chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; No AEs were reported; HCP stated that in one of their facilities they accidentally administered 2 doses on 01JUN2023 after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated that in one of their facilities they accidentally administered 2 doses on 01JUN2023 after the expiration date.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No AEs were reported) in a 26-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057A22A) for COVID-19 prophylaxis.     Patient relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.     On 01-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 01-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated that in one of their facilities they accidentally administered 2 doses on 01JUN2023 after the expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No AEs were reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated that in one of their facilities they accidentally administered 2 doses on 01JUN2023 after the expiration date.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No AEs were reported) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No AEs were reported) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated that in one of their facilities they accidentally administered 2 doses on 01JUN2023 after the expiration date.) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter.  Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728181 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728181:same reporter
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bell's palsy, Ear pain, Facial paralysis, Infection
Clinical narrative: 4/2/2023 I had pain in the left ear that progressively got more painful. Then Bells Palsy kicked in. The left side of my face was not moving. It got worse the next day. I went to the doctor, and he thought I had an infection and was prescribed Gabapentin. I got worse for a couple of days, then I have slowly been getting better day by day, but I still have issues.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: The COVID-19 Pfizer-BioNTech Bivalent Vaccine for ages 12+ was given to a 9 year old child without a signed parental consent.  CDC was consulted about the vaccination.  They advised that the child may have stronger side-effects than if she had received the appropriate pediatric dose. They also advised that the child be dosed with Acetaminophen before she develops symptoms, and continue per usual dosing direction for the next two days.  The mother was notified by phone by both the medical assistant and also by the provider Dr. They were also instructed to keep the child hydrated, have her rest and observe her for the next few days.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Headache, Idiopathic intracranial hypertension, Nausea, Vomiting
Clinical narrative: Unexpected headaches, temporary blindness, vomiting, nausea, resulted in IIH
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Appendicectomy, Appendicitis perforated, Computerised tomogram abdomen abnormal
Clinical narrative: On 10Jul2023 about 9PM, I felt like I had an air bubble in my stomach like I needed to pass gas. It was slowly getting uncomfortable, the longer I sat there the more it got uncomfterble. I layed down I felt better, I layed there for 2 hours it kept getting worsts it was so painful I couldn't get up. I went to the hospital and they found out I had appendix, that ruptured and was leaking inside of me. They did surgery and cleaned out the infection.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Mobility decreased, Sensory disturbance
Clinical narrative: On 10Jul2023 about 9PM, I felt like I had an air bubble in my stomach like I needed to pass gas. It was slowly getting uncomfortable, the longer I sat there the more it got uncomfterble. I layed down I felt better, I layed there for 2 hours it kept getting worsts it was so painful I couldn't get up. I went to the hospital and they found out I had appendix, that ruptured and was leaking inside of me. They did surgery and cleaned out the infection.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Loss of personal independence in daily activities, Oropharyngeal pain, Productive cough
Clinical narrative: On 9/28/2022, I was exposed to COVID-19. On 10/1/2022, I went to a party at noon. While I was there, I noticed my nose was running a little, and I had a slight tickle in the back of the throat. After about an hour, I left and went home. I took a nap and ended up sleeping until the morning of 10/2/2022. When I woke up, I had a painful, burning sensation in the back of the throat, plus phlegm. This continued for about five days and then began to subside. I was not able to function for another week. On 10/2/2022, I took a home antigen test and got a positive result. I had a telehealth visit with a local urgent care clinic on 10/3/2022, and I was prescribed Paxlovid, which I began taking 10/6/2022. I had no perceived improvement after beginning the medicine, but my symptoms also did not worsen. I took OTC Mucinex and Ricola lozenges to help treat the symptoms, but they weren't very effective. After about a week, I began to feel a little better. I felt much better after two weeks, but it took a month before I felt like I was back to normal. On 11/30/2022, I was again exposed to COVID-19. On 12/3/2022, I began to develop a sore throat, but it was less intense than it had been in October. I thought I had strep throat. I had sore throat and runny nose that continued for several days, but I powered through them and continued with my normal activities. Since I had recently had COVID-19, I didn't think I could possibly get it again so soon. On 12/9/2022, I went to a local urgent care clinic to undergo a strep test. A throat swab was performed, and I was given a brief physical exam before I was sent home. I learned within minutes after being tested that I was negative for streptococcus, but on 12/10/2022, I found out that I had tested positive for COVID-19 and RSV. I was offered Paxlovid, but I decided not to take it, because my symptoms this time around were less severe than they had been the first time around. I just treated my symptoms with OTC Mucinex and Ricola lozenges, but they didn't seem to help much. Because the symptoms were less severe this time, I was able to function well enough to work from home. I just took lots of naps and slept a lot. The symptoms lasted for about two weeks. It took a full month before I returned to my pre-COVID-19 functioning level.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test positive, Rhinorrhoea, SARS-CoV-2 test positive, Streptococcus test negative, Throat irritation
Clinical narrative: On 9/28/2022, I was exposed to COVID-19. On 10/1/2022, I went to a party at noon. While I was there, I noticed my nose was running a little, and I had a slight tickle in the back of the throat. After about an hour, I left and went home. I took a nap and ended up sleeping until the morning of 10/2/2022. When I woke up, I had a painful, burning sensation in the back of the throat, plus phlegm. This continued for about five days and then began to subside. I was not able to function for another week. On 10/2/2022, I took a home antigen test and got a positive result. I had a telehealth visit with a local urgent care clinic on 10/3/2022, and I was prescribed Paxlovid, which I began taking 10/6/2022. I had no perceived improvement after beginning the medicine, but my symptoms also did not worsen. I took OTC Mucinex and Ricola lozenges to help treat the symptoms, but they weren't very effective. After about a week, I began to feel a little better. I felt much better after two weeks, but it took a month before I felt like I was back to normal. On 11/30/2022, I was again exposed to COVID-19. On 12/3/2022, I began to develop a sore throat, but it was less intense than it had been in October. I thought I had strep throat. I had sore throat and runny nose that continued for several days, but I powered through them and continued with my normal activities. Since I had recently had COVID-19, I didn't think I could possibly get it again so soon. On 12/9/2022, I went to a local urgent care clinic to undergo a strep test. A throat swab was performed, and I was given a brief physical exam before I was sent home. I learned within minutes after being tested that I was negative for streptococcus, but on 12/10/2022, I found out that I had tested positive for COVID-19 and RSV. I was offered Paxlovid, but I decided not to take it, because my symptoms this time around were less severe than they had been the first time around. I just treated my symptoms with OTC Mucinex and Ricola lozenges, but they didn't seem to help much. Because the symptoms were less severe this time, I was able to function well enough to work from home. I just took lots of naps and slept a lot. The symptoms lasted for about two weeks. It took a full month before I returned to my pre-COVID-19 functioning level.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Exercise tolerance decreased, X-ray limb normal
Clinical narrative: My left knee developed acute pain the day after I received the booster. I had never had knee pain before and was very active-walking about 4 miles each day without any pain. I went to my doctor on  the third day of the pain and she ordered an x-ray of my knee. The x-ray revealed no trauma to the knee so she issued me a Prednisone for 6 days. She also told me to use the arthritis cream Voltaren
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Headache, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling at vaccine site, HA
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Electric shock sensation, Injection site erythema, Injection site paraesthesia, Injection site warmth, Paraesthesia
Clinical narrative: Reports tingling and electric shock pain from the L finger up to the site of injection; 7cm erythema surrounded the site of injection; warm to touch; very tender to palpation along the L arm;
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Reports tingling and electric shock pain from the L finger up to the site of injection; 7cm erythema surrounded the site of injection; warm to touch; very tender to palpation along the L arm;
Age: 0.75
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered the Pink Cap Moderna Bivalent COVID-19 vaccine instead of the Blue Cap Moderna Bivalent COVID-19 vaccine on Friday, June 9th, 2023.  Upon audit on June 12th, 2023, the error was found and mother was immediately contacted via phone call. Mother did not report any side effects and scheduled to bring patient back to receive the correct Blue Cap dose on Monday, June 19th, 2023.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent.  manufacturer sent wrong one both have gray tabs
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent.  sent wrong product both have gray tabs
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent.  sent wrong product both have gray tabs
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent.  wrong product sent, both have gray tops
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent.  wrong product sent, both gray tops
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent. wrong product sent, both gray tops
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent. wrong product sent, both have gray tops
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent. wrong product sent, both have gray tabs
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Blood urine present, Burning sensation, Eosinophil count increased, Glomerular filtration rate increased, Mean cell volume increased
Clinical narrative: Received vaccine approximately at 3 pm on 11/2/22. By 7:30 pm my arm started to burn and hurt. Pain worsened throughout the night.  On 11/3/22, I awoke with intense pain and my arm being paralyzed. I called EMS and was admitted for 3 days at Hospital.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Monoplegia, Neutrophil count decreased, Pain in extremity, Red blood cell count decreased
Clinical narrative: Received vaccine approximately at 3 pm on 11/2/22. By 7:30 pm my arm started to burn and hurt. Pain worsened throughout the night.  On 11/3/22, I awoke with intense pain and my arm being paralyzed. I called EMS and was admitted for 3 days at Hospital.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anal ulcer, Aphthous ulcer
Clinical narrative: Aphthous Stomatitis, Rectal ulceration lidocaine viscous 2% mouth solution as needed prednisone 10mg - take 5 daily x 2 days, 4 daily x 2 days, 3 daily x 2 days, 2 daily x 2 days, 1 daily x 2 days Triamcinolone 0.1% paste - use in mouth/throat 2x/day lidocaine 2% jelly to rectal area
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electroencephalogram, Epilepsy, Laboratory test, Scan brain, Seizure
Clinical narrative: I now have epilepsy and seizures
Age: 51.0
Sex: M
Vaccine: ANTH
Symptoms: Dental caries, Tooth fracture
Clinical narrative: within 12 months after final vaccination my teeth started rotting and breaking
Sex: F
Vaccine: COVID19-2
Symptoms: Syncope
Clinical narrative: Patient received the first Moderna COVID Bivalent vaccine & hadn't had anything to eat yet that day. She had a syncopal episode after receiving the vaccine. She also had a PPD placed before the incident as well.
Age: 3.0
Sex: M
Vaccine: FLU4, MMR, MMR
Symptoms: Expired product administered
Clinical narrative: The MMR had expired 12/4/2021 He had no symptoms or reaction to the shot that day or win next month and no reaciton since. See my printout of note of  my discussion with mom the day of hot pediatric injection  Then see 3/14/2023 visit. Have another MMR on 3/24/23 Had a viral gastrointestinal  see enclosed
Age: 7.0
Sex: U
Vaccine: DTAP, IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inadvertently gave Dtap past age 6. She had No Reaction locally or systemically  she en closed
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: a sore right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a sore right arm injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 007B21A, 091D21A and 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (a sore right arm injection site). At the time of the report, VACCINATION SITE PAIN (a sore right arm injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient received other vaccines 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient experienced sore right arm injection site after the first two doses of 19-Mar-2021 and 23-Apr-2021 and did not had any adverse reaction after later two doses of 15-Aug-2021 and 22-Jan-2022.  Treatment information was not provided.   This case was linked to MOD-2023-727717 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein normal, Fatigue, Full blood count normal, Incorrect dose administered
Clinical narrative: Patient received 10 times the dose of vaccine. Shortly after administration (24 hours later) had neck swelling due to lymphadenopathy, hand and feet swelling. That subsided. Now has ongoing posterior neck and shoulder pain, lower extremity pain and easy fatigability. He has lost his job and is unable to perform activities of daily living.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of employment, Loss of personal independence in daily activities, Lymphadenopathy, Metabolic function test normal, Neck pain
Clinical narrative: Patient received 10 times the dose of vaccine. Shortly after administration (24 hours later) had neck swelling due to lymphadenopathy, hand and feet swelling. That subsided. Now has ongoing posterior neck and shoulder pain, lower extremity pain and easy fatigability. He has lost his job and is unable to perform activities of daily living.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Patient received 10 times the dose of vaccine. Shortly after administration (24 hours later) had neck swelling due to lymphadenopathy, hand and feet swelling. That subsided. Now has ongoing posterior neck and shoulder pain, lower extremity pain and easy fatigability. He has lost his job and is unable to perform activities of daily living.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Blood pressure increased, Condition aggravated
Clinical narrative: OBSTRUCTIVE SLEEP APNEA UNSTABLE ANGINA ANGINA, UNSPECIFIED
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Angina pectoris, Angina unstable, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA UNSTABLE ANGINA ANGINA, UNSPECIFIED
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Arthralgia, Juvenile idiopathic arthritis, Knee operation
Clinical narrative: Pt. developed swelling around her left knee in early March of 2022 without injury or any other health concern. At first it was just swollen without pain, but overtime it became more painful, and less flexible. After seeing doctors and specialists, the initial diagnosis was pigmented villonodular synovitis (PVNS), and arthroscopic surgery was performed in June of 2022. After surgery and follow-up visits, she is now diagnosed with juvenile idiopathic arthritis. While it started with only her left knee joint, it has since spread to her left ankle, left wrist, left hip, left elbow, and right knee. She is currently on methotrexate and weaning off of prednisone. She wakes up every morning in pain, which usually subsides a little due to her taking the prednisone daily, but then returns at night, and into the next morning. Her flexibility has been compromised and can not fully extend/bend the joints mentioned above.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Arthralgia, Arthritis, Arthroscopic surgery, Giant cell tumour of tendon sheath, Joint swelling
Clinical narrative: Pt. developed swelling around her left knee in early March of 2022 without injury or any other health concern. At first it was just swollen without pain, but overtime it became more painful, and less flexible. After seeing doctors and specialists, the initial diagnosis was pigmented villonodular synovitis (PVNS), and arthroscopic surgery was performed in June of 2022. After surgery and follow-up visits, she is now diagnosed with juvenile idiopathic arthritis. While it started with only her left knee joint, it has since spread to her left ankle, left wrist, left hip, left elbow, and right knee. She is currently on methotrexate and weaning off of prednisone. She wakes up every morning in pain, which usually subsides a little due to her taking the prednisone daily, but then returns at night, and into the next morning. Her flexibility has been compromised and can not fully extend/bend the joints mentioned above.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Juvenile idiopathic arthritis, Laboratory test, Magnetic resonance imaging, Mobility decreased, Pain
Clinical narrative: Pt. developed swelling around her left knee in early March of 2022 without injury or any other health concern. At first it was just swollen without pain, but overtime it became more painful, and less flexible. After seeing doctors and specialists, the initial diagnosis was pigmented villonodular synovitis (PVNS), and arthroscopic surgery was performed in June of 2022. After surgery and follow-up visits, she is now diagnosed with juvenile idiopathic arthritis. While it started with only her left knee joint, it has since spread to her left ankle, left wrist, left hip, left elbow, and right knee. She is currently on methotrexate and weaning off of prednisone. She wakes up every morning in pain, which usually subsides a little due to her taking the prednisone daily, but then returns at night, and into the next morning. Her flexibility has been compromised and can not fully extend/bend the joints mentioned above.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Sleep disorder, X-ray
Clinical narrative: Pt. developed swelling around her left knee in early March of 2022 without injury or any other health concern. At first it was just swollen without pain, but overtime it became more painful, and less flexible. After seeing doctors and specialists, the initial diagnosis was pigmented villonodular synovitis (PVNS), and arthroscopic surgery was performed in June of 2022. After surgery and follow-up visits, she is now diagnosed with juvenile idiopathic arthritis. While it started with only her left knee joint, it has since spread to her left ankle, left wrist, left hip, left elbow, and right knee. She is currently on methotrexate and weaning off of prednisone. She wakes up every morning in pain, which usually subsides a little due to her taking the prednisone daily, but then returns at night, and into the next morning. Her flexibility has been compromised and can not fully extend/bend the joints mentioned above.
Age: 81.0
Sex: F
Vaccine: PNC20, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Rash pustular
Clinical narrative: Redness; Itching; Stinging; Pustules with whiteheads; Fever; Chills; Pustules; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUN-2023, the patient received the 1st dose of Shingrix (left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Redness), pruritus (Verbatim: Itching), stinging (Verbatim: Stinging), whiteheads (Verbatim: Pustules with whiteheads), fever (Verbatim: Fever), chills (Verbatim: Chills) and pustular rash (Verbatim: Pustules). The outcome of the erythema, pruritus, stinging, whiteheads and pustular rash were not resolved and the outcome of the fever and chills were resolved.   It was unknown if the reporter considered the erythema, pruritus, stinging, whiteheads, fever, chills and pustular rash to be related to Shingrix.     It was unknown if the company considered the erythema, pruritus, stinging, whiteheads, fever, chills and pustular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter was a patient. The patient received her first dose of Shingrix and had redness, itching, stinging and pustules with whiteheads on her left arm. The reporter stated that all the symptoms were still ongoing. The reporter also mentioned that she had fever and chills which resolved. The reporter did consent to follow up. This case had been link to US2023079169 reported by same reporter.; Sender's Comments:  US-GSK-US2023079169:same reporter
Age: 81.0
Sex: F
Vaccine: PNC20, VARZOS, VARZOS
Symptoms: Acne, Chills, Erythema, Pain, Pruritus
Clinical narrative: Redness; Itching; Stinging; Pustules with whiteheads; Fever; Chills; Pustules; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUN-2023, the patient received the 1st dose of Shingrix (left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Redness), pruritus (Verbatim: Itching), stinging (Verbatim: Stinging), whiteheads (Verbatim: Pustules with whiteheads), fever (Verbatim: Fever), chills (Verbatim: Chills) and pustular rash (Verbatim: Pustules). The outcome of the erythema, pruritus, stinging, whiteheads and pustular rash were not resolved and the outcome of the fever and chills were resolved.   It was unknown if the reporter considered the erythema, pruritus, stinging, whiteheads, fever, chills and pustular rash to be related to Shingrix.     It was unknown if the company considered the erythema, pruritus, stinging, whiteheads, fever, chills and pustular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter was a patient. The patient received her first dose of Shingrix and had redness, itching, stinging and pustules with whiteheads on her left arm. The reporter stated that all the symptoms were still ongoing. The reporter also mentioned that she had fever and chills which resolved. The reporter did consent to follow up. This case had been link to US2023079169 reported by same reporter.; Sender's Comments:  US-GSK-US2023079169:same reporter
Age: 81.0
Sex: F
Vaccine: PNC20, VARZOS, VARZOS
Symptoms: Pustule, Pyrexia, Rash pustular
Clinical narrative: Redness; Itching; Stinging; Pustules with whiteheads; Fever; Chills; Pustules; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUN-2023, the patient received the 1st dose of Shingrix (left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Redness), pruritus (Verbatim: Itching), stinging (Verbatim: Stinging), whiteheads (Verbatim: Pustules with whiteheads), fever (Verbatim: Fever), chills (Verbatim: Chills) and pustular rash (Verbatim: Pustules). The outcome of the erythema, pruritus, stinging, whiteheads and pustular rash were not resolved and the outcome of the fever and chills were resolved.   It was unknown if the reporter considered the erythema, pruritus, stinging, whiteheads, fever, chills and pustular rash to be related to Shingrix.     It was unknown if the company considered the erythema, pruritus, stinging, whiteheads, fever, chills and pustular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter was a patient. The patient received her first dose of Shingrix and had redness, itching, stinging and pustules with whiteheads on her left arm. The reporter stated that all the symptoms were still ongoing. The reporter also mentioned that she had fever and chills which resolved. The reporter did consent to follow up. This case had been link to US2023079169 reported by same reporter.; Sender's Comments:  US-GSK-US2023079169:same reporter
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Confirmed that there were no symptomatic adverse event reported; Inbound call from nurse who reported one dose of VARIVAX was administered following a temperature excursion.  After evaluation, VARIVAX was found to be supported.  Confirmed that there were no symptomatic adverse event reported.  No additional inform; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 01-JUN-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters (ml) once as prophylaxis (lot number: U039723, which was determined to be valid, with an expiration date on 15-DEC-2023) (scheme, route and anatomical location of administration were not reported) (Product storage error).  The administered dose underwent a temperature excursion of between -10 and 8 Celsius (C), for 2 hours 50 minutes. No previous temperature excursion was reported.  No additional symptomatic adverse event reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date).    This is case is for Patient 3 of 3 patients.  No concomitant medications were reported.   It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna Bivalent COVID-19 Vaccine with Lot number: 083B22A was received on 15-Nov-2022 with expiration date as 28-Feb-2023 but the date of administration was 05-Apr-2023 with doses of 3.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow up received with no significant information
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Moderna Bivalent Covid-19 vaccine that expired on 30-May-2023; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on 30-May-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on 30-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on 30-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on 30-May-2023).    No concomitant medications were provided. Dosage text for suspect drug reported as unknown. No treatment medication was provided. This case contains information for the 1st of 2 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728274 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728274:Same reporter
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 ". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 27May2023 to 01Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective , Covid-19 and the use of suspect product BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: started taking Paxlovid yesterday/received his last Covid vaccine 8 months ago, he is unsure what manufacturer he received; started taking Paxlovid yesterday/received his last Covid vaccine 8 months ago, he is unsure what manufacturer he received; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. An 88-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "started taking Paxlovid yesterday/received his last Covid vaccine 8 months ago, he is unsure what manufacturer he received". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Having Covid after previous Covid vaccination- manufacturer unknown, potential lack of efficacy if patient did receive Pfizer as last Covid dose. The patient currently has Covid, and received his last Covid vaccine 8 months ago, he is unsure what manufacturer he received. The patient was not immunocompromised started taking Paxlovid yesterday and will be done in 3-4 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Migraine, Protein S increased
Clinical narrative: Inflamation; High spike protein; Migraines daily; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6204, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 13Apr2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER 8732, Location of injection: Leg Left, Vaccine Administration Time: 04:30 PM), administration date: 23Mar2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "Location of injection: Leg Left". The following information was reported: PROTEIN S INCREASED (non-serious) with onset 07Jun2023 at 15:30, outcome "recovered", described as "High spike protein"; INFLAMMATION (non-serious) with onset 07Jun2023 at 15:30, outcome "recovered", described as "Inflamation"; MIGRAINE (non-serious) with onset 07Jun2023 at 15:30, outcome "recovered", described as "Migraines daily". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inflammation, protein s increased, migraine.  Additional Information: It was reported that the patient did not take any other vaccine or any other medication in four weeks . The patient was not diagnosed with covid prior to vaccination and was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna dose 21May2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 26Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21May2022, outcome "unknown", described as "Moderna dose 21May2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 20May2023 to 25May2023. Additional information: No known allergies. Patient received Moderna covid-19 Vaccine on 05Jun2023 at Left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Interchange of vaccine products; COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Apr2023 as dose 6 (booster), single (Lot number: GJ6743) at the age of 65 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8737), in right arm, on 24Apr2021 as dose 2, single (Lot number: ER8735), in right arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Nov2021 as dose 3 (booster), single (Lot number: 071F21A), in right arm and on 08Oct2022 as dose 5 (booster), single (Lot number: 027E22A), in right arm for COVID -19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: CALCIUM; VITAMIN B COMPLEX; LYSINE; SELENIUM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2023, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient took nirmatrelvir/ritonavir (PAXLOVID; Lot Number: GG4031) as treatment for five days starting on the first day of symptoms and a positive COVID-19 test (26May2023) until 31May2023.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Moderna dose number 3/ Pfizer / BioNTech dose number 2/Pfizer / BioNTech dose number 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2021 as dose 1, single (Lot number: ER8735), in right arm and on 09May2021 as dose 2, single (Lot number: EW0173) at the age of 35 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Nov2021 as dose 3 (booster), single (Lot number: 066F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: Aspirin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Moderna dose number 3/ Pfizer / BioNTech dose number 2/Pfizer / BioNTech dose number 1"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: and after 2 negative tests 48 hours apart; (unspecified date) Negative, notes: and after 2 negative tests 48 hours apart; (02Jun2023) Positive, notes: Covid positive test 2 days after last paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 12:00 as dose 5 (booster), single (Lot number: LM9703) at the age of 51 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Mar2021 at 12:00 as dose 1, single (Lot number: EN6199), in left arm and on 13Apr2021 at 12:15 as dose 2, single (Lot number: ER8731), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Dec2021 at 09:45 as dose 3 (booster), single (Lot number: 18F2LA), in left arm and on 09Apr2022 at 09:30 as dose 4 (booster), single (Lot number: 065K21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperglycemia" (unspecified if ongoing); "beta thalassemia" (unspecified if ongoing); "Known allergies: Sulfa-based antibiotics" (unspecified if ongoing). Concomitant medication(s) included: DROSPIRENONE AND ETHINYL ESTRADIOL, start date: 01Jan2019, stop date: 08Jun2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Dec2021 at 09:45, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2023) Negative; (04Jun2023) Negative; (05Jun2023) Negative; (06Jun2023) Negative; (07Jun2023) Negative; (08Jun2023) Positive, notes: Tested positive twice. Therapeutic measures were taken as a result of vaccination failure and covid-19 with Paxlovid from 30May2023 to 03Jun2023.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 04Mar2021 as dose 2, single (Lot number: EN6200), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FV8020) at the age of 65 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VYVANSE; ATORVASTATIN; TRAZODONE and FISH. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Apr2023, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2021) Negative; (05Apr2023) Positive, notes: Nasal Swab. The patient had not received any other vaccines within 4 weeks. The known allergies were reported as none and other medical history was reported as none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300216196 same patient, different dose/AE.;