chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired driving ability, Joint range of motion decreased, Loss of personal independence in daily activities, No reaction on previous exposure to drug, Pain
Clinical narrative: 2 days after I received the 2 vaccinations, I lost range of motion in my shoulder.  It was very painful. I had a difficult time doing every day things like getting dressed and driving. This has lasted several weeks, although it has improved. I am still not pain free and I do not have full range of motion.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: 2 days after I received the 2 vaccinations, I lost range of motion in my shoulder.  It was very painful. I had a difficult time doing every day things like getting dressed and driving. This has lasted several weeks, although it has improved. I am still not pain free and I do not have full range of motion.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Product administered at inappropriate site
Clinical narrative: Patient reported to the pharmacy 11/2/23 that she believes the vaccine was given too high on her left arm. She noticed right away as she could feel the vaccine going into her arm at the time of vaccination. She reported the first couple days immediately following vaccination were very painful and she described the pain as feeling like a "hammer hit" to her shoulder. She said after the first couple days, the pain decreased a little to where it feels like a "half hammer hit", but the pain is still there. She has tried ice, ibuprofen, and tylenol with little relief. She has not seen a doctor for this yet, but she has an appointment with her primary doctor in mid-November and will discuss with the them if the pain does not improve.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: headache, muscle pain and slight nausea
Age: 86.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Contusion, Injection site pain, Pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Pt received Fluzone HD and Comirnaty 12+ from store (both in the left arm) on 9/27/2023. Pt states that she had pain during the vaccinations and believed that the vaccines were given "too high" and "in the shoulder". She stated that she has had pain radiating in the left arm ever since the vaccinations. The administering technician and the pharmacist on duty was the same person. I examined the patient's arm after she came to this pharmacy on 11/02/2023. She has a red bruise-like area along the acromion process of the left scapula. SIRVA suspected.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Erythema, Feeling hot, Pain, Pain in extremity
Clinical narrative: COMIRNATY COVID 23-24 (12Y  UP) PFS was ok for the first 8 hours, then felt achy and went to bed. Woke up with chills, burning hot, bright red patches all over my body, facial swelling, hands and feet swelling. Pain in arm. Hives and welts all over face, hands, arms, legs, back and feet.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Swelling face, Urticaria
Clinical narrative: COMIRNATY COVID 23-24 (12Y  UP) PFS was ok for the first 8 hours, then felt achy and went to bed. Woke up with chills, burning hot, bright red patches all over my body, facial swelling, hands and feet swelling. Pain in arm. Hives and welts all over face, hands, arms, legs, back and feet.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abnormal faeces, C-reactive protein, Full blood count, Jaundice
Clinical narrative: Patient developed jaundice 10/31 with abdominal pain and stool changes. Improved slightly 11/1, worsening again 11/2
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Metabolic function test, Red blood cell sedimentation rate, Ultrasound abdomen
Clinical narrative: Patient developed jaundice 10/31 with abdominal pain and stool changes. Improved slightly 11/1, worsening again 11/2
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient states area of vaccine is tender to touch, and can not lift arm, hurts to raise arm
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Ageusia, Decreased appetite, Diarrhoea, Fatigue, Nausea
Clinical narrative: patient reported loss of taste, loss of appetite, pain, swelling, fatigue, nausea and severe diarrhea
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Swelling
Clinical narrative: patient reported loss of taste, loss of appetite, pain, swelling, fatigue, nausea and severe diarrhea
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: PT CALLED AND STATED SHE HAS REDNESS/SWELLING/WARMTH AT INJECTION SITE- SOUNDS LIKE INJECTION SITE REACTION, PT TOLD TO MONITOR AND LET PHARMACY KNOW IF IT DOESNT GET BETTER/IF SYMPTOMS WORSEN
Age: 10.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Extra dose administered
Clinical narrative: Student was given extra vaccines during their appt.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Very tired, fatigue, achy, and mild headache early next morning.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Administrated Beyfortus (RSV) children vaccine to an adult
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Underdose
Clinical narrative: Administarted Beyfortus (RSV childrens dose to an adult.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Underdose
Clinical narrative: Administered Beyfortus (RSV) children dose to an adult
Age: 76.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Underdose
Clinical narrative: Administrated Beyfortus (RSV) children's dose to an adult
Age: 72.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Erythema
Clinical narrative: 3 days after receiving the vaccine the pt came in with the bandaids still on the skin. There was redness around the bandaids and below towards the elbow. patient states it wasn't irriated at all, he just noticed the redness in the mirror.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms with a sore arm.  Fever, chills, body aches.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia
Clinical narrative: Joint pain
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: One day after being vaccinated, my right hand  swelled up. I could not bend my fingers nor make a fist. My right knee was sore also. My left hand had some slight swelling, but I could make a fist.
Age: 76.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Injection site pain
Clinical narrative: PROLONGED SORENESS IN RIGHT ARM AT INJECTION SITE. PT STATES PAIN COMES AND GOES
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Disorientation, Loss of consciousness
Clinical narrative: Patient received vaccine and within a few seconds passed out.  He was out for about 15 seconds.  Patient was disoriented for about 5 minutes.  He was able to get up and sit down on a chair.  Father states he has a history of passing out with vaccines. Paramedics were called and determined he was fine and allowed him to leave on his own.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Alanine aminotransferase normal, Basophil count decreased, Basophil percentage, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: Diffuse papular/plaque dermatitis including involvement of the oral mucosa, tongue, lips, and throat starting 3 days after vaccination and lasting up to 2 weeks prior to improvement after systemic corticosteroids.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: Diffuse papular/plaque dermatitis including involvement of the oral mucosa, tongue, lips, and throat starting 3 days after vaccination and lasting up to 2 weeks prior to improvement after systemic corticosteroids.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal, Eosinophil count normal
Clinical narrative: Diffuse papular/plaque dermatitis including involvement of the oral mucosa, tongue, lips, and throat starting 3 days after vaccination and lasting up to 2 weeks prior to improvement after systemic corticosteroids.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Eosinophil percentage, Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal, Lymphocyte count normal
Clinical narrative: Diffuse papular/plaque dermatitis including involvement of the oral mucosa, tongue, lips, and throat starting 3 days after vaccination and lasting up to 2 weeks prior to improvement after systemic corticosteroids.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Monocyte count normal
Clinical narrative: Diffuse papular/plaque dermatitis including involvement of the oral mucosa, tongue, lips, and throat starting 3 days after vaccination and lasting up to 2 weeks prior to improvement after systemic corticosteroids.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Monocyte percentage increased, Neutrophil count normal, Neutrophil percentage decreased, Platelet count normal, Protein total normal
Clinical narrative: Diffuse papular/plaque dermatitis including involvement of the oral mucosa, tongue, lips, and throat starting 3 days after vaccination and lasting up to 2 weeks prior to improvement after systemic corticosteroids.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Rash papular, Red blood cell count decreased, Red cell distribution width normal, Skin plaque, Streptococcus test positive
Clinical narrative: Diffuse papular/plaque dermatitis including involvement of the oral mucosa, tongue, lips, and throat starting 3 days after vaccination and lasting up to 2 weeks prior to improvement after systemic corticosteroids.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: White blood cell count normal
Clinical narrative: Diffuse papular/plaque dermatitis including involvement of the oral mucosa, tongue, lips, and throat starting 3 days after vaccination and lasting up to 2 weeks prior to improvement after systemic corticosteroids.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Extreme joint pain for 24 hours which got better after 48 hours, but  1-1/2 month later I am still suffering from joint pain. Never had it before. Most uncomfortable are my both pinkies. They are now very swollen and painful still to this day. I feel they are getting worse. I never had that before. Knee, hip, hands, clavicle, lower back, toes,  ankles, and hands are still sore.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site reaction
Clinical narrative: Patient asked about numbness that was about 1-1.5 inches above and 1 in towards back of where the vaccine was given.  Stated that every once in a while it feels like the muscle is tearing and it get a burning sensation.  Going  to have checked out 11/3/23 by her doctor.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Dyspnoea
Clinical narrative: Fever of 103.7, chills, weakness, lethargy, body and joint aches, severe arm soreness, lightheadedness, headache, shortness of breath, phlegmy cough
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain, Pain in extremity, Productive cough
Clinical narrative: Fever of 103.7, chills, weakness, lethargy, body and joint aches, severe arm soreness, lightheadedness, headache, shortness of breath, phlegmy cough
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 103.7, chills, weakness, lethargy, body and joint aches, severe arm soreness, lightheadedness, headache, shortness of breath, phlegmy cough
Age: 26.0
Sex: M
Vaccine: FLUR4, TDAP
Symptoms: Facial pain, Fall, Head injury, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient was sitting on exam table to receive both the tdap and flu vaccines. Verified pt's name and DOB before giving the vaccines. Patient was given the flu vaccine in his right upper arm after area had been cleaned with aseptic and a minute later the tdap vaccine was given in a different spot on his right upper arm. Patient passed out and loss consciousness for about 2 minutes (definitely less than 5 minutes) immediately after receiving the tdap vaccine. When patient passed out, he fell face forward from the exam table and hit his head on the floor. The force from his glasses smashing against his face created a laceration above his left eyebrow. The glasses broke on the left side as well. The laceration was approximately 4 cm in length and less than 1 cm in depth and well- approximated. Cleaned the laceration with hibiclens solution, dried area, placed bacitracin ointment and covered laceration with gauze. Patient monitored in the clinic for 1.5 hours while waiting on his mom to arrive who lived an hour away. Pt closely monitored after fall. Vital signs stable throughout the entire episode. Hemostasis obtained. Patient remained neurologically intact. No evidence of concussion or headache, just pain around laceration site. Mother did not want ambulance called. Recommended that patient be taken to an urgent care or the ER to get laceration above left eyebrow stitched up. Mother verbalizes understanding and is in agreement to plan of care.
Age: 26.0
Sex: M
Vaccine: FLUR4, TDAP
Symptoms: Skin laceration
Clinical narrative: Patient was sitting on exam table to receive both the tdap and flu vaccines. Verified pt's name and DOB before giving the vaccines. Patient was given the flu vaccine in his right upper arm after area had been cleaned with aseptic and a minute later the tdap vaccine was given in a different spot on his right upper arm. Patient passed out and loss consciousness for about 2 minutes (definitely less than 5 minutes) immediately after receiving the tdap vaccine. When patient passed out, he fell face forward from the exam table and hit his head on the floor. The force from his glasses smashing against his face created a laceration above his left eyebrow. The glasses broke on the left side as well. The laceration was approximately 4 cm in length and less than 1 cm in depth and well- approximated. Cleaned the laceration with hibiclens solution, dried area, placed bacitracin ointment and covered laceration with gauze. Patient monitored in the clinic for 1.5 hours while waiting on his mom to arrive who lived an hour away. Pt closely monitored after fall. Vital signs stable throughout the entire episode. Hemostasis obtained. Patient remained neurologically intact. No evidence of concussion or headache, just pain around laceration site. Mother did not want ambulance called. Recommended that patient be taken to an urgent care or the ER to get laceration above left eyebrow stitched up. Mother verbalizes understanding and is in agreement to plan of care.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Ischaemic stroke, Laboratory test, Muscular weakness
Clinical narrative: I got Flu and RSV vaccines on 9/28/23. Then the latest Covid vaccine on 10/03/23.  On 10/28/23 I suffered an ischemic stroke to my left frontal lobe.  I did not have a prior history of either high blood pressure or cholesterol.   The effect of my stroke is weakness to my right hand.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Nausea, Photophobia
Clinical narrative: Daily headache not relieved by ibuprofen, mild nausea, photophobia
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Basal ganglia infarction, Cerebral atrophy, Condition aggravated, Dysarthria
Clinical narrative: Facial droop and slurred speech began 10/24/2023. Hospital admission 10/27-10/28/2023, MRI "IMPRESSION: 1. Small acute infarct in the posterior right basal ganglia. No associated hemorrhage. 2. Multiple chronic lacunar infarcts and moderate to advanced leukoaraiosis, most commonly seen in the setting of chronic ischemic disease.   3. Mild atrophy. 4. Complete opacification of the right maxillary sinus, possibly representing chronic sinusitis". Discharge Assessment & Plan (Problem List) Principal Problem: Infarction of right basal ganglia  Active Problems: Age-related physical debility HTN (hypertension) Resolved Problems: Stroke-like symptom Subjective Assessment: Patient evaluated on the day of discharge, she is awake, alert and oriented does not appear to have any neurological deficits at this time with improving facial droop. Full review of systems was performed and found to be negative. Discharge to home, diet and activity as tolerated.  Referral to PCP to establish care. MD
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypertension, Laboratory test normal, Lacunar infarction, Magnetic resonance imaging head abnormal
Clinical narrative: Facial droop and slurred speech began 10/24/2023. Hospital admission 10/27-10/28/2023, MRI "IMPRESSION: 1. Small acute infarct in the posterior right basal ganglia. No associated hemorrhage. 2. Multiple chronic lacunar infarcts and moderate to advanced leukoaraiosis, most commonly seen in the setting of chronic ischemic disease.   3. Mild atrophy. 4. Complete opacification of the right maxillary sinus, possibly representing chronic sinusitis". Discharge Assessment & Plan (Problem List) Principal Problem: Infarction of right basal ganglia  Active Problems: Age-related physical debility HTN (hypertension) Resolved Problems: Stroke-like symptom Subjective Assessment: Patient evaluated on the day of discharge, she is awake, alert and oriented does not appear to have any neurological deficits at this time with improving facial droop. Full review of systems was performed and found to be negative. Discharge to home, diet and activity as tolerated.  Referral to PCP to establish care. MD
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Sinus disorder, White matter lesion
Clinical narrative: Facial droop and slurred speech began 10/24/2023. Hospital admission 10/27-10/28/2023, MRI "IMPRESSION: 1. Small acute infarct in the posterior right basal ganglia. No associated hemorrhage. 2. Multiple chronic lacunar infarcts and moderate to advanced leukoaraiosis, most commonly seen in the setting of chronic ischemic disease.   3. Mild atrophy. 4. Complete opacification of the right maxillary sinus, possibly representing chronic sinusitis". Discharge Assessment & Plan (Problem List) Principal Problem: Infarction of right basal ganglia  Active Problems: Age-related physical debility HTN (hypertension) Resolved Problems: Stroke-like symptom Subjective Assessment: Patient evaluated on the day of discharge, she is awake, alert and oriented does not appear to have any neurological deficits at this time with improving facial droop. Full review of systems was performed and found to be negative. Discharge to home, diet and activity as tolerated.  Referral to PCP to establish care. MD
Age: 78.0
Sex: F
Vaccine: FLUR4
Symptoms: Crying, Immediate post-injection reaction, Incorrect dose administered, Injection site pain, Pain
Clinical narrative: The patient stated that she had an adverse reaction to the Fluzone HD she received last year. She reported pain, redness, swelling, itching, and a red rash at the injection site on her left arm that persisted for over 6 months. She stated she still wanted to receive a flu shot this year despite her previous adverse reaction. I counseled her on her options, and risk of cross-reaction, and the patient agreed to receive FluBlok to see if she tolerated this formulation. I also recommended that the injection be placed into her right arm due to previous reaction in her left arm. The patient refused the recommendation and insisted that she receive the FluBlok injection into her left arm. Immediately upon injection into the left deltoid, the patient cried out and stated she was in terrible "excruciating" pain. Approximately half of the pre-filled syringe (about 0.25 ml) was injected into the middle of the patient's left deltoid before the needle was removed. The patient stated that her arm continued to hurt at the injection site for a few minutes, and then the pain subsided and that she was "ok".  She refused to receive the other 0.25 ml remaining in the prefilled syringe. Upon visual and tactile inspection of the injection site no visible or palpable abnormalities were observed. No redness, swelling, bruising, or discoloration was noted. The patient did not report any numbness of the left arm, she stated that her pain had subsided, and that she still had full function of her left arm. The patient was advised to notify her PCP of the atypical reaction and for advice on how to proceed since she only received half of her flu vaccine. I also advised her to receive any subsequent vaccines in her right arm. The patient was notified that we are available at the pharmacy 24 hours/day and to contact us if any further issues/reactions occurred or with any questions or concerns. The patient understood.
Age: 78.0
Sex: F
Vaccine: FLUR4
Symptoms: Underdose
Clinical narrative: The patient stated that she had an adverse reaction to the Fluzone HD she received last year. She reported pain, redness, swelling, itching, and a red rash at the injection site on her left arm that persisted for over 6 months. She stated she still wanted to receive a flu shot this year despite her previous adverse reaction. I counseled her on her options, and risk of cross-reaction, and the patient agreed to receive FluBlok to see if she tolerated this formulation. I also recommended that the injection be placed into her right arm due to previous reaction in her left arm. The patient refused the recommendation and insisted that she receive the FluBlok injection into her left arm. Immediately upon injection into the left deltoid, the patient cried out and stated she was in terrible "excruciating" pain. Approximately half of the pre-filled syringe (about 0.25 ml) was injected into the middle of the patient's left deltoid before the needle was removed. The patient stated that her arm continued to hurt at the injection site for a few minutes, and then the pain subsided and that she was "ok".  She refused to receive the other 0.25 ml remaining in the prefilled syringe. Upon visual and tactile inspection of the injection site no visible or palpable abnormalities were observed. No redness, swelling, bruising, or discoloration was noted. The patient did not report any numbness of the left arm, she stated that her pain had subsided, and that she still had full function of her left arm. The patient was advised to notify her PCP of the atypical reaction and for advice on how to proceed since she only received half of her flu vaccine. I also advised her to receive any subsequent vaccines in her right arm. The patient was notified that we are available at the pharmacy 24 hours/day and to contact us if any further issues/reactions occurred or with any questions or concerns. The patient understood.
Age: 0.5
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: No side effects happen to the patient, no fever, just redness and swelling at the vaccine site lasted for days and did not require any treatment
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Syncope
Clinical narrative: patient received 2 IMZ.  Patient fainted after the 2nd IMZ. Patients partner said that he faints all the time when receiving IMZ due to anxiety. Partner was ready to hold him up after pt said "that hurt" and was not concerned. Patient was unconscious for approx 30 seconds.  I asked if they wanted me to call anyone and they declined. Patient sat in IMZ room for about 5 min, then walked out .
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Tennis ball sized area of swelling, redness, and warmth to injection site. Sore muscles around injection site. Congestion and low-grade fever.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory tract congestion
Clinical narrative: Tennis ball sized area of swelling, redness, and warmth to injection site. Sore muscles around injection site. Congestion and low-grade fever.
Age: 0.25
Sex: M
Vaccine: HEP, RSV
Symptoms: No adverse event
Clinical narrative: No side effects of the vaccine, no fever or other symptoms were reported from the mother
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Chills, Headache, Loss of consciousness
Clinical narrative: I had the vaccine on Friday, October 27. Saturday, October 28, I woke up with fever, chills, fever, severe headache, general pain and weakness. I was lying down all day drinking only water. Sunday, October 29, I went out to the patio to move my body a little and get some sun, but in less than 5 minutes a very strong pain in my middle back started, an unbearable pain and I immediately fainted to the ground, losing consciousness from complete. I was in the hospital all day, but they couldn't tell me what the origin of the fainting was, since my heart was fine, but a little weak. They said it was possibly an adverse effect of the Covid vaccine that I had had almost two days before.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Syncope
Clinical narrative: I had the vaccine on Friday, October 27. Saturday, October 28, I woke up with fever, chills, fever, severe headache, general pain and weakness. I was lying down all day drinking only water. Sunday, October 29, I went out to the patio to move my body a little and get some sun, but in less than 5 minutes a very strong pain in my middle back started, an unbearable pain and I immediately fainted to the ground, losing consciousness from complete. I was in the hospital all day, but they couldn't tell me what the origin of the fainting was, since my heart was fine, but a little weak. They said it was possibly an adverse effect of the Covid vaccine that I had had almost two days before.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Contusion, Tenderness
Clinical narrative: Severe arm tenderness bruising
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling, Pruritus, Vaccination site reaction
Clinical narrative: After the injection on 9.25.2023 my arm started itching and was pink below the injection site. At 2:00 am on 9.26 the itching as so bad I had to put cold compresses on it and noticed the swelling. Went to pharmacy to show them the sight and was told it was allergic reaction and the only thing I could do was to take Benadryl. I took the Benadryl once because I have glaucoma. The swelling spread but the itching lessened and I put ice compresses on the sight. The swelling continued to spread for a few more days and the itching was minimal. Swelling started going down 9.29.2023, but developed into a bruise and the itching would flare up suddenly then go away. As of Oct. 6th the bruise is gone but a blemish is visable where all the swelling was and the itching is still present at times.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9cm red, swollen, and perfect circle site of where the flu shot was given. Site was also warm to touch.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Alpha-1 anti-trypsin, Asthma, Blood test, Brain natriuretic peptide, Bronchitis
Clinical narrative: WITHIN 10 HOURS, SEVERE HEADACHE, HAD FLU LIKE SYMPTOMS FOR APPROX. 2 WKS. FOLLOWED BY HEADACHE, SHORTNESS OF BREATH, WHEEZING. PRESCRIBED ALBUTEROL INHALER TYLENOL Z-PAC. FEW MONTHS LATER WENT TO IMMEDIATE CARE WITH ACUTE BRONCHITIS - TUSSIONE X COUGH SYRUP, MUCINES. USE HUMIDIFIER, CONTINUE INHALER 11/27/2022 - IC ASTHMATIC BRONCHITIS W/ACUTE EXACERBATION ACUTE COUGH, WHEEZING. PRES. ALBUTEROL SULFATE - HFA INHALER, PREDNISONE TYLENOL. 1/29/23 - URGENT CARE - ACUTE PANSINSITIS, BRONCHITIS. PRES. CEFDINIR AND PREDNISONE - CONT. ALBUTEROL SULFATE INHALER. 3/14/23 - ER. UNABLE TO BREATH. ACUTE COUGH UPPER RESPIRATORY INFECTION, EXCERBATION OF ASTHMA, UNSPECIFIED ASTHMA SEVERITY. GIVEN AZITHROMYCIN, BENZONATE, BROMPHENIRAMINE - PSEUDOEPHEDRIN - DM, IPATROPIUM - ALBUTEROL, METHYLPREDNISOLONE - CONT. W/INHALER. REFERRED TO LUNG SPECIALIST. 4/4/23 - DR, MF FCCP - CHEST X-RAY, BLOOD WORK, ALPHA-I BLOOD WORK TO RULE OF COPD. NEXT APPT. APRN - EOSIOPHILS WAS 10 - SHOULD BE - LESS THAN 3. GAVE ME A FASENRA SHOT IMMEDIATELY, START BREZTR, INHALER. PHAR. WOULD NOT COVER ME RECEIVING THIS SHOT. AUGUST - FINALLY APPROVED NUCALA 100/ML AUTO-INJECTOR. THRU 12/31/2023 - VERY, VERY COSTLY CO-PAY UP TO $1300 - COULD NOT AFFORD. A LADY HELPED ME APPLY FOR PATIENT ASSISTANCE PROGRAM. APPROVED FOR NUCAL THRU 12/31/2023
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Condition aggravated, Cough, Dyspnoea, Eosinophil count
Clinical narrative: WITHIN 10 HOURS, SEVERE HEADACHE, HAD FLU LIKE SYMPTOMS FOR APPROX. 2 WKS. FOLLOWED BY HEADACHE, SHORTNESS OF BREATH, WHEEZING. PRESCRIBED ALBUTEROL INHALER TYLENOL Z-PAC. FEW MONTHS LATER WENT TO IMMEDIATE CARE WITH ACUTE BRONCHITIS - TUSSIONE X COUGH SYRUP, MUCINES. USE HUMIDIFIER, CONTINUE INHALER 11/27/2022 - IC ASTHMATIC BRONCHITIS W/ACUTE EXACERBATION ACUTE COUGH, WHEEZING. PRES. ALBUTEROL SULFATE - HFA INHALER, PREDNISONE TYLENOL. 1/29/23 - URGENT CARE - ACUTE PANSINSITIS, BRONCHITIS. PRES. CEFDINIR AND PREDNISONE - CONT. ALBUTEROL SULFATE INHALER. 3/14/23 - ER. UNABLE TO BREATH. ACUTE COUGH UPPER RESPIRATORY INFECTION, EXCERBATION OF ASTHMA, UNSPECIFIED ASTHMA SEVERITY. GIVEN AZITHROMYCIN, BENZONATE, BROMPHENIRAMINE - PSEUDOEPHEDRIN - DM, IPATROPIUM - ALBUTEROL, METHYLPREDNISOLONE - CONT. W/INHALER. REFERRED TO LUNG SPECIALIST. 4/4/23 - DR, MF FCCP - CHEST X-RAY, BLOOD WORK, ALPHA-I BLOOD WORK TO RULE OF COPD. NEXT APPT. APRN - EOSIOPHILS WAS 10 - SHOULD BE - LESS THAN 3. GAVE ME A FASENRA SHOT IMMEDIATELY, START BREZTR, INHALER. PHAR. WOULD NOT COVER ME RECEIVING THIS SHOT. AUGUST - FINALLY APPROVED NUCALA 100/ML AUTO-INJECTOR. THRU 12/31/2023 - VERY, VERY COSTLY CO-PAY UP TO $1300 - COULD NOT AFFORD. A LADY HELPED ME APPLY FOR PATIENT ASSISTANCE PROGRAM. APPROVED FOR NUCAL THRU 12/31/2023
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Headache, Inability to afford medication, Influenza like illness, Metabolic function test
Clinical narrative: WITHIN 10 HOURS, SEVERE HEADACHE, HAD FLU LIKE SYMPTOMS FOR APPROX. 2 WKS. FOLLOWED BY HEADACHE, SHORTNESS OF BREATH, WHEEZING. PRESCRIBED ALBUTEROL INHALER TYLENOL Z-PAC. FEW MONTHS LATER WENT TO IMMEDIATE CARE WITH ACUTE BRONCHITIS - TUSSIONE X COUGH SYRUP, MUCINES. USE HUMIDIFIER, CONTINUE INHALER 11/27/2022 - IC ASTHMATIC BRONCHITIS W/ACUTE EXACERBATION ACUTE COUGH, WHEEZING. PRES. ALBUTEROL SULFATE - HFA INHALER, PREDNISONE TYLENOL. 1/29/23 - URGENT CARE - ACUTE PANSINSITIS, BRONCHITIS. PRES. CEFDINIR AND PREDNISONE - CONT. ALBUTEROL SULFATE INHALER. 3/14/23 - ER. UNABLE TO BREATH. ACUTE COUGH UPPER RESPIRATORY INFECTION, EXCERBATION OF ASTHMA, UNSPECIFIED ASTHMA SEVERITY. GIVEN AZITHROMYCIN, BENZONATE, BROMPHENIRAMINE - PSEUDOEPHEDRIN - DM, IPATROPIUM - ALBUTEROL, METHYLPREDNISOLONE - CONT. W/INHALER. REFERRED TO LUNG SPECIALIST. 4/4/23 - DR, MF FCCP - CHEST X-RAY, BLOOD WORK, ALPHA-I BLOOD WORK TO RULE OF COPD. NEXT APPT. APRN - EOSIOPHILS WAS 10 - SHOULD BE - LESS THAN 3. GAVE ME A FASENRA SHOT IMMEDIATELY, START BREZTR, INHALER. PHAR. WOULD NOT COVER ME RECEIVING THIS SHOT. AUGUST - FINALLY APPROVED NUCALA 100/ML AUTO-INJECTOR. THRU 12/31/2023 - VERY, VERY COSTLY CO-PAY UP TO $1300 - COULD NOT AFFORD. A LADY HELPED ME APPLY FOR PATIENT ASSISTANCE PROGRAM. APPROVED FOR NUCAL THRU 12/31/2023
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngeal swab, Respiratory pathogen panel, Sinusitis, Troponin, Upper respiratory tract infection
Clinical narrative: WITHIN 10 HOURS, SEVERE HEADACHE, HAD FLU LIKE SYMPTOMS FOR APPROX. 2 WKS. FOLLOWED BY HEADACHE, SHORTNESS OF BREATH, WHEEZING. PRESCRIBED ALBUTEROL INHALER TYLENOL Z-PAC. FEW MONTHS LATER WENT TO IMMEDIATE CARE WITH ACUTE BRONCHITIS - TUSSIONE X COUGH SYRUP, MUCINES. USE HUMIDIFIER, CONTINUE INHALER 11/27/2022 - IC ASTHMATIC BRONCHITIS W/ACUTE EXACERBATION ACUTE COUGH, WHEEZING. PRES. ALBUTEROL SULFATE - HFA INHALER, PREDNISONE TYLENOL. 1/29/23 - URGENT CARE - ACUTE PANSINSITIS, BRONCHITIS. PRES. CEFDINIR AND PREDNISONE - CONT. ALBUTEROL SULFATE INHALER. 3/14/23 - ER. UNABLE TO BREATH. ACUTE COUGH UPPER RESPIRATORY INFECTION, EXCERBATION OF ASTHMA, UNSPECIFIED ASTHMA SEVERITY. GIVEN AZITHROMYCIN, BENZONATE, BROMPHENIRAMINE - PSEUDOEPHEDRIN - DM, IPATROPIUM - ALBUTEROL, METHYLPREDNISOLONE - CONT. W/INHALER. REFERRED TO LUNG SPECIALIST. 4/4/23 - DR, MF FCCP - CHEST X-RAY, BLOOD WORK, ALPHA-I BLOOD WORK TO RULE OF COPD. NEXT APPT. APRN - EOSIOPHILS WAS 10 - SHOULD BE - LESS THAN 3. GAVE ME A FASENRA SHOT IMMEDIATELY, START BREZTR, INHALER. PHAR. WOULD NOT COVER ME RECEIVING THIS SHOT. AUGUST - FINALLY APPROVED NUCALA 100/ML AUTO-INJECTOR. THRU 12/31/2023 - VERY, VERY COSTLY CO-PAY UP TO $1300 - COULD NOT AFFORD. A LADY HELPED ME APPLY FOR PATIENT ASSISTANCE PROGRAM. APPROVED FOR NUCAL THRU 12/31/2023
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: WITHIN 10 HOURS, SEVERE HEADACHE, HAD FLU LIKE SYMPTOMS FOR APPROX. 2 WKS. FOLLOWED BY HEADACHE, SHORTNESS OF BREATH, WHEEZING. PRESCRIBED ALBUTEROL INHALER TYLENOL Z-PAC. FEW MONTHS LATER WENT TO IMMEDIATE CARE WITH ACUTE BRONCHITIS - TUSSIONE X COUGH SYRUP, MUCINES. USE HUMIDIFIER, CONTINUE INHALER 11/27/2022 - IC ASTHMATIC BRONCHITIS W/ACUTE EXACERBATION ACUTE COUGH, WHEEZING. PRES. ALBUTEROL SULFATE - HFA INHALER, PREDNISONE TYLENOL. 1/29/23 - URGENT CARE - ACUTE PANSINSITIS, BRONCHITIS. PRES. CEFDINIR AND PREDNISONE - CONT. ALBUTEROL SULFATE INHALER. 3/14/23 - ER. UNABLE TO BREATH. ACUTE COUGH UPPER RESPIRATORY INFECTION, EXCERBATION OF ASTHMA, UNSPECIFIED ASTHMA SEVERITY. GIVEN AZITHROMYCIN, BENZONATE, BROMPHENIRAMINE - PSEUDOEPHEDRIN - DM, IPATROPIUM - ALBUTEROL, METHYLPREDNISOLONE - CONT. W/INHALER. REFERRED TO LUNG SPECIALIST. 4/4/23 - DR, MF FCCP - CHEST X-RAY, BLOOD WORK, ALPHA-I BLOOD WORK TO RULE OF COPD. NEXT APPT. APRN - EOSIOPHILS WAS 10 - SHOULD BE - LESS THAN 3. GAVE ME A FASENRA SHOT IMMEDIATELY, START BREZTR, INHALER. PHAR. WOULD NOT COVER ME RECEIVING THIS SHOT. AUGUST - FINALLY APPROVED NUCALA 100/ML AUTO-INJECTOR. THRU 12/31/2023 - VERY, VERY COSTLY CO-PAY UP TO $1300 - COULD NOT AFFORD. A LADY HELPED ME APPLY FOR PATIENT ASSISTANCE PROGRAM. APPROVED FOR NUCAL THRU 12/31/2023
Age: 31.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blood test normal, Exposure during pregnancy, Ultrasound foetal
Clinical narrative: covid test result=Positive; covid test result=Positive; brand=Pfizer/Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 18:00 as dose 5 (booster), single (Lot number: GJ6739) at the age of 31 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0158), in left arm and on 30Apr2021 as dose 2, single (Lot number: EW0173), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Nov2021 as dose 3 (booster), single (Lot number: 058H21A), in left arm and on 06Aug2022 as dose 4 (booster), single (Lot number: 051B22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: I have Hashimotos. My son only has SVT, no other issues at this time. The patient was 18 weeks pregnant at the time of exposure to elasomeran. The patient is expected to deliver a baby(s) on 14Jan2023. Concomitant medication(s) included: TDAP taken for immunisation, on 21Oct2022 as dose 1, single; LEVOTHYROXINE; BABY ASPIRIN.The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Nov2021, outcome "unknown", described as "brand=Pfizer/Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Oct2023, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2023) Positive, notes: Nasal Swab. Additional information: other medications in two weeks also included Prenatal Vit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351825 same reporter/drug, different patient and AE(baby/mother);US-PFIZER INC-202300351759 same reporter/patient, different drug and AE(baby/mother);
Age: 31.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: covid test result=Positive; covid test result=Positive; brand=Pfizer/Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 18:00 as dose 5 (booster), single (Lot number: GJ6739) at the age of 31 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0158), in left arm and on 30Apr2021 as dose 2, single (Lot number: EW0173), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Nov2021 as dose 3 (booster), single (Lot number: 058H21A), in left arm and on 06Aug2022 as dose 4 (booster), single (Lot number: 051B22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: I have Hashimotos. My son only has SVT, no other issues at this time. The patient was 18 weeks pregnant at the time of exposure to elasomeran. The patient is expected to deliver a baby(s) on 14Jan2023. Concomitant medication(s) included: TDAP taken for immunisation, on 21Oct2022 as dose 1, single; LEVOTHYROXINE; BABY ASPIRIN.The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Nov2021, outcome "unknown", described as "brand=Pfizer/Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Oct2023, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2023) Positive, notes: Nasal Swab. Additional information: other medications in two weeks also included Prenatal Vit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351825 same reporter/drug, different patient and AE(baby/mother);US-PFIZER INC-202300351759 same reporter/patient, different drug and AE(baby/mother);
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: COVID test positive; COVID test positive; COVID test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Jan2023 at 13:00 as dose 4 (booster), single (Lot number: GJ6796) at the age of 46 years intramuscular, in left deltoid for covid-19 immunisation; bnt162b2 (BNT162B2), on 15Jan2021 at 16:30 as dose 1, single (Lot number: EL3248) intramuscular, in left deltoid, on 05Feb2021 at 16:45 as dose 2, single (Lot number: EL9264) intramuscular, in left deltoid and on 22Dec2021 at 13:45 as dose 3 (booster), single (Lot number: FE3594), in left deltoid for covid-19 immunisation. A 3rd dose was administered due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications), patient indicated working at clinic and school. The patient's relevant medical history included: "COVID", start date: 10Nov2020 (unspecified if ongoing), notes: COVID test Positive. The patient's concomitant medications were not reported. Vaccination history included: Fluzone quadrivalent (yearly), for immunization. No other medical history or family medical history relevant to adverse events. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11Mar2023, outcome "unknown", COVID-19 (medically significant) with onset 11Mar2023, outcome "unknown", DISEASE RECURRENCE (medically significant) with onset 15Sep2023, outcome "unknown" and all described as "COVID test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Mar2023) Positive, notes: home test; (15Sep2023) Positive, notes: home test.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300294496 Same patient/ vaccine, different dose/ AE.;
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test positive; COVID test positive; COVID test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Jan2023 at 13:00 as dose 4 (booster), single (Lot number: GJ6796) at the age of 46 years intramuscular, in left deltoid for covid-19 immunisation; bnt162b2 (BNT162B2), on 15Jan2021 at 16:30 as dose 1, single (Lot number: EL3248) intramuscular, in left deltoid, on 05Feb2021 at 16:45 as dose 2, single (Lot number: EL9264) intramuscular, in left deltoid and on 22Dec2021 at 13:45 as dose 3 (booster), single (Lot number: FE3594), in left deltoid for covid-19 immunisation. A 3rd dose was administered due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications), patient indicated working at clinic and school. The patient's relevant medical history included: "COVID", start date: 10Nov2020 (unspecified if ongoing), notes: COVID test Positive. The patient's concomitant medications were not reported. Vaccination history included: Fluzone quadrivalent (yearly), for immunization. No other medical history or family medical history relevant to adverse events. The following information was reported: VACCINATION FAILURE (medically significant) with onset 11Mar2023, outcome "unknown", COVID-19 (medically significant) with onset 11Mar2023, outcome "unknown", DISEASE RECURRENCE (medically significant) with onset 15Sep2023, outcome "unknown" and all described as "COVID test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Mar2023) Positive, notes: home test; (15Sep2023) Positive, notes: home test.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300294496 Same patient/ vaccine, different dose/ AE.;
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTERED AFTER BUD
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AFTER BUD
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTERED AFTER BUD
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AFTER BUD
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Heart rate increased, Uterine contractions during pregnancy
Clinical narrative: I was wrongly administered Arexvy at 9 months pregnant; This non-serious prospective pregnancy case was reported by a consumer via sales rep and described the occurrence of drug exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced drug exposure during pregnancy (Verbatim: I was wrongly administered Arexvy at 9 months pregnant). The outcome of the drug exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 23-OCT-2023 The patient reported that was wrongly administered with Arexvy at 9 months pregnant.  The patient was concern because it was contraindicated for pregnant women.  The reporter asked the risks to the fetus. The reporter consented to follow up.