chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood test, COVID-19, Cardiac stress test, Chest pain
Clinical narrative: I started feeling like I was having worse than usual asthma symptoms a week after my first dose. I would take albuterol but it did nothing to help. For the following 5 months I experienced pretty much constant fatigue, being easily winded, varying degrees of chest pain, fever if overly exerted, difficulty breathing, and elevated heart rate with no cause. After stopping all physical activity to try and recover, about 4 months after the first symptoms, I started to feel improvement. It has now been 11 months and the symptoms ebb and flow, worsened significantly for a bit after having covid, and again after catching a cold that was not covid. Though in that time I have been able to get back to some physical normalcy, I have definitely never been back to my old self. I still need to significantly reduce physical activity, am easily winded, experience high heart rate, and take much longer than I used to to recover from physical activity. All of the testing I got did not come back with anything to suggest what was happening. I would guess that that was the case because I wasn't able to get any heart scans until 5 months after the fact, when I had started to improve and was very well rested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Condition aggravated, Decreased activity, Dyspnoea, Echocardiogram
Clinical narrative: I started feeling like I was having worse than usual asthma symptoms a week after my first dose. I would take albuterol but it did nothing to help. For the following 5 months I experienced pretty much constant fatigue, being easily winded, varying degrees of chest pain, fever if overly exerted, difficulty breathing, and elevated heart rate with no cause. After stopping all physical activity to try and recover, about 4 months after the first symptoms, I started to feel improvement. It has now been 11 months and the symptoms ebb and flow, worsened significantly for a bit after having covid, and again after catching a cold that was not covid. Though in that time I have been able to get back to some physical normalcy, I have definitely never been back to my old self. I still need to significantly reduce physical activity, am easily winded, experience high heart rate, and take much longer than I used to to recover from physical activity. All of the testing I got did not come back with anything to suggest what was happening. I would guess that that was the case because I wasn't able to get any heart scans until 5 months after the fact, when I had started to improve and was very well rested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Exercise test, Exercise tolerance decreased, Fatigue, Feeling abnormal
Clinical narrative: I started feeling like I was having worse than usual asthma symptoms a week after my first dose. I would take albuterol but it did nothing to help. For the following 5 months I experienced pretty much constant fatigue, being easily winded, varying degrees of chest pain, fever if overly exerted, difficulty breathing, and elevated heart rate with no cause. After stopping all physical activity to try and recover, about 4 months after the first symptoms, I started to feel improvement. It has now been 11 months and the symptoms ebb and flow, worsened significantly for a bit after having covid, and again after catching a cold that was not covid. Though in that time I have been able to get back to some physical normalcy, I have definitely never been back to my old self. I still need to significantly reduce physical activity, am easily winded, experience high heart rate, and take much longer than I used to to recover from physical activity. All of the testing I got did not come back with anything to suggest what was happening. I would guess that that was the case because I wasn't able to get any heart scans until 5 months after the fact, when I had started to improve and was very well rested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nasopharyngitis, Pulmonary function test, Pyrexia, Scan
Clinical narrative: I started feeling like I was having worse than usual asthma symptoms a week after my first dose. I would take albuterol but it did nothing to help. For the following 5 months I experienced pretty much constant fatigue, being easily winded, varying degrees of chest pain, fever if overly exerted, difficulty breathing, and elevated heart rate with no cause. After stopping all physical activity to try and recover, about 4 months after the first symptoms, I started to feel improvement. It has now been 11 months and the symptoms ebb and flow, worsened significantly for a bit after having covid, and again after catching a cold that was not covid. Though in that time I have been able to get back to some physical normalcy, I have definitely never been back to my old self. I still need to significantly reduce physical activity, am easily winded, experience high heart rate, and take much longer than I used to to recover from physical activity. All of the testing I got did not come back with anything to suggest what was happening. I would guess that that was the case because I wasn't able to get any heart scans until 5 months after the fact, when I had started to improve and was very well rested.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Insomnia
Clinical narrative: Shoulder pain unrelieved by OTC pain relievers and difficulty sleeping due to pain
Age: 77.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash and swelling on upper arm under the injection site. Started on 11/2 and continued up to mid-day 11/3 at time of notification. Patient had not taken anything for the condition at time of notification.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chest X-ray abnormal, Chest pain, Computerised tomogram thorax abnormal
Clinical narrative: Bloody cough, bloody phlegm, weakness, dizziness, chest pain, wheezing, rapid heart rate, heart palpitations, very high pulse(160bpm), nausea and vomiting, mucus buildup, leg cramps, stomach cramps.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Haemoptysis, Heart rate increased, Muscle spasms, Nausea
Clinical narrative: Bloody cough, bloody phlegm, weakness, dizziness, chest pain, wheezing, rapid heart rate, heart palpitations, very high pulse(160bpm), nausea and vomiting, mucus buildup, leg cramps, stomach cramps.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pulmonary embolism, Secretion discharge, Sputum discoloured, Vomiting
Clinical narrative: Bloody cough, bloody phlegm, weakness, dizziness, chest pain, wheezing, rapid heart rate, heart palpitations, very high pulse(160bpm), nausea and vomiting, mucus buildup, leg cramps, stomach cramps.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Bloody cough, bloody phlegm, weakness, dizziness, chest pain, wheezing, rapid heart rate, heart palpitations, very high pulse(160bpm), nausea and vomiting, mucus buildup, leg cramps, stomach cramps.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient states that on 11/1/22, she woke up (9AM) with swelling/redness/pain/rash/itching at site of injections,  Patient presented to pharmacy at 12:25PM on 11/3/22 asking about symptoms and what she should do. Patient states that since 11/1 (when first woke up with symptoms) she has noticed the rash is spreading/original symptoms worsening. Rash was visible, red,  hot to touch and felt uneven when presented to pharmacy. Patient was instructed to seek medical attention asap at 12:35PM. Patient agreed and left pharmacy.  At 3:06PM on 11/3/22, the pharmacy received a prescription for this patient for Bactrim DS 800-160mg ( 1 tab twice daily for 5 days). RX was written by local urgent care MD. Patient picked up the medicine at 3:48PM and stated the MD at urgent care was treating for possible infection.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Injection site warmth
Clinical narrative: Patient states that on 11/1/22, she woke up (9AM) with swelling/redness/pain/rash/itching at site of injections,  Patient presented to pharmacy at 12:25PM on 11/3/22 asking about symptoms and what she should do. Patient states that since 11/1 (when first woke up with symptoms) she has noticed the rash is spreading/original symptoms worsening. Rash was visible, red,  hot to touch and felt uneven when presented to pharmacy. Patient was instructed to seek medical attention asap at 12:35PM. Patient agreed and left pharmacy.  At 3:06PM on 11/3/22, the pharmacy received a prescription for this patient for Bactrim DS 800-160mg ( 1 tab twice daily for 5 days). RX was written by local urgent care MD. Patient picked up the medicine at 3:48PM and stated the MD at urgent care was treating for possible infection.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Drooling, Lip swelling, Oropharyngeal discomfort
Clinical narrative: swelling of lips, drooling, discomfort in throat
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Salivary hypersecretion, Throat tightness
Clinical narrative: swelling of lips, drooling, discomfort in throat
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Drooling, Lip swelling, Oropharyngeal discomfort
Clinical narrative: Patient stated she felt her throat tighten and was oversalivating after receiving the bivalent booster, after 30 minute observation period.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Salivary hypersecretion, Throat tightness
Clinical narrative: Patient stated she felt her throat tighten and was oversalivating after receiving the bivalent booster, after 30 minute observation period.
Age: 2.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT RECIEVED COVID19 PFIZER - SERIES DOSE #3 TOO SOON . DOSE #1 GIVEN 8/2/22 DOSE #2 GIVEN 9/16/22 NO REACTIONS TO VACCINE ON ADMINISTRATION DAY OR THAT MOTHER REPOSTED .   ATTEMPT TO REACH MOTHER TO NOTIFY WAS MADE , NO ANSWER . LEFT MESSAGE ON VOICEMAIL ASKING THAT MOTHER RETURN CALL
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: COVID Pfizer Pediatric dose 5-11 years was ordered. However COVID Pfizer Infant / toddler 6 mo -4 years dose was administered. No adverse reactions reported at the time of discharge.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Moderna primary administered instead of bivalent
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: pt was to get bivalent instead moovalent
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac monitoring normal
Clinical narrative: Heart arthmia  occurred about three times in November after shot.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: Large red rash on injection site and fever
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pustule
Clinical narrative: Patient states at injection site, a pimple" like pustule with white head has appeared. Patient says sterile technique by the pharmacist was used (vigorous alcohol swabbing and sterile bandage). His MD will continue to monitor, patient is not too concerned.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: moderna primary administered instead of moderna bivalent
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: pt was given monovalent instead of bivalent
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Decreased appetite, Discomfort, Fatigue, Feeling abnormal
Clinical narrative: Very uncomfortable and poor sleep.  Nearly fainted in kitchen the next am. Profuse sweating followed by Cold. Headache.  Lasted til about 5pm. Did not feel feverish but not checked. No appetite. Left me washed out and fatigued. Aggravated both sinuses and gut. IBS attack started 2 weeks later. I'm still not myself. 3 weeks tomorrow. Home covid test negative. Afebrile. Sleep still very irregular. 3 weeks!!! I've reacted to every shot but nothing like this. My trust is gone.....
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gastrointestinal disorder, Headache, Hyperhidrosis, Irritable bowel syndrome, Nasopharyngitis
Clinical narrative: Very uncomfortable and poor sleep.  Nearly fainted in kitchen the next am. Profuse sweating followed by Cold. Headache.  Lasted til about 5pm. Did not feel feverish but not checked. No appetite. Left me washed out and fatigued. Aggravated both sinuses and gut. IBS attack started 2 weeks later. I'm still not myself. 3 weeks tomorrow. Home covid test negative. Afebrile. Sleep still very irregular. 3 weeks!!! I've reacted to every shot but nothing like this. My trust is gone.....
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Poor quality sleep, Presyncope, SARS-CoV-2 test negative, Sinus disorder
Clinical narrative: Very uncomfortable and poor sleep.  Nearly fainted in kitchen the next am. Profuse sweating followed by Cold. Headache.  Lasted til about 5pm. Did not feel feverish but not checked. No appetite. Left me washed out and fatigued. Aggravated both sinuses and gut. IBS attack started 2 weeks later. I'm still not myself. 3 weeks tomorrow. Home covid test negative. Afebrile. Sleep still very irregular. 3 weeks!!! I've reacted to every shot but nothing like this. My trust is gone.....
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: moderna primary administered instead of  moderna bivalent
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: The Adult version of the Bivalent Covid vaccine was administered instead of the pediatric version.  Pharmacist reached out to patient's guardian several times after the event. The father of patient stated that the patient is doing fine and just had sore arm.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was due for Bivalent booster and was given Monovalent. No symptoms were present.
Age: 84.0
Sex: F
Vaccine: FLUA4
Symptoms: Condition aggravated, Dizziness, Headache, Hypertension, Malaise
Clinical narrative: Patient received Fluad @ approx 2:45pm. In a few minutes she complained of dizziness and feeling unwell while seated. Patient had no history of allergic reaction to flu shot and has been getting flu shot in the past.  Patient initially declined us calling ambulance for her. Patient stated she has high pressure and her blood pressure was elevated upon checking. She stated she was feeling better and would just remain seated with her friend. When the pharmacist checked back with her she agreed to get ambulance called as she was feeling dizzy and had a headache. Paramedic came and performed the checkups. Patient stayed in the pharmacy area and left when she was feeling fine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Vertigo
Clinical narrative: I developed severe vertigo on September 14, 2022.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient called on 11/1/2022 to report left shoulder pain onset 10/12/2022.  Pt came to facility on 11/3/2022 and reported L shoulder pain onset as above. Pain has not changed in intensity since onset. He has pain in L deltoid only with lateral abduction and shoulder extension. Shoulder flexion, adduction, and placing forearm on low back do not elicit pain. There is no tenderness to palpation or touch anywhere on shoulder or arm. All pain is reported as "internal". He denies paraesthesias or weakness.  Patient reports that he has contacted an attorney familiar with SIRVA and has scheduled an appointment later in the month - he is unsure of the date, possibly 11/22/2022
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood creatine phosphokinase, C-reactive protein, Full blood count, Gait disturbance, Metabolic function test
Clinical narrative: Morning after injection experienced aching in left thigh around 10 am which progressed throughout the day becoming increasingly painful. No swelling or redness visible. By evening there was muscle weakness and difficulty walking. By the next morning (11/2/22) the pain was so bad I was nauseous and thought I might get sick. Great difficulty walking. Pain worse with leg abduction, sitting in chair with legs 90 degrees and walking.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscular weakness, Nausea, Pain, Pain in extremity, Platelet count
Clinical narrative: Morning after injection experienced aching in left thigh around 10 am which progressed throughout the day becoming increasingly painful. No swelling or redness visible. By evening there was muscle weakness and difficulty walking. By the next morning (11/2/22) the pain was so bad I was nauseous and thought I might get sick. Great difficulty walking. Pain worse with leg abduction, sitting in chair with legs 90 degrees and walking.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Red blood cell sedimentation rate, Sitting disability, Urine analysis
Clinical narrative: Morning after injection experienced aching in left thigh around 10 am which progressed throughout the day becoming increasingly painful. No swelling or redness visible. By evening there was muscle weakness and difficulty walking. By the next morning (11/2/22) the pain was so bad I was nauseous and thought I might get sick. Great difficulty walking. Pain worse with leg abduction, sitting in chair with legs 90 degrees and walking.
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Neck pain, Pain, Vaccination site pain
Clinical narrative: PATIENT REPORTS PAIN IN NECK RADIATING UP FROM LEFT ARM AT VACCINATION SITE
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Electrocardiogram, Electrocardiogram ambulatory, Ventricular extrasystoles
Clinical narrative: PVC?s noticed at doctor visit on October 19th, 2022. Also my diastolic number at my blood pressure reading was 98 at this visit . Both of these events were first noted at this doctor visit, however,  the reason for the visit was for back pain. I had no previous conditions. I was prescribed a holter  monitor on  October 19th which I wore for 7 days. The doctor also told me to continue to monitor my blood pressure for 5-7days  and submit the information to the doctor at the end of  the monitored time line. I mailed the monitor back to the company and am awaiting the results.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Arthralgia, Chills, Cold sweat, Dizziness
Clinical narrative: About 5.5 hours after injection I had a sudden onset of symptoms starting with cramps and nausea. I nearly fainted at work while seated at my desk. Symptoms were dizziness, faint, blurred vision, nausea, stomach cramps, chills, clamminess, and fever.  The symptoms improved slightly with Tylenol for about 4-5 hours and then became severe again.  Throughout the night I had chills/shaking and sweats and body aches.  The next day I had a low fever that was better with Tylenol and severe muscle pain in my lower back and around my spine. The third day (today) I had severe neck and shoulder pain.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Muscle spasms, Myalgia, Nausea, Neck pain
Clinical narrative: About 5.5 hours after injection I had a sudden onset of symptoms starting with cramps and nausea. I nearly fainted at work while seated at my desk. Symptoms were dizziness, faint, blurred vision, nausea, stomach cramps, chills, clamminess, and fever.  The symptoms improved slightly with Tylenol for about 4-5 hours and then became severe again.  Throughout the night I had chills/shaking and sweats and body aches.  The next day I had a low fever that was better with Tylenol and severe muscle pain in my lower back and around my spine. The third day (today) I had severe neck and shoulder pain.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Presyncope, Pyrexia, Tremor, Vision blurred
Clinical narrative: About 5.5 hours after injection I had a sudden onset of symptoms starting with cramps and nausea. I nearly fainted at work while seated at my desk. Symptoms were dizziness, faint, blurred vision, nausea, stomach cramps, chills, clamminess, and fever.  The symptoms improved slightly with Tylenol for about 4-5 hours and then became severe again.  Throughout the night I had chills/shaking and sweats and body aches.  The next day I had a low fever that was better with Tylenol and severe muscle pain in my lower back and around my spine. The third day (today) I had severe neck and shoulder pain.
Age: 0.08
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient inadvertently received a dose of the Hepatitis A vaccine instead of the Hiberix vaccine as part of his routine 2 month vaccination. no adverse effects or reactions noted.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Ear discomfort, Influenza virus test negative, Laryngitis, Nasopharyngitis
Clinical narrative: cold with laryngitis, sore throat, turning into sinus infection with persistent cough, aches in jaw and teeth, plugged ears
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Pain in jaw, SARS-CoV-2 test negative, Sinusitis, Toothache
Clinical narrative: cold with laryngitis, sore throat, turning into sinus infection with persistent cough, aches in jaw and teeth, plugged ears
Age: 72.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Pain
Clinical narrative: As per patient, right after the vaccine she experienced pain on the left side of the whole body from toes and up. She has to go through physical therapy and is still in pain to some extent.
Age: 72.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Gait disturbance, Insomnia, Magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: As per patient, right after the vaccine she experienced pain on the left side of the whole body from toes and up. She has to go through physical therapy and is still in pain to some extent.
Age: 72.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Vaccination site pain, X-ray
Clinical narrative: As per patient, right after the vaccine she experienced pain on the left side of the whole body from toes and up. She has to go through physical therapy and is still in pain to some extent.
Age: 24.0
Sex: M
Vaccine: COVID19-2, FLUR4
Symptoms: Fall, Pallor
Clinical narrative: The following account is per RN -- The patient came to the pharmacy to receive the flu and pfizer bivalent booster and received both vaccines in the left deltoid region per patient preference (vaccine administered by RN.) Shortly after receiving vaccine while patient was getting up to stand the patient fell. Per RN., "I went down with the patient while he was getting up to make sure he wouldn't get hurt." Per RN, he did not hit his head or get injured on the fall. Per RN, "I called for RPh right away who then came by immediately." RN and RPh, then proceded to help the patient off the floor and into a chair where his legs were then elevated. Patient appeared pale. RN then proceded to take his vitals and patient had a blood pressure of 121/74 mmHg and heart rate 83 bpm. Several minutes later this was retaken and found to be 126/71 mmHg and heart rate 81 bpm. Per RN after a few minutes the patient began to regain color.  Patient called his mother to come sit with him and was observed for 30 minutes before leaving. Per RPh the patient reported having eaten and didn't have any medical conditions of concern and no prior history of fainting after receiving a vaccination. Patients mother stated "I think he just got overwhelmed".
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient was administered vaccine that had experienced temperature excursion during shipment and should have been quarantined.  Quality report was not seen/received by provider prior to administering dose.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient was administered vaccine that had experienced temperature excursion during shipment and should have been quarantined.  Quality report was not seen/received by provider prior to administering dose.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: An expired Pfsier Bivalent Booster 18+ was possibly administer to this patient at his visit. It is unclear if an expired or current vaccine was given at the time of administration.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient was administered vaccine that had experienced temperature excursion during shipment and should have been quarantined.  Quality report was not seen/received by provider prior to administering dose.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given a Monovalent Covid vaccine instead of Covid Bivalent booster.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: An expired Pfsier Bivalent Booster 18+ was possibly administer to this patient at his visit. It is unclear if an expired or current vaccine was given at the time of administration.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given a Monovalent Covid vaccine instead of Covid Bivalent booster
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Arrhythmia, Blood thyroid stimulating hormone decreased, Decreased appetite, Hypothyroidism
Clinical narrative: In late May or early June, I started developing a cluster of symptoms that began with anorexia and weight loss and progressed over several weeks to include insomnia, tremulousness, arrhythmia and palpitations. I sought medical attention and was diagnosed with toxic multi-nodular goiter. Conservative treatment was started with atenolol and low-dose methimazole. This week, after three months of treatment, repeat labs now reveal hypothyroidism. Atenolol is being weaned and methimazole has been discontinued. Labs will be repeated in four weeks, at which time it is anticipated that methimazole will be restarted with a different regimen. Atenolol will not be restarted as numerous side effects occurred with its use.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Palpitations, Thyroxine normal, Toxic nodular goitre, Tremor
Clinical narrative: In late May or early June, I started developing a cluster of symptoms that began with anorexia and weight loss and progressed over several weeks to include insomnia, tremulousness, arrhythmia and palpitations. I sought medical attention and was diagnosed with toxic multi-nodular goiter. Conservative treatment was started with atenolol and low-dose methimazole. This week, after three months of treatment, repeat labs now reveal hypothyroidism. Atenolol is being weaned and methimazole has been discontinued. Labs will be repeated in four weeks, at which time it is anticipated that methimazole will be restarted with a different regimen. Atenolol will not be restarted as numerous side effects occurred with its use.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tri-iodothyronine decreased, Weight decreased
Clinical narrative: In late May or early June, I started developing a cluster of symptoms that began with anorexia and weight loss and progressed over several weeks to include insomnia, tremulousness, arrhythmia and palpitations. I sought medical attention and was diagnosed with toxic multi-nodular goiter. Conservative treatment was started with atenolol and low-dose methimazole. This week, after three months of treatment, repeat labs now reveal hypothyroidism. Atenolol is being weaned and methimazole has been discontinued. Labs will be repeated in four weeks, at which time it is anticipated that methimazole will be restarted with a different regimen. Atenolol will not be restarted as numerous side effects occurred with its use.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Balance disorder, CSF protein increased, Dyspnoea, Dysstasia
Clinical narrative: Transverse myelitis. Multiple symptoms woke up one morning and couldn't stand couldn't walk. Went to primary care Dr. and was giving a wheelchair. Started peeing myself without even knowing. I was teen extremely leg pain. Was months before I could start partially walking in extreme pain. Still have problems with urination. Still have problems with pain and legs, extreme migraines, pain in head, muscle spasms, muscle weakness, swollen lymph nodes, lots of balance, problems breathing, always winded, and probably other things I can't think of right now. Oh yeah extreme problems with brain fog, memory problems, forget my words.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Gait inability, Headache, Lumbar puncture
Clinical narrative: Transverse myelitis. Multiple symptoms woke up one morning and couldn't stand couldn't walk. Went to primary care Dr. and was giving a wheelchair. Started peeing myself without even knowing. I was teen extremely leg pain. Was months before I could start partially walking in extreme pain. Still have problems with urination. Still have problems with pain and legs, extreme migraines, pain in head, muscle spasms, muscle weakness, swollen lymph nodes, lots of balance, problems breathing, always winded, and probably other things I can't think of right now. Oh yeah extreme problems with brain fog, memory problems, forget my words.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging, Memory impairment, Migraine, Muscle spasms
Clinical narrative: Transverse myelitis. Multiple symptoms woke up one morning and couldn't stand couldn't walk. Went to primary care Dr. and was giving a wheelchair. Started peeing myself without even knowing. I was teen extremely leg pain. Was months before I could start partially walking in extreme pain. Still have problems with urination. Still have problems with pain and legs, extreme migraines, pain in head, muscle spasms, muscle weakness, swollen lymph nodes, lots of balance, problems breathing, always winded, and probably other things I can't think of right now. Oh yeah extreme problems with brain fog, memory problems, forget my words.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myelitis transverse, Pain in extremity, Urinary incontinence
Clinical narrative: Transverse myelitis. Multiple symptoms woke up one morning and couldn't stand couldn't walk. Went to primary care Dr. and was giving a wheelchair. Started peeing myself without even knowing. I was teen extremely leg pain. Was months before I could start partially walking in extreme pain. Still have problems with urination. Still have problems with pain and legs, extreme migraines, pain in head, muscle spasms, muscle weakness, swollen lymph nodes, lots of balance, problems breathing, always winded, and probably other things I can't think of right now. Oh yeah extreme problems with brain fog, memory problems, forget my words.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Body temperature increased, Cough, Impaired work ability, Nasopharyngitis, Pain
Clinical narrative: Felt like a very bad cold.  Coughed a lot, extremely achy.  Had a temprature around 100-101 for 2 days.  After day 5 felt better. Stayed home from work for 5 days + the weekend.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Thyroid mass
Clinical narrative: Within 3 days I had a large knot on my left collar bone. I went to the doctors and reported and was told it was normal and would go away. It has been over 1 year and the knot is still there. I had a recent cat scan of the knot and now am told it is a thyroid nodule. They now was to do further testing to make sure it isn?t cancerous.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product use issue
Clinical narrative: The vaccine was used 2 days post beyond use date. The manufacturer Moderna was contacted, their analysis states that the lot number AS7148B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration therefore no further actions needed.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature decreased, Chills, Cough, Pyrexia, Tremor
Clinical narrative: 11/3/22 2:00 AM Severe cough for 2 hours (suppressed with Dextromethorphan 11/3/22 4:00 AM Severe chills and violent shaking for three hours 11/3/22 6:00 AM Fever 96.5 (yes, low.  Common for me) for two hours (suppressed with Tylenol) 11/3/22 9:00 AM Fever 99.4 for most of day 11/3/22 5:00 PM Fever 100.4 for two hours so far, and still going (Tylenol not helping)
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Palpitations, Tremor
Clinical narrative: Extreme shaking at 7 hours after Vax with racing heart 120 bpm from 1:00  am til 12:00 pm. Forced Dr visit.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered 3 days post Beyond use date. Moderna was contacted with no further actions needed.  Per Moderna, the lot number AS7148B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Myalgia, Pyrexia, Vomiting
Clinical narrative: vomiting x5 episodes, fever (tmax 101), headache, myalgia
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT RECEIVED PFIZER BIVALENT AS FIRST, PRIMARY DOSE OF COVID VACCINE SERIES
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest discomfort, Heart rate increased, Injection site discomfort, Injection site hypoaesthesia
Clinical narrative: High heart rate (120-140bpm) while laying down/stationary recorded from 4:30pm - 7:30pm day after injection.  Mild Chest tightness and left arm discomfort, numbness, experienced during that time and continuing into late evening hours (continuing now at 10:30pm)
Age: 56.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Adverse drug reaction, Fatigue, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Four days after Covid and flu vaccination, the patient developed slightly itchy erythematous patches on limbs and abdomen. He also had mild fatigue but was otherwise well.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient presented to pharmacy and requested a "Covid shot". Patient was informed that pharmacy only had bivalent booster doses available. She said that will work. When questioned if she had a previous dose within the last two months she stated "no". Patient completed a VAR and informed consent form. Patient received vaccine from vaccinating technician. Technician showed patient location for digital vaccine record and asked if patient wanted her physical covid card updated. Patient said she didn't have one. Upon further questioning it was learned from patient that this was her first dose. Pharmacy contacted CDC for guiadance. Patient was informed that a complete series with monovalent vaccine would need to be completed. Patient was informed of the consideration of an 8 week separation from bivalent to reduce the chance of cardiac adverse events as seen in teens.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody increased, Arthralgia, Blood test, Condition aggravated, Imaging procedure
Clinical narrative: Started having increased Osteoarthritis pain and stiffness in my joints; Mainly in my knees, hips, ankles, back, pelvis and SI joints; is worse on my left side. Along with past tests am having a Colonoscopy on 12/2/2022.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Osteoarthritis
Clinical narrative: Started having increased Osteoarthritis pain and stiffness in my joints; Mainly in my knees, hips, ankles, back, pelvis and SI joints; is worse on my left side. Along with past tests am having a Colonoscopy on 12/2/2022.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Fatigue, Heart rate increased, Odynophagia, Oropharyngeal pain
Clinical narrative: Three days after vaccine I developed a pain in my through when I swallowed, yawned, took deep breaths. Pain would not go away. Went for thyroid ultra sound which showed inflammation of thyroid right at the spot I  feel the pain. Experiencing extreme fatigue and rapid heart rate.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Painful respiration, Thyroid disorder, Ultrasound thyroid abnormal
Clinical narrative: Three days after vaccine I developed a pain in my through when I swallowed, yawned, took deep breaths. Pain would not go away. Went for thyroid ultra sound which showed inflammation of thyroid right at the spot I  feel the pain. Experiencing extreme fatigue and rapid heart rate.
Age: 14.0
Sex: F
Vaccine: COVID19-2, FLU4, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received 0.5ml imtramuscular of Flulaval to the Left Deltoid.  Mom stated and patient's records documented that patient received flu vaccine in 8/2022.  Mom and Dad informed.  Post vac instructions provided and they were able to repeat them and stated they understood
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Eye disorder
Clinical narrative: HAVE BEEN TREATED FOR EYE MANY TIMES; BELL'S PALSY; This spontaneous report received from a patient via a company representative concerned a female patient of unspecified age, race and ethnicity. Initial information was processed along with additional information received on 28-OCT-2022. 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 not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced Bell's palsy. On an unspecified date, the patient had been treated for eye many times and the treatment was still continued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from have been treated for eye many times, and the outcome of Bell's palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221059137- Bell's palsy-  The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes were swollen for 4 months and had to be removed from his neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003887.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (medically significant), outcome "not recovered", described as "lymph nodes were swollen for 4 months and had to be removed from his neck". The patient had a bad reaction after the first dose of the Pfizer shot. The patient's lymph nodes were swollen for 4 months and had to be removed from his neck because the swelling did not subside.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in left leg and foot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 at 01:15 as dose 1, single (Lot number: En6205) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "numbness in left leg and foot". Additional information: : About 3 Days after Dose 1 had numbness in left leg and foot about 10 Days after dose 2 had extreme Numbness and weakness in both legs and could hardly walk was about to go to ER but made appointment Dr said had nerve damage from COVID 19 vaccination and referred to Neurologist did tests legs and feet for Nerve and muscle damage with electric pins on legs Had MRI Spinal Cord Dr office Spinal cord was OK and wanted blood test office called blood test OK and Dr told no treatment for my condition nerve damage will take about 1 to 1.5 years to recover from nerve Damage.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: pay her extra medical bills due to COVID-19; pay her extra medical bills due to COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9264) and on 19Feb2021 as dose 2, single (Lot number: EN6200) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "pay her extra medical bills due to COVID-19".  Clinical course: patient called about the COVID-19 Vaccine. She has been giving Pfizer all kinds of information and has sent 10 packets back in and what she was wanting, some money in her pocket to pay her extra medical bills due to COVID-19. She asks will this get to the legal team. She can't get this under control and wants to help people and feel like Pfizer should be doing more for her. She was just tried to pay medical things and that's why she needed help from Pfizer due to her health going on a downward spiral. She would not have gotten no more if as sick as she has been from the first 2. She has suffered for well over 2 years from these shots. She states somebody needs to talk a little more to her and no one talked to her, shots didn't like her.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Computerised tomogram, Depression, Erythema, Feeling hot
Clinical narrative: So tired; I had menstrual problems; depressed/my depression has plummeted since; Breast pain; I feel I have no voice to speak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious) with onset 2021, outcome "unknown"; MUTISM (non-serious) with onset 2021, outcome "unknown", described as "I feel I have no voice to speak"; MENSTRUAL DISORDER (medically significant) with onset 2021, outcome "unknown", described as "I had menstrual problems"; DEPRESSION (non-serious) with onset 2021, outcome "unknown", described as "depressed/my depression has plummeted since"; FATIGUE (non-serious), outcome "unknown", described as "So tired". Therapeutic measures were taken as a result of menstrual disorder.  Additional information: In 2021, the patient got Pfizer version of the COVID vaccine, and her depression had plummeted since. The patient had menstrual problems that led to a D and C and breast pain, and the patient felt the patient had no voice to speak. And no one acknowledged the pain or cared - if she had known what would result, she wouldn't have taken the vaccine - and she could only assume it was the cause because nothing was found wrong with her reproductive system, and she had no other recent medical changes. The patient was so tired and so depressed and so tired of being depressed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling of body temperature change, Frustration tolerance decreased, Haemorrhage, Heavy menstrual bleeding, Mammogram
Clinical narrative: So tired; I had menstrual problems; depressed/my depression has plummeted since; Breast pain; I feel I have no voice to speak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious) with onset 2021, outcome "unknown"; MUTISM (non-serious) with onset 2021, outcome "unknown", described as "I feel I have no voice to speak"; MENSTRUAL DISORDER (medically significant) with onset 2021, outcome "unknown", described as "I had menstrual problems"; DEPRESSION (non-serious) with onset 2021, outcome "unknown", described as "depressed/my depression has plummeted since"; FATIGUE (non-serious), outcome "unknown", described as "So tired". Therapeutic measures were taken as a result of menstrual disorder.  Additional information: In 2021, the patient got Pfizer version of the COVID vaccine, and her depression had plummeted since. The patient had menstrual problems that led to a D and C and breast pain, and the patient felt the patient had no voice to speak. And no one acknowledged the pain or cared - if she had known what would result, she wouldn't have taken the vaccine - and she could only assume it was the cause because nothing was found wrong with her reproductive system, and she had no other recent medical changes. The patient was so tired and so depressed and so tired of being depressed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.