chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: ipol was administered to a patient intradermally with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 52 years old female patient who experienced ipol was administered to a patient intradermally with no reported adverse event while receiving vaccine Ipv (Vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2022, the patient received a  0.1 ml once of suspect Ipv (Vero) Suspension for injection (strength: unknown) (batch number: V1A022M and expiry date: 17-FEB-2024 ) via intradermal route in left forearm for immunization  On 26-SEP-2022 the patient developed a non-serious ipol was administered to a patient intradermally with no reported adverse event (incorrect route of product administration) same day following the administration of Ipv (Vero).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event ipol was administered to a patient intradermally with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received the fluzone quad but he was supposed to get the fluzone HD with no reported adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received the Influenza quadrival A-B vaccine [Fluzone Quadrivalent]but he was supposed to get the Fluzone HD with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza quadrival A-B vaccine, suspension for injection (dose, strength, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination but he was supposed to get the Fluzone HD with no reported adverse event (wrong product administered) (unknown latency).  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: received only the dtap-ipv potion of the product and would like to know if the acthib component of pentacelwith no reported adverse event; received only the dtap-ipv potion of the product and would like to know if the acthib component of pentacelwith no reported adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had received only the dtap-ipv potion of the product and would like to know if the acthib component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On an unknown date the patient developed a non-serious event of received only the dtap-ipv potion of the product and would like to know if the acthib component of pentacle (strength, formulation, dose, route, administration site, batch number and expiry date was unknown for prophylactic vaccination) with no reported adverse event (single component of a two-component product administered, product preparation error) (latency: same day).  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 78.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Fatigue, Sensitive skin, Swelling
Clinical narrative: red, swollen sensitive shoulder, very tired,
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Influenza like illness, Joint range of motion decreased, Localised oedema, Pain
Clinical narrative: After 2nd  vaccination, experienced more of the flu-like symptoms that were minor and tolerable  About 10 days later notices some slight body type aches that were pronounced in any body position lasting more that 15-30 mins. As time went on, 8 wks post vaccination I noticed a left side clavicle edema and limited range of motion. Pain has been a 3-5 and on some day 6/7. This has continued regularly sine June 2022 and pain has disseminated  fully. Edema is noticeable to the blind eye In comparison with the right side clavicle. Overall there is a tighter, less range of motion type of body ache that takes over the entire body. In particular like a bone-ache flossing all over Likened to a tough workout. Even when there is limited additional exercise thrust upon the body. A constant full body sore that does not go away. Overall the the clavicle bone pain seems To be the worst of the ailments.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lymph gland, Breast conserving surgery, Chemotherapy, HER2 positive breast cancer, Invasive ductal breast carcinoma
Clinical narrative: First J&J vaccine was on 4/4/2021. Booster was on 12/9/21 Diagnosed with Invasive Ductal Carcinoma, Grade 3, 2.7 x 2.4 x 3.1 cm ER & PgR Negative,  HER2 Positive (Score 3+) Right Breast, Stage 2b No history of breast cancer in my family.  Very healthy before this diagnosis. Treatment - (6 cycles) Neoadjuvant Chemotherapy: Trastuzumab, Pertuzumab, DOCEtaxel, CARBOplatin 1st on 4/8/22, last was on 7/22/22. Currently on Trastuzumab every 3 weeks for 14 cycles. Lumpectomy Surgery, Right Breast and Right Sentinal Lymph Node Biopsy - 8/25/22 Radiation Treatment - 20 treatments to begin on 10/5/22 for 4 weeks
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pathology test, Positron emission tomogram, Radiotherapy, Scan with contrast
Clinical narrative: First J&J vaccine was on 4/4/2021. Booster was on 12/9/21 Diagnosed with Invasive Ductal Carcinoma, Grade 3, 2.7 x 2.4 x 3.1 cm ER & PgR Negative,  HER2 Positive (Score 3+) Right Breast, Stage 2b No history of breast cancer in my family.  Very healthy before this diagnosis. Treatment - (6 cycles) Neoadjuvant Chemotherapy: Trastuzumab, Pertuzumab, DOCEtaxel, CARBOplatin 1st on 4/8/22, last was on 7/22/22. Currently on Trastuzumab every 3 weeks for 14 cycles. Lumpectomy Surgery, Right Breast and Right Sentinal Lymph Node Biopsy - 8/25/22 Radiation Treatment - 20 treatments to begin on 10/5/22 for 4 weeks
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Condition aggravated, Dizziness, Dry throat, Dyspnoea
Clinical narrative: Client received her Pfizer COVID Bivalent booster lot # GJ3277 exp. 12.05.22 IM on her right arm at 1112 by RN on 10.02.22 at Testing Vaccine Site. At 1126, client reported to RN that she was having ?anxiety,? and feeling like she ?couldn?t breathe and having a dry throat,? with feeling of dizziness and ?shaking internally.? RN assisted client to antigravity chair and placed client in a high fowler position. RN notified lead PHN. Lead PHN assessed client. Client is alert and oriented x 4. Client reported she has a history of anxiety and took one pill by mouth anti-anxiety medication (Atarax) when she sat at the observation area at 1113. Client denied any shortness of breath (SOB) or any chest pain. At 1129, RN took client's vitals: BP 127/74, HR 92, R 20, O2 Sat. 100%, and client stated, she ate breakfast at 0900 today. Client denied any history of allergies or any chronic health conditions. Client reported that she ?feel the same? when she experienced anxiety with the symptoms of feeling unable to breathe well, dry throat, dizziness, and ?shaking internally.? At 1137, RN took client's vitals: BP 113/78, HR 94, R 20, O2 Sat. 99%, and client denied any previous symptoms above and stated, ?I feel a little better.? At 1144, RN took client's vitals: BP 112/74, HR 86, R 18, O2 Sat. 99%, and denied any previous symptoms. At 1150, lead PHN educated client on adverse reactions and when to seek EMS. At 1150, client?s mother came to see client at the observation area and client requested to leave because she stated, ?I feel better now.? At 1151, client left the vaccination site with a steady gait with her mother.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor
Clinical narrative: Client received her Pfizer COVID Bivalent booster lot # GJ3277 exp. 12.05.22 IM on her right arm at 1112 by RN on 10.02.22 at Testing Vaccine Site. At 1126, client reported to RN that she was having ?anxiety,? and feeling like she ?couldn?t breathe and having a dry throat,? with feeling of dizziness and ?shaking internally.? RN assisted client to antigravity chair and placed client in a high fowler position. RN notified lead PHN. Lead PHN assessed client. Client is alert and oriented x 4. Client reported she has a history of anxiety and took one pill by mouth anti-anxiety medication (Atarax) when she sat at the observation area at 1113. Client denied any shortness of breath (SOB) or any chest pain. At 1129, RN took client's vitals: BP 127/74, HR 92, R 20, O2 Sat. 100%, and client stated, she ate breakfast at 0900 today. Client denied any history of allergies or any chronic health conditions. Client reported that she ?feel the same? when she experienced anxiety with the symptoms of feeling unable to breathe well, dry throat, dizziness, and ?shaking internally.? At 1137, RN took client's vitals: BP 113/78, HR 94, R 20, O2 Sat. 99%, and client denied any previous symptoms above and stated, ?I feel a little better.? At 1144, RN took client's vitals: BP 112/74, HR 86, R 18, O2 Sat. 99%, and denied any previous symptoms. At 1150, lead PHN educated client on adverse reactions and when to seek EMS. At 1150, client?s mother came to see client at the observation area and client requested to leave because she stated, ?I feel better now.? At 1151, client left the vaccination site with a steady gait with her mother.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Arthralgia, Burning sensation, Headache, Neck pain
Clinical narrative: Brief headache when standing up from bent over position (like when I am touching my toes, then stand up).  The headache is a burning feeling that lasts a few seconds and radiates from the left-top of my head, down to the lower-left are of my head. It lasts for  a few seconds.    Pain in left ankle, left wrist, left neck muscle.  All these pains are on the left side, which is the same side where I got the shot (left arm).  I never had these pains on previous shots.  Also, previous shots didn't make me feel bad, but this bivalent shot
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Blood test, Computerised tomogram, Death
Clinical narrative: 9 days after 3rd Moderna shot, he couldn't move out of bed at about 9PM due to extreme back pain. He thought it was due to gardening earlier in the day and taking Advil reduced pain and helped him get out of bed for urination. Over next few days, he also felt pain in right abdomen.  His primary doctor ordered ultrasound and MRI and result indicated cancer has spread to entire liver and to spine causing extreme pain.  My father passed away on 2/5/22 while waiting for biopsy procedure in ER.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Metastases to liver, Metastases to spine, Mobility decreased, Pain
Clinical narrative: 9 days after 3rd Moderna shot, he couldn't move out of bed at about 9PM due to extreme back pain. He thought it was due to gardening earlier in the day and taking Advil reduced pain and helped him get out of bed for urination. Over next few days, he also felt pain in right abdomen.  His primary doctor ordered ultrasound and MRI and result indicated cancer has spread to entire liver and to spine causing extreme pain.  My father passed away on 2/5/22 while waiting for biopsy procedure in ER.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: 9 days after 3rd Moderna shot, he couldn't move out of bed at about 9PM due to extreme back pain. He thought it was due to gardening earlier in the day and taking Advil reduced pain and helped him get out of bed for urination. Over next few days, he also felt pain in right abdomen.  His primary doctor ordered ultrasound and MRI and result indicated cancer has spread to entire liver and to spine causing extreme pain.  My father passed away on 2/5/22 while waiting for biopsy procedure in ER.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Extremely bad angry rash over whole body
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Itching injection site left arm after Bivalent booster; Spreading reaction injection site left arm after Bivalent booster; Red injection site left arm after Bivalent booster; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching injection site left arm after Bivalent booster), VACCINATION SITE REACTION (Spreading reaction injection site left arm after Bivalent booster) and VACCINATION SITE ERYTHEMA (Red injection site left arm after Bivalent booster) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal. Concomitant products included VITAMINS NOS for an unknown indication.    On 28-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced VACCINATION SITE PRURITUS (Itching injection site left arm after Bivalent booster), VACCINATION SITE REACTION (Spreading reaction injection site left arm after Bivalent booster) and VACCINATION SITE ERYTHEMA (Red injection site left arm after Bivalent booster). At the time of the report, VACCINATION SITE PRURITUS (Itching injection site left arm after Bivalent booster), VACCINATION SITE REACTION (Spreading reaction injection site left arm after Bivalent booster) and VACCINATION SITE ERYTHEMA (Red injection site left arm after Bivalent booster) outcome was unknown.            Patient was taking Cholesterol Medication. It was reported that patient received 2 primary and 2 Monovalent Booster shots of Moderna COVID-19 vaccine. On 21-Jan-2021 (lot 029L20A) patient received the first dose of Moderna Vaccine. On 18-Feb-2021 (lot 013M20A) patient received the second dose of Moderna Vaccine. On 25-Oct-2021 (lot 039D21K) patient received the first booster dose of Moderna Vaccine. On 26-May-2022 (lot 038A22A) patient received the second booster dose of Moderna Vaccine. It was reported that 24 hrs after receiving the bivalent booster patient had injection site was red, itching, and spreading. No treatment information was provided.
Age: 0.58
Sex: F
Vaccine: FLUR3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK being administered to pediatric patients with no reported AE; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA402396(CLUSTER), 2022SA402436(CLUSTER), 2022SA402500(CLUSTER), 2022SA402707(CLUSTER), 2022SA402704(CLUSTER), 2022SA402662(CLUSTER), 2022SA402619(CLUSTER), 2022SA402525(CLUSTER) and 2022SA402530(CLUSTER).  This case involves a 7 months old female patient who experienced flublok being administered to pediatric patients with no reported ae while receiving vaccine influenza quadrivalent recombinant vaccine [flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (hepatitis a) for Prophylactic vaccination.  On 12-Sep-2022, the patient received a  dose of suspect influenza quadrivalent recombinant vaccine lot UJ887AA via intramuscular route in the left vastus lateralis being administered to pediatric patients with no reported ae (product administered to patient of inappropriate age)  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event flublok being administered to pediatric patients with no reported ae.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: influenza quadrivalent recombinant vaccine [flublok].
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: CONTRACTED COVID-19; This spontaneous report received from a consumer via other company (Novavax) concerned a 65 year old male of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on unspecified date for covid-19 prophylaxis.  The patient had no adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) first booster shot, dose, start therapy date were not reported, 1 total, for covid-19 prophylaxis.  The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date four months after vaccination, the patient contracted covid-19 (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of contracted covid-19 was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Erythema, Induration, Rash
Clinical narrative: local skin rash, +induration, + erythema,  Full ROM, 2+ pulses
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Fatigue, Injection site pain, Malaise, Nausea
Clinical narrative: Pain at injection site, diarrhea, fatigue, nausea. 10/2/22 was my worst day. I'm getting better but I am not well yet.
Age: 40.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Chest X-ray normal, Chills, Computerised tomogram normal, Dyspnoea, Electrocardiogram normal
Clinical narrative: I had both the Covid 19 (bivalent) booster and flu shot at 9 am.  I did not have any symptoms throughout the day except for a slight dull pain in the injection area on my arm.  I have had the same for each of my previous Covid boosters.  (2 original and 1 booster)  The latest was administered in December 2021.  While at home that evening and right about 9 pm, I stood up and was quickly hit with severe chills.  I quickly crawled back into bed to try and get warm and within approximately 30-45 seconds, I began having trouble breathing.  I told my wife I was waving issues breathing and to call 911.  She came over to me and began calling.  At that point I lost consciousness and according to my wife, stopped breathing.  She said I was out for roughly 10-20 seconds.  I began to gain consciousness to her on the phone with the 911 dispatcher and pressing on the left side of my chest.  She said she was not instructed to do so but rather just started doing it.  I recall it felt positive and asked her to continue doing so.  The first responders arrived and took my vitals and started giving me oxygen.  EMS took me to an ER and was there roughly 8 hours.  While being admitted, they ran an EKG and everything looked good.  The doctors also ran a cat-scan on my head and X-Ray of my chest.  Again, they said everything looked good there.  There is not a defined reason for the experience however leans heavily towards a reaction to one or both of the shots.
Age: 40.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Injection site pain, Loss of consciousness, Pain, Respiratory arrest
Clinical narrative: I had both the Covid 19 (bivalent) booster and flu shot at 9 am.  I did not have any symptoms throughout the day except for a slight dull pain in the injection area on my arm.  I have had the same for each of my previous Covid boosters.  (2 original and 1 booster)  The latest was administered in December 2021.  While at home that evening and right about 9 pm, I stood up and was quickly hit with severe chills.  I quickly crawled back into bed to try and get warm and within approximately 30-45 seconds, I began having trouble breathing.  I told my wife I was waving issues breathing and to call 911.  She came over to me and began calling.  At that point I lost consciousness and according to my wife, stopped breathing.  She said I was out for roughly 10-20 seconds.  I began to gain consciousness to her on the phone with the 911 dispatcher and pressing on the left side of my chest.  She said she was not instructed to do so but rather just started doing it.  I recall it felt positive and asked her to continue doing so.  The first responders arrived and took my vitals and started giving me oxygen.  EMS took me to an ER and was there roughly 8 hours.  While being admitted, they ran an EKG and everything looked good.  The doctors also ran a cat-scan on my head and X-Ray of my chest.  Again, they said everything looked good there.  There is not a defined reason for the experience however leans heavily towards a reaction to one or both of the shots.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: red with swelling and rash at site of reaction starting day after vaccine given and has lasted about a week so far
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Severe, Additional Details: Cellulitis
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Injection site pruritus, Pruritus, Rash, Urticaria
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: discomfort-Mild, Additional Details: PT says he has had hives, itching, and still has some discomfort following initial doses of Moderna vaccine
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia, Photophobia, Visual impairment
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Tingling in left foot. eye is sensitive to light.
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was sitting after giving both vaccinations, 5 minutes later fell over in his chair, was still conscious, was able to slowly get back up into sitting position. Caregiver stated that patient was OK after waiting about 10-15 minutes
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Right after immunization pt stated that she had a numbing/tingling feeling on the arm. I told pt that it might be due to needle accidentally touching a nerve, and that I will call in a few hours to follow up. After a few hours when I called pt, she stated that it was not a numbing feeling, there is pain around injection site, though. I offered pt to call her primary care and/or call her back to check on her in a few hours later during the day. Pt stated that further follow up is not necessary.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: PATIENT STATED THAT ARM ITCHED AND HAS SMALL BUMPS ON ARM
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Tachycardia
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Mild
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: per patient mother on 9/16/2022 interview mom reports pt "passed out" ~ 1 min but no er visits but rather ems was called and mom declined transport to er as her vitals were normal upon awakening.
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: 0.5mL administered rather than 0.3mL
Age: 23.0
Sex: F
Vaccine: FLUR4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after vaccine given
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asymptomatic COVID-19, Blood test normal, Eye pain, Headache, Heart rate increased
Clinical narrative: Tested positive in January 2022 even though I was not having any symptoms.   At that time had 2 of the original Covid shots and two of the boosters.  shortly after, started have severe headaches, pain around the eyes, rapid heart beat, etc.  Was tested from head to toe with blood work and MRI's.   Nothing out of the ordinary appeared in those.  Finally a neurologist declared it to be long Covid and prescribed Nortriptyline.   The medicine quickly began to work and several months later, my symptoms were pretty well gone to the point where we were going to stop the medication.  However, within a couple of days of getting the Bivalent booster, all the symptoms returned and are still prevalent.  Thus I did not stop the medication.  I'm hoping the medication will soon start working again as it took nearly 2 months during the first treatment to work.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test normal, Magnetic resonance imaging normal, SARS-CoV-2 test positive
Clinical narrative: Tested positive in January 2022 even though I was not having any symptoms.   At that time had 2 of the original Covid shots and two of the boosters.  shortly after, started have severe headaches, pain around the eyes, rapid heart beat, etc.  Was tested from head to toe with blood work and MRI's.   Nothing out of the ordinary appeared in those.  Finally a neurologist declared it to be long Covid and prescribed Nortriptyline.   The medicine quickly began to work and several months later, my symptoms were pretty well gone to the point where we were going to stop the medication.  However, within a couple of days of getting the Bivalent booster, all the symptoms returned and are still prevalent.  Thus I did not stop the medication.  I'm hoping the medication will soon start working again as it took nearly 2 months during the first treatment to work.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Per 8/2/2022 pharmacy telephone note, pt received zoster vaccine at clinic on 7/22/21 and had rash with 1st dose. Pt offered second dose and declined due to rash with 1st dose.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine increased, COVID-19, Chills, Dyspnoea, Exposure to SARS-CoV-2
Clinical narrative: Patient admitted with COVID detected PCR and complications from COVID.  Provider d/c note:  "65 y/o male with a pmhx of COPD, T2DM, AAA, CAD, HFpEF, CKD stage 3, HTN, and MI (with stents) who presented to the emergency department on 9/17/2022 with complaints of increased difficulty breathing. He also complained of myalgias, body chills, cough with greenish/yellow sputum production, and HA. He stated that his wife had COVID. He is vaccinated against COVID x3. In the ED he was COVID (+) and subsequently placed on isolation. He was treated with 2L oxygen NC, Symbicort 80-4.5mcg 2 puffs QD and Spiriva Respimat 2.5mcg 2 puffs QD inhalers, Roflumilast 500mg QD, in addition to Remdesivir and a 5 day course of Decadron 6mg QD. His breathing improved over the next 5 days. He had an elevation in his creatinine during his stay from 1.6 on admit to 1.8. A renal US was performed, which was negative for any obstructive process. His Furosemide was discontinued for 1 day and his creatinine improved to 1.4, which is where it remained at the following day. Pt was stable on discharge and says his breathing is near his baseline."
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Productive cough, SARS-CoV-2 test positive, Sputum discoloured
Clinical narrative: Patient admitted with COVID detected PCR and complications from COVID.  Provider d/c note:  "65 y/o male with a pmhx of COPD, T2DM, AAA, CAD, HFpEF, CKD stage 3, HTN, and MI (with stents) who presented to the emergency department on 9/17/2022 with complaints of increased difficulty breathing. He also complained of myalgias, body chills, cough with greenish/yellow sputum production, and HA. He stated that his wife had COVID. He is vaccinated against COVID x3. In the ED he was COVID (+) and subsequently placed on isolation. He was treated with 2L oxygen NC, Symbicort 80-4.5mcg 2 puffs QD and Spiriva Respimat 2.5mcg 2 puffs QD inhalers, Roflumilast 500mg QD, in addition to Remdesivir and a 5 day course of Decadron 6mg QD. His breathing improved over the next 5 days. He had an elevation in his creatinine during his stay from 1.6 on admit to 1.8. A renal US was performed, which was negative for any obstructive process. His Furosemide was discontinued for 1 day and his creatinine improved to 1.4, which is where it remained at the following day. Pt was stable on discharge and says his breathing is near his baseline."
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound kidney normal
Clinical narrative: Patient admitted with COVID detected PCR and complications from COVID.  Provider d/c note:  "65 y/o male with a pmhx of COPD, T2DM, AAA, CAD, HFpEF, CKD stage 3, HTN, and MI (with stents) who presented to the emergency department on 9/17/2022 with complaints of increased difficulty breathing. He also complained of myalgias, body chills, cough with greenish/yellow sputum production, and HA. He stated that his wife had COVID. He is vaccinated against COVID x3. In the ED he was COVID (+) and subsequently placed on isolation. He was treated with 2L oxygen NC, Symbicort 80-4.5mcg 2 puffs QD and Spiriva Respimat 2.5mcg 2 puffs QD inhalers, Roflumilast 500mg QD, in addition to Remdesivir and a 5 day course of Decadron 6mg QD. His breathing improved over the next 5 days. He had an elevation in his creatinine during his stay from 1.6 on admit to 1.8. A renal US was performed, which was negative for any obstructive process. His Furosemide was discontinued for 1 day and his creatinine improved to 1.4, which is where it remained at the following day. Pt was stable on discharge and says his breathing is near his baseline."
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Pfizer 9/17/21, 10/9/21. Positive on 10/1/22
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus two days after booster, has gotten worst with time.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Computerised tomogram neck, Dyspnoea, Laryngoscopy
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and dyspnea.  Provider d/c note:  "Patient with history of small cell lung carcinoma with mets, progressing to cause supraglottic airway narrowing. This caused patient to have hoarseness, shortness of breath, and difficulty swallowing. Patient also found to have COVID 19 pneumonia. In ED she received racemic epinephrine which subjectively helped, and she was sent to hospital for further evaluation and management. After CT neck imaging, patient debated transitioning to hospice care instead of continuing chemotherapy and further workup including ENT consult with direct layngoscopy. Patient did eventually decide to focus on comfort and further workup was cancelled.   Overnight last night she did have an episode of increased dyspnea after going to the bathroom. Was given anxiolytic which helped 'tremendously' per patient. She wishes to continue this if needed.   She has a history of pAfib on anticoagulation, hypertension, and anemia. Found to also have thrombocytopenia on labs on 9/20. For chronic problems she was continued on home medications. For new findings, no further workup was planned due to transition to hospice. Per patient preference no more labs or procedures were planned"
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and dyspnea.  Provider d/c note:  "Patient with history of small cell lung carcinoma with mets, progressing to cause supraglottic airway narrowing. This caused patient to have hoarseness, shortness of breath, and difficulty swallowing. Patient also found to have COVID 19 pneumonia. In ED she received racemic epinephrine which subjectively helped, and she was sent to hospital for further evaluation and management. After CT neck imaging, patient debated transitioning to hospice care instead of continuing chemotherapy and further workup including ENT consult with direct layngoscopy. Patient did eventually decide to focus on comfort and further workup was cancelled.   Overnight last night she did have an episode of increased dyspnea after going to the bathroom. Was given anxiolytic which helped 'tremendously' per patient. She wishes to continue this if needed.   She has a history of pAfib on anticoagulation, hypertension, and anemia. Found to also have thrombocytopenia on labs on 9/20. For chronic problems she was continued on home medications. For new findings, no further workup was planned due to transition to hospice. Per patient preference no more labs or procedures were planned"
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Awakened with swollen lips, slight facial itching. Also found hives around other pressure points along bra line, underwear waistband.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Angiogram pulmonary normal, COVID-19, COVID-19 pneumonia, Computerised tomogram abdomen abnormal
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and COVID PNA.  Provider d/c note:  "75 YO female with a PMHx of hypertension, hyperlipidemia, anxiety/depression who presents with fevers, sore throat, shortness of breath, abdominal pain.  Found to have COVID pneumonia and uncomplicated diverticulitis.  CT PE negative for pneumonia or pulmonary embolism.  CT abdomen did show sigmoid diverticulitis without abscess.  She was also hypoxic requiring oxygen with ambulation.  She was treated with dexamethasone and remdesivir.  She was also treated with ciprofloxacin and Flagyl for diverticulitis.  Hypoxia resolved the next day, even with ambulation.  PT recommended home with assist and she stays with her son and his family.  Patient felt well and wanted to return home.  I offered the opportunity to stay in the hospital to complete remdesivir course if she wanted and she declined.  Due to the fact that she received IV contrast twice in 2 days, she was given a 500 mL bolus to protect her kidneys."
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diverticulitis, Dyspnoea, Hypoxia, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and COVID PNA.  Provider d/c note:  "75 YO female with a PMHx of hypertension, hyperlipidemia, anxiety/depression who presents with fevers, sore throat, shortness of breath, abdominal pain.  Found to have COVID pneumonia and uncomplicated diverticulitis.  CT PE negative for pneumonia or pulmonary embolism.  CT abdomen did show sigmoid diverticulitis without abscess.  She was also hypoxic requiring oxygen with ambulation.  She was treated with dexamethasone and remdesivir.  She was also treated with ciprofloxacin and Flagyl for diverticulitis.  Hypoxia resolved the next day, even with ambulation.  PT recommended home with assist and she stays with her son and his family.  Patient felt well and wanted to return home.  I offered the opportunity to stay in the hospital to complete remdesivir course if she wanted and she declined.  Due to the fact that she received IV contrast twice in 2 days, she was given a 500 mL bolus to protect her kidneys."
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and COVID PNA.  Provider d/c note:  "75 YO female with a PMHx of hypertension, hyperlipidemia, anxiety/depression who presents with fevers, sore throat, shortness of breath, abdominal pain.  Found to have COVID pneumonia and uncomplicated diverticulitis.  CT PE negative for pneumonia or pulmonary embolism.  CT abdomen did show sigmoid diverticulitis without abscess.  She was also hypoxic requiring oxygen with ambulation.  She was treated with dexamethasone and remdesivir.  She was also treated with ciprofloxacin and Flagyl for diverticulitis.  Hypoxia resolved the next day, even with ambulation.  PT recommended home with assist and she stays with her son and his family.  Patient felt well and wanted to return home.  I offered the opportunity to stay in the hospital to complete remdesivir course if she wanted and she declined.  Due to the fact that she received IV contrast twice in 2 days, she was given a 500 mL bolus to protect her kidneys."
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZED
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Irritability, Pyrexia, Rash
Clinical narrative: Crankiness, fatigue, loss of appetite started ~1 day post vaccine (9/17/22). Fever of ~102 F started around 3 days post vaccine (9/19/22).  Controlled with Tylenol. Mild rash started on neck ~6 days post vaccine (9/22/22) and continued to get worse over several days. Rash (looked like moderate sunburn in circular patches on face, legs, arms, back... not raised, no weeping, no itching or pain). Fever varied around 99-102 F for several days. No elevated temperature as of 9/29/22. As of 10/02/22, fatigue and lack of appetite has persisted and has just started to get better. Rash significantly improved as of 10/02/22 - rashes began to fade from center of circle outward.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Crankiness, fatigue, loss of appetite started ~1 day post vaccine (9/17/22). Fever of ~102 F started around 3 days post vaccine (9/19/22).  Controlled with Tylenol. Mild rash started on neck ~6 days post vaccine (9/22/22) and continued to get worse over several days. Rash (looked like moderate sunburn in circular patches on face, legs, arms, back... not raised, no weeping, no itching or pain). Fever varied around 99-102 F for several days. No elevated temperature as of 9/29/22. As of 10/02/22, fatigue and lack of appetite has persisted and has just started to get better. Rash significantly improved as of 10/02/22 - rashes began to fade from center of circle outward.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID19
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient was given Moderna Monovalent, instead of Moderna Bivalent Booster.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID19
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient received monovalent vaccine instead of bivalent booster. Patient has been contacted to receive bivalent booster in 8 weeks, per CDC recommendation.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine instead of bivalent booster. Patient has been contacted to receive bivalent booster in 8 weeks, per CDC recommendation.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Moderna Monovalent instead of the Moderna Bivalent booster
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine instead of bivalent booster. Patient has been contacted to receive bivalent booster in 8 weeks, per CDC recommendation.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Gait disturbance, Heart rate increased
Clinical narrative: She got her vaccine, and had no problems.  Two days later her heart started being quickly to the point that it feels like she could not catch her breath as it was beating rapidly.  Her heart rate was 111 per home oxygen, then went to possibly to 145 but cannot remember for sure.  She went into the pharmacy and informed them that she was having issues, she has a hard time walking.  The pharmacist told her that Pfizer has issues with heart problems, call her cardiologist, which she did and gave them the information and on Friday she is going to be fitted for a Holter monitor for 48 hours.  The rapid heart beats are sporadic, not as frequently as it was, at first it was nonstop and took her BP medicines which helped some, but still continues to have the rapid heart beat.   She did not have problems with her heart prior to the last vaccine.    She did not have any problems with the other four vaccines.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Viral upper respiratory tract infection
Clinical narrative: I had a viral upper respiratory infection. I consulted my physician who prescribed me a nebulizer and inhaler. They performed a COVID-19 test on me to ensure it wasn't COVID-19 or pneumonia. I was using the nebulizer every 3 hours as well as some other medication. I'm still having some slight complications, but now to where I only use the nebulizer once a day especially when needed.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Moderna Monovalent instead of Moderna Bivalent Booster.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER 09/26/2022
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No symptoms or advers events reported by patient.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: I experienced a hive like rash. This started a few days after or within the week of receiving the 4th dose. The rash was the size of a nickel or a quarter. My rash was on the right shoulder. It was not raised, they were flat. The rash started going away after a week or two.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Moderna monovalent instead of the Moderna Bivalent booster
Age: 91.0
Sex: F
Vaccine: FLUA4
Symptoms: Death, Gait disturbance, Laboratory test, Respiratory failure, Seizure
Clinical narrative: Had Fluad vaccine on 9.28.22.  On 9.29.22  started new onset of ambulatory dysfunction.  On 9.30.22 new onset of seizures and sent to Hospital.  Progressed to Respiratory Failure.  Passed away 10.2.22
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Erythema, Palpitations, Throat tightness
Clinical narrative: In a few minutes following administration of both vaccines, the patient's face turned red and she stated her heart was racing  and her throat felt tight but she was able to continue talking to us. The pharmacist  administered an epi-pen and stayed with the patient until she reported feeling better and her heart rate was normal and was still able to talk and have a conversation.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the Fluzone High Dose vaccine instead of the approved Flublok or regular Fluzone quadrivalent. Pt notified. Pt reports he experience no adverse effects from the vaccine administration.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: 10.1.22: vax received 12pm; reactions started ~8pm: 101 F fever, shuddering, chills, sweating, full body aches, headache, fatigue, very sore arm, warm at injection site. Today is 10.3.22, same reactions, no improvement yet.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site warmth, Pain, Pain in extremity, Pyrexia
Clinical narrative: 10.1.22: vax received 12pm; reactions started ~8pm: 101 F fever, shuddering, chills, sweating, full body aches, headache, fatigue, very sore arm, warm at injection site. Today is 10.3.22, same reactions, no improvement yet.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraines for 1-3 days
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Injection site pain, Pain, Pyrexia
Clinical narrative: I had a little soreness at the injection site for a day. I tested positive for COVID-19 via a home test on 08/19/2022. I had body aches, fever of 102 degrees and a lot of congestion. I contacted my doctor and got the prescription for PAXLOVID. By day three, I started feeling better and I tested again and it was negative. In a day or two, I felt bad again and tested positive again. I drank a lot of fluids, consumed soups, for the body aches and fever I took ibuprofen and I also took DAYQUIL and NYQUIL.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I had a little soreness at the injection site for a day. I tested positive for COVID-19 via a home test on 08/19/2022. I had body aches, fever of 102 degrees and a lot of congestion. I contacted my doctor and got the prescription for PAXLOVID. By day three, I started feeling better and I tested again and it was negative. In a day or two, I felt bad again and tested positive again. I drank a lot of fluids, consumed soups, for the body aches and fever I took ibuprofen and I also took DAYQUIL and NYQUIL.