chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Pain in extremity, Weight
Clinical narrative: heart started racing; She took a test and she caught the virus/started getting sick/low-grade fever/Coughing; She took a test and she caught the virus/started getting sick/low-grade fever/Coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8729), on 20May2021 as dose 2, single (Lot number: EW0175) and on 17Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "pacemaker", start date: 2012 (ongoing), notes: Comments: pacemaker; "Blood pressure" (unspecified if ongoing), notes: Indication for use in the case: Blood pressure. Concomitant medication(s) included: VALSARTAN taken for blood pressure abnormal, start date: 2012 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "She took a test and she caught the virus/started getting sick/low-grade fever/Coughing"; PALPITATIONS (non-serious), outcome "unknown", described as "heart started racing". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Low grade fever; SARS-CoV-2 test: (May2022) Positive, notes: She took a test and she caught the virus; Weight: (unspecified date) weight is 140 something. Therapeutic measures were taken as a result of vaccination failure, covid-19, palpitations. Clinical course: She gave a nurse a ride that didn't take vaccine on a Tuesday, and Wednesday morning she started getting sick. Her heart started racing and had a low-grade fever, ran and got water and Gatorade and took Tylenol. She caught the virus from her. She is saying if she didn't take the 1st (as reported), maybe it could have been worse. She was very sick those 24 hours. Coughing. She took a test and she caught the virus. Patient also had a Flu shot on an unknown date - no further details.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300100075 same reporter/patient, different dose/event;
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Immobile, Loss of personal independence in daily activities, Rash
Clinical narrative: Patient's daughter reports patient has extreme fatigue/immobility and rash; can't physically dress oneself despite trying.
Age: 51.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Brain injury, Disability, Impaired work ability, Loss of personal independence in daily activities, Memory impairment
Clinical narrative: (the second vaccine in the form above was a mistaken button press) I have suffered and lived with an extreme brain injury ever since the event.  This began three days after the first dose.  I am an ivy league physics phd in the prime of my life, and I can barely fill out this form.  The wave that came over my brain 3 days after the first vaccine was extremely foreign and unlike anything I have ever experienced.  I don't have words to fully describe it.  After a few weeks it got somewhat better, so I tried the second vaccine.  Again, exactly three days after the second vaccine, the same thing happened to my brain, and it has not stopped since.  Because I am now disabled, I can't adequately describe this to anybody.  My verbal abilities have been greatly limited.  My working memory, (using the technical term) is gone.  I have none.  If I am speaking to you and you ask me what I just said, I will not be able to answer.  I am in a constant fight with my brain to just function, and I have nobody to turn to for help.    It is also important to note that the effects that the vaccine had on my brain are in no way related to long-covid brain fog.  It is a completely different experience.  In addition to the extreme brain impairment, my body is unable to regulate temperature effectively.  This has been most pronounced in my genital area, where my testicles spent an entire year shrunk up inside of my body.  They have finally dropped again, but things are not normal.
Age: 51.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Speech disorder, Temperature regulation disorder, Testicular disorder
Clinical narrative: (the second vaccine in the form above was a mistaken button press) I have suffered and lived with an extreme brain injury ever since the event.  This began three days after the first dose.  I am an ivy league physics phd in the prime of my life, and I can barely fill out this form.  The wave that came over my brain 3 days after the first vaccine was extremely foreign and unlike anything I have ever experienced.  I don't have words to fully describe it.  After a few weeks it got somewhat better, so I tried the second vaccine.  Again, exactly three days after the second vaccine, the same thing happened to my brain, and it has not stopped since.  Because I am now disabled, I can't adequately describe this to anybody.  My verbal abilities have been greatly limited.  My working memory, (using the technical term) is gone.  I have none.  If I am speaking to you and you ask me what I just said, I will not be able to answer.  I am in a constant fight with my brain to just function, and I have nobody to turn to for help.    It is also important to note that the effects that the vaccine had on my brain are in no way related to long-covid brain fog.  It is a completely different experience.  In addition to the extreme brain impairment, my body is unable to regulate temperature effectively.  This has been most pronounced in my genital area, where my testicles spent an entire year shrunk up inside of my body.  They have finally dropped again, but things are not normal.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Influenza, Influenza B virus test positive, Malaise
Clinical narrative: My flu symptoms started on 02/01/2023. I had cough and fever. I went to the urgent care in the morning around 10:00AM. We both were sick, so I was trying to get somewhere. In the urgent care they tested me for COVID-19 and flu. I was positive for Flu B. They only prescribed me with TAMIFLU at that time. After 2 days on 02/03/2023 I tested positive for COVID-19 infection with a home test. I called the urgent care and told them that I tested positive, and they called in a prescription for PAXLOVID for 5 days. After 1 week later on 02/13/2023 I still had the cough which was severe. I was constant coughing, so I called my doctor who then prescribed me with amoxicillin. I tested with a home COVID-19 test on 02/10/2023 which was negative.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: My flu symptoms started on 02/01/2023. I had cough and fever. I went to the urgent care in the morning around 10:00AM. We both were sick, so I was trying to get somewhere. In the urgent care they tested me for COVID-19 and flu. I was positive for Flu B. They only prescribed me with TAMIFLU at that time. After 2 days on 02/03/2023 I tested positive for COVID-19 infection with a home test. I called the urgent care and told them that I tested positive, and they called in a prescription for PAXLOVID for 5 days. After 1 week later on 02/13/2023 I still had the cough which was severe. I was constant coughing, so I called my doctor who then prescribed me with amoxicillin. I tested with a home COVID-19 test on 02/10/2023 which was negative.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Increased upper airway secretion, Nasal congestion, Pharyngitis
Clinical narrative: Two days before I tested positive, I felt an infection in my throat. There was phlegm, but I didn't whether I was getting sick or not. At 4 PM on 1/11/2023, I began sneezing. I took a home antigen test and got a positive result.  I got Paxlovid the same day and began taking it around 6 PM. I isolated from my husband and took the Paxlovid according to the instructions. I consumed plenty of fluids and kept eating. I mainly had nasal congestion, cough, and phlegm in the throat. I had no difficulty breathing or a fever, and my blood oxygen level was normal. On 1/16/2023, I tested negative. On the afternoon of 1/11/2023, I noticed that I had welts on my hips, thighs, and abdomen. They were flat and raised a little bit. Some were small, and some were larger. They did not itch, though. The welts were gone within 12 hours, though. About a week before I tested positive, I had similar welts appear on my legs, belly, and thighs. They also lasted maybe 12 hours.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Productive cough, SARS-CoV-2 test positive, Sneezing, Swelling, Urticaria
Clinical narrative: Two days before I tested positive, I felt an infection in my throat. There was phlegm, but I didn't whether I was getting sick or not. At 4 PM on 1/11/2023, I began sneezing. I took a home antigen test and got a positive result.  I got Paxlovid the same day and began taking it around 6 PM. I isolated from my husband and took the Paxlovid according to the instructions. I consumed plenty of fluids and kept eating. I mainly had nasal congestion, cough, and phlegm in the throat. I had no difficulty breathing or a fever, and my blood oxygen level was normal. On 1/16/2023, I tested negative. On the afternoon of 1/11/2023, I noticed that I had welts on my hips, thighs, and abdomen. They were flat and raised a little bit. Some were small, and some were larger. They did not itch, though. The welts were gone within 12 hours, though. About a week before I tested positive, I had similar welts appear on my legs, belly, and thighs. They also lasted maybe 12 hours.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chest pain, Dizziness, Fatigue, Headache, Impaired driving ability
Clinical narrative: Burning pain in mid to upper chest and into throat. Breathing is compromised however, pulse /ox readings are usually upper 90's.  24hr. headaches varying in intensity. Dizziness and fatigue. Unable to drive sometimes.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Oropharyngeal pain, Respiratory disorder, Throat irritation
Clinical narrative: Burning pain in mid to upper chest and into throat. Breathing is compromised however, pulse /ox readings are usually upper 90's.  24hr. headaches varying in intensity. Dizziness and fatigue. Unable to drive sometimes.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Grip strength decreased, Joint stiffness, Magnetic resonance imaging normal, Massage
Clinical narrative: I started having pretty stiff hands after dose 4.  I then began feeling hand and joint stiffness in my hands.  My hands would get so tense and stiff during the night.  It was so bad that when I would wake up in the night, I would have to massage my hands so they would release.  They were also very tender with mild pain.  I saw my rheumatologist.  I was tested for arthritis.  I had an ultrasound on my fingers and carpal tunnel was not found.  As of today, there is no cause for this pain and stiffness during the night.  I had a second rheumatologist.  We went over my blood test results.  She suggested compression gloves.  I had a hand MRI.  The gloves did not help at all.  I am taking more regularly ibuprofen.  MRI results were all negative which still did not explain my pain, swelling and stiffness.  As of today, it is so bad I am unable to grasp things as normal.  I am dropping things more often.  The nighttime episodes are worse.  It only happens when I sleep - even when I take a nap on the couch.  I have tried a hand splint, but it has not helped either.  I have visited my doctor again for help.  I have a nerve conduction test on March 31st.  I have been prescribed prednisone as well.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Sleep disorder, Splint application
Clinical narrative: I started having pretty stiff hands after dose 4.  I then began feeling hand and joint stiffness in my hands.  My hands would get so tense and stiff during the night.  It was so bad that when I would wake up in the night, I would have to massage my hands so they would release.  They were also very tender with mild pain.  I saw my rheumatologist.  I was tested for arthritis.  I had an ultrasound on my fingers and carpal tunnel was not found.  As of today, there is no cause for this pain and stiffness during the night.  I had a second rheumatologist.  We went over my blood test results.  She suggested compression gloves.  I had a hand MRI.  The gloves did not help at all.  I am taking more regularly ibuprofen.  MRI results were all negative which still did not explain my pain, swelling and stiffness.  As of today, it is so bad I am unable to grasp things as normal.  I am dropping things more often.  The nighttime episodes are worse.  It only happens when I sleep - even when I take a nap on the couch.  I have tried a hand splint, but it has not helped either.  I have visited my doctor again for help.  I have a nerve conduction test on March 31st.  I have been prescribed prednisone as well.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tenderness, Ultrasound scan normal
Clinical narrative: I started having pretty stiff hands after dose 4.  I then began feeling hand and joint stiffness in my hands.  My hands would get so tense and stiff during the night.  It was so bad that when I would wake up in the night, I would have to massage my hands so they would release.  They were also very tender with mild pain.  I saw my rheumatologist.  I was tested for arthritis.  I had an ultrasound on my fingers and carpal tunnel was not found.  As of today, there is no cause for this pain and stiffness during the night.  I had a second rheumatologist.  We went over my blood test results.  She suggested compression gloves.  I had a hand MRI.  The gloves did not help at all.  I am taking more regularly ibuprofen.  MRI results were all negative which still did not explain my pain, swelling and stiffness.  As of today, it is so bad I am unable to grasp things as normal.  I am dropping things more often.  The nighttime episodes are worse.  It only happens when I sleep - even when I take a nap on the couch.  I have tried a hand splint, but it has not helped either.  I have visited my doctor again for help.  I have a nerve conduction test on March 31st.  I have been prescribed prednisone as well.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: Diagnosised Bilateral Pulmonary embih
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Migraine, Mobility decreased, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Patient stated that he woke up on 3/7/23 and could hardly move. Said he had previously had Covid and this felt much worse than that. His arm swelled & was sore (which he reported happened with dose 1 as well). Had body aches, a sore throat, and the worst migraine he's ever had (eyes were extremely light sensitive). Almost went to the ER but did not.  He is not immunocompromised. Called us on 3/8/23 & reported that he was starting to feel much better and wondered if this had been a normal reaction or not. We informed him if he continued to get worse to contact his prescriber or go see a medical professional.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Photophobia
Clinical narrative: Patient stated that he woke up on 3/7/23 and could hardly move. Said he had previously had Covid and this felt much worse than that. His arm swelled & was sore (which he reported happened with dose 1 as well). Had body aches, a sore throat, and the worst migraine he's ever had (eyes were extremely light sensitive). Almost went to the ER but did not.  He is not immunocompromised. Called us on 3/8/23 & reported that he was starting to feel much better and wondered if this had been a normal reaction or not. We informed him if he continued to get worse to contact his prescriber or go see a medical professional.
Age: 1.67
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient here with mother for 2nd dose primary pfizer vaccine. Checked "Covid Vaccine Schedule" handout provided by facility to staff, rev 10.13.2022. Schedule stated "2nd dose primary," Note in dot with no mention on Monovalent vs. Bivalent.  Given pfizer covid 19 vaccine bilvalent 0.2ml IM on RVL. tolerated well. No adverse reactions noted at the time of administration. In the afternoon nurse was given updated "covid-19 vaccine schedule" handout, dated 12/12/2022. Noted on updated schedule stating "2nd dose Monovalent." Supervisor notified. Chart cc'ed to md for review.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Localised infection
Clinical narrative: The patient called on 03/05/2023 saying she got a vaccine at rite aid on 01/05/2023 and caused an infection at her left arm. She thought it would get better but it did not, She sought medical treatment on 03/09/2023. According to the patient, the doctor diagnosed her arm as being infected and prescribed antibiotic.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came in on 03/10/2023 with father for 2nd dose pfizer vaccine. Noted due. Checked facility-approved "Covid Vaccine Schedule" Handout, rev. 10/13/2022. States in handout for pfizer 6mo-4y, 2nd dose primary. Did not in dotted note if monovalent or bivalent. Given Pzifer bivalent 0.2ml IM on rvl. tolerated well. no adverse reactions noted at this time. In the afternoon, nurse given updated "Covid Vaccine Schedule" handout, rev. 12/12/2022. Updated handout states on dotted note, "2nd dose primary monovalent." notified supervisor of event. chart cc'ed to md.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anaemia, Condition aggravated, Hypertension, Infection, Inflammation
Clinical narrative: Patient had pre-existing medical issues kidney transplant (2017), so he was not a candidate for an experimental vaccine.  Anemia worsened, infection, high blood pressure, respiratory issues, inflammation and worsening kidney function
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Renal impairment, Respiratory disorder
Clinical narrative: Patient had pre-existing medical issues kidney transplant (2017), so he was not a candidate for an experimental vaccine.  Anemia worsened, infection, high blood pressure, respiratory issues, inflammation and worsening kidney function
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Computerised tomogram, Condition aggravated, Echocardiogram, Feeling abnormal
Clinical narrative: On Tuesday night, June 21st, 2022, I was transported by Ambulance to Hosp. Emergency Room, where it was determined that I had an Ischemic Stroke. I did not connect it at the time that maybe it was from vaccine?? On Tuesday night, June 13, 2022, my husband and I were sitting at the dining room table, playing checkers. Suddenly I felt strange and I started to go lie down. When I was up walking my left ankle felt like it was begining to get numb, also my left hand. My blood pressure was extremely high. My husband called 911 and an ambulance and fire truck arrived. By the time the paramedics saw me, I was feeling better. I was taken by ambulance to Medical Center. My blood pressure was still high. I could see "a row of lights" more from my left. Later while at hospital, I could see the "lights" again, two or three times. My vision was being affected I suppose. Tests were run while I was there. I was diagnosed as having an Ischemic Stroke. The Neurologist thought it was caused from Atrial fib. I don't believe he knew about the vaccination I had the week before this all happened. Recently on the news I became aware that the Pfizer vaccines (are believed to may have) been the cause of Ischemic Strokes in people over a certain age 60 or 65 (?) who had received a dose of the vaccine. I really appreciate your concern about my having an Ischemic Stroke.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Ischaemic stroke, Laboratory test, Visual impairment
Clinical narrative: On Tuesday night, June 21st, 2022, I was transported by Ambulance to Hosp. Emergency Room, where it was determined that I had an Ischemic Stroke. I did not connect it at the time that maybe it was from vaccine?? On Tuesday night, June 13, 2022, my husband and I were sitting at the dining room table, playing checkers. Suddenly I felt strange and I started to go lie down. When I was up walking my left ankle felt like it was begining to get numb, also my left hand. My blood pressure was extremely high. My husband called 911 and an ambulance and fire truck arrived. By the time the paramedics saw me, I was feeling better. I was taken by ambulance to Medical Center. My blood pressure was still high. I could see "a row of lights" more from my left. Later while at hospital, I could see the "lights" again, two or three times. My vision was being affected I suppose. Tests were run while I was there. I was diagnosed as having an Ischemic Stroke. The Neurologist thought it was caused from Atrial fib. I don't believe he knew about the vaccination I had the week before this all happened. Recently on the news I became aware that the Pfizer vaccines (are believed to may have) been the cause of Ischemic Strokes in people over a certain age 60 or 65 (?) who had received a dose of the vaccine. I really appreciate your concern about my having an Ischemic Stroke.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient has had long lasting severe pain in the arm that was injected
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash arms
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Electrocardiogram, Hypoaesthesia oral
Clinical narrative: Chest pressure and pain light head dizzy lip dumb
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test
Clinical narrative: Chest pressure and pain light head dizzy lip dumb
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse events at present time
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Underdose, Wrong product administered
Clinical narrative: Pt had given Covid vaccine age 5-11yrs old instead of 11yr up dose. MA has given pt the wrong vaccine
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abstains from alcohol, Chest pain, Disturbance in attention, Hearing aid therapy, Helplessness
Clinical narrative: The night of the day after the shot I woke up with racing heart, wooshing / white noise in ears. (neither of these things have ever happened to me before.)  Over the next days the wooshing noise rapdily developed into a very loud ringing in ears at times, like a smoke alarm going off volume, held by my ear, impossibly loud for a noise that did not exist).  This was mostly when going to sleep, during night and in morning when waking up, but also throughout the day.  I was able to reduce this some by listening to certain sounds.  I have since gotten hearing aids to keep white noise in ears, which really helps manage, along with listening to other specific sounds at times.  This ringing prevented sleep, concentration and made me feel helpless.  While I would not commit suicide, it made me understand why people have, who are affected by this.  I am lucky I can manage mine at all.   After multiple dr consults I do not have hearing loss, and was prescribed these hearing aids.   my primary dr did try steroids and antibiotics, if anything I feel like that made it worse, maybe just the same.   I also tried no caffeine and no alcohol for ~ 3 months, as it was said that might help, however, that was at the same time I tried noises.... I am pretty sure the alcohol and caffeine did not have much, if any effect.  generated noises, fortunately, seem effective.   The sound got much worse on right side overall, but has since evened out between ears.  I at time in right ear would actually get a strange chirping... that has stopped for some months, and is now just a normal ring or white noise just like left ear.  Also in days / weeks following I experienced: -occasional "numb feeling" spots in head, temporary and would pass, never quite had feeling like this before.  would happen randomly and last for maybe 3-15 seconds.  stopped about 4 months after the shot - occasional chest cramping / ache feeling - also stopped about 4 months after - numbness and tingling from elbows to pinkys and 4th fingers on left and right. this cleared up after about 5 months.  had some residual numb-ish spots in pinky's a big longer, all that is gone now.  more in left than right
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Palpitations, Sleep disorder, Tinnitus
Clinical narrative: The night of the day after the shot I woke up with racing heart, wooshing / white noise in ears. (neither of these things have ever happened to me before.)  Over the next days the wooshing noise rapdily developed into a very loud ringing in ears at times, like a smoke alarm going off volume, held by my ear, impossibly loud for a noise that did not exist).  This was mostly when going to sleep, during night and in morning when waking up, but also throughout the day.  I was able to reduce this some by listening to certain sounds.  I have since gotten hearing aids to keep white noise in ears, which really helps manage, along with listening to other specific sounds at times.  This ringing prevented sleep, concentration and made me feel helpless.  While I would not commit suicide, it made me understand why people have, who are affected by this.  I am lucky I can manage mine at all.   After multiple dr consults I do not have hearing loss, and was prescribed these hearing aids.   my primary dr did try steroids and antibiotics, if anything I feel like that made it worse, maybe just the same.   I also tried no caffeine and no alcohol for ~ 3 months, as it was said that might help, however, that was at the same time I tried noises.... I am pretty sure the alcohol and caffeine did not have much, if any effect.  generated noises, fortunately, seem effective.   The sound got much worse on right side overall, but has since evened out between ears.  I at time in right ear would actually get a strange chirping... that has stopped for some months, and is now just a normal ring or white noise just like left ear.  Also in days / weeks following I experienced: -occasional "numb feeling" spots in head, temporary and would pass, never quite had feeling like this before.  would happen randomly and last for maybe 3-15 seconds.  stopped about 4 months after the shot - occasional chest cramping / ache feeling - also stopped about 4 months after - numbness and tingling from elbows to pinkys and 4th fingers on left and right. this cleared up after about 5 months.  had some residual numb-ish spots in pinky's a big longer, all that is gone now.  more in left than right
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Bell's palsy, Cardiac monitoring, Chills, Facial paralysis, Immunisation reaction
Clinical narrative: had a bad case of Covid/high daily fevers of 104 for 26 days; had a bad case of Covid/high daily fevers of 104 for 26 days; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" and all described as "had a bad case of Covid/high daily fevers of 104 for 26 days". The event "had a bad case of covid/high daily fevers of 104 for 26 days" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) low grade fever; (unspecified date) 104, notes: high daily fevers for 26 days; SARS-CoV-2 test: (19Jan2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, suspected COVID-19.  Additional information: Patient had a bad case of Covid in Oct2022 with high daily fevers of 104 for 26 days but patient was fully up to date on her Pfizer booster at that time. She was never hospitalized but visited the ER twice for check ups because it was so miserably concerning. Finally recovered after contacting the flu and given flu meds. As the CDC recommended however, patient received this Jan2023 vaccine as it was 3 months from the "start" of when she had Covid symptoms in Oct2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300101116 Same reporter/patient/product, different dose/event;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Malaise, Ophthalmic migraine, Palpitations, Pyrexia
Clinical narrative: had a bad case of Covid/high daily fevers of 104 for 26 days; had a bad case of Covid/high daily fevers of 104 for 26 days; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" and all described as "had a bad case of Covid/high daily fevers of 104 for 26 days". The event "had a bad case of covid/high daily fevers of 104 for 26 days" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) low grade fever; (unspecified date) 104, notes: high daily fevers for 26 days; SARS-CoV-2 test: (19Jan2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, suspected COVID-19.  Additional information: Patient had a bad case of Covid in Oct2022 with high daily fevers of 104 for 26 days but patient was fully up to date on her Pfizer booster at that time. She was never hospitalized but visited the ER twice for check ups because it was so miserably concerning. Finally recovered after contacting the flu and given flu meds. As the CDC recommended however, patient received this Jan2023 vaccine as it was 3 months from the "start" of when she had Covid symptoms in Oct2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300101116 Same reporter/patient/product, different dose/event;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Bell's palsy, Body temperature, Cardiac monitoring, Chills, Headache
Clinical narrative: had a bad case of Covid/high daily fevers of 104 for 26 days; had a bad case of Covid/high daily fevers of 104 for 26 days; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" and all described as "had a bad case of Covid/high daily fevers of 104 for 26 days". The event "had a bad case of covid/high daily fevers of 104 for 26 days" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) low grade fever; (unspecified date) 104, notes: high daily fevers for 26 days; SARS-CoV-2 test: (19Jan2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, suspected COVID-19.  Additional information: Patient had a bad case of Covid in Oct2022 with high daily fevers of 104 for 26 days but patient was fully up to date on her Pfizer booster at that time. She was never hospitalized but visited the ER twice for check ups because it was so miserably concerning. Finally recovered after contacting the flu and given flu meds. As the CDC recommended however, patient received this Jan2023 vaccine as it was 3 months from the "start" of when she had Covid symptoms in Oct2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300101116 Same reporter/patient/product, different dose/event;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Ophthalmic migraine, Palpitations, Pyrexia, SARS-CoV-2 test
Clinical narrative: had a bad case of Covid/high daily fevers of 104 for 26 days; had a bad case of Covid/high daily fevers of 104 for 26 days; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" and all described as "had a bad case of Covid/high daily fevers of 104 for 26 days". The event "had a bad case of covid/high daily fevers of 104 for 26 days" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) low grade fever; (unspecified date) 104, notes: high daily fevers for 26 days; SARS-CoV-2 test: (19Jan2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, suspected COVID-19.  Additional information: Patient had a bad case of Covid in Oct2022 with high daily fevers of 104 for 26 days but patient was fully up to date on her Pfizer booster at that time. She was never hospitalized but visited the ER twice for check ups because it was so miserably concerning. Finally recovered after contacting the flu and given flu meds. As the CDC recommended however, patient received this Jan2023 vaccine as it was 3 months from the "start" of when she had Covid symptoms in Oct2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300101116 Same reporter/patient/product, different dose/event;
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Body temperature, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: had a bad case of Covid/high daily fevers of 104 for 26 days; had a bad case of Covid/high daily fevers of 104 for 26 days; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication included: SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" and all described as "had a bad case of Covid/high daily fevers of 104 for 26 days". The event "had a bad case of covid/high daily fevers of 104 for 26 days" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) low grade fever; (unspecified date) 104, notes: high daily fevers for 26 days; SARS-CoV-2 test: (19Jan2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, suspected COVID-19.  Additional information: Patient had a bad case of Covid in Oct2022 with high daily fevers of 104 for 26 days but patient was fully up to date on her Pfizer booster at that time. She was never hospitalized but visited the ER twice for check ups because it was so miserably concerning. Finally recovered after contacting the flu and given flu meds. As the CDC recommended however, patient received this Jan2023 vaccine as it was 3 months from the "start" of when she had Covid symptoms in Oct2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300101116 Same reporter/patient/product, different dose/event;
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; patient received a dose of PROQUAD intramuscularly (IM) instead of the subcutaneously (SC); HCP was instructed to administer another dose of PROQUAD to the same patient subcutaneously; This spontaneous report has been received from medical assistant concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions or allergies, and concomitant medications were not provided.   On 25-JAN-2023, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Recombinant Human Albumin recombinant Human albumin) (rHA) (PROQUAD) 0.5 mL once (lot number W007748 has been verified to be valid, expiration date reported and established as 04-SEP-2023).  The patient was vaccinated intramuscularly (IM) instead of subcutaneously (SC) (Incorrect route of product administration), and medical assistant was instructed to administer another dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) SC to the patient (Extra dose administered), the reporter did not specify if both doses of Measles, Mumps, Rubella and Varicella (Okaa-Merck) Virus Vaccine Live (PROQUAD) had the same lot number and expiration date. The reporter refused to answer questions to further clarify the adverse events. No additional adverse events were reported (No adverse event).  This case was classified as non-valid report due to lack of patient identifiers.  Follow-up information has been received from a vaccine provider on 27-FEB-2023.  The patient was female of 12-months. Her birth weight was 4505 Kg. Historical vaccines included 3 previous doses of PVC13. On 25-JAN-2023, she received two doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Recombinant Human Albumin Recombinant Human albumin) (rHA) (PROQUAD) under direction of medical assistant (noted that re-vaccination was necessary) as previously reported, both doses were given with product of the same lot number W007748 with expiration date 04-SEP-2023 in the right thigh. On the same date, she also was vaccinated with hepatitis A Vaccine, inactivated (VAQTA) IM in left vastus lateral (LVL) (lot number reported as: W017344) and "PVC13" (lot number FF7356, expiration date 30-APR-2024) IM on the LVL. All given by a health care professional at a private doctor's office or hospital by private funds. Subsequently, the were aware of both errors, and the patient's mother was advice of precautions. Patient did no experienced any adverse effect. This report has been previously reported to doctor and manufacturer.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 at 13:00 as dose 1, single (Lot number: EL9262), in right arm, on 17Mar2021 at 14:00 as dose 2, single (Lot number: ENGZ08), in right arm, on 28Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 301558A), in right arm and on 09Apr2022 at 15:00 as dose 4 (booster), single (Lot number: F55682), in right arm for covid-19 immunisation. The patient's relevant medical history included: "SVT" (unspecified if ongoing); "HTN" (unspecified if ongoing); "chronic nerve pain" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "not recovered", described as "COVID 19"; VACCINATION FAILURE (medically significant) with onset 2023, outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: after having tested negative twice; (unspecified date) Negative, notes: after having tested negative twice; (unspecified date) Negative, notes: isolated for 5 more days, tested negative,; (2023) Positive, notes: then again tested positive 14 days after completing Paxlovid; (Feb2023) Positive, notes: Nine days after completing the 5-day Paxlovid course of treatment for Covid, I tested positive (after having tested negative twice). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Nine days after completing the 5-day Paxlovid course of treatment for Covid, I tested positive (after having tested negative twice). I isolated for 5 more days, tested negative, then again tested positive 14 days after completing Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "POTS" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 14Feb2023, outcome "not recovered", COVID-19 (medically significant) with onset 14Feb2023, 12 days after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". First tested positive 14Feb and started Paxlovid that day until 19Feb, was isolating until then. Remained at home and masking. Wound up symptomatic 25Feb, tested negative twice that day on at home test and negative 26Feb on lab test. Continued feeling unwell. Tested on ay home test 03Mar and was positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2023) Positive; (26Feb2023) Negative, notes: negative twice that day on at home test and negative; (03Mar2023) Positive, notes: home test; (07Mar2023) Positive, notes: home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Feb2023 to 19Feb2023..  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (Jan2023) came down with COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300044987 Same reporter/ drug/ event for different patients;
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "chronic rhinitis" (unspecified if ongoing); "known allergies: passion fruit and mangoes" (unspecified if ongoing), notes: known allergies: passion fruit and mangoes. The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "known allergies: Allergies to Lisinopril", notes: known allergies: Allergies to Lisinopril; Lactose, reaction(s): "known allergies: Allergies to lactose", notes: known allergies: Allergies to lactose. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.