chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue, Headache
Clinical narrative: In the afternoon on 01/30/2023, I began to feel tired. More tired than I expected to be at that time of day. I was at work and I left work at the usual time around 4:30PM and I felt like I was coming down with a cold. By that evening, I was more tired and a little congested. I slept for a good 9 hours which is 2 hours longer than usual for me. I got up and called work and told them I wouldn't be in that day. On 01/31/2023, I was very congested, head congestion. No chest congestion. I thought I had a cold but I kept falling asleep. I took 3 naps that day 1 1/2 hours each which is unusual for me. Later that evening, I took a home test and it came back positive immediately. I alerted my employer that I wouldn't be in. I stayed home the rest of that week as well as the weekend, and I did return to work on Monday 02/06/2023. It was like a bad cold with a lot of fatigue. Slight headache on and off. I reported the positive test to my doctor on Wednesday morning and left a phone message. I didn't hear back from them until Thursday and they had sent in a prescription for PAXLOVID. My wife picked it up and I took the medication as directed. I started feeling better about Friday afternoon. Between Thursday and after the 3rd dose of PAXLOVID, I started to feel better. I took that until 02/06/2023 which was my last dose. I still felt like I had a head cold for part of that second week but I was no longer positive for COVID-19. I took another home test on Thursday 02/02 and I was positive. I took another test 02/05/2023 and I was negative. During my COVID-19 infection, I did also lose my sense of taste and smell on 02/03/2023, but that felt like more of a side effect of PAXLOVID. I didn't lose those senses until I took that medication. It took about 24 hours after my final dose on Monday to get those back. They slowly returned over the next week or so.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Impaired work ability, Nasopharyngitis, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: In the afternoon on 01/30/2023, I began to feel tired. More tired than I expected to be at that time of day. I was at work and I left work at the usual time around 4:30PM and I felt like I was coming down with a cold. By that evening, I was more tired and a little congested. I slept for a good 9 hours which is 2 hours longer than usual for me. I got up and called work and told them I wouldn't be in that day. On 01/31/2023, I was very congested, head congestion. No chest congestion. I thought I had a cold but I kept falling asleep. I took 3 naps that day 1 1/2 hours each which is unusual for me. Later that evening, I took a home test and it came back positive immediately. I alerted my employer that I wouldn't be in. I stayed home the rest of that week as well as the weekend, and I did return to work on Monday 02/06/2023. It was like a bad cold with a lot of fatigue. Slight headache on and off. I reported the positive test to my doctor on Wednesday morning and left a phone message. I didn't hear back from them until Thursday and they had sent in a prescription for PAXLOVID. My wife picked it up and I took the medication as directed. I started feeling better about Friday afternoon. Between Thursday and after the 3rd dose of PAXLOVID, I started to feel better. I took that until 02/06/2023 which was my last dose. I still felt like I had a head cold for part of that second week but I was no longer positive for COVID-19. I took another home test on Thursday 02/02 and I was positive. I took another test 02/05/2023 and I was negative. During my COVID-19 infection, I did also lose my sense of taste and smell on 02/03/2023, but that felt like more of a side effect of PAXLOVID. I didn't lose those senses until I took that medication. It took about 24 hours after my final dose on Monday to get those back. They slowly returned over the next week or so.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: In the afternoon on 01/30/2023, I began to feel tired. More tired than I expected to be at that time of day. I was at work and I left work at the usual time around 4:30PM and I felt like I was coming down with a cold. By that evening, I was more tired and a little congested. I slept for a good 9 hours which is 2 hours longer than usual for me. I got up and called work and told them I wouldn't be in that day. On 01/31/2023, I was very congested, head congestion. No chest congestion. I thought I had a cold but I kept falling asleep. I took 3 naps that day 1 1/2 hours each which is unusual for me. Later that evening, I took a home test and it came back positive immediately. I alerted my employer that I wouldn't be in. I stayed home the rest of that week as well as the weekend, and I did return to work on Monday 02/06/2023. It was like a bad cold with a lot of fatigue. Slight headache on and off. I reported the positive test to my doctor on Wednesday morning and left a phone message. I didn't hear back from them until Thursday and they had sent in a prescription for PAXLOVID. My wife picked it up and I took the medication as directed. I started feeling better about Friday afternoon. Between Thursday and after the 3rd dose of PAXLOVID, I started to feel better. I took that until 02/06/2023 which was my last dose. I still felt like I had a head cold for part of that second week but I was no longer positive for COVID-19. I took another home test on Thursday 02/02 and I was positive. I took another test 02/05/2023 and I was negative. During my COVID-19 infection, I did also lose my sense of taste and smell on 02/03/2023, but that felt like more of a side effect of PAXLOVID. I didn't lose those senses until I took that medication. It took about 24 hours after my final dose on Monday to get those back. They slowly returned over the next week or so.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: I started having a headache, fatigue, sneezing. I felt like I had a cold for another 10 days after. I tested positive for COVID-19 for about a week following. I still felt pretty tired and fatigue a week following. I wasn't prescribed anything, but I took acetaminophen for my headache and rested until I recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: I started having a headache, fatigue, sneezing. I felt like I had a cold for another 10 days after. I tested positive for COVID-19 for about a week following. I still felt pretty tired and fatigue a week following. I wasn't prescribed anything, but I took acetaminophen for my headache and rested until I recovered.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rash, Rash macular
Clinical narrative: After vaccination pt started with blotchy rash on face, ears, upper chest.  No respiratory symptoms.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Pruritus, Rash, Rash pruritic
Clinical narrative: I started getting itchy bumps in my body and scalp, I went to dermatologist she told me I have eczema. They are all over my body but scalp is really bad.
Age: 0.08
Sex: M
Vaccine: RV1
Symptoms: Barium swallow normal, Ultrasound abdomen normal, Vomiting
Clinical narrative: Bilious vomiting s/p administration
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram normal, Deafness unilateral, Headache
Clinical narrative: When I went the first night, I had seven hearing losses in my left ear. I was given steroids to take in the ER with a prescription to take home. I woke up the next day with better hearing but a headache, I filled the prescription and took it, but it gave me a worse headache. I went back to the ER, and I was given IV fluids along with TYLENOL before I left. It took the edge off but not completely. The headache continued for a few days from about Monday to Friday. I started feeling better Saturday, not completely better but better than before.
Age: 50.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Biopsy, Lichen sclerosus
Clinical narrative: I had my vaccination on 11/17/2022. I had a routine wellness examination on 01/23/2023. I was diagnosed with Lichen sclerosus on 01/30/2023. I was prescribed two different steroids. I do have a follow up scheduled for 03/06/2023.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Heart rate increased, Heart rate irregular
Clinical narrative: I experienced shortness of breath, I could not carry anything without losing my breath, my heart rate was very rapid and was jumping very high and coughing.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pneumonitis
Clinical narrative: I experienced shortness of breath, I could not carry anything without losing my breath, my heart rate was very rapid and was jumping very high and coughing.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Heart arrythmia
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gastroenteritis viral, Nausea, Pyrexia
Clinical narrative: I had an intestinal flu, a lot of diarrheas and this occurred on February 5th. I had a temperature/fever of 100.8. I also had a lot of stomach nausea & diarrhea.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Influenza like illness, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Flu like, tired, running nose, throat congestion, trouble concentrating .  Dizzy spells over last 2 weeks after apparent recovery
Age: 36.0
Sex: M
Vaccine: TD
Symptoms: Injection site nodule, Joint range of motion decreased, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient called on 2/17/23 and reports that he has been experiencing arm pain since receiving tetanus vaccination on 1/26/2023. Reports initially had swelling in arm after injection, now a knot remains at injection site. Reports arm tenderness, and decreased range of motion due to pain and ?like my arm doesn?t want to go anymore?.  Provider spoke with patient and discussed cold compress at injection site and anti-inflammatories. Advised to make follow up appt. for evaluation, but patient did  not schedule appt.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received monovalent instead of bivalent
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received monovalent instead of bivalent
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: I had a runny nose with fever and a fatigue. I also had a headache. I tested for COVID-19 on 02/11/2023 and the test was positive. I contacted my provider on the patient's portal and asked for PAXLOVID. I was taking over the counter TYLENOL and throat lozenges for my symptoms. I began to take the PAXLOVID and felt improvement within 1 day of taking it. I still had fatigue and a slight fever that lasted a few days. I am currently still experiencing the fatigue but the fever as well as other symptoms have gone away.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a runny nose with fever and a fatigue. I also had a headache. I tested for COVID-19 on 02/11/2023 and the test was positive. I contacted my provider on the patient's portal and asked for PAXLOVID. I was taking over the counter TYLENOL and throat lozenges for my symptoms. I began to take the PAXLOVID and felt improvement within 1 day of taking it. I still had fatigue and a slight fever that lasted a few days. I am currently still experiencing the fatigue but the fever as well as other symptoms have gone away.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received monovalent instead of bivalent
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTIONS
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received monovalent instead of bivalent
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Movement disorder
Clinical narrative: Patient describes limited movement in arm.
Age: 72.0
Sex: M
Vaccine: COVID19, UNK, VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: I had vaccination on 10/18/2022. On 10/18/2022 my arm started to swell up and I had a fever for 3-5 days.  I reached out to the nurse advice line on 10/18/2022 and was not given a course of treatment. After 5 days I felt better.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received monovalent instead of bivalent
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Hypoaesthesia, Laboratory test normal, Neuropathy peripheral, Sensory disturbance
Clinical narrative: I've had minor neuropathy in my feet since undergoing chemo treatments in 2017, but following my latest covid vaccine shot, the neuropathy has gotten SIGNIFICANTLY worse, by legs below my knees are virtually 100% numb and throbbing.
Age: 47.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage,
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Macular degeneration, Visual impairment
Clinical narrative: Sometime in October, my vision started to get dark. Words were being curved instead of straight across. I went to my doctor and they gave me an injection of my eye and every 3 months I have to go back. It is in my right eye. I was diagnosis was emasculate degeneration. The treatment has cleared up the darkness but I still do see the curvy lines.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deafness neurosensory, Deafness unilateral, Sudden hearing loss, Tinnitus
Clinical narrative: Sudden Sensorineural Hearing Loss and tinnitus, right ear.
Age: 55.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Headache
Clinical narrative: Headache in exactly the same spot on the side where the vaccine was given.  Does not respond well to NSAIDS rizatriptan refilled to counter headaches.  Will be getting an MRI for more info in the future.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse effects. The patient was given the pfizer bivalent covid 19 vaccine erroneously as the first dose of the covid19 vaccine series instead of a monovalent vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Lung disorder
Clinical narrative: I experienced nasals on lungs and inflamed colon.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: I gave Kinrix but should be given over the age 4 per manufacture.   no adverse reaction.  Not age appropriate.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer monovalent vaccine administered as a booster instead of a Pfizer bivalent vaccine.
Age: 67.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received a third dose of the Shingrix vaccine. Pt contacted after the injection was given and Pt reports no ill effects from getting a third dose of the vaccine.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had a sore arm that lasted about a week.
Age: 53.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Blood test, Magnetic resonance imaging, Papilloedema, Visual impairment
Clinical narrative: Optic nerve edema in left eye a few days after COVID booster. Unclear if related but other possible diagnosis would be NAION and he does not have risk factors nor anatomy for that. Nerve swelling has since resolved but he still has vision deficit.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Herpes zoster, Laboratory test normal, Skin lesion, Vulval disorder
Clinical narrative: Patient reported to pharmacy 2/17/23 that she had a "shingles" outbreak a few days after her Shingrix vaccination. Her medical chart indicates that she had similar lesions and outbreak shen she had CMV from her lung transplant. Was evaluated in clinic on 10/11/22 and had HSV diagnosis and symptoms started 5 days after the Shingrix vaccine showing lesions on leg and labia. Immuno compromised patient then prescribed Valtrex (PO) and Zovirax (topical) to address symptoms.
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the pfizer Bivalent vaccine today in office, without previously having the initial pfizer recommended first series
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Normal reaction. Was given pediatric dose rather than adult dose
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I had cold-like symptoms and a sore throat
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood cortisol, Chronic fatigue syndrome, Computerised tomogram abdomen, Computerised tomogram thorax
Clinical narrative: Two days after vaccine booster developed unexplained paroxysmal surge in hypertension accompanied by new onset atrial fibrillation with rapid ventricular response that lasted 10 hours and self-terminated.  Accompanied by chronic fatigue syndrome, which has persisted.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Echocardiogram, Electrocardiogram, Full blood count, Hypertension
Clinical narrative: Two days after vaccine booster developed unexplained paroxysmal surge in hypertension accompanied by new onset atrial fibrillation with rapid ventricular response that lasted 10 hours and self-terminated.  Accompanied by chronic fatigue syndrome, which has persisted.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Troponin, Ultrasound abdomen
Clinical narrative: Two days after vaccine booster developed unexplained paroxysmal surge in hypertension accompanied by new onset atrial fibrillation with rapid ventricular response that lasted 10 hours and self-terminated.  Accompanied by chronic fatigue syndrome, which has persisted.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Malaise, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse event after receiving the vaccine. I started feeling sick 01/17/2023 with sneezing, coughing and a slight fever. I tested positive for COVID-19 on 01/19/2023.  I had a telehealth visit with my doctor and got two prescriptions, doxycycline and prednisone, to help me my symptoms. I tolerated the medication without any complications.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: I did not have an adverse event after receiving the vaccine. I started feeling sick 01/17/2023 with sneezing, coughing and a slight fever. I tested positive for COVID-19 on 01/19/2023.  I had a telehealth visit with my doctor and got two prescriptions, doxycycline and prednisone, to help me my symptoms. I tolerated the medication without any complications.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received out of date vaccine. No adverse reactions noted.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature increased, Fatigue, Headache, Myalgia, Paranasal sinus discomfort
Clinical narrative: Every day: afternoon-evening temperature between 100 -101.8 starting the day after  getting the shot 12/29/2022 to present. Fatigue, headache, sinus pressure, muscle aches. Have to rest.
Age: 42.0
Sex: M
Vaccine: COVID19-2, TYP, YF
Symptoms: Consciousness fluctuating, Loss of consciousness, Seizure
Clinical narrative: gave typhoid and covid booster first. when giving yellow fever patient said [he didn't like that one] Upon completion, patient passed out and started seizing. Called 911. He came to for a little bit, then passed out again. Layed him down and elevated feet. EMS arrived and performed vitals. He was taken in for further evaluation.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebellar haemorrhage, Computerised tomogram, Laboratory test, Posterior fossa decompression
Clinical narrative: Patient admitted to hospital on 1/20/2023 and diagnosed with a cerebellar hemorrhage requiring posterior fossa decompression.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient did not experience any adverse reactions; however, an additional dose of the Pfizer Bivalent Booster was given as he did not report that he received a Bivalent Booster on 10/3/2022 until a couple hours post vaccination.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: Administeredf what she thought was proquad but turned out to be Hib. Hib was frozen, diluted with sterile diluent and given subcutaneous. Contacted nurse on call and was informed no real danger to patient but dose will not count. She said patient may be sore as that is a lot of fluid to be given subq. Doctor was notified. Mom was also notified of error and that Hib vaccine would not count. Mom was given option to come back in for proquad but states she will wait until 15 mth appt that is already scheduled.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site papule, Injection site pruritus, Injection site swelling
Clinical narrative: Patient was vaccinated for HPV on 2/17/23 on the left deltoid. Injection site was sore but pain began increasing on the 19th at night. The patients mother produced photos of the area from that night that showed erythema and a raised papule like lesion that appeared elongated. Photo from this morning was similar with some slight decrease in erythema. Patient has been applying an ice pack since this morning and the erythema is no longer present. Raised lesion has decreased in size but still present. Patient describes the area as itchy and painful with some slight burning. Mom says patient is very sensitive to metals and detergents.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Limb discomfort
Clinical narrative: patient said can still feel where shot was give, and can have radiating discomfort down the arm once awhile
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Patient had loose watery green stools starting  6/10/22 and lasting for 10 days.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: patient could not get out of the bed the next morning
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Moderna 2/5/21 Lot# 032H20A;  Moderna 3/6/21 Lot# 027L20A;  Moderna 12/5/21 Lot# 058H21A;  Moderna 6/3/22 Lot# 059M21A
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 2/16/21 Lot# 031M201;  Moderna 3/16/21 Lot# 040021A  Moderna 1029/21 Lot# 939904
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 1 Janssen
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Lethargy, Oropharyngeal pain
Clinical narrative: 12/31/2022 Slight sore throat and a little postnasal drip.  At Home COVID-19 test on 1/1/2023, positive.  1/2/2023 Sought care with doctor.  Tested again with a PCR test which was positive.  Prescribed Paxlovid.  I experienced a slight cough, lethargy and aches.  Fatigue lasted a month, but all other symptoms ended when the Paxlovid prescription ran out.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: 12/31/2022 Slight sore throat and a little postnasal drip.  At Home COVID-19 test on 1/1/2023, positive.  1/2/2023 Sought care with doctor.  Tested again with a PCR test which was positive.  Prescribed Paxlovid.  I experienced a slight cough, lethargy and aches.  Fatigue lasted a month, but all other symptoms ended when the Paxlovid prescription ran out.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaemia, Asthenia, Chills, Haemoglobin decreased, Lethargy
Clinical narrative: shaking, chills, fever over 103, severe weakness and full body pain,lethargic
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Tremor, White blood cell count increased
Clinical narrative: shaking, chills, fever over 103, severe weakness and full body pain,lethargic
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaemia, Asthenia, Blood albumin decreased, Blood culture negative, Blood sodium decreased
Clinical narrative: shaking, chills, fever over 103, severe weakness and full body pain,lethargic
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray normal, Chills, Culture urine negative, Fatigue, Haemoglobin decreased
Clinical narrative: shaking, chills, fever over 103, severe weakness and full body pain,lethargic
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hyponatraemia, Inflammation, Leukocytosis, Pain, Pyrexia
Clinical narrative: shaking, chills, fever over 103, severe weakness and full body pain,lethargic
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: White blood cell count increased
Clinical narrative: shaking, chills, fever over 103, severe weakness and full body pain,lethargic
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was to receive Moderna COVID vaccine (3rd dose) but received Pfizer  Bivalent Covid for 5-11yo vaccine instead.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Varicella virus test positive
Clinical narrative: Vaccine was administered on 1/19/23. Patient developed blister like rash approximately on 2/9/23, seen in doctors office on 2/13/23,  rash was swabbed, and came back positive for Varicella.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Exposure during pregnancy, Pityriasis rosea
Clinical narrative: Pityriasis rosea or pityriasis rosea-like eruptions. 28 weeks pregnant at onset. Due date is May 6, 2023. No pregnancy complications to date.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient at 37 weeks gestation received Gardasil. No reaction.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient has a bone marrow transplant in October 2022 and was to restart his Moderna vaccines due to them being depleted.  Patient should have restarted with Moderna (1st and 2nd doses) but instead received the bivalent covid 19 booster.  After researching and per the CDC we are going to be restarting the primary series as soon as we get the vaccine in, and we will restart the series.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Interchange of vaccine products, Periarthritis
Clinical narrative: shoulder pain; lost mobility of my shoulder/diagnosed with Frozen Shoulder; Dose Number: 4, Moderna ; Dose Number: 5, Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 14:30 as dose 5 (booster), single (Lot number: GJ3277) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing), notes: if covid prior vaccination Yes; "Penicillin" (unspecified if ongoing), notes: known allergies Penicillin; "known allergies Sulfa" (unspecified if ongoing), notes: known allergies Sulfa. Concomitant medication(s) included: WELLBUTRIN; GABAPENTIN; TRAZODONE. Past drug history included: E-myacin, reaction(s): "known allergies: E-myacin", notes: known allergies: E-myacin. Vaccination history included: moderna (Dose Number: 1, Batch/Lot No: 004m20a, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 24Feb2021, when the patient was 50-year-old, for Covid-19 immunization; moderna (Dose Number: 2, Batch/Lot No: 046a21a, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 25Mar2021, when the patient was 50-year-old, for Covid-19 immunization; moderna (Dose Number: 3, Batch/Lot No: 023C21A, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 19Nov2021, when the patient was 50-year-old, for Covid-19 immunization; moderna (Dose Number: 4, Batch/Lot No: 004M21A, Location of injection: Arm Left, Vaccine Administration Time: 11:45 PM), administration date: 29Apr2022, when the patient was 51-year-old, for Covid-19 immunization.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Sep2022 at 14:30, outcome "unknown", described as "Dose Number: 4, Moderna ; Dose Number: 5, Pfizer"; PERIARTHRITIS (non-serious) with onset 06Oct2022, outcome "not recovered", described as "lost mobility of my shoulder/diagnosed with Frozen Shoulder"; ARTHRALGIA (non-serious) with onset 06Oct2022, outcome "not recovered", described as "shoulder pain". The events "shoulder pain" and "lost mobility of my shoulder/diagnosed with frozen shoulder" required physician office visit. Therapeutic measures were taken as a result of arthralgia, periarthritis.  Additional information: The patient did not take other vaccines in four weeks. Patient took other medications in two weeks. Patient experienced covid prior to vaccination and was not covid tested post vaccination. Patient started having shoulder pain shortly after receiving the Pfizer vaccine. The shoulder started hurting more, and then lost mobility of shoulder. Patient have been diagnosed with Frozen Shoulder. This has affected patient's work and home life. Patient was treated for adverse event with Physical therapy, steroid injections, Celebrex.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: Fatigue; lightheadedness; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Feb2023 at 14:30 as dose 4 (booster), single (Lot number: GJ3270) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tardive dyskinesia" (unspecified if ongoing); "tardive dystonia" (unspecified if ongoing); "chores" (unspecified if ongoing); "ataxia" (unspecified if ongoing); "touretteism" (unspecified if ongoing). Concomitant medication(s) included: BACLOFEN; LORAZEPAM; RISPERIDONE; TESTOSTERONE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number 001m21a; Anatomical location: arm left), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 12Feb2023 at 03:45, outcome "not recovered"; DIZZINESS (non-serious) with onset 12Feb2023 at 03:45, outcome "not recovered", described as "lightheadedness"; VERTIGO (non-serious) with onset 12Feb2023 at 03:45, outcome "not recovered". Therapeutic measures were not taken as a result of fatigue, dizziness, vertigo.  Additional information: there were no other vaccines administered in four weeks. The patient had no COVID prior to vaccination, and was not tested post vaccination. He had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Breast enlargement
Clinical narrative: unusually enlarged right breast; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 13-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BREAST ENLARGEMENT (non-serious), outcome "unknown", described as "unusually enlarged right breast".  Clinical course: It was reported that physician ordered ultrasound after enlarged breast was reported to the physician. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (004756). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: A consumer on the other line would like to know whether or not 4th booster shot had virus in it. She received 3 packages from the mail and wanted the consumer to fill out information and return the package; she didn't have any adverse reactions. She had one sore arm from one of the shots and had some fatigue after several hours after the shot as she claims. She would like to take off her name and mailing list. Advise that she would be transferred to Customer Service Center for Pfizer BioNTech Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction, Electrocardiogram, Myopericarditis, Troponin, Ultrasound scan
Clinical narrative: Myopericarditis; This is a literature report for the following literature source(s).  A 16-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (medically significant), 2 days after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Ejection fraction: normal; Electrocardiogram: Diffuse ST segment elevation, notes: On admission; Troponin: Increased; Ultrasound scan: normal EF.  Clinical information: symptoms: chest pain, fever.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event  myopericarditis and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional information: Caller was medical assistant called regarding the Comirnaty Covid-19 Vaccine that was administered to his family and then his brother died, and he also mentioned (Name withheld) died as well after the vaccination; also, his uncle and other family members were sick as well. Caller was the only one who didn't receive the vaccination. Customer and/or medical inquiry was not forwarded or referred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300031634 same reporter/drug, different patient/event.;US-PFIZER INC-PV202300031636 same reporter/drug, different patient/event.;US-PFIZER INC-PV202300031963 same reporter/drug, different patient/event.;
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Reaction from the flu shot; Initial information received on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 76-year-old female patient who experienced reaction from the influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for Flu vaccination (Influenza immunisation).  On an unknown date the patient developed a non-serious reaction from the flu shot (allergy to vaccine) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event reaction from the flu shot.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: patient received vaccine that was administered post temperature excursion with no reported adverse event; patient received vaccine that was administered post temperature excursion with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old female patient who received Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] vaccine that was administered post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Feb-2023, the patient received a dose 1 of 0.5 ml once of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection that was administered post temperature excursion with no reported adverse event (poor quality product administered) (latency: same day) (lot: U7450AA, expiry date: 10-Oct-2024) via intramuscular route in the right deltoid with unknown strength for immunization.  On an unknown date the patient received vaccine that was administered post temperature excursion with no reported adverse event (product storage error) (latency: unknown).  Action taken: not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: inadvertently administered a dose of Fluzone Quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F, with no reported adverse event; inadvertently administered a dose of Fluzone Quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F, with no reported adverse event; inadvertently administered a dose of Fluzone Quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F, with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 years old male patient who was inadvertently administered a dose of Fluzone quadrivalent (influenza quadrival a-b vaccine) prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f, with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) for Immunisation.  On 07-Feb-2023, the patient received a 0.5 ml dose of suspect influenza quadrival a-b vaccine prefilled syringe (lot UT7752MA expiry date: unknown) via intramuscular route in left deltoid with unknown strength for Immunization which was inadvertently administered, that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f, with no reported adverse event (accidental exposure to product) (poor quality product administered) (product storage error) on same day  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: patient was administered Menquadfi after temperature excursion deemed vaccines non-viable for usage with no reported adverse event; lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 12 years old male patient who was administered Menquadfi (meningococcal a-c-y-w135 (t conj) vaccine ) after temperature excursion deemed vaccines non-viable for usage with no reported adverse event and lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Feb-2023, the patient received a 0.5 ml dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Suspension for injection (strength were not reported) (lot U7450AA and expiry date- 10-Oct-2024) via intramuscular route in the left deltoid for Immunization after temperature excursion deemed vaccines non-viable for usage with no reported adverse event (poor quality product administered) (latency: same day)  On 13-Feb-2023 , vaccine has lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event (product storage error) (latency: same day)  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: was inadvertently administered a dose of fluzone quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event; Initial information was received on 15-Feb-2023 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 3 years old male patient who was inadvertently administered a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 08-Feb-2023, the patient was inadvertently received Total 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe (lot number: UT7752MA, strength, expiry date: Unknown) via intramuscular route in unknown administration site for Immunisation that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (poor quality product administered) (latency: same day)  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event was inadvertently administered a dose of fluzone quadrivalent prefilled syringe that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01489379: 01493585: 01493618: 01493871: 01493882: 01493896: 01493906: 01495050: 01495133: 01495161: 01495184: 01495203: 01495215: 01495235: 01495279: 01495295: 01495310: