chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: She has issues such as trouble walking and different things, but she felt better after the first COVID-19 shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "trouble walking" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "She has issues such as trouble walking and different things, but she felt better after the first COVID-19 shot".  Additional information: it was an unusual reaction with the first shot. She has issues such as trouble walking and different things, but she felt better after the first COVID-19 shot and she was not expecting that.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300409564 same reporter/patient, different vaccine dose/event;
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: some cold symptoms of congestion, stuffy nose, sore throat; had some cold symptoms of congestion, stuffy nose; sore throat; Initial information received on 20-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 51-year-old male patient who had some cold symptoms of congestion, stuffy nose, sore throat, had some cold symptoms of congestion, stuffy nose and sore throat after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had events of some cold symptoms of congestion, stuffy nose, sore throat (nasopharyngitis), had some cold symptoms of congestion, stuffy nose (nasal congestion) and sore throat (oropharyngeal pain) (unknown latency) following the administration of influenza vaccine.  It was unknown if any lab data/test results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Not Recovered / Not Resolved for the events.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Opened ipol was exposed to 1.9c upto 55 minutes which was caused by human error with no reported adverse event; opened IPOL has been administered to a patient post excursion with no reported adverse event; Initial information received on 20-Nov-2023 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves an unknown age and patient who was administered with opened Ipv (Vero) [Ipol] was exposed to 1.9c upto 55 minutes which was caused by human, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a (0.5 ml, once) dose of suspect Ipv (Vero) (Suspension for injection, strength: unknown) (lot: W1A101M, Expiry date: not reported) which was exposed to 1.9c upto 55 minutes which was caused by human error, with no reported adverse event (poor quality product administered) (latency: same day) and (product storage error) via unknown route in unknown administration site for immunization.  No lab data reported.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for both 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.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: opened IPOL had an excursion of 46.53°F, 70 minutes (1 hour 10 minutes) due to human error with no reported adverse event; vaccines been administered post-excursion with no reported adverse event; Initial information received on 21-Nov-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a patient (unknown age and gender) to  whom  IPV (VERO) [IPOL] was administered post-excursion and opened ipol had an excursion of 46.53°f, 70 minutes (1 hour 10 minutes) due to human error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the opened IPOL had an excursion of 46.53°f, 70 minutes (1 hour 10 minutes) due to human error with no reported adverse event (product storage error) (unknown latency).  On an unknown date, the patient received unknown dose of suspect IPV (VERO), Suspension for injection (lot number and expiry date  not reported) via unknown route in unknown administration site for .Immunization post-excursion with no reported adverse event (poor quality product administered) (unknown latency).   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: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Computerised tomogram abnormal, Computerised tomogram limb, Culture positive, Debridement, Injection site abscess
Clinical narrative: Developed a large MSSA abscess at the injection site requiring surgical debridement, admission to intensive care for septic shock and IV antibiotics.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Intensive care, Magnetic resonance imaging abnormal, Septic shock, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: Developed a large MSSA abscess at the injection site requiring surgical debridement, admission to intensive care for septic shock and IV antibiotics.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gastrointestinal hypomotility, Laboratory test, Pain in extremity, Paralysis
Clinical narrative: Severe right knee pain, went to Hospital Emergency room, no diagnosis. After two more days, pain and swelling in right leg Left leg loss of sensation, then right leg The loss of sensation and loss of motility skipped dermatomes Creeping paralysis up to my chest.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Sensory loss, Ultrasound scan, X-ray limb
Clinical narrative: Severe right knee pain, went to Hospital Emergency room, no diagnosis. After two more days, pain and swelling in right leg Left leg loss of sensation, then right leg The loss of sensation and loss of motility skipped dermatomes Creeping paralysis up to my chest.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Diplopia, Dizziness, Dyspnoea, Gait disturbance
Clinical narrative: I woke up at 4am after the RSV Vaccines, with a very bad headache, sweating profusely, hard to walk, knee pain, had to crawl on floor, very dizzy, double vision, full body aches, shortness of breath, heart is pounding, hard to hold my head up, it seems like everything is getting much work I've been feeling like this and it really getting worse, my sweat is now falling on my computer and it's getting hard to see, Please please help me, I'm very scared!!!!  What do I do now???
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Hyperhidrosis, Pain, Palpitations, Posture abnormal
Clinical narrative: I woke up at 4am after the RSV Vaccines, with a very bad headache, sweating profusely, hard to walk, knee pain, had to crawl on floor, very dizzy, double vision, full body aches, shortness of breath, heart is pounding, hard to hold my head up, it seems like everything is getting much work I've been feeling like this and it really getting worse, my sweat is now falling on my computer and it's getting hard to see, Please please help me, I'm very scared!!!!  What do I do now???
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Horrible body aches that lasted 5 days  Terrible joint pain initially in fingers, toes, hips, knees and ONGOING in fingers and toes.
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Abdominal distension, Abdominal pain, Cholelithiasis, Cold sweat, Fatigue
Clinical narrative: Cold sweats, fever, headache, abdominal pain, exhaustion and fatigue, immobile for 2 hours, vomiting. itchy skin, inflamed and swollen midsection
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Headache, Helicobacter test positive, Hepatic enzyme increased, Hepatitis A virus test positive, Immobile
Clinical narrative: Cold sweats, fever, headache, abdominal pain, exhaustion and fatigue, immobile for 2 hours, vomiting. itchy skin, inflamed and swollen midsection
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Inflammation, Liver disorder, Pruritus, Pyrexia, Ultrasound liver abnormal
Clinical narrative: Cold sweats, fever, headache, abdominal pain, exhaustion and fatigue, immobile for 2 hours, vomiting. itchy skin, inflamed and swollen midsection
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Vomiting
Clinical narrative: Cold sweats, fever, headache, abdominal pain, exhaustion and fatigue, immobile for 2 hours, vomiting. itchy skin, inflamed and swollen midsection
Age: 67.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, fever, muscle pains, weakness/fatigue
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Pain in shoulder joint. Patient believes she has bursal inflammation
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tennitus
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Dyspnoea, Exercise tolerance decreased, Extrasystoles, Palpitations
Clinical narrative: Three days after injection, I had skipped heart beats, pounding heart, shortness of breath, and an inability to do even moderate exercise. Went to my primary doctor first, and then a cardiologist who gave me a heart monitor to wear for a week. I also had to increase my blood pressure medicine and space it out to better control the episodes. About 4.5 weeks later, it has calmed down somewhat, and I?m hoping for continued improvement.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Therapy change
Clinical narrative: Three days after injection, I had skipped heart beats, pounding heart, shortness of breath, and an inability to do even moderate exercise. Went to my primary doctor first, and then a cardiologist who gave me a heart monitor to wear for a week. I also had to increase my blood pressure medicine and space it out to better control the episodes. About 4.5 weeks later, it has calmed down somewhat, and I?m hoping for continued improvement.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Musculoskeletal stiffness, Nightmare, Pain
Clinical narrative: Headache, Extreme body aches, 102 fever, Fatigue, Nightmares, Neck Stiffness , Increased respiration rate, Increased resting heart rate.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory rate increased
Clinical narrative: Headache, Extreme body aches, 102 fever, Fatigue, Nightmares, Neck Stiffness , Increased respiration rate, Increased resting heart rate.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: PATIENT HAD HIVES SAME NIGHT BY 6 PM ALL OVER HER BOBY( ARM, CHEST, NECK , LEGS .BY 8 PM TOOK A BENADRYL. IT WAS REDNESS ON INJECTION SITE . WENT TO URGENT CARE AND RECEIVED A STEROID SHOT .
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Magnetic resonance imaging abnormal, Pain in extremity, Rotator cuff syndrome
Clinical narrative: INCREASING R SHOULDER AND ARM PAIN, IMPAIRED MOBILITY OF DOMINENET UPPER EXTREMITY-----SENT TO ER FOR INITIAL CHECK UP---HAD MRI AND AND GIVEN STEROIDS AND SHOWED TINDINITIS AND THE RADIOLOGIST RECOMMENDED ANOTHER MRI TO FOCUS ON THR SHOULDER AND ELBOW AREA AND GO FROM THERE----AWAITING APPT FOR F/U AND TO HAVE ANOTHER MRI----
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Impaired work ability, Influenza like illness, Pain, Paraesthesia
Clinical narrative: On 12/2/23 patient called pharmacy to report an adverse event to her shingles vaccination on 11/24/23. The next 2 days after the vaccine she had flu like symptoms, low grade fever, and achiness. On Monday she had to call out of work and noticed tingling all over her body - specifically her feet, hands, and cuticles.  She reported the tingling comes and goes. The next day she noticed her breast had an itchy rash that appeared. On Friday evening she noticed a rash on her back mostly on the right side - but the whole right side. She said it was a little itchy, but very warm to the touch. She took benadryl for the rash and it seems to help it. I suggested she go to urgent care for evaluation.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash pruritic, Skin warm
Clinical narrative: On 12/2/23 patient called pharmacy to report an adverse event to her shingles vaccination on 11/24/23. The next 2 days after the vaccine she had flu like symptoms, low grade fever, and achiness. On Monday she had to call out of work and noticed tingling all over her body - specifically her feet, hands, and cuticles.  She reported the tingling comes and goes. The next day she noticed her breast had an itchy rash that appeared. On Friday evening she noticed a rash on her back mostly on the right side - but the whole right side. She said it was a little itchy, but very warm to the touch. She took benadryl for the rash and it seems to help it. I suggested she go to urgent care for evaluation.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus. Never had tinnitus before, now I have constant ringing in ears.
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient indicates that when receiving the vaccine developed arm pain. But the next day the pain worsened and spread from the shoulder/neck to elbow. Patient did not have redness, rash, or hot area.
Age: 71.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Acoustic stimulation tests, Deafness, Deafness unilateral, Dizziness, Nausea
Clinical narrative: Nausea and dizziness for 3 days, then complete loss of hearing in left ear.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Irritability
Clinical narrative: Fussiness/crying x2-3 days
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: I have a photograph I can send. The day of the shot I had no adverse reactions but awoke with a lot of pain. I hadn?t noticed but a nurse came by last night & pointed out that under the injection site it is a dark red (crimson) color. It begins about 2? below & is approximately 3?-4? wide. It is raised significantly & very hot/feverish.   The pharmacist asked which arm & I had forgotten that I?ve never had a vaccine on the left which was the start of the Stage IV breast cancer, removal of axilla & sentinel nodes. I even mentioned to her that I have pretty severe lymphedema in that arm (it looks about double the size of my right arm). Yet since I?m right handed & in anticipation of possible injection site pain, I opted for the left side.   I?m in the middle of the reaction. For a day I?ve had fever, chills, pain esp in the arm but all over just flu-like symptoms.  I even had a little nausea/vomitting over night. My father says to go to the ER but I read all about how false CT scans are common with this vaccine especially in the event of breast cancer. I had none of this other than the ongoing lymphedema prior to the vaccine. All that I read discussed axilla swelling so my main concern is what is actually swollen side my left axilla was removed.   I?m on the phone with pharmacy & the pharmacist says it?s the SPIKE vax. I don?t see that as a choice but it?s the most current Moderna vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oedema peripheral, Pain, Pain in extremity, Pyrexia
Clinical narrative: I have a photograph I can send. The day of the shot I had no adverse reactions but awoke with a lot of pain. I hadn?t noticed but a nurse came by last night & pointed out that under the injection site it is a dark red (crimson) color. It begins about 2? below & is approximately 3?-4? wide. It is raised significantly & very hot/feverish.   The pharmacist asked which arm & I had forgotten that I?ve never had a vaccine on the left which was the start of the Stage IV breast cancer, removal of axilla & sentinel nodes. I even mentioned to her that I have pretty severe lymphedema in that arm (it looks about double the size of my right arm). Yet since I?m right handed & in anticipation of possible injection site pain, I opted for the left side.   I?m in the middle of the reaction. For a day I?ve had fever, chills, pain esp in the arm but all over just flu-like symptoms.  I even had a little nausea/vomitting over night. My father says to go to the ER but I read all about how false CT scans are common with this vaccine especially in the event of breast cancer. I had none of this other than the ongoing lymphedema prior to the vaccine. All that I read discussed axilla swelling so my main concern is what is actually swollen side my left axilla was removed.   I?m on the phone with pharmacy & the pharmacist says it?s the SPIKE vax. I don?t see that as a choice but it?s the most current Moderna vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I have a photograph I can send. The day of the shot I had no adverse reactions but awoke with a lot of pain. I hadn?t noticed but a nurse came by last night & pointed out that under the injection site it is a dark red (crimson) color. It begins about 2? below & is approximately 3?-4? wide. It is raised significantly & very hot/feverish.   The pharmacist asked which arm & I had forgotten that I?ve never had a vaccine on the left which was the start of the Stage IV breast cancer, removal of axilla & sentinel nodes. I even mentioned to her that I have pretty severe lymphedema in that arm (it looks about double the size of my right arm). Yet since I?m right handed & in anticipation of possible injection site pain, I opted for the left side.   I?m in the middle of the reaction. For a day I?ve had fever, chills, pain esp in the arm but all over just flu-like symptoms.  I even had a little nausea/vomitting over night. My father says to go to the ER but I read all about how false CT scans are common with this vaccine especially in the event of breast cancer. I had none of this other than the ongoing lymphedema prior to the vaccine. All that I read discussed axilla swelling so my main concern is what is actually swollen side my left axilla was removed.   I?m on the phone with pharmacy & the pharmacist says it?s the SPIKE vax. I don?t see that as a choice but it?s the most current Moderna vaccine.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to pharmacy on 12/2/23 to pick up medication and alert pharmacy team of adverse reaction experienced after receiving Arexvy vaccination on 11/25/23. Patient stated that later in the day after receiving the vaccination a red area appeared around the vaccination site approximately 2 inches in diameter. Patient stated problem persisted from 11/25/23 to approximately 11/28/23 with the same red area around the injection site that also swelled and was very painful. Nurse colleague recommended patient report event to pharmacy team for vaccine reporting. VAERs completed 12/2/23 shortly after patient informed team of adverse event.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Culture wound, Skin infection
Clinical narrative: skin infection
Age: 72.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema
Clinical narrative: Arm is Red from where shot given to almost to Elbow on left Arm where given.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received the same vaccine twice. Patient received the first fluzone quad HD on September 16 2023 and received a second dose of the fluzone quad HD on 12/1/23.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Influenza virus test, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Fever, vomiting, parents called 911 and had an ambulance come to the house
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Dyspnoea, Influenza virus test negative, Laboratory test normal, Neck pain
Clinical narrative: Patient stated he developed bothersome shortness of breath within a close time frame of receiving his Arexvy (RSV) vaccine, complaints of neck and shoulder soreness as well, on the opposite side (Left) of vaccination. The patient was instructed to go to urgent care due to his cardiac history by his PCP. Urgent care refused treatment and referred him to the emergency room. He was tested for FLU, RSV, COVID, PNA which all came back negative. He is not sure what caused the shortness of breath but was concerned of potential correlation with his RSV vaccine. He is not able to provide exact timing of when the shortness of breath started versus the administration of the vaccine. Patient is now doing well and was treated in the hospital. Patient was not given any medication in the hospital. He will be following up with an allergist/pulmonologist to further investigate.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Patient stated he developed bothersome shortness of breath within a close time frame of receiving his Arexvy (RSV) vaccine, complaints of neck and shoulder soreness as well, on the opposite side (Left) of vaccination. The patient was instructed to go to urgent care due to his cardiac history by his PCP. Urgent care refused treatment and referred him to the emergency room. He was tested for FLU, RSV, COVID, PNA which all came back negative. He is not sure what caused the shortness of breath but was concerned of potential correlation with his RSV vaccine. He is not able to provide exact timing of when the shortness of breath started versus the administration of the vaccine. Patient is now doing well and was treated in the hospital. Patient was not given any medication in the hospital. He will be following up with an allergist/pulmonologist to further investigate.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Headache, Migraine, Panic attack, Tachyphrenia
Clinical narrative: Severe depression, mind racing, panic attacks, severe headaches and migraines
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: I got my Covid shot (5th one) late morning. By that evening, I started feeling badly?fatigued & chilled. By the time I went to bed, I was shivering and couldn?t get warm. Despite having 5 blankets on me & heater blasting, I had convulsive shivering (contractions) for about 2 hours. I couldn?t sleep & it was exhausting b/c I couldn?t stop them. (If I were elderly with a weak heart, I don?t think I would have lived thru it.). I had 101 fever. I finally fell asleep. I woke up with a fever (100.1) and feeling weak, achy and fatigued. I also had a headache. I felt totally sick. The fever lasted until the next day, but I was still fatigued, achy etc. for 3 more days. I had one good day (5th day after vaccine) and I think I over did it that day because I got fatigued again the next day (couldn?t wake up with alarm, etc). I had to work the next few days, and by 8th day, I started feeling sick again in the late afternoon. Same symptoms?hot/cold, weak, achy, fatigued. I basically slept for that whole evening, the next whole day, and the next day again. I still am not feeling well, and I felt I should report this. I did have bad side affects from previous Covid shots but this was different & much worse.  I also have had Covid twice.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Malaise, Pain, Pyrexia
Clinical narrative: I got my Covid shot (5th one) late morning. By that evening, I started feeling badly?fatigued & chilled. By the time I went to bed, I was shivering and couldn?t get warm. Despite having 5 blankets on me & heater blasting, I had convulsive shivering (contractions) for about 2 hours. I couldn?t sleep & it was exhausting b/c I couldn?t stop them. (If I were elderly with a weak heart, I don?t think I would have lived thru it.). I had 101 fever. I finally fell asleep. I woke up with a fever (100.1) and feeling weak, achy and fatigued. I also had a headache. I felt totally sick. The fever lasted until the next day, but I was still fatigued, achy etc. for 3 more days. I had one good day (5th day after vaccine) and I think I over did it that day because I got fatigued again the next day (couldn?t wake up with alarm, etc). I had to work the next few days, and by 8th day, I started feeling sick again in the late afternoon. Same symptoms?hot/cold, weak, achy, fatigued. I basically slept for that whole evening, the next whole day, and the next day again. I still am not feeling well, and I felt I should report this. I did have bad side affects from previous Covid shots but this was different & much worse.  I also have had Covid twice.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: I got my Covid shot (5th one) late morning. By that evening, I started feeling badly?fatigued & chilled. By the time I went to bed, I was shivering and couldn?t get warm. Despite having 5 blankets on me & heater blasting, I had convulsive shivering (contractions) for about 2 hours. I couldn?t sleep & it was exhausting b/c I couldn?t stop them. (If I were elderly with a weak heart, I don?t think I would have lived thru it.). I had 101 fever. I finally fell asleep. I woke up with a fever (100.1) and feeling weak, achy and fatigued. I also had a headache. I felt totally sick. The fever lasted until the next day, but I was still fatigued, achy etc. for 3 more days. I had one good day (5th day after vaccine) and I think I over did it that day because I got fatigued again the next day (couldn?t wake up with alarm, etc). I had to work the next few days, and by 8th day, I started feeling sick again in the late afternoon. Same symptoms?hot/cold, weak, achy, fatigued. I basically slept for that whole evening, the next whole day, and the next day again. I still am not feeling well, and I felt I should report this. I did have bad side affects from previous Covid shots but this was different & much worse.  I also have had Covid twice.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Incorrect dose administered, Laboratory test, Muscular weakness
Clinical narrative: On October 10 both flu & Covid shots were administered and they both were given again on November 28 all in 2023 . Night time she was vomiting . On The morning of 29 weakness in her leg?s and high blood pressure she was rushed to hospital sent home 12/1/23 .12/2/23 vomit& headache started
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: On October 10 both flu & Covid shots were administered and they both were given again on November 28 all in 2023 . Night time she was vomiting . On The morning of 29 weakness in her leg?s and high blood pressure she was rushed to hospital sent home 12/1/23 .12/2/23 vomit& headache started
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Visual impairment
Clinical narrative: Pt recevied Fluad at 6:47 PM on Dec 1st and reported his left eye vision was impaired the next day morning Dec 2nd.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Patient reports swollen, tender area since receiving vaccination. Patient states sore to extend arm.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Patient complained of itchy L arm at injection site followed by left side face itchiness. RN administered Benadryl 25mg x2 and symptoms resolved. Left via private auto.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Muscle electrostimulation therapy, Myositis, Pain, Pain in extremity
Clinical narrative: Right arm was sore after the vaccination; but after a week it was not improving.  On 11-2-23, she was unable to lift her right arm due to severe pain (no visible swelling seen in arm per patient).  She as unable to cross her arm as well.  She had dull achiness if not moving the right arm.   She went in the see Dr's PA that day (does not know the name).  The PA's assessment was major inflamation of the muscle.  She took ibuprofen orally and Voltaren topically for 4 days straight with about 20% improvement.  After that she said that she put up with the pain, until 11-14-23 when she went to see her chiropractor.  She said that he also concluded that it was inflamation of the arm muscle.  He did e-stim or something like that on 11-14-23, 11-16-23, and 11-20-23.  Patient stated that it was maybe 10% better.  On 11-24-23, she returned to the chiropractor due to no further progress.  He did a deep tissue massage of the upper arm to try to loosen the tension.  That weekend she had severe body acnes and the arm pain.  11-27-23- She returned to Dr and they showed her some physical therapy type arm exercises and stretches.  11-28-23 She started to feel better.  I asked her today and she reported feeling steadily better; but not 100% yet.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Constipation, Cough, Epistaxis, Fatigue, Headache
Clinical narrative: 11/20 mild headache, fatigue.  11/21 sore throat, sneezing, coughing, feverish.  11/22 sore throat worsened, constipated, deep coughing with blood in mucus, blood in nasal discharge, fever - used metho-lyptus for cough and sore throat relief, wrapped up in blankets to break the fever.  11/23 constipated, fever broke, still coughing and sneezing with blood in mucus, started taking DayQuil. 11/24 symptoms less severe.  11/26 Tested Negative for Covid 19.  11/27 - 12/2 symptoms improving.  12/2 still using DayQuil and have less coughing and sneezing with reduced amount of blood in the mucus.  Finally sleeping through the night.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Oropharyngeal pain, Productive cough, Pyrexia, SARS-CoV-2 test negative, Sneezing
Clinical narrative: 11/20 mild headache, fatigue.  11/21 sore throat, sneezing, coughing, feverish.  11/22 sore throat worsened, constipated, deep coughing with blood in mucus, blood in nasal discharge, fever - used metho-lyptus for cough and sore throat relief, wrapped up in blankets to break the fever.  11/23 constipated, fever broke, still coughing and sneezing with blood in mucus, started taking DayQuil. 11/24 symptoms less severe.  11/26 Tested Negative for Covid 19.  11/27 - 12/2 symptoms improving.  12/2 still using DayQuil and have less coughing and sneezing with reduced amount of blood in the mucus.  Finally sleeping through the night.
Age: 11.0
Sex: F
Vaccine: FLU4, HEPAB, IPV, MNQ, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Twinrix given under 18 years of age
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypersomnia
Clinical narrative: EXTREME FATIGUE FOR 24 HOURS; SLEPT ABOUT 24 HOURS CHILLS FOR ABOUT 4 HOURS; SLEPT UNDER ELECTRIC BLANKET AND COMFORTER
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: pt reports intermittent pain at injection site of Spikevax COVID 23-24 SDV  that has been occurring for the past several weeks on a daily to every other day frequency and is relived upon rubbing the injection site. pain showed up >1week after injection. also reports small red rash at injection site that measures 0.5"x1" that is not raised or itchy. pt request no treatment at this time.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: C-reactive protein, Chest pain, Computerised tomogram thorax abnormal, Cough, Dyspnoea
Clinical narrative: I had continual worsening coughing, difficulty breathing and chest pain that I attributed to newly acquired allergies. I did not have allergies before Covid.  Last week I learned they are blood clots. I had abnormal CT scan, high d-dimer 13x normal. I'm taking anticoagulants,  pain meds, steroids and other things. I think Covid boosters are not for me!
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fibrin D dimer increased, Laboratory test, Pulmonary thrombosis, Thrombosis
Clinical narrative: I had continual worsening coughing, difficulty breathing and chest pain that I attributed to newly acquired allergies. I did not have allergies before Covid.  Last week I learned they are blood clots. I had abnormal CT scan, high d-dimer 13x normal. I'm taking anticoagulants,  pain meds, steroids and other things. I think Covid boosters are not for me!
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased
Clinical narrative: After getting the vaccine, patient's blood pressure went up to 150-160 SBP for about 10 days.  It has since gone back down to normal.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Computerised tomogram head normal, Confusional state, Electrocardiogram, Injection site erythema, Injection site pain
Clinical narrative: TIA event, memory confusion for a 4 hour period.  Left arm flushed red in large area way left of the injection site, tender and hot to touch when you pressed it, lasted for 3 days
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Transient ischaemic attack
Clinical narrative: TIA event, memory confusion for a 4 hour period.  Left arm flushed red in large area way left of the injection site, tender and hot to touch when you pressed it, lasted for 3 days
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cutaneous vasculitis, Erythema, Peripheral swelling, Tenderness
Clinical narrative: leukocytoclastic vasculitis of fingers - 4 tender, red, swollen fingers.  Continues to recur since first vaccination and exacerbated with each booster.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Tinnitus following positive test of Covid-10
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion, Tinnitus
Clinical narrative: Tinnitus following positive test of Covid-10
Age: 33.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Condition aggravated, Syncope
Clinical narrative: SYNCOPE: LASTED ROUGHLY 5 MINUTES, LAID PATIENT ON FLOOF WITH COLD WATER. RECOVERED FINE.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Peripheral swelling, Pruritus
Clinical narrative: Severe swelling from left shoulder to left fingertips for 3 days. Also had severe itching through the body both were relieved with benadryl.
Age: 32.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient came to get Pneumonia and Covid vaccinations only.  Patient was given a flu shot as well.  She had already previously received the flu vaccination.  No adverse reactions at the time, just given wrong vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fall
Clinical narrative: Chills and teeth chattering, weakness causing falling
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Injection site rash
Clinical narrative: rash around injection site
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong patient received product
Clinical narrative: Mother and child came in for a vaccine. The child accidentally got the mother's covid shot. The flu shot was administered on the child's other arm.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Night sweats, Oral pain, Pain
Clinical narrative: About 7 hours after vaccine I began to feel ill, feverish, headache.  During the night,  sweats, aching legs and all over body aches.  Sore and red at vaccination site. The next morning, Tuesday, 28th  fever of 100.1 lasting most of the day into the next. Took Advil to relieve headache twice.  Wednesday no fever, still headache,  body aches improved Developed sore on the roof of my mouth, contributing to sinus pain and headache still.  Nov 29th, arm still sore and red.  Roof of mouth very sore, headache still
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sinus pain, Stomatitis, Vaccination site erythema
Clinical narrative: About 7 hours after vaccine I began to feel ill, feverish, headache.  During the night,  sweats, aching legs and all over body aches.  Sore and red at vaccination site. The next morning, Tuesday, 28th  fever of 100.1 lasting most of the day into the next. Took Advil to relieve headache twice.  Wednesday no fever, still headache,  body aches improved Developed sore on the roof of my mouth, contributing to sinus pain and headache still.  Nov 29th, arm still sore and red.  Roof of mouth very sore, headache still
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: About 7 hours after vaccine I began to feel ill, feverish, headache.  During the night,  sweats, aching legs and all over body aches.  Sore and red at vaccination site. The next morning, Tuesday, 28th  fever of 100.1 lasting most of the day into the next. Took Advil to relieve headache twice.  Wednesday no fever, still headache,  body aches improved Developed sore on the roof of my mouth, contributing to sinus pain and headache still.  Nov 29th, arm still sore and red.  Roof of mouth very sore, headache still
Age: 17.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Blood chloride increased, Blood magnesium normal, Blood test abnormal, Dehydration, Fatigue
Clinical narrative: Received the Covid and Flu immunizations the afternoon of 11/30/23.  Went to bed about 9:30 pm.  Woke up at 8 am 12/1/23 and felt sick - sore all over, especially in left arm where received injections.  Stayed home from school and went back to bed.  Woke up at 11 am and went to the bathroom.   Passed out there.  Got up and tried to go back to bed.  Passed out in the hall.  Mom called 911 and the EMTs said  she had low blood pressure and seemed dehydrated.  She had not eaten or had fluid since 9:30 pm the night before.   Went to ER via ambulance.  They gave her 600 cc of fluid.  At hospital for 6 hours, during which time they gave her 2 more liters of fluid.  Doctors don't know why she passed out, but think it is a combination of the immunizations, being a little dehydrated, and a change 1 week ago in the dose of Intuniv from 2 mg to 3 mg.  It can lower blood pressure.  She started feeling better after receiving the fluids and eating.    Today 12/2/23 she is doing much better, but still a little tired.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fluid intake reduced, Hypophagia, Hypotension, Immunisation reaction, Influenza virus test negative
Clinical narrative: Received the Covid and Flu immunizations the afternoon of 11/30/23.  Went to bed about 9:30 pm.  Woke up at 8 am 12/1/23 and felt sick - sore all over, especially in left arm where received injections.  Stayed home from school and went back to bed.  Woke up at 11 am and went to the bathroom.   Passed out there.  Got up and tried to go back to bed.  Passed out in the hall.  Mom called 911 and the EMTs said  she had low blood pressure and seemed dehydrated.  She had not eaten or had fluid since 9:30 pm the night before.   Went to ER via ambulance.  They gave her 600 cc of fluid.  At hospital for 6 hours, during which time they gave her 2 more liters of fluid.  Doctors don't know why she passed out, but think it is a combination of the immunizations, being a little dehydrated, and a change 1 week ago in the dose of Intuniv from 2 mg to 3 mg.  It can lower blood pressure.  She started feeling better after receiving the fluids and eating.    Today 12/2/23 she is doing much better, but still a little tired.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site pain, Loss of consciousness, Loss of personal independence in daily activities, Malaise, Pain
Clinical narrative: Received the Covid and Flu immunizations the afternoon of 11/30/23.  Went to bed about 9:30 pm.  Woke up at 8 am 12/1/23 and felt sick - sore all over, especially in left arm where received injections.  Stayed home from school and went back to bed.  Woke up at 11 am and went to the bathroom.   Passed out there.  Got up and tried to go back to bed.  Passed out in the hall.  Mom called 911 and the EMTs said  she had low blood pressure and seemed dehydrated.  She had not eaten or had fluid since 9:30 pm the night before.   Went to ER via ambulance.  They gave her 600 cc of fluid.  At hospital for 6 hours, during which time they gave her 2 more liters of fluid.  Doctors don't know why she passed out, but think it is a combination of the immunizations, being a little dehydrated, and a change 1 week ago in the dose of Intuniv from 2 mg to 3 mg.  It can lower blood pressure.  She started feeling better after receiving the fluids and eating.    Today 12/2/23 she is doing much better, but still a little tired.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pregnancy test urine negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Viral test negative
Clinical narrative: Received the Covid and Flu immunizations the afternoon of 11/30/23.  Went to bed about 9:30 pm.  Woke up at 8 am 12/1/23 and felt sick - sore all over, especially in left arm where received injections.  Stayed home from school and went back to bed.  Woke up at 11 am and went to the bathroom.   Passed out there.  Got up and tried to go back to bed.  Passed out in the hall.  Mom called 911 and the EMTs said  she had low blood pressure and seemed dehydrated.  She had not eaten or had fluid since 9:30 pm the night before.   Went to ER via ambulance.  They gave her 600 cc of fluid.  At hospital for 6 hours, during which time they gave her 2 more liters of fluid.  Doctors don't know why she passed out, but think it is a combination of the immunizations, being a little dehydrated, and a change 1 week ago in the dose of Intuniv from 2 mg to 3 mg.  It can lower blood pressure.  She started feeling better after receiving the fluids and eating.    Today 12/2/23 she is doing much better, but still a little tired.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient presented to pharmacy requesting a "Flu, RSV, and COVID" shots.  He filled out all the paperwork, and received all the vaccines.  An hour later, the patient's spouse called the pharmacy to report the patient had already received his Flu shot at the free drive-thru clinic sometime in October, and had 'forgotten' that he already received it.  Patient did not have any reported adverse events or symptoms, but he should not have received the vaccine.  The patient denied having already received the shot, and marked 'no' on the question if he had the vaccine before.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Immediate post-injection reaction, Injected limb mobility decreased, Magnetic resonance imaging abnormal
Clinical narrative: I went into Dr. for an annual physical on October 4, 2021 -- when the exam was over, Dr. sent in his medical assistant to administer my annual flu shot. When she administered it in my left shoulder, I had immediate shooting pain in my shoulder, and she said she must have hit a nerve. When I got home from the appointment, I could hardly move my arm, and was in excruciating pain. I called Dr.'s office many times over the following weeks as my pain remained excruciating, and they continued to tell me to take advil and ice it. After a few weeks of that not working, they recommended that I see an orthopedist in their medical pratice, and I went to see Dr. on 10/21/21. He took an xray and gave me an exam, and immediately diagnosed me with SIRVA, gave me a cortisone shot for the pain, and prescribed physical therapy and naproxen. I then went to physical therapy for four months at RPT and took Naproxen regularly until the pain went from a 10 to a 2. I stopped going to PT once the pain lowered to a 2, and it remained at that level until July 2023, when the pain started worsening. It got bad enough that I made an appointment to see Dr.'s associate Dr. (Dr. wasn't available), and he did an xray and an exam on 10/17/23, and recommended more naproxen for the pain and PT. My shoulder wasn't getting any better from PT or Naproxen, so Dr. ordered an MRI, which I just completed on Friday Dec 1, 2023. The report showed:  - Mild infraspinatus tendinosis.  Low-grade articular surface partial-thickness, partial width tear of the subscapularis tendon. - Nondisplaced labral SLAP tear extends into the biceps-labral anchor. Nondisplaced tear at the posterosuperior/posteroinferior labrum. Nondisplaced tear at the anteroinferior labrum. - Obliteration of fat within the rotator interval. Thickening of the glenohumeral joint capsule. Findings may be seen in the clinical setting of adhesive capsulitis. - Mild subacromial/subdeltoid bursitis.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Shoulder injury related to vaccine administration, Tendon disorder, Tendon rupture, X-ray limb abnormal
Clinical narrative: I went into Dr. for an annual physical on October 4, 2021 -- when the exam was over, Dr. sent in his medical assistant to administer my annual flu shot. When she administered it in my left shoulder, I had immediate shooting pain in my shoulder, and she said she must have hit a nerve. When I got home from the appointment, I could hardly move my arm, and was in excruciating pain. I called Dr.'s office many times over the following weeks as my pain remained excruciating, and they continued to tell me to take advil and ice it. After a few weeks of that not working, they recommended that I see an orthopedist in their medical pratice, and I went to see Dr. on 10/21/21. He took an xray and gave me an exam, and immediately diagnosed me with SIRVA, gave me a cortisone shot for the pain, and prescribed physical therapy and naproxen. I then went to physical therapy for four months at RPT and took Naproxen regularly until the pain went from a 10 to a 2. I stopped going to PT once the pain lowered to a 2, and it remained at that level until July 2023, when the pain started worsening. It got bad enough that I made an appointment to see Dr.'s associate Dr. (Dr. wasn't available), and he did an xray and an exam on 10/17/23, and recommended more naproxen for the pain and PT. My shoulder wasn't getting any better from PT or Naproxen, so Dr. ordered an MRI, which I just completed on Friday Dec 1, 2023. The report showed:  - Mild infraspinatus tendinosis.  Low-grade articular surface partial-thickness, partial width tear of the subscapularis tendon. - Nondisplaced labral SLAP tear extends into the biceps-labral anchor. Nondisplaced tear at the posterosuperior/posteroinferior labrum. Nondisplaced tear at the anteroinferior labrum. - Obliteration of fat within the rotator interval. Thickening of the glenohumeral joint capsule. Findings may be seen in the clinical setting of adhesive capsulitis. - Mild subacromial/subdeltoid bursitis.