following CDC guideline on administration errors and deviations because they don't have data on bivalent booster yet.  Doctor said he did not want patient to get another dose today because we do not know how much patient actually received (partial or nothing), he will monitor patient.  Patient has a scheduled appointment, and he plans to have patient to repeat the full dose in a few weeks after he monitors patient.   Doctor's office called patient and related doctor's message as well.  Patient stayed for 15 minutes after vaccine to make sure he's feeling okay.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: red rash around injection site with heat.. was presented to the pharmacy the next day ...
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 18+ influenza vaccine given to 16 yo patient. no adverse symptoms reported
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given non-bivalent dose instead of bivalent dose as requested
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received non-bivalent vaccine instead of requested bivalent vaccine
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received non-bivalent vaccine instead of requested bivalent vaccine