chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Had 1st shot in Feb, i recently broke out; No knowing there was a 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's comment: The patient self-reported this case. The patient stated that he/she received his/her 1st shot but not his/her second it there a cut off time. The patient had his/her 1st shot in February 2022, no knowing there was a 2nd shot. The patient was recently breaking out.  The patient asked when he/she should get his/her next shot. The patient also asked what a patient should do if their second dose of Shingrix was later than six months after receiving the first dose, how soon after GlaxoSmithKline had shingles could GlaxoSmithKline get vaccinated. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Pyrexia
Clinical narrative: Low fever (around 100.3F); Fatigue; This case was reported by a consumer and described the occurrence of fever in a 11-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2022-2023 season) (batch number 9249L, expiry date unknown) for prophylaxis.   On 3rd October 2022, the patient received Influenza vaccine Quadrivalent 2022-2023 season. On an unknown date, less than 2 months after receiving Influenza vaccine Quadrivalent 2022-2023 season, the patient experienced fever and fatigue. On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fever and fatigue to be related to Influenza vaccine Quadrivalent 2022-2023 season.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's Comment: The patient's parent reported this case. The patient received dose of Quadrivalent Influenza (flu shot) and was experiencing a low fever (around 100.3F) since getting the flu shot.  The fever had persisted for 7 weeks and was still ongoing. The only symptom had been the fatigue. The reporter was writing to ask had GlaxoSmithKline received reports of this side effect (long term low fever), especially for this particular flu shot, was there a way to report this side effect. The reporter also asked did GlaxoSmithKline had a suggestion about the potential treatment. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red injection site; Swollen injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Nov-2022 Reporter's comment: The reporter was the consumer. The patient asked how long injection site should be red and swollen after the shot. The patient had red and swollen injection site. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives all over; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22nd November 2022, the patient received Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's comment: This case was reported by the patient via (Shingrix GSK) interactive digital media. The reporter stated that he/she had got a shot one day before reporting and was experiencing hives all over at the time of reporting. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Pain, Pain in extremity, Pruritus
Clinical narrative: Severe itching; Stabbing pains on back, legs; Stabbing pains on back; Stabbing pains on back, legs; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus, leg pain, back pain and pain. On an unknown date, the outcome of the pruritus, leg pain, back pain and pain were unknown.   It was unknown if the reporter considered the pruritus, leg pain, back pain and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-NOV-2022 Reporter's Comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient reported that had severe itching and stabbing pain on back and legs.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 9 days of BUD
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 9 days of BUD
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: Vaccinated after 9 days of BUD
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: November 8th, 2021: I went for my first COVID-19 Moderna Booster. 2 weeks later, I developed hives over my entire body.  December 20th, 2021: I went to the allergist and we tested for food sensitivities.  December 17th, 2021: I went back to the allergist and was confirmed positive for Milk Protein Allergy.  My instructions were to take up to 4, 10mg cetirizine/daily to control hives and to stop using milk products in my diet. Following the doctor's order, my hives went away and I have had no problems.  September 26th, 2022: I went for my second COVID-19 Moderna Booster. 2 weeks later, I developed hives over my entire body. October 24th, 2022: I went to the allergist again and we suspect the COVID-19 Moderna Booster activated my milk protein allergy.  I would like to add that prior to my first booster, I was an avid dairy user. Cheese, deserts, etc... and I have never had reactions to dairy until after my first covid booster.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a 12+ Bivalent Booster of Pfizer when it should have been Peds Bivalent Pfizer (5-11yrs). Patients parents were called and notified of mistake and cleared that the only symptom he had was tiredness.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received undiluted second dose of Pfizer orange cap 5-11 vaccine.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: No signs or symptoms of any reaction.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 9 days of BUD
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient will have to get a first dose vaccine.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient received undiluted second dose of pfizer 5-11 years orange cap covid vaccine.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 9 days of BUD
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Loss of consciousness
Clinical narrative: AFTER RECEIVING 2ND SHOT FOR FLU VACCINE, PATIENT STARTED TO PASS OUT. THEN QUICKLY CAME BACK AFTER CONTINUING CALLING OUT PATIENT. SHE DID NOT EAT ANYTHING BEFORE VACCINATIONS AND HAD FAINTED BEFORE. PHARMACY CALLED PARAMEDICS TO FOLLOW UP ON PATIENT BEFORE LEAVING THE PHARMACY. PATIENT WAS GIVEN ORANGE JUICE AND CRACKERS AFTER AWAKENING AND BEFORE PARAMEDICS ARRIVED.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated after 9 days of BUD
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: 12/1/22: started with fatigue, runny nose
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fall, Loss of consciousness
Clinical narrative: Approx 10 minty yes after vaccination patient lost consciousness and fell.  Regained consciousness after approx 1 minute.   First occurrence.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test positive
Clinical narrative: 11/30/2022: started with fatigue, cough
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Magnetic resonance imaging, Neck pain, Neuralgia
Clinical narrative: I was going for a morning run, and I felt a sharp pain in the back of my skull. It felt like a nerve pain, but I kept running and I got a massive headache in my forehead. I had to stop and walk and when I made it home I laid down for a couple of days. I had a bad headache for a couple days and I vomited as well. I started to feel better, and I went to the doctor. They sent me another hospital because they were concerned. When I got the hospital, they said I had SAH which is a brain bleed that is around the brain stem. They said it would heal on its own. I still have headaches and neck pain.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Subarachnoid haemorrhage, Venous haemorrhage, Vomiting
Clinical narrative: I was going for a morning run, and I felt a sharp pain in the back of my skull. It felt like a nerve pain, but I kept running and I got a massive headache in my forehead. I had to stop and walk and when I made it home I laid down for a couple of days. I had a bad headache for a couple days and I vomited as well. I started to feel better, and I went to the doctor. They sent me another hospital because they were concerned. When I got the hospital, they said I had SAH which is a brain bleed that is around the brain stem. They said it would heal on its own. I still have headaches and neck pain.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: no symptoms
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Photophobia
Clinical narrative: BODY ACHES, EXTREME SENSITIVITY TO LIGHT LASTING 3 DAYS
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Rash papular, Rash pruritic
Clinical narrative: The arm the patient got the vaccine in, on the forearm was painful and had a not raised rash. Started small area, got better and then had a bigger rash on the other side of the same arm. Itchiness where the rash is but only local to the forearm
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Pain, Urticaria
Clinical narrative: Immediate welt, approximately 3/8? in diameter and 0.25? tall. Pain followed after roughly 30 seconds. Welt was 90% reduced and pain mostly gone after 5 minutes of rotating arm/rubbing injection site.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye inflammation, Eye pain, Metamorphopsia, Ocular discomfort
Clinical narrative: Patient states she has increased eye pressure (described symptoms as distorted vision, inflammation, pain). Currently undergoing treatment with eye drops to lower inflammation. Outcome, patient is working with eye specialist.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity
Clinical narrative: After getting the flu shot in my right arm it hurt really bad and I had a limited range of motion in my right arm. It has been months now and I am still experiencing a limited range of motion in my right arm
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Immunology test normal, Pruritus, Rash erythematous, Rash papular
Clinical narrative: 7/23/22 (15 days after injection) persistent hives observed. They are itchy and change location on the body every few hours. They mostly appear on hands, arms, chest, neck and knees. Sometimes they are raised bumps, sometimes red patches, sometimes long red lines.  Tried, Benadryl, Tagamet and Zyrtec but they didn't do anything.   7/29/22 - Consulted Teladoc who prescribed a short course of Prednasone. Hives stopped in 2 days but came back a few days after Rx was complete. 8/31/22 - GP tested my blood for an immune system problem but all results were normal 9/8/22 - Dermatologist advised me to take Claritin every day for 30 days, which seemed to stop the hives. 9/23/22 - Hives stopped
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: 7/23/22 (15 days after injection) persistent hives observed. They are itchy and change location on the body every few hours. They mostly appear on hands, arms, chest, neck and knees. Sometimes they are raised bumps, sometimes red patches, sometimes long red lines.  Tried, Benadryl, Tagamet and Zyrtec but they didn't do anything.   7/29/22 - Consulted Teladoc who prescribed a short course of Prednasone. Hives stopped in 2 days but came back a few days after Rx was complete. 8/31/22 - GP tested my blood for an immune system problem but all results were normal 9/8/22 - Dermatologist advised me to take Claritin every day for 30 days, which seemed to stop the hives. 9/23/22 - Hives stopped
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Left arm feel numb from injection site down including palm and fingers.  Can not feel things when touch.  Patient is currently away at school.  Will visit physician during brake in mid-December
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site induration, Injection site swelling, Malaise, Myalgia
Clinical narrative: Pediatric office didn't discuss vaccine options and gave the Novavax but patient previously received only the two dose primary series for Pfizer.  Patient reports a hard little bump at the injection site (similar to TB testing bump) and is surrounded by a large red rash about 12 hours following administration. Patient reports having trouble moving arm due to pain she is in. The little hard bump at the injection site is the most concerning as this is not a typical adverse reaction. Patient also has other side effects like headache, uncontrolled fever, general malaise, and muscle aches. Patient is concerned the office should not have given Novavax as the first booster when she received Pfizer for her primary series.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Wrong product administered
Clinical narrative: Pediatric office didn't discuss vaccine options and gave the Novavax but patient previously received only the two dose primary series for Pfizer.  Patient reports a hard little bump at the injection site (similar to TB testing bump) and is surrounded by a large red rash about 12 hours following administration. Patient reports having trouble moving arm due to pain she is in. The little hard bump at the injection site is the most concerning as this is not a typical adverse reaction. Patient also has other side effects like headache, uncontrolled fever, general malaise, and muscle aches. Patient is concerned the office should not have given Novavax as the first booster when she received Pfizer for her primary series.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Flushing, Swelling
Clinical narrative: child's face and hands turned red/flushed with mild swelling  (lungs clear, no respiratory symptoms, airway was not compromised), chidl was alert and crying HR 156 and 99% oxygen saturation  child was given Benadryl 5 mL (12.5 mg) and was monitored for next 15-20 minutes. eventually the redness/swelling resolved  This was the 4th flu vaccine she has had in her lifetime.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Central venous catheterisation, Drug hypersensitivity, Exercise tolerance decreased, Impaired driving ability, Mobility decreased
Clinical narrative: Although my arm had not hurt at all after my previous three Covid vaccines, my left arm has been sore for over a month after the 4th vaccine.  A few weeks after that 4th Covid vaccine, I was in my morning weight-lifting class when it felt like the muscles in my upper right arm had shrunk up.  I had the bar across my upper back doing squats at  that point and my arm muscles felt so atrophied that I had to flip my left hand over and hold the bar with my hand facing backwards instead of forwards. The next week this same thing happened.  The reason I think it MIGHT be vaccine-related is because not long after I had my first Covid vaccine, I had a PICC-line inserted in my right arm at Clinic.  A couple days later, the muscles in that arm shrunk up so much that my arm was curled in on itself; I could not extend it to shift gears in the car or reach into a cupboard to get a glass.  X-rays showed that the PICC-line placement was fine and two ultrasounds revealed no blood clots. Then that right arm broke out in a rash; then I had an allergic reaction to the Gabapentin I was given for the rash.  It seemed like my body was very reactive right then.  My doctors were baffled. It took months of physical therapy for my arm to become mostly normal and even now it is no longer my dominant arm.  What my left arm did recently in my gym class felt exactly the same, just not to such an extreme level.  I don't know if these things happened due to the vaccine or not; I'm just reporting what happened.  My husband and I have had decades-long issues as a result of a virus, so I'd rather take my chances with the vaccine, and I appreciate the work scientists have done to help protect us.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle atrophy, Pain in extremity, Rash, Ultrasound Doppler normal, X-ray normal
Clinical narrative: Although my arm had not hurt at all after my previous three Covid vaccines, my left arm has been sore for over a month after the 4th vaccine.  A few weeks after that 4th Covid vaccine, I was in my morning weight-lifting class when it felt like the muscles in my upper right arm had shrunk up.  I had the bar across my upper back doing squats at  that point and my arm muscles felt so atrophied that I had to flip my left hand over and hold the bar with my hand facing backwards instead of forwards. The next week this same thing happened.  The reason I think it MIGHT be vaccine-related is because not long after I had my first Covid vaccine, I had a PICC-line inserted in my right arm at Clinic.  A couple days later, the muscles in that arm shrunk up so much that my arm was curled in on itself; I could not extend it to shift gears in the car or reach into a cupboard to get a glass.  X-rays showed that the PICC-line placement was fine and two ultrasounds revealed no blood clots. Then that right arm broke out in a rash; then I had an allergic reaction to the Gabapentin I was given for the rash.  It seemed like my body was very reactive right then.  My doctors were baffled. It took months of physical therapy for my arm to become mostly normal and even now it is no longer my dominant arm.  What my left arm did recently in my gym class felt exactly the same, just not to such an extreme level.  I don't know if these things happened due to the vaccine or not; I'm just reporting what happened.  My husband and I have had decades-long issues as a result of a virus, so I'd rather take my chances with the vaccine, and I appreciate the work scientists have done to help protect us.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthritis, Arthropathy, Joint lock, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Since the vaccine  however I am experiencing arthritis type symptoms on the right side of my body which is  the side vaccine was administered. The next morning my whole side was stiff and my thumb locked. My big toe has pain my left leg at the top socket has pain  and my big toe. I cannot move my thumb in the mornings. I felt like it was maybe trigger finger but other joints unrelated like my big toe are having trouble
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Since the vaccine  however I am experiencing arthritis type symptoms on the right side of my body which is  the side vaccine was administered. The next morning my whole side was stiff and my thumb locked. My big toe has pain my left leg at the top socket has pain  and my big toe. I cannot move my thumb in the mornings. I felt like it was maybe trigger finger but other joints unrelated like my big toe are having trouble
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Dizziness, Dysstasia, Feeling abnormal, Gait disturbance
Clinical narrative: I received the second dose of the Moderna vaccine on 09/23/22, Couple hours later I became lightheaded. The following day it got worse to the point I couldn't stand on my own because if I did I would fall. The entire room was spinning. Even when I was helped to go to the bathroom because I was vomiting I wasn't steady . This continued for a week! I was seen in the ER and DX with vertigo. Never had such experience of this magnitude until I received the second dose of Moderna vaccine! I was given Rx Meclizine but it doesn't help . My life changed since then but not for the better it changed for the worse!! When I get vertigo I'm bed bound for a week and can't work . After that one week . Week 2 I'm still not myself. This is awful !!! FDA needs to label Moderna vaccine with this side affect
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Vertigo, Vomiting
Clinical narrative: I received the second dose of the Moderna vaccine on 09/23/22, Couple hours later I became lightheaded. The following day it got worse to the point I couldn't stand on my own because if I did I would fall. The entire room was spinning. Even when I was helped to go to the bathroom because I was vomiting I wasn't steady . This continued for a week! I was seen in the ER and DX with vertigo. Never had such experience of this magnitude until I received the second dose of Moderna vaccine! I was given Rx Meclizine but it doesn't help . My life changed since then but not for the better it changed for the worse!! When I get vertigo I'm bed bound for a week and can't work . After that one week . Week 2 I'm still not myself. This is awful !!! FDA needs to label Moderna vaccine with this side affect
Sex: M
Vaccine: FLUA4
Symptoms: Impaired work ability, Influenza, Malaise
Clinical narrative: received high dose flu shot 11/23/22 and sick with Flu symptoms since. Lost a week of self-employed work.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Contracted COVID despite having been boosted with the Moderna Bivalent Booster Oct 17, 2022 Lot# AS7140C
Sex: M
Vaccine: FLUA4
Symptoms: Arthritis, Mobility decreased, Myalgia
Clinical narrative: Inflammation of joints, muscle aches, limited mobility that started 1 day after Fluad Quad 2022-2023 vaccine was received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Pruritus, Treponema test negative, Urticaria
Clinical narrative: I took my second dose of the phizer vaccine in October because my work required it. I didn't want to get it, but it was out of my hands. I noticed a month or so after, that I started breaking out in hives on my hands and wrists. They hurt and are very itchy, but nothing leaks from these spots. I would also occasionally break out around my neck and inner thighs. Nothing would cause the reaction and I've never had such a thing happen before. I'd wake up with the hives and they'd last for days. They'd eventually go away on their own and come back a day or two later. My feet also started itching, but no hives there. I've been tested for syphilis with negative results and I've been to an allergist. He diagnosed me with a condition basically saying I have persistent urticaria that will eventually go away on its own. He prescribed with with a bunch of meds and creams to help them subside, but they haven't gone away. I'm enraged that a vaccine I was forced to take has caused such a side effect. I've read articles and similar circumstances and I'd like to report it to the FDA so perhaps something better can be done other than just throwing meds at me and saying it will eventually go away. Well it's been a year and my hands are still covered in hives.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Electrocardiogram QT interval, Fear of death, Hallucination
Clinical narrative: I had hallucinations the night I received the first dose of my covid vaccine. I had this overwhelming feeling of gloom and an immense fear that I would die in my sleep and never wake up. I messaged my parents, telling them how scared I was, and I had no clue why. The next day my pulse was very high; it got to 204, I had a syncope, and my pulse was undetectable by my monitor; it only went to 60, I believe. It was undetected for 8 and then 4 minutes before being normalized. My QT was over 500, and I was diagnosed with LQTS; I'm currently seeing a cardiologist to confirm. I was on my back, stiff, with my arms in the air for 3 of the 8 minutes. My physical trainer told the paramedics it looked like it could be a seizure; however, the doctors later said it wasn't.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Long QT syndrome, Musculoskeletal stiffness, Posture abnormal, Pulse absent
Clinical narrative: I had hallucinations the night I received the first dose of my covid vaccine. I had this overwhelming feeling of gloom and an immense fear that I would die in my sleep and never wake up. I messaged my parents, telling them how scared I was, and I had no clue why. The next day my pulse was very high; it got to 204, I had a syncope, and my pulse was undetectable by my monitor; it only went to 60, I believe. It was undetected for 8 and then 4 minutes before being normalized. My QT was over 500, and I was diagnosed with LQTS; I'm currently seeing a cardiologist to confirm. I was on my back, stiff, with my arms in the air for 3 of the 8 minutes. My physical trainer told the paramedics it looked like it could be a seizure; however, the doctors later said it wasn't.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: I had hallucinations the night I received the first dose of my covid vaccine. I had this overwhelming feeling of gloom and an immense fear that I would die in my sleep and never wake up. I messaged my parents, telling them how scared I was, and I had no clue why. The next day my pulse was very high; it got to 204, I had a syncope, and my pulse was undetectable by my monitor; it only went to 60, I believe. It was undetected for 8 and then 4 minutes before being normalized. My QT was over 500, and I was diagnosed with LQTS; I'm currently seeing a cardiologist to confirm. I was on my back, stiff, with my arms in the air for 3 of the 8 minutes. My physical trainer told the paramedics it looked like it could be a seizure; however, the doctors later said it wasn't.
Age: 14.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Underdose
Clinical narrative: Pt came on 11/22/22 to get covid booster was given 0.25 mL should have been given 0.5 mL. Will return in 2 month for full dose.
Age: 15.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Underdose
Clinical narrative: Child came in office to recieve Bivalent booster and was given 0.25 mL, should have been given 0.5 mL - will return in 2 months for full dosage.
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Pt was given 0.25 mL of Bivalent booster, should have been given  0.5 mL. parents contacted and letter sent to home. Pt will come back in 2 months for full dosage.
Age: 14.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Underdose
Clinical narrative: Child came to office to recieve Bivalent booster - was given 0.25 mL, should have been given 0.5 mL child will retun in 2 months to get correct dose.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administered the adult dose of 0.5ml vs the 0.25 for her age
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: child was given 0.25 mL of Bivalent booster - should have received 0.5 mL. child will return in 2 months to receive full dosage.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: child came in office to recieved  Bivalent booster - child was given 0.25 mL should have been given 0.5 m L. Will return in  two months for correct dosage.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient agreeded to Moderna Covid-19 Bivalent vaccine, but was given Moderna Covid-19 Vaccine. No symptoms reported after 15+ minutes of observation.
Sex: M
Vaccine: PPV
Symptoms: Influenza virus test negative, Malaise, Pain, Rash, SARS-CoV-2 test negative
Clinical narrative: generalized rash, not feeling well after getting pneumonia 23 vaccine, generalized body aches (5 days), neg covid & neg flu, rapid test, Benadryl (Hx lyme disease) and medrol dose pack ordered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received a monovalent booster dose after primary series instead of bivalent booster dose. Pt informed and will returned 1-7-23 for bivalent booster.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Immune system disorder, Investigation
Clinical narrative: got ALS from the vaccine; the vaccine damage my immune system healthy before the vaccine shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EN5318) and on 26Feb2021 as dose 2, single (Lot number: EN6203) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant) with onset Jun2022, described as "got ALS from the vaccine"; IMMUNE SYSTEM DISORDER (non-serious) with onset Jun2022, described as "the vaccine damage my immune system healthy before the vaccine shot". The patient went to primary doctor and could not find any, went to ENT and did not find anything, went around to several doctors and did not find anything. Went to a Neurologist and did not find anything. In Sep2021, a doctor friend introduced the patient to s Neurologist and tested the patient's entire body. After 9 months he suggested that the patient got ALS from the vaccines. The vaccines damage the patient's immune system. The patient was very healthy before the vaccine shot. The events "got als from the vaccine" and "the vaccine damage my immune system healthy before the vaccine shot" required physician office visit. The patient underwent the following laboratory tests and procedures: Test (entire body): (Sep2021) Unknown results. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201341350 Same reporter, drug and event; different patient.;
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLUC4, FLUC4
Symptoms: Aspartate aminotransferase, Atrial fibrillation, Blood magnesium, Cardiac monitoring, Cardiac stress test
Clinical narrative: Systemic: afib on 10/6-Mild, Additional Details: afib on 10/6   doctor advised her to fill out advere reaction
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLUC4, FLUC4
Symptoms: Chest X-ray, Dizziness, Drug screen, Dyspnoea, Echocardiogram
Clinical narrative: Systemic: afib on 10/6-Mild, Additional Details: afib on 10/6   doctor advised her to fill out advere reaction
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLUC4, FLUC4
Symptoms: Electrocardiogram, Fibrin D dimer, Full blood count, Heart rate increased, Laboratory test
Clinical narrative: Systemic: afib on 10/6-Mild, Additional Details: afib on 10/6   doctor advised her to fill out advere reaction
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLUC4, FLUC4
Symptoms: Metabolic function test, Presyncope, Red blood cell sedimentation rate, Thyroid function test, Troponin
Clinical narrative: Systemic: afib on 10/6-Mild, Additional Details: afib on 10/6   doctor advised her to fill out advere reaction
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLUC4, FLUC4
Symptoms: Urine analysis
Clinical narrative: Systemic: afib on 10/6-Mild, Additional Details: afib on 10/6   doctor advised her to fill out advere reaction
Age: 54.0
Sex: F
Vaccine: COVID19-2, FLUC4, FLUC4
Symptoms: Atrial fibrillation
Clinical narrative: Systemic: afib on 10/6-Mild, Additional Details: afib on 10/6   doctor advised her to fill out advere reaction
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, FLUX
Symptoms: Vaccination site swelling
Clinical narrative: CHILLS; FEVER; ARM SWELLED UP A LITTLE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 69 year old female of unspecified ethnicity. The patient's weight was 69.85 kilograms, and height was 163 centimeters. No past medical history or concurrent conditions were reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient got very sick and experienced chills and fever (Dose number in series 1).  The patient received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 7 decade old. No concomitant medications were reported.  On an unspecified date, the patient again got very sick and experienced recurrence of chills and fever (Dose number in series 2).  The patient also received dose 3 with Non-company suspect vaccine Comirnaty (tozinameran), (Dose number in series 3), (intramuscular, batch number: GJ6796 expiry: 31-JUL-2023, form of admin was not reported) dose was not reported, administered on 18-NOV-2022 to left arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). The patient also received Non-company suspect influenza vaccine (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on NOV-2022 for prophylactic vaccination. On 18-NOV-2022, the patient's arm swelled up a little (Dose number in series 3). The patient put ice on it. She had no fever, no headaches, nothing, she did not even get sick. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and influenza vaccine was not applicable. The patient recovered from arm swelled up a little on night of 18-NOV-2022, and the outcome of fever, chills and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20221201988 (Dose number in series 1).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, FLUX
Symptoms: COVID-19 immunisation, Chills, Peripheral swelling, Pyrexia
Clinical narrative: CHILLS; FEVER; ARM SWELLED UP A LITTLE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 69 year old female of unspecified ethnicity. The patient's weight was 69.85 kilograms, and height was 163 centimeters. No past medical history or concurrent conditions were reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient got very sick and experienced chills and fever (Dose number in series 1).  The patient received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 7 decade old. No concomitant medications were reported.  On an unspecified date, the patient again got very sick and experienced recurrence of chills and fever (Dose number in series 2).  The patient also received dose 3 with Non-company suspect vaccine Comirnaty (tozinameran), (Dose number in series 3), (intramuscular, batch number: GJ6796 expiry: 31-JUL-2023, form of admin was not reported) dose was not reported, administered on 18-NOV-2022 to left arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). The patient also received Non-company suspect influenza vaccine (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on NOV-2022 for prophylactic vaccination. On 18-NOV-2022, the patient's arm swelled up a little (Dose number in series 3). The patient put ice on it. She had no fever, no headaches, nothing, she did not even get sick. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and influenza vaccine was not applicable. The patient recovered from arm swelled up a little on night of 18-NOV-2022, and the outcome of fever, chills and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20221201988 (Dose number in series 1).
Age: 55.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, Chest pain, Chills, Fatigue, Feeling hot
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 55 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Time: unknown, Anatomical Site of injection: right arm, Route of Administration: Intramuscular;, Batch/Lot number: EL9261, Expiration: May2021), administration date: 03Feb2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Single, Time: unknown, Anatomical Site of injection: Upper right arm, Route of Administration: Intramuscular, Batch/Lot number: EN6201), administration date: 24Feb2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3, Single, Time: unknown, Anatomical Site of injection: Upper right arm, Route of Administration: Intramuscular;, Batch/Lot number: FF2593), administration date: 28Oct2021, when the patient was 54-year-old, for COVID-19 Immunization.  Additional information: Patient got vaccine booster yesterday. Patient experienced events when she woke up this morning. Booster dose due to high risk or frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications): states she is a home aid; works with elderly patients. No prior vaccination (within 4 weeks).
Age: 55.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Headache, Injection site pain, Malaise, Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 55 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Time: unknown, Anatomical Site of injection: right arm, Route of Administration: Intramuscular;, Batch/Lot number: EL9261, Expiration: May2021), administration date: 03Feb2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Single, Time: unknown, Anatomical Site of injection: Upper right arm, Route of Administration: Intramuscular, Batch/Lot number: EN6201), administration date: 24Feb2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3, Single, Time: unknown, Anatomical Site of injection: Upper right arm, Route of Administration: Intramuscular;, Batch/Lot number: FF2593), administration date: 28Oct2021, when the patient was 54-year-old, for COVID-19 Immunization.  Additional information: Patient got vaccine booster yesterday. Patient experienced events when she woke up this morning. Booster dose due to high risk or frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications): states she is a home aid; works with elderly patients. No prior vaccination (within 4 weeks).
Age: 55.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Asthenia, Fatigue, Feeling hot, Headache, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 55 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Time: unknown, Anatomical Site of injection: right arm, Route of Administration: Intramuscular;, Batch/Lot number: EL9261, Expiration: May2021), administration date: 03Feb2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Single, Time: unknown, Anatomical Site of injection: Upper right arm, Route of Administration: Intramuscular, Batch/Lot number: EN6201), administration date: 24Feb2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3, Single, Time: unknown, Anatomical Site of injection: Upper right arm, Route of Administration: Intramuscular;, Batch/Lot number: FF2593), administration date: 28Oct2021, when the patient was 54-year-old, for COVID-19 Immunization.  Additional information: Patient got vaccine booster yesterday. Patient experienced events when she woke up this morning. Booster dose due to high risk or frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications): states she is a home aid; works with elderly patients. No prior vaccination (within 4 weeks).
Age: 55.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 55 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Time: unknown, Anatomical Site of injection: right arm, Route of Administration: Intramuscular;, Batch/Lot number: EL9261, Expiration: May2021), administration date: 03Feb2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Single, Time: unknown, Anatomical Site of injection: Upper right arm, Route of Administration: Intramuscular, Batch/Lot number: EN6201), administration date: 24Feb2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3, Single, Time: unknown, Anatomical Site of injection: Upper right arm, Route of Administration: Intramuscular;, Batch/Lot number: FF2593), administration date: 28Oct2021, when the patient was 54-year-old, for COVID-19 Immunization.  Additional information: Patient got vaccine booster yesterday. Patient experienced events when she woke up this morning. Booster dose due to high risk or frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications): states she is a home aid; works with elderly patients. No prior vaccination (within 4 weeks).
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: slight fever; runny nose; dry cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EM9809), administration date: 27Feb2021, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EN6203), administration date: 06Nov2021, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset 28Nov2022, outcome "recovering", described as "dry cough"; RHINORRHOEA (non-serious) with onset 28Nov2022, outcome "recovering", described as "runny nose"; PYREXIA (non-serious) with onset 28Nov2022, outcome "recovering", described as "slight fever". Therapeutic measures were not taken as a result of pyrexia, rhinorrhoea, cough.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201342591 same patient, different vaccine dose number, different event;US-PFIZER INC-202201342590 same patient, different vaccine dose number, different event;