chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: I received the Pfizer Bivalent booster on 11/17/2022. On 11/28/2022, I had a severe headache and a little bit of nausea. I took some hydrocodone and promethazine. They didn't get rid of the headache, but the promethazine did take away the nausea. After I took the medicines, I just slept, because there was nothing else to do. During the week of 11/28/2022 to 12/2/2022, the symptoms got progressively worse. On 11/30/2022, I had persistent chest pains. On that day, I had a telehealth visit with a PA who works with my pulmonologist. She agreed to ask my pulmonologist to prescribe me some prednisone. At this point, I had taken a home antigen test every day between 11/27/2022 and 11/30/2022 and had gotten a negative result each time. However, my wife had tested positive, so the PA felt pretty confident that I also had it, despite the results of the tests. On 12/1/2022, I took another home antigen test and got a positive result. The symptoms I was dealing with during this time included difficulty breathing, body aches, severe cough, chest pains, nasal congestion, and nausea. I had to use my rescue inhaler when I had difficulty breathing; the inhaler helped somewhat, but not completely. On 12/1/2022, I finally got a prescription for prednisone, Z-PAK, and promethazine, and I began taking the prednisone and the Z-PAK on 12/2/2022. On the night of 12/2/2022, the chest pains had diminished somewhat, so I had less discomfort. At the time of this writing, I continue to have chest pains, which are now somewhat intermittent and are much milder than they were at the beginning of my illness. I also continue to have a persistent (but milder) headache, a mild cough, and intermittent nausea. Of all those, I would say that nausea is the worst symptom, but it now seems to be diminishing. On 12/13/2022, I took another home antigen test and got a positive result. When I took another antigen test on 12/15/2022, I finally got a negative result for the first time since the beginning of my illness.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging abnormal, Pain, Tendon rupture
Clinical narrative: 9/21/2022. I have a history of an auto immune disease. That day my body became more achy. I contacted my doctor. I was placed on meloxicam about a month ago. I am doing physical therapy. It is getting better now.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Contusion, Lethargy, Nausea, Neck pain
Clinical narrative: Swollen arm; Bruised Arm; Sick to the stomach; Neck Pain; Lethargic; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2022, the patient received the 1st dose of Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced swelling arm, bruising of arm, stomach discomfort, neck pain and lethargy. The patient was treated with non-drug therapy (Heating Pad (Nos)). On an unknown date, the outcome of the swelling arm, bruising of arm, stomach discomfort, neck pain and lethargy were unknown.   It was unknown if the reporter considered the swelling arm, bruising of arm, stomach discomfort, neck pain and lethargy to be related to Shingrix.     Additional Information: GSK Receipt date: 6th December 2022. Reporter's Comment: The reporter was the patient. The patient received her first dose of SHINGRIX yesterday (5th December 2022). The patient experienced a swollen and bruised arm, felt sick to her stomach, neck pain, and felt lethargic. The patient used a heating pad to her neck to alleviate the neck pain.  The reporter did not consent to follow-up
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm; Bruised Arm; Sick to the stomach; Neck Pain; Lethargic; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2022, the patient received the 1st dose of Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced swelling arm, bruising of arm, stomach discomfort, neck pain and lethargy. The patient was treated with non-drug therapy (Heating Pad (Nos)). On an unknown date, the outcome of the swelling arm, bruising of arm, stomach discomfort, neck pain and lethargy were unknown.   It was unknown if the reporter considered the swelling arm, bruising of arm, stomach discomfort, neck pain and lethargy to be related to Shingrix.     Additional Information: GSK Receipt date: 6th December 2022. Reporter's Comment: The reporter was the patient. The patient received her first dose of SHINGRIX yesterday (5th December 2022). The patient experienced a swollen and bruised arm, felt sick to her stomach, neck pain, and felt lethargic. The patient used a heating pad to her neck to alleviate the neck pain.  The reporter did not consent to follow-up
Age: 78.0
Sex: M
Vaccine: FLUA4
Symptoms: Unevaluable event
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Eyelid oedema, Swelling of eyelid
Clinical narrative: Eyelid edema in both eyes. Swollen nearly entirely shut. No other symptoms. Starting to improve after 24 hours. Had the same reaction to the firs Pfizer booster, but then the onset was much sooner.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Illness, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE for COVID-19 after 5 vaccinations. Tested positive for COVID-19 (At-Home BD Veritor COVID-19 Test) on November 5, 2022 with mild symptoms (runny nose). On November 7, symptoms grew worse with severe sore throat Started prescription of Paxlovid on November 8 with quickly reduced severity of my illness. By November 11, I was feeling nearly normal and essentially no symptoms, however tested positive with At-Home BD Veritor COVID-19 Test On November 14 continued to test positive. On November 15 tested negative and had no symptoms.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, COVID-19, Delirium, Mental status changes, Pneumonia bacterial
Clinical narrative: Patient came to the ED with altered mental status and lower abdominal pain.  Patient was admitted to the hospital with bacterial pneumonia, delirium, and Covid.  Patient was treated for Covid with remdesivir.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: Vaccine was over diluted when reconstituted. No adverse reaction reported by mother. Patient to be boosted per CDC guidelines.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Cough, Fatigue, Feeling cold, Nasal congestion
Clinical narrative: I got my third booster at about 10AM. That night at about 3 or 4 in the morning, I woke up feverish. I tested about 103 fever. I took ADVIL and TYLENOL, and it would drop for a little bit and come back. I would have chills, I could not get warm at all for about a week. I had a cough, nasal congestion. After about day 8 I called my PCP, they gave me a tele-visit appointment. They prescribed some medicine that I got the next day. I was still having issues with my fever so he instructed me to continue taking ADVIL or TYLENOL throughout the day instead of just to make it go down. I've also had some nasal drainage, which I took ZYRTEC for, and some fatigue. I've been using my inhaler to help me breathe a little easier. I had a cough at some point but that's gotten better as well, I no longer have to take cough syrup to sleep. I had the fever up to a few days ago, around 12/12/22.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paranasal sinus hypersecretion, Pyrexia, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: I got my third booster at about 10AM. That night at about 3 or 4 in the morning, I woke up feverish. I tested about 103 fever. I took ADVIL and TYLENOL, and it would drop for a little bit and come back. I would have chills, I could not get warm at all for about a week. I had a cough, nasal congestion. After about day 8 I called my PCP, they gave me a tele-visit appointment. They prescribed some medicine that I got the next day. I was still having issues with my fever so he instructed me to continue taking ADVIL or TYLENOL throughout the day instead of just to make it go down. I've also had some nasal drainage, which I took ZYRTEC for, and some fatigue. I've been using my inhaler to help me breathe a little easier. I had a cough at some point but that's gotten better as well, I no longer have to take cough syrup to sleep. I had the fever up to a few days ago, around 12/12/22.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Malaise, Pain
Clinical narrative: It started on 11/26/22 I've been sick since then. I started to get pain two weeks ago. My fingers on my left hand started to get numb, It feels like the numbness has gotten worst. I had a phone consultation yesterday 12/15/2022 and doctor advised chronic medication treatment but they both disagreed on that treatment, and I will wait it out. I've never been sick like this.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Hypoaesthesia, Inflammation, Swelling
Clinical narrative: 04/03/2021 08:00AM, when I woke, my right arm was numb. (The opposite arm from the injection site.) That symptom continued for about 6 months. It lasts 20-20 minutes every morning and then it goes away for the day until the next morning. On April 19, 2021, I had a CRP test done for inflammation. Normal range is 1-10. My number was 69. My body was inflamed and swollen. After each vaccine, there is a period that I am extremely inflamed and swollen.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose year ago, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, over a year before date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: The pharmacist enquired if person failed to receive the 2nd dose for over a year, did the series need to be restarted.  The reporter consented to follow up. No further information provided The reporter mentioned submitting to safety as potential adverse event out of caution. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Fibrin D dimer normal, Heart rate increased, Mobility decreased
Clinical narrative: I had chest pains and then I could not get out of bed as my heartrate would increase, my doctor told me to go to the ER. I went to see my doctor and he performed an EKG he diagnosed pericarditis and I was in a lot of pain. I was told to take ibuprofen for two weeks and colchicine I took this for three months. The symptoms stopped but occurred again in October 2022 when I had to go the emergency room due to an increased rate heartrate and chest pains.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pericarditis, Troponin normal
Clinical narrative: I had chest pains and then I could not get out of bed as my heartrate would increase, my doctor told me to go to the ER. I went to see my doctor and he performed an EKG he diagnosed pericarditis and I was in a lot of pain. I was told to take ibuprofen for two weeks and colchicine I took this for three months. The symptoms stopped but occurred again in October 2022 when I had to go the emergency room due to an increased rate heartrate and chest pains.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient requested COVID 19 Moderna Updated Booster 12+ and by error the pharmacist administered 0.5mL of the COVID 19 Moderna Age 6-11. No adverse events was reported by the patient.
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Unevaluable event
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: erythema, swelling and pain at the site
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Hyperglycaemia, Mental status changes, Oropharyngeal pain, Pyrexia
Clinical narrative: 11/03/22 presents to ED for "hyperglycemia with AMS" "fever and sore throat". PMHx of " DM, HTN, HLD, hypothyroidism, Autoimmune Hepatitis"
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 11/03/22 presents to ED for "hyperglycemia with AMS" "fever and sore throat". PMHx of " DM, HTN, HLD, hypothyroidism, Autoimmune Hepatitis"
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, COVID-19, Cough, Eye irritation
Clinical narrative: I contracted COVID-19. My symptoms included congestion, sinus pressure, soreness of the throat, coughing, my eyes were burning & irritated, loss of taste, and complete lack of energy. I went to Urgent Care. My oxygen saturation was less than 90%. My temperature was slightly elevated and was at 99.2. My blood pressure was very high and it was 168 over 62.  I received Oral steroids. That same night after returning from Urgent Care, I was extremely sweaty. I still have a bit of congestion and sneezing. I'm still experiencing some loss of taste.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension, Oropharyngeal pain, Paranasal sinus discomfort, Respiratory tract congestion
Clinical narrative: I contracted COVID-19. My symptoms included congestion, sinus pressure, soreness of the throat, coughing, my eyes were burning & irritated, loss of taste, and complete lack of energy. I went to Urgent Care. My oxygen saturation was less than 90%. My temperature was slightly elevated and was at 99.2. My blood pressure was very high and it was 168 over 62.  I received Oral steroids. That same night after returning from Urgent Care, I was extremely sweaty. I still have a bit of congestion and sneezing. I'm still experiencing some loss of taste.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sneezing
Clinical narrative: I contracted COVID-19. My symptoms included congestion, sinus pressure, soreness of the throat, coughing, my eyes were burning & irritated, loss of taste, and complete lack of energy. I went to Urgent Care. My oxygen saturation was less than 90%. My temperature was slightly elevated and was at 99.2. My blood pressure was very high and it was 168 over 62.  I received Oral steroids. That same night after returning from Urgent Care, I was extremely sweaty. I still have a bit of congestion and sneezing. I'm still experiencing some loss of taste.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Following receiving her vaccination, patient began feeling  a sharp type pain at her shoulder, running down her arm, experienced mainly with movement. No swelling, redness or warmth. She reports no specific injury, with a gradual onset of pain.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, COVID-19, Cough, Diarrhoea, Fatigue
Clinical narrative: I mainly had diarrhea and great fatigue. I started having this right after November 24th evening, but I didn't develop a cough until I went to urgent care the next day. I had a cough and sniffling from a runny nose. I also developed headache migraines, nasal congestion, a heavier cough, and some body pain. The perimeters of my sinuses and knees began to ache and hurt. I took an at-home COVID-19 test on 12/02/2022 once the symptoms decided not to go away which came back quickly as positive. I called my doctor who prescribed me molnupiravir 200mg for treatment of my COVID-19 infection. I was taking BENADRYL and TYLENOL before going to the doctor again after the molnupiravir finished. I'm still not getting any better so I called my doctor again who brought me into the office and gave me methylprednisone and azithromycin which I'm currently taking now.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Migraine, Nasal congestion, Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I mainly had diarrhea and great fatigue. I started having this right after November 24th evening, but I didn't develop a cough until I went to urgent care the next day. I had a cough and sniffling from a runny nose. I also developed headache migraines, nasal congestion, a heavier cough, and some body pain. The perimeters of my sinuses and knees began to ache and hurt. I took an at-home COVID-19 test on 12/02/2022 once the symptoms decided not to go away which came back quickly as positive. I called my doctor who prescribed me molnupiravir 200mg for treatment of my COVID-19 infection. I was taking BENADRYL and TYLENOL before going to the doctor again after the molnupiravir finished. I'm still not getting any better so I called my doctor again who brought me into the office and gave me methylprednisone and azithromycin which I'm currently taking now.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinus pain
Clinical narrative: I mainly had diarrhea and great fatigue. I started having this right after November 24th evening, but I didn't develop a cough until I went to urgent care the next day. I had a cough and sniffling from a runny nose. I also developed headache migraines, nasal congestion, a heavier cough, and some body pain. The perimeters of my sinuses and knees began to ache and hurt. I took an at-home COVID-19 test on 12/02/2022 once the symptoms decided not to go away which came back quickly as positive. I called my doctor who prescribed me molnupiravir 200mg for treatment of my COVID-19 infection. I was taking BENADRYL and TYLENOL before going to the doctor again after the molnupiravir finished. I'm still not getting any better so I called my doctor again who brought me into the office and gave me methylprednisone and azithromycin which I'm currently taking now.
Age: 71.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Bivalent Booster dose from vial that had "end of use date" that was expired by 13 days.  No untoward effects to patient.
Age: 70.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 11/03/22 presents to ED for "shortness of breath". PMHx of "COPD, metastatic melanoma to the lung"
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: 1st dose April 2022, 2nd 7.5 months later; feverish; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (The patient received 1st dose of Shingrix in Apr 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced fever and drug dose administration interval too long. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comment: The case was self reported by the patient. The patient received second dose of Shingrix 7.5 months after the first dose of Shingrix and felt feverish, but that the feverish feeling went away after one day. No further information reported to the agent by the patient. The reporter did not consent to follow up. Additional supportive information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID after completing vaccine series.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Pyrexia, Respiratory tract congestion
Clinical narrative: No adverse reaction to the vaccine, but 6 weeks later I had congestion, cough, headache. I tested at back in October all my test were Negative, it was testing at a vaccination site, and today I tested positive. From last Wednesday I had consistent symptoms with low fever, cough, congestion, headache. I am taking MUCINEX & TYLENOL. I called the doctor, and he will recommend PAXLOVID.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: No adverse reaction to the vaccine, but 6 weeks later I had congestion, cough, headache. I tested at back in October all my test were Negative, it was testing at a vaccination site, and today I tested positive. From last Wednesday I had consistent symptoms with low fever, cough, congestion, headache. I am taking MUCINEX & TYLENOL. I called the doctor, and he will recommend PAXLOVID.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cerebrovascular accident, Laboratory test, Pain in extremity
Clinical narrative: A few days after getting the vaccine I noticed that my arm started hurting and then went away after I took something for pain. Then the first of May I had a stroke. I was then admitted into the hospital for a month. I was doing rehab to rebuild my strength.
Age: 83.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 11/03/22 presents to ED for "shortness of breath". PMHx of "DVT"
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I received the Pfizer Bivalent booster for COVID-19 on 9/15/2022; this was my third booster. On 11/16/2022, I ran a low-grade fever overnight. I also had sneezing and a runny nose. On 11/17/2022, I took a home antigen test and got a positive result. I called my PCP to ask him to prescribe me PAXLOVID, which he did. Later that evening, I developed a severe sore throat. It went away after a couple of days. Ever since then, I've been fine.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sneezing
Clinical narrative: I received the Pfizer Bivalent booster for COVID-19 on 9/15/2022; this was my third booster. On 11/16/2022, I ran a low-grade fever overnight. I also had sneezing and a runny nose. On 11/17/2022, I took a home antigen test and got a positive result. I called my PCP to ask him to prescribe me PAXLOVID, which he did. Later that evening, I developed a severe sore throat. It went away after a couple of days. Ever since then, I've been fine.
Age: 91.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Tinnitus, Visual impairment
Clinical narrative: Received 2nd dose Shangrix on 11/29. Muscle and body soreness for 2-3 days. Developed ringing in ears on 12/1. Slightly reduced vision on 12/1.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, COVID-19, Dyspnoea, Malaise, SARS-CoV-2 test positive
Clinical narrative: I was snowed in over the weekend. When I got home I was not feeling well, I took a home COVID-19 test that came back positive. I called the on-call nurse practitioner because I was having such a hard time breathing. She advised me to go to the emergency room. I went to the emergency where they did a blood test, prescribed PAXLOVID and albuterol for the breathing. I'm not feeling as bad but I have only had two doses so far.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test negative, Throat irritation
Clinical narrative: 11/28/2022 that evening I began having a scratchy, sore throat when I went  to bed. On 11/30/22, I took a home COVID test and it was negative. I started having congestion in my chest and head. On 12/5/22, I went to the doctor's office. They said since my symptoms started so long ago, they would not test for COVID or flu. I was prescribed benzonatate and TUSSIN with codeine. She told me to take MUCINEX, which did not help. I called back and was prescribed cefuroxime, on 12/8/2022. I began taking it that day and am still taking it. I am much better now, a huge improvement.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Pruritus, Urticaria
Clinical narrative: dizziness; itchiness (left arm); hives on left arm, size of her hand; injection site pain in left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, dizziness, itchy upper limbs and hives. On an unknown date, the outcome of the injection site pain and dizziness were recovered/resolved and the outcome of the itchy upper limbs and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, dizziness, itchy upper limbs and hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: The reporter was patient itself. After her first dose of Shingrix, she experienced dizziness which lasted for a few arms and a pain in her left arm at the site of the injection which lasted about 4 days.  24 hours after the Shingrix injection, she experienced itchiness in her left arm along with hives on her upper left arm which were the size of her hand. The itchiness and hives had not resolve. The reporter did not consent to follow-up.
Age: 95.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Unevaluable event
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient COVID positive after completing vaccine series.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, COVID-19, Cough, Diarrhoea, Fatigue
Clinical narrative: I contracted Covid. I had a headache, fatigue, scratchy throat, cough, diarrhea, and slight fever. The cough lasted 5 days. I was prescribed PAXLOVID, and tested negative after 5 days. However, 10 days after the rebound happened and it took me another 10 days to test negative. Same symptoms except my stomach was more upset during the rebound.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Pyrexia, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I contracted Covid. I had a headache, fatigue, scratchy throat, cough, diarrhea, and slight fever. The cough lasted 5 days. I was prescribed PAXLOVID, and tested negative after 5 days. However, 10 days after the rebound happened and it took me another 10 days to test negative. Same symptoms except my stomach was more upset during the rebound.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Patient requested COVID 19 Moderna Updated Booster 12+ and by error the pharmacist administered the COVID 19 Moderna Pediatric Age 6-11
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Cough, Fatigue, Myalgia
Clinical narrative: High fever (101-103.2F), cough, fatigue, chills, muscle aches, joint pain for 7 days post vaccination
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: High fever (101-103.2F), cough, fatigue, chills, muscle aches, joint pain for 7 days post vaccination
Age: 84.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient diagnosed with COVID on 12-10-2022 after completing COVID vaccine series.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Influenza like illness, Pain, Pyrexia, Vision blurred
Clinical narrative: Within 3 hours of receiving vaccine, pt. started experiencing flu-like symptoms, headache, body ache, fever and slightly blurred vision.  He is still in bed with the same symptoms.  We are treating with Tylenol, 2 every 4-6 hours.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient has not received any doses of primary series previously. Patient received bivalent booster as 1st dose today (should have been monovalent). Per CDC guidance on clinical considerations site, will continue with schedule of dose 2 (monovalent) in 3 weeks, dose 3 (monovalent) 4 weeks after dose 2, and 4th dose (bivalent) 2 months after dose 3.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Breast cyst, Breast swelling, Breast tenderness, Menstrual disorder
Clinical narrative: On 11/12 I had tenderness and swelling in left breast. The following week I went in for an ultrasound and found a partially fluid filled cyst in my left breast. The doctor is watching it and want me to return in 6 months. My menstrual cycles stopped in September and didn't resume until mid November.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound breast abnormal
Clinical narrative: On 11/12 I had tenderness and swelling in left breast. The following week I went in for an ultrasound and found a partially fluid filled cyst in my left breast. The doctor is watching it and want me to return in 6 months. My menstrual cycles stopped in September and didn't resume until mid November.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was to be given a Moderna BiValent vaccine but was mistakenly given a Covid booster.  No adverse reaction or harm done.
Age: 103.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Unevaluable event
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 77.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 11/04/22 presents to ED for "shortness of breath". PMHx of "COPD, hypertension, pernicious anemia"
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in Mar2022, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in March 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: The patient got his first shingrix shot and never got the second dose. No further information was reported to the agent by the patient. Did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL.  No adverse events were noted at the time of the administration.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram abnormal, Coordination abnormal, Death, Decreased appetite
Clinical narrative: 81 y/o lady in excellent health experienced severe dizziness and profound weakness started the evening after vaccine was received. This persisted with progression of nausea and loss of appetite. So bad, she declined the second vaccine. Unable to raise hands to fix her hair, with in a year she was unable to do her own finances anymore.  By late November 2022, when seen by me, her legs were tremoring when standing from sitting, unable to touch finger to nose or alternate palms on her thighs. Cancer was diagnosed and the oncologist speculated 6 mos survival w/o treatment, 2 years with treatment but she was dead 2 weeks later.  Rapid neurologic decline in 1 -1/2 years.  She just stopped breathing 12/2/2022. This was not typical of her cancer, nor typical of dementia- it was much faster.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Endoscopy upper gastrointestinal tract normal, Incomplete course of vaccination, Loss of personal independence in daily activities, Lung neoplasm malignant
Clinical narrative: 81 y/o lady in excellent health experienced severe dizziness and profound weakness started the evening after vaccine was received. This persisted with progression of nausea and loss of appetite. So bad, she declined the second vaccine. Unable to raise hands to fix her hair, with in a year she was unable to do her own finances anymore.  By late November 2022, when seen by me, her legs were tremoring when standing from sitting, unable to touch finger to nose or alternate palms on her thighs. Cancer was diagnosed and the oncologist speculated 6 mos survival w/o treatment, 2 years with treatment but she was dead 2 weeks later.  Rapid neurologic decline in 1 -1/2 years.  She just stopped breathing 12/2/2022. This was not typical of her cancer, nor typical of dementia- it was much faster.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Metastases to bone, Mobility decreased, Nausea, Neoplasm malignant
Clinical narrative: 81 y/o lady in excellent health experienced severe dizziness and profound weakness started the evening after vaccine was received. This persisted with progression of nausea and loss of appetite. So bad, she declined the second vaccine. Unable to raise hands to fix her hair, with in a year she was unable to do her own finances anymore.  By late November 2022, when seen by me, her legs were tremoring when standing from sitting, unable to touch finger to nose or alternate palms on her thighs. Cancer was diagnosed and the oncologist speculated 6 mos survival w/o treatment, 2 years with treatment but she was dead 2 weeks later.  Rapid neurologic decline in 1 -1/2 years.  She just stopped breathing 12/2/2022. This was not typical of her cancer, nor typical of dementia- it was much faster.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological decompensation, Renal cancer, Respiratory arrest, Tremor, Weight decreased
Clinical narrative: 81 y/o lady in excellent health experienced severe dizziness and profound weakness started the evening after vaccine was received. This persisted with progression of nausea and loss of appetite. So bad, she declined the second vaccine. Unable to raise hands to fix her hair, with in a year she was unable to do her own finances anymore.  By late November 2022, when seen by me, her legs were tremoring when standing from sitting, unable to touch finger to nose or alternate palms on her thighs. Cancer was diagnosed and the oncologist speculated 6 mos survival w/o treatment, 2 years with treatment but she was dead 2 weeks later.  Rapid neurologic decline in 1 -1/2 years.  She just stopped breathing 12/2/2022. This was not typical of her cancer, nor typical of dementia- it was much faster.
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Patient is a 22 year old male who received an undiluted 0.3ml dose of the pediatric Pfizer BioNTech Covid-19 Bivalent. No adverse side effects or symptoms were noted at the time of administration.  (rehab facility where patient resides) was notified and no adverse effects were reported as of 12/15/22 at 12:26 pm.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain
Clinical narrative: Patient came in for Pfizer Bivalent booster and instructed to wait for 30 due to anaphylactic reaction to Penicillin. Patient was vaccinated with Pfizer Bivalent Booster 0932 and began feeling chest pain at 0945, Patient is AxOx4 speaking in full complete sentences. Patient color was WNL and dry. Patient stated "When this happens I take my Nitro it's my standard order."  Patient self administered Nitro SL at 09:47. Patient was closely monitored. 9:52 stated " I feel a lot better the nitro helped" Patient was instructed due to high risk patient will need to go to ER. Patient agreed, ER was called and hand off report was given to ER RN.  Patient was transported to ER report was given to ER RN, patient is AxOx4 speaking in full complete sentences with unlabored breathing.
Age: 85.0
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT CAME ON 12/16/2022 AND REPORTED THAT HIS LEFT MIDDLE TOE PAIN. He had so much pain that he could not move
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Wrong product administered
Clinical narrative: Pt came in for a flu shot Flucelvax and instead received a second updated Covid booster. Pt woke with fever 102. Dr was contacted and stated pt could take ibuprofen or acetaminophen and to seek her primary dr at school if needed any further care.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Received a second Bivalent  booster within 3 months of 1st Bivalent booster.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL.  No adverse events were noted at the time of the administration.
Age: 85.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: GAVE PATIENT 0.5MLS OF THE COVID 19 MODERNA BIVALENT BOOSTER INSTEAD OF THE PEDIATRIC DOSE OF 0.25MLS
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt should have received a Fluzone immunization. Instead, he inadvertently was given a Flublok immunization.  No treatment.  No adverse outcome.  No symptoms observed while in clinic room.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose a year later; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose 1 year before receiving 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: Reporter was the HCP (pharmacist) who stated that a patient received his first dose of shingrix and his second dose a year later.  The patient was looking to see if he could receive a third dose since it had been longer than 6 months between the first and second dose.  The patient was not given a third dose of shingrix. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose a year after 1st dose, later than the recommended standard schedule, which led to lengthening of the vaccination schedule.
Age: 75.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Blood culture, Blood lactic acid, Chest X-ray, Chest pain, Condition aggravated
Clinical narrative: pt presented to ED with c/o of chest pain and SOB. pt also endorsing worsening fibromyalgia and states "it is worse then it has ever been, it doesnt feel like my normal pain". pt currently being  worked up for a CP and infectious work up, This includes blood cultures, lactic acid, standard labs, checs xray, and medications. outcome unknown at the time of this report.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dyspnoea, Fibromyalgia, Laboratory test
Clinical narrative: pt presented to ED with c/o of chest pain and SOB. pt also endorsing worsening fibromyalgia and states "it is worse then it has ever been, it doesnt feel like my normal pain". pt currently being  worked up for a CP and infectious work up, This includes blood cultures, lactic acid, standard labs, checs xray, and medications. outcome unknown at the time of this report.
Age: 13.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Fall, Loss of consciousness, Mydriasis
Clinical narrative: Patient presented to clinic with her family for flu and Covid Bivalent booster vaccine.  Vaccines were administered without incident, patient was walking from exam room to lobby and mentioned to her mother that she felt like she was "blacking out" at this time mom was hugging patient and I inquired if everything was ok.  At this time, the patient was lowered to the ground by mom, she sustained no injury from the fall.  The patients pupils were enlarged but she was responsive within 5 seconds.  Her blood pressure, pulse oxygen saturation and HR were all evaluated and were normal.  After about 5 minutes she was moved to a chair in the lobby were she was monitored for an additional 30 minutes.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cerebrovascular accident, Laboratory test, Transient ischaemic attack
Clinical narrative: One week after COVID-19 vaccine my blood pressure started to rise; Called doctor and had it closely monitored and trying to find out why; Five months later had a TIA Stroke and was hospitalized; Hospitalized for 6 days; Released and doctor prescribed losartan and hydroxyzine.
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: RN admistered Act HIB vaccine on 12/15/22 to patient, the vaccine had expired on 12/13/22. RN realized this error after administration. RN immediately notified doctor as well as patient mom. RN let pt. mom know that pt. may need another dose of vaccine depending on manufacturer protocol. Pt. mom expressed understanding. RN called manufacturer who clarified that another dose of Act HIB will need to be administered and can that can be done as soon as today. RN will call pt. mom to let her know. RN documented in pt. chart as well as followed facility protocol.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient was given 2nd bivalent booster dose.  First dose was 9/23/22.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 11 1/2 weeks later tested positive for covid 19
Age: 42.0
Sex: M
Vaccine: DTAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling, Laboratory test
Clinical narrative: Okay after the vaccination shot I had a serious allergic reaction which it swelled for like a week red around the injection point excruciating pain for like a month continuous ongoing pain I've complained numerous times I got the documents to show and it was noted every time I went and for treatment they just gave me exercises stretching to do and that's about it send me on my way it got so bad that I couldn't perform my daily activities like make the bed and whatnot shower sleep Etc
Age: 42.0
Sex: M
Vaccine: DTAP
Symptoms: Loss of personal independence in daily activities, Sleep disorder
Clinical narrative: Okay after the vaccination shot I had a serious allergic reaction which it swelled for like a week red around the injection point excruciating pain for like a month continuous ongoing pain I've complained numerous times I got the documents to show and it was noted every time I went and for treatment they just gave me exercises stretching to do and that's about it send me on my way it got so bad that I couldn't perform my daily activities like make the bed and whatnot shower sleep Etc
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: none to report