chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: It felt like I developed chronic fatigue, needed to sleep through the day, muscle fatigue, hard time for me to work, and muscle aches. This lasted for a couple of months. This also happened to me on my 3rd dose, but not as severe and only lasted for 3-4 weeks.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fluid retention, Hyperaesthesia, Magnetic resonance imaging abnormal, Movement disorder
Clinical narrative: Loss of: strength, movement, flexability in my right arm (bicep/shoulder area), pinching in my right arm (bicep shoulder area), extreme pain when preassure is applied to the right arm (bicep/shoulder area). MRI was taken that showed fluid in my arm along with other issues which Vaers has a copy of, physical therapy at home since I cant afford it 3x a week for 4 weeks, still have pain, issues with strength, movement and flexability along with pinching as of today.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Sensory disturbance
Clinical narrative: Loss of: strength, movement, flexability in my right arm (bicep/shoulder area), pinching in my right arm (bicep shoulder area), extreme pain when preassure is applied to the right arm (bicep/shoulder area). MRI was taken that showed fluid in my arm along with other issues which Vaers has a copy of, physical therapy at home since I cant afford it 3x a week for 4 weeks, still have pain, issues with strength, movement and flexability along with pinching as of today.
Age: 40.0
Sex: M
Vaccine: COVID19-2, FLU4, TDAP
Symptoms: Product preparation issue, Underdose
Clinical narrative: Pt requested  Pfizer Booster/Bivalent to be given, with other vaccines of TDaP and Flu. Pt was given Pedi Pfizer (5-11yo) dose, that was undiluted. AE was noted when counting waste of vaccine for day. Pfizer was called for advise of treatment or steps to be completed for Pt health concerns. Pfizer reported, "Pedi Pfizer Bivalent (5-11yo) dose undiluted , is same as Pfizer Bivalent  12 and up." No further treatment or steps should be taken.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient reported only 4 doses of Pfizer vaccines, and no bivalent booster. It was discovered after the fact that they had received a bivalent booster on 9/16/22. The informed consent form reported only 4 doses, last given on April 12, 2022.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia oral, Photopsia, Vitreous floaters
Clinical narrative: Shortly after vaccine as I was driving home, I got floaties in my right eye and had flashes in my peripheral  vision.  The flashes are finally gone, (2 months later), but the floaties are still in my eye.  After my very first Pfizer vaccine, shortly after the dose as I was driving home my upper lip on my left side went numb.  This lasted several days and is gone now.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient reported to clinic to receive flu shot. Front desk staff reported to nurse that client here to receive covid vaccine. Asked if client had any reactions to the previous vaccines, did not specify COVID vaccines. Clients reported no issues with previous shots. Covid bivalent booster given. Client was eligible to receive vaccine, last dose was 12/13/2021. No known adverse side effects from vaccine noted as of yet.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Laboratory test, Sudden death
Clinical narrative: Sudden death in sleep- no rationale reason.  Patient had recent labs and MD visits showing all chronic medical conditions were stable and under control.  Reporting death as patient did have both recommended COVID vaccine injections about 1 year prior.  Since long term safety and efficacy is still unknown for this vaccine for patients with medical history such as the patient we wished to have it reported as possible adverse event.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient received a second bivalent booster, patient's paperwork listed 4 vaccination dates and not the bivalent booster that was given 9/16/22.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient presented to the clinic for second COVID-19 vaccine. Vaccine was administered 9 days before due date. Patient was informed of the error on 12/1/22, and reports no side effects or adverse reactions.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Client reported to mother to clinic for flu shot. Reported to nurse that child was here for covid vaccine. Verified with mother that child was to receive his 1st dose, mother confirmed. Child received 1st dose of Covid19 vaccine for ages 6month-5years. No adverse side effects from vaccines noted at this time.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Dyspnoea, Fatigue, Illness
Clinical narrative: I received the Pfizer Bivalent booster for COVID-19 on 9/27/2022. I developed a sore throat on 10/30/2022, and it persisted for several weeks. Shortly thereafter, I also developed nasal congestion and a cough, both of which also persisted for several weeks. On 11/18/2022, I then also developed fatigue, body aches, and a low-grade fever of 99.9. During this entire time, I tested myself for COVID-19 3 times a week, as it is a requirement at my workplace. None of my tests yielded a positive result until 11/18/2022. On that day, I took a home antigen test and got a positive result. I spoke to a doctor on the phone afterwards, and he did not believe that I really had COVID-19. He asked me to undergo a PCR test for confirmation of the positive result on the home test, which I did, and it also yielded a positive result. Afterwards, I spoke to a doctor through an online service, and I was prescribed PAXLOVID, benzonatate, and an albuterol inhaler. I continued to feel sick afterwards, and I didn't begin to feel better until 11/26/2022. By then, my cough had greatly diminished, and I no longer felt winded whenever I moved around. It was also the first time since the onset of illness that I was able to get out of bed and resume some of my normal activities. I took another home antigen test on 11/25/2022 and got a negative result. My symptoms have continued to improve ever since. I still sometimes have a slight cough and a little bit of phlegm, but they're nothing major.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of personal independence in daily activities, Malaise, Mobility decreased, Nasal congestion, Oropharyngeal pain
Clinical narrative: I received the Pfizer Bivalent booster for COVID-19 on 9/27/2022. I developed a sore throat on 10/30/2022, and it persisted for several weeks. Shortly thereafter, I also developed nasal congestion and a cough, both of which also persisted for several weeks. On 11/18/2022, I then also developed fatigue, body aches, and a low-grade fever of 99.9. During this entire time, I tested myself for COVID-19 3 times a week, as it is a requirement at my workplace. None of my tests yielded a positive result until 11/18/2022. On that day, I took a home antigen test and got a positive result. I spoke to a doctor on the phone afterwards, and he did not believe that I really had COVID-19. He asked me to undergo a PCR test for confirmation of the positive result on the home test, which I did, and it also yielded a positive result. Afterwards, I spoke to a doctor through an online service, and I was prescribed PAXLOVID, benzonatate, and an albuterol inhaler. I continued to feel sick afterwards, and I didn't begin to feel better until 11/26/2022. By then, my cough had greatly diminished, and I no longer felt winded whenever I moved around. It was also the first time since the onset of illness that I was able to get out of bed and resume some of my normal activities. I took another home antigen test on 11/25/2022 and got a negative result. My symptoms have continued to improve ever since. I still sometimes have a slight cough and a little bit of phlegm, but they're nothing major.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Productive cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I received the Pfizer Bivalent booster for COVID-19 on 9/27/2022. I developed a sore throat on 10/30/2022, and it persisted for several weeks. Shortly thereafter, I also developed nasal congestion and a cough, both of which also persisted for several weeks. On 11/18/2022, I then also developed fatigue, body aches, and a low-grade fever of 99.9. During this entire time, I tested myself for COVID-19 3 times a week, as it is a requirement at my workplace. None of my tests yielded a positive result until 11/18/2022. On that day, I took a home antigen test and got a positive result. I spoke to a doctor on the phone afterwards, and he did not believe that I really had COVID-19. He asked me to undergo a PCR test for confirmation of the positive result on the home test, which I did, and it also yielded a positive result. Afterwards, I spoke to a doctor through an online service, and I was prescribed PAXLOVID, benzonatate, and an albuterol inhaler. I continued to feel sick afterwards, and I didn't begin to feel better until 11/26/2022. By then, my cough had greatly diminished, and I no longer felt winded whenever I moved around. It was also the first time since the onset of illness that I was able to get out of bed and resume some of my normal activities. I took another home antigen test on 11/25/2022 and got a negative result. My symptoms have continued to improve ever since. I still sometimes have a slight cough and a little bit of phlegm, but they're nothing major.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: pt was 8 years old at time vaccine was given. Wrong formulation was given. No symptoms were reported
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Red hot to touch hard lump at the site of the injection
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None reported/noted at this time.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure seven days post vaccine with high fever unresponsive to ibuprofen/acetaminophen at home
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, Mobility decreased, Tremor
Clinical narrative: Patient stated he experienced "severe chills" that lasted "6 hours straight on and off for about 2 days," before making a full recovery. He also stated that he "felt so tired" that he "could not get out of bed" and that his "hands were shaking so much" that he "could not write." He did not take any medications to alleviate those symptoms during that time. He did NOT experience any redness, rash, or difficulty breathing/wheezing.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: pt was given vaccine by the ma  that had expired 11/28/22  no symptoms
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Electromyogram abnormal, Intervertebral disc protrusion, Nerve compression, Pain
Clinical narrative: 2 hours after the vaccine patient has sharp pain on outside of right half on/off. Standing up helps the pain, sitting down makes it worse. Continues to experience side effects today.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Dyspnoea, Pericardial effusion, Positron emission tomogram normal
Clinical narrative: He started to have more and more shortness of breath. He was not able to do anything without getting short of breath. He was having breathing issues. Then we saw the doctor and they did a CAT scan. It showed he had fluid around the heart. He can't have an MRI he had a PET scan instead. The PET scan was fine. In the meantime, the doctor called to see how he was doing, and the fluid was building around his heart. The doctor said he doesn't feel like it was heart failure. The doctor didn't know what it was and where it started. The doctor said I wonder if this is happening due to the vaccine or the booster. As of right now they are running tests on him.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Started feeling achy, feverish, and had a sore throat; Took home COVID-19 test and it was positive; doctor prescribed PAXLOVID; Felt better 5 days later; Took a home COVID-19 test and it was negative; Then 2 weeks later on 11/25/2022 I tested positive for COVID-19 again; Just took MUCINEX and rested; Took another COVID-19 test two days later and I tested negative again.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Started feeling achy, feverish, and had a sore throat; Took home COVID-19 test and it was positive; doctor prescribed PAXLOVID; Felt better 5 days later; Took a home COVID-19 test and it was negative; Then 2 weeks later on 11/25/2022 I tested positive for COVID-19 again; Just took MUCINEX and rested; Took another COVID-19 test two days later and I tested negative again.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: 0.5 ml flu vaccine was administered on 12/01/2022. We later learned that the patient had a flu vaccine on 11/06/2022. This is shorter than the recommended interval between flu vaccines and more doses than recommended for the influenza season.
Age: 50.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Pain
Clinical narrative: 2 hours after the vaccine patient has sharp pain on outside of right half on/off. Continues to experience side effects today. Same side effects in husband who had vaccine the day prior.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the Bivalent Covid vaccine as dose one of the series.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Seizure
Clinical narrative: patient had a seizure within the hour of receiving vaccines. Mom called Drs. office, spoke with Dr. and was advised to take patient to Emergency Room.
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Erythema, Incoherent
Clinical narrative: Patient received her first ever dose of Depo-Provera in her left deltoid IM and Moderna Bivalent IM in right deltoid about 1530. Patient's mother who was accompanying patient to office visit called into provider's office at 1555 stating that patient was red, short of breath, unable to form a coherent sentence in car. Mother was instructed to take patient to nearest hospital right away. We contacted local hospital to let them know that patient  was coming and her medical history. Contacted mother at 1620 and patient was able to be seen in the hospital right away.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was inadvertently given the Monovalent Booster instead of the Bivalent Booster (Moderna)  Pt experienced no adverse event.  He is scheduled to return 2 months from date of this vaccination to receive the Moderna Bivalent Booster
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given a bivalent moderna shot on 12-01-2022 however, he had the new bivalent shot of moderna back in 09-12-2022. Pt felt ok and just fine after given the shot. He walked out of the store few minutes after the shot with no issues.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: With the third dose I reported ringing in my right ear. After this last dose (4th dose) I now have ringing in my left ear.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Feeling abnormal, Transient ischaemic attack
Clinical narrative: brain fog, tia,
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain
Clinical narrative: Headache, body ache, and patient stated she felt hot but did not measure temp.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation, Chest pain, Insomnia, Pain
Clinical narrative: Intense burning along left side of chest and upper inner left arm started 2 to 3 hours after vaccine. Helped a little the next day by ibuprofen but still painful just lessened it a little. Part of the pain occurred where I had been feeling an ache at left upper chest since March 2022 in area where node removed with left mastectomy. Previously pain very mild and very licalixed to upper left chest near axilla now intense burning pain in much larger area unrelenting kept me from sleeping.
Age: 17.0
Sex: M
Vaccine: COVID19-2, UNK, UNK, UNK, UNK
Symptoms: Aspartate aminotransferase increased, Brain natriuretic peptide increased, C-reactive protein normal, Chest pain, Echocardiogram normal
Clinical narrative: Patient is admitted to the hospital with chest pain and an elevated troponin concerning for myocarditis. He first presented with chest pain on 11/30. His chest pain has improved. His troponin continues to be elevated 12/1. His echocardiogram shows normal biventricular function.    COVID vaccine history 4/15/21 - Pfizer 5/8/21 - Pfizer 1st booster 12/15/21 - Pfizer 2nd booster 11/27/22 - Pfizer bivalent
Age: 17.0
Sex: M
Vaccine: COVID19-2, UNK, UNK, UNK, UNK
Symptoms: Metabolic function test abnormal, Troponin increased
Clinical narrative: Patient is admitted to the hospital with chest pain and an elevated troponin concerning for myocarditis. He first presented with chest pain on 11/30. His chest pain has improved. His troponin continues to be elevated 12/1. His echocardiogram shows normal biventricular function.    COVID vaccine history 4/15/21 - Pfizer 5/8/21 - Pfizer 1st booster 12/15/21 - Pfizer 2nd booster 11/27/22 - Pfizer bivalent
Age: 58.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Erythema, Headache, Hypertension, SARS-CoV-2 test negative
Clinical narrative: On 11/09/2022 I had headaches for few weeks after the vaccine. At night my face was red. My blood pressure was high. On the 11/17/2022 I went to my doctor she also checked my blood pressure  which was extremely high it was 159/106. I never had blood pressure before but now I have it. My doctor prescribed me metoprolol 1 per day. I will be doing a follow- up with my doctor within 4 weeks. I haven't recovered from it yet.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was inadvertently given the monovalent. He is scheduled to return for the Bivalent. No reaction reported.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Dysphonia, Dyspnoea
Clinical narrative: I received the Moderna Bivalent booster for COVID-19 on 9/12/2022. On 11/26/2022, I woke up coughing and had nasal congestion, and I had trouble breathing. The symptoms got progressively worse throughout the day. At one point, I had a fever of 100.9. I had difficulty breathing while I slept on account of the congestion and cough, and I had to sit up rather than lie down to get some sleep. I took an ALEVE for my temperature and BENADRYL for the other symptoms; they helped a little. The ALEVE was especially helpful since it got rid of my headache. On 11/27/2022, my fever was a little higher, plus my cough was worse and I had chills. I took some ALEVE and BENADRYL, which helped just a little. On the morning of 11/28/2022, I went to an urgent care clinic and underwent a rapid test for COVID-19, which yielded a positive result. I was prescribed molnupiravir, plus cefdinir, which I was to take in case I developed pneumonia. I started taking the molnupiravir that day. On 11/29/2022, I felt a little bit better. My temperature was down a little, my voice was less hoarse, and the coughing was less frequent and less intense. Ever since then, I have progressively gotten better, though at the time of this writing, I still have an annoying cough. On a happier note, though, my temperature is now in the normal range.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Nasal congestion, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I received the Moderna Bivalent booster for COVID-19 on 9/12/2022. On 11/26/2022, I woke up coughing and had nasal congestion, and I had trouble breathing. The symptoms got progressively worse throughout the day. At one point, I had a fever of 100.9. I had difficulty breathing while I slept on account of the congestion and cough, and I had to sit up rather than lie down to get some sleep. I took an ALEVE for my temperature and BENADRYL for the other symptoms; they helped a little. The ALEVE was especially helpful since it got rid of my headache. On 11/27/2022, my fever was a little higher, plus my cough was worse and I had chills. I took some ALEVE and BENADRYL, which helped just a little. On the morning of 11/28/2022, I went to an urgent care clinic and underwent a rapid test for COVID-19, which yielded a positive result. I was prescribed molnupiravir, plus cefdinir, which I was to take in case I developed pneumonia. I started taking the molnupiravir that day. On 11/29/2022, I felt a little bit better. My temperature was down a little, my voice was less hoarse, and the coughing was less frequent and less intense. Ever since then, I have progressively gotten better, though at the time of this writing, I still have an annoying cough. On a happier note, though, my temperature is now in the normal range.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was inadvertently given the monovalent vaccine. He is scheduled to return to obtain the bivalent. No reaction to monovalent given.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain
Clinical narrative: Per patient has experienced abdominal pain after taking vaccine. Per patient it comes and goes
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt was inadvertently given the Moderna monovalent booster instead of the Moderna Bivalent booster.  She is scheduled to come in and get the bivalent.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache, fever 102, nausea, severe muscle and joint pain, full body rash , chills
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Rash
Clinical narrative: Headache, fever 102, nausea, severe muscle and joint pain, full body rash , chills
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer monovalent is given to patient instead of Bivalent as requeted.  Patient does not experience any symptoms or side effect the day after.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt was inadvertenly given the Moderna monovalent vaccine instead of the Moderna bivalent booster.  He is scheduled to return to receive the Moderna bivalent vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PFIZER MONOVALENT WAS GIVEN STEAD OF PFIZER BIVALENT COVID 19 VACCINE
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt was inadvertenly given the Moderna monovalent vaccine instead of the Moderna bivalent booster.  He is scheduled to return to receive the Moderna bivalent vaccine.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was inadvertenly given the Moderna monovalent vaccine instead of the Moderna bivalent booster.  He is scheduled to return to receive the Moderna bivalent vaccine.  Pt had no reaction.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: patient did not experience any side effect from the Pfizer monovalent dose the day after
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was inadvertenly given the Moderna monovalent vaccine instead of the Moderna bivalent booster.  He is scheduled to return to receive the Moderna bivalent vaccine.  Pt had no reaction.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient received the shot at about 3:30pm. In the left thigh.  At about 8:45pm, parent noticed several flesh tone bumps on the patient?s left thigh (back).   Parent thought it was mosquito bites.  In the morning, the next day at 6:55am, noticed flash tone bumps all over the legs, arms, and trunk.  Gave her 5ml of Zyrtec.  There were also several red bumps throughout the body.  Then later in the day the bumps spread to the ear and face.  At 4:45pm, noticed the lips were swollen.  Also saw that all the flesh stone bumps were now all red bumps.  There was also a significant number of bumps compared to the morning.  The patient was acting normal throughout the entire day and also eating and drinking.  There is some itching in some of the places on the body such as the thigh area (left and right) and the ankle (right). Took the patient to see a physician at 6:00pm.  At this time noticed there were red bumps around the lips.  The doctor didn?t find anything wrong after performing an examination besides the bumps on the body and advised to continue giving Zyrtec and that the side effects could last weeks.  The doctor did inform the parents of signs to look out for that would warrant a need to go to the ER.  The doctor also advised to speak to another doctor. Allergist and primary physician to determine if we should continue with the 3rd dose of Covid.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT DID NOT EXPERIENCE SIDE EFFECTS FROM THE PFIZER MONOVALENT COVID 19 VACCINE
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep apnoea syndrome
Clinical narrative: Unrelated to the vaccine. I was diagnosed with sleep apnea a few months ago.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt was inadvertenly given the Moderna monovalent vaccine instead of the Moderna bivalent booster.  He is scheduled to return to receive the Moderna bivalent vaccine.  Pt had no reaction.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt was inadvertenly given the Moderna monovalent vaccine instead of the Moderna bivalent booster.  He is scheduled to return to receive the Moderna bivalent vaccine.  Pt had no reaction.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: NO ADVERSE EVENTS , NO SIDE EFFECTS FROM PFIZER MONOVALENT COVID19 VACCINE
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt was inadvertenly given the Moderna monovalent vaccine instead of the Moderna bivalent booster.  He is scheduled to return to receive the Moderna bivalent vaccine.  Pt had no reaction.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt was inadvertenly given the Moderna monovalent vaccine instead of the Moderna bivalent booster.  He is scheduled to return to receive the Moderna bivalent vaccine.  Pt had no reaction.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was inadvertenly given the Moderna monovalent vaccine instead of the Moderna bivalent booster.  He is scheduled to return to receive the Moderna bivalent vaccine.  Pt had no reaction.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Rash, Rash macular, Skin burning sensation
Clinical narrative: Got the shot on Monday 4 days later on Friday had red dot rash in various sizes covering neck shoulders torso and back.  The skin felt like it was burning. As day progressed the rash spread down arms lower abdomen and buttocks and some of the dots began to have a raised pimple like head. Skin felt like a mild sunburn.  Began taking Benadryl, Pepcid, Zyrtec, and Claritin every day. 1 week later and nothing has improved.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Depressed mood, Fatigue, Malaise
Clinical narrative: Short term side effects. Joint pain. Exhaustion, malaise. Longer term side effects are depressed mood, fatigue.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pain
Clinical narrative: Patient has reported that they experienced body pain and shortness of breath
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: 11/28/2022 onset of urticaria
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was inadvertenly given the Moderna monovalent vaccine instead of the Moderna bivalent booster.  He is scheduled to return to receive the Moderna bivalent vaccine.  Pt had no reaction.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Poor quality sleep, Pruritus, Pyrexia, Throat tightness, Urticaria
Clinical narrative: Woke up the 10th with fever up to 103 but by late evening it was down to 99. While I was falling asleep I started to get itchy in different parts and it caused a bad night of sleep. By 7am on the 11th my broke out in hives all over my body and I went to the ER.  I was told to isolate for 48 hours and take Benadryl every 6 hours and Zyrtec once a day. Today is 12/1/2022 and I am still experiencing itchiness and closing of throat (this only had occurred twice when I did not take Zyrtec. I was told symptoms may last up to a month.  It's been 22 days
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was inadvertenly given the Moderna monovalent vaccine instead of the Moderna bivalent booster.  He is scheduled to return to receive the Moderna bivalent vaccine.  Pt had no reaction.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Pfizer booster instead of 2nd dose Pfizer
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Tongue cancer recurrent
Clinical narrative: Started having sore throat. Diagnosed with recurrent tongue cancer needing major reconstructive surgery.  Check up on September with prior 2020 cancer negative
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus, Urticaria, Vaccine positive rechallenge
Clinical narrative: Itchiness and hives all over my body 2 weeks after the injection. The same occurred with my first booster (3rd dose - Moderna 064H21A)
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Chills, fever, nausea, tiredness, light-headed,stomach pains, diarrhea
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills, fever, nausea, tiredness, light-headed,stomach pains, diarrhea
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardio-respiratory arrest, Cold sweat, Cyanosis, Dizziness
Clinical narrative: 13y/o male received Pfizer bivalent booster on 11/29/22 minutes after pt felt faint, clammy, and cyanosis. Provider notified and code blue called. Oxygen and epi pen was administered by provider FNP. Patient seemed to be alert once epi was administered. 911 called once ambulance arrived pt was assessed by EMT then taken to hospital
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Per Dr. request was here today. Localized reaction and noticed on R deltoid 98 x 6mm and redness. Per patient Hx this is not the first time, but not recall if is the first time with same vaccine or combinations.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Headache, Influenza A virus test positive, Pyrexia
Clinical narrative: fever, chills, headache
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: NOTHING AS A RESULT OF SHOT.  I WAS ADVISED BY FACILITY TO REPORT TESTING POSITIVE FOR COVID ON 9-15-22.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: pain I had been experiencing in my left knee and ankle suddenly disappeared.  I reported the same thing when I received the first two doses of Cominarty; 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 male patient received BNT162b2 (COMIRNATY), on 12Mar2021 as dose 2, single (Lot number: EL3247) at the age of 46 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (dose 1; lot number: EL3247; location of injection: left arm; route of administration: intramuscular), administration date: 19Feb2021, when the patient was 45-year-old, for Covid-19 immunization, reaction(s): "pain I had been experiencing in my left knee and ankle suddenly disappeared". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "pain I had been experiencing in my left knee and ankle suddenly disappeared.  I reported the same thing when I received the first two doses of Cominarty".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337257 Same patient/product; different dose/event;US-PFIZER INC-202201337269 Same patient/product/event; different dose;US-PFIZER INC-202201337387 Same patient/product/event; different dose;
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: PERICARDITIS; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced pericarditis and his mountain bike career was done. As per consumer, "[Name redacted] now has pericarditis and his mountain bike career is done" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221166559- Pericarditis. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mechanical urticaria, Rash pruritic, Skin warm, Urticaria
Clinical narrative: 2 weeks after receiving booster have been experiencing daily chronic urticaria for the last 11 months with no signs of improving and allergy medicine (benadryl, claritan, zyrtec) providing minimal relief
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria chronic
Clinical narrative: 2 weeks after receiving booster have been experiencing daily chronic urticaria for the last 11 months with no signs of improving and allergy medicine (benadryl, claritan, zyrtec) providing minimal relief
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Cardio-respiratory arrest, Cardioversion, Death, Loss of consciousness, Resuscitation
Clinical narrative: Heavy menstrual bleeding after 2nd dose 09/27/2022 Following day after 3rd dose -1:00 p.m. Sudden cardiac arrest, never regained consciousness 11:15 p.m. Death 09/27/2022
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Cardiac arrest, Cardiac function test, Death, Heavy menstrual bleeding, Laboratory test
Clinical narrative: Heavy menstrual bleeding after 2nd dose 09/27/2022 Following day after 3rd dose -1:00 p.m. Sudden cardiac arrest, never regained consciousness 11:15 p.m. Death 09/27/2022
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Loss of consciousness
Clinical narrative: Heavy menstrual bleeding after 2nd dose 09/27/2022 Following day after 3rd dose -1:00 p.m. Sudden cardiac arrest, never regained consciousness 11:15 p.m. Death 09/27/2022
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Adult patient received Monovalent vaccine 1 day after MFG expiration date; No adverse event; Patient received Monovalent vaccine after MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent vaccine after MFG expiration date), PRODUCT STORAGE ERROR (Adult patient received Monovalent vaccine 1 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent vaccine after MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Adult patient received Monovalent vaccine 1 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent vaccine after MFG expiration date), PRODUCT STORAGE ERROR (Adult patient received Monovalent vaccine 1 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent vaccine after MFG expiration date) and PRODUCT STORAGE ERROR (Adult patient received Monovalent vaccine 1 day after MFG expiration date).    Pharmacist was calling to report that 8 adult patients received Moderna COVID-19 vaccine beyond manufacture expiration date. No concomitant medications were reported. MFG Expiration date was 20May2022 (agent checked, it had not been extended). It was unbroken cartons. Vial size was reported as 5.5 ml. The vial was initially stored in the refrigerator on 20-MAY-2022 and 28-MAY-2022 The vaccine was administered to 4 adult patients on 21-MAY-2022 and 4 more adult patients on 29-MAY-2022 The vial did not underwent any temperature excursions. No treatment medications were reported. This case contains information for the 3rd of 8 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-679408, US-MODERNATX, INC.-MOD-2022-679413, US-MODERNATX, INC.-MOD-2022-679412 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679408:same reporter US-MODERNATX, INC.-MOD-2022-679412:same reporter US-MODERNATX, INC.-MOD-2022-679413:same reporter
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Adult patient received Monovalent vaccine 1 day after MFG expiration date; No adverse event; Patient received Monovalent vaccine after MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent vaccine after MFG expiration date), PRODUCT STORAGE ERROR (Adult patient received Monovalent vaccine 1 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent vaccine after MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Adult patient received Monovalent vaccine 1 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent vaccine after MFG expiration date), PRODUCT STORAGE ERROR (Adult patient received Monovalent vaccine 1 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent vaccine after MFG expiration date) and PRODUCT STORAGE ERROR (Adult patient received Monovalent vaccine 1 day after MFG expiration date).    Pharmacist was calling to report that 8 adult patients received Moderna COVID-19 vaccine beyond manufacture expiration date. No concomitant medications were reported. MFG Expiration date was 20May2022 (agent checked, it had not been extended). It was unbroken cartons. Vial size was reported as 5.5 ml. The vial was initially stored in the refrigerator on 20-MAY-2022 and 28-MAY-2022 The vaccine was administered to 4 adult patients on 21-MAY-2022 and 4 more adult patients on 29-MAY-2022 The vial did not underwent any temperature excursions. No treatment medications were reported. This case contains information for the 3rd of 8 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-679408, US-MODERNATX, INC.-MOD-2022-679413, US-MODERNATX, INC.-MOD-2022-679412 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679408:same reporter US-MODERNATX, INC.-MOD-2022-679412:same reporter US-MODERNATX, INC.-MOD-2022-679413:same reporter
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: No adverse event; 4 adult patients received Monovalent vaccine 9 day after MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date).    No concomitant medications were reported.  8 adult patients received monovalent vaccine Beyond manufacture Expiration Date. It was reported that expiry date of vaccine had not been extended.It was unbroken cartons. Vial size was reported as 5.5 mL. Vial was initially stored in the refrigerator 20-MAY-2022 and 28-MAY-2022. 4 adult patients on 21-MAY-2022 and 4 more adult patients on 29-MAY-2022. Vial did not undergo any temperature excursions.  No treatment information was provided.  This case contains information for the 7th of 8 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-679408, US-MODERNATX, INC.-MOD-2022-679413, US-MODERNATX, INC.-MOD-2022-679412 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679408:same reporter US-MODERNATX, INC.-MOD-2022-679412:same reporter US-MODERNATX, INC.-MOD-2022-679413:same reporter
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 4 adult patients received Monovalent vaccine 9 day after MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date).    No concomitant medications were reported.  8 adult patients received monovalent vaccine Beyond manufacture Expiration Date. It was reported that expiry date of vaccine had not been extended.It was unbroken cartons. Vial size was reported as 5.5 mL. Vial was initially stored in the refrigerator 20-MAY-2022 and 28-MAY-2022. 4 adult patients on 21-MAY-2022 and 4 more adult patients on 29-MAY-2022. Vial did not undergo any temperature excursions.  No treatment information was provided.  This case contains information for the 7th of 8 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-679408, US-MODERNATX, INC.-MOD-2022-679413, US-MODERNATX, INC.-MOD-2022-679412 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679408:same reporter US-MODERNATX, INC.-MOD-2022-679412:same reporter US-MODERNATX, INC.-MOD-2022-679413:same reporter