chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: PPV, RAB
Symptoms: Syncope, Ultrasound scan abnormal, Urticaria
Clinical narrative: Day 1 (11/25) - noticed a golf ball sized welt in my left SQ space with redness surrounding the injection site, swelling in my dorsal left arm near my armpit, heat in the injection area, and notable pain upon palpation  Day 2 (11/26) - noticed the welt slowly getting larger but opted to wait and ice/use ibuprofen to manage the symptoms after researching common reactions from Pneumovax 23  Day 3 (11/27) - woke up in the morning with tennis ball sized swelling and the same symptoms as before except the redness had spread and become deeper, chose to call a triage line and was told to mark the redness with a sharpie, continue supportive care, and be seen in the ER if the redness spreads at all or if the swelling does not go down by tomorrow; ended up going to the ER later that night (10 PM) due to increased heat and swelling and severe pain upon just touching the area but the ER doctor said it was a normal reaction at this point and sent me home with supportive care and instructions to return if it did not spontaneously resolve in 1 week or 3-4 days after the vaccination (the discharge instructions stated both, so not sure which was correct)  Day 6 (11/30) - swelling had continued to progress along with redness and never resolved, ice/ibuprofen/heat/Tylenol were not effective in managing swelling or pain, at this point the swelling was as hard as a rock and the size of a softball, redness had spread about halfway to the elbow, heat was still present, pain was unbearable and increased drastically upon palpation to the point that if the site was pushed or bumped hard enough the entire arm would go numb and I would collapse; chose to go to a different ER at this point in which I was immediately rushed to ultrasound for imaging which revealed severe edema ribboned throughout the swelling continuing all the way down the arm, I was sent home on oral antibiotics for now and given strict instructions to monitor for any symptoms of systemic infection or spreading as well as to return if anything should change, also told to follow up with a primary care provider tomorrow for further diagnostics and follow up treatments, began first dose of antibiotics around 7 PM this night   Day 7 (12/1) - woke up and took 2nd dose of antibiotics, would has still progressed and is a similar size, the skin around the wound is painful to the touch and tight feeling like it is pinched, there is significant bruising all the way down to my elbow and the redness is beginning to ribbon down to my elbow as well, I am going into the doctor this afternoon again for follow up
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Symptoms: numbness and tingling of left arm/fingers Treatment: Prednisone pack and ibuprofen 600mg q8hours PRN
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient experiencing rash at injection site as well as itching and some swelling. Site is red.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Severe headache Nausea Chills Extreme muscle aches Tiredness
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Electrocardiogram, Eye movement disorder, Hypotonia, Pallor
Clinical narrative: Patient present in the clinic today to receive 12 yr. vaccines of Tdap and MCV4. Paperwork filled out and completed by mother and patient and mother explained the procedure. Patient noted to be calm and relaxed and showed no signs of being afraid of shots. First Tdap was administered IM into the left deltoid, approximately one min later MCV4 was administered into right deltoid IM. Nurse turned her back to get band aid to apply to site when patient began to go limp and shake with eyes rolled in the back of his head. Nurse grabbed patient's head and guided him to the floor. Patient seemed to have what looked like a seizure for approx. 30 sec before being able to speak. instructed to call 911. Patient reported "I need to throw up". Nurse helped patient to a sitting position and given a waste basket where he spit up. Patient rested his head against the wall where it seemed he was going out again. Nurse grabbed defibrillator from hall, and Benadryl and epi pen in case any was needed. Patient skin became cold and clammy, skin color pale. Patient kept saying "I do not want to die". Mother began praying for child until EMS arrived. No defibrillator or emergency medications was used. EMS present and performed vital signs and EKG. Patient was taken to local ER approx. 2 miles away via mother's private car, per mother's request
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Seizure, Vomiting
Clinical narrative: Patient present in the clinic today to receive 12 yr. vaccines of Tdap and MCV4. Paperwork filled out and completed by mother and patient and mother explained the procedure. Patient noted to be calm and relaxed and showed no signs of being afraid of shots. First Tdap was administered IM into the left deltoid, approximately one min later MCV4 was administered into right deltoid IM. Nurse turned her back to get band aid to apply to site when patient began to go limp and shake with eyes rolled in the back of his head. Nurse grabbed patient's head and guided him to the floor. Patient seemed to have what looked like a seizure for approx. 30 sec before being able to speak. instructed to call 911. Patient reported "I need to throw up". Nurse helped patient to a sitting position and given a waste basket where he spit up. Patient rested his head against the wall where it seemed he was going out again. Nurse grabbed defibrillator from hall, and Benadryl and epi pen in case any was needed. Patient skin became cold and clammy, skin color pale. Patient kept saying "I do not want to die". Mother began praying for child until EMS arrived. No defibrillator or emergency medications was used. EMS present and performed vital signs and EKG. Patient was taken to local ER approx. 2 miles away via mother's private car, per mother's request
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Photophobia
Clinical narrative: Received flu clinic on 10/15/2020. On 10/16/2020 patient developed headache. Persisted for another 12 days before patient contacted office to notify. No temperature, no congestion. Headache located "middle of head, from one ear to another". Eyes are light sensitive. Headache worse some days than others.  Patient currently taking: metformin, Montelukast, famotidine, meloxicam, primrose oil, black coshosh, Zyrtec, acetaminophen, spironolactone, nifedipine ER.   Provider sent in prednisone burst and taper. Symptoms resolved after treatment.
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Administered the flu shot 1 week prior. Started to experience ringing in both ears within 24 hours after. Feels like ears are 'stuffed up'. Pt complains of slight blurred vision.  Cataract surgery about a month prior to flu shot. After surgery, still experienced the blurry vision. Lasted 'longer then it should'.  Patient is very healthy male, only takes the flu shot.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Myalgia
Clinical narrative: Patient has an muscle pain and weakness for about 4 weeks following the flu vaccine. Patient has seen a doctor for the pain and received pain medication that has partially resolved the issue
Age: 0.33
Sex: F
Vaccine: DTAPIPV, PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Infant has received Kinrix, patient is 4 months. No current adverse effect/outcome/treatment.
Age: 86.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Pain in extremity, Skin discolouration, Tenderness
Clinical narrative: Pain in left arm. Arm turned blacked. Sore to touch.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Shivering, fever for x 2 days. Treated with over the counter acetaminophen 4x daily
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Cold sweat, Computerised tomogram abdomen, Computerised tomogram pelvis
Clinical narrative: Sleepy, continuous strong lower abdominal cramps, loose bowel movements with abdominal pain, cold sweat nausea, dizzy, symptoms of blacking out,  blacked out - loss of consciousness, slow speech - hard to speak, shakiness and weakness, hard to walk, slow heart rate at Emergency Room between 37-47 bpm. IV, benadryl and prednisone, sodium choloride and Iopamidol treatments provided during Emergency Care.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Differential white blood cell count, Dizziness, Electrocardiogram, Full blood count
Clinical narrative: Sleepy, continuous strong lower abdominal cramps, loose bowel movements with abdominal pain, cold sweat nausea, dizzy, symptoms of blacking out,  blacked out - loss of consciousness, slow speech - hard to speak, shakiness and weakness, hard to walk, slow heart rate at Emergency Room between 37-47 bpm. IV, benadryl and prednisone, sodium choloride and Iopamidol treatments provided during Emergency Care.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Heart rate decreased, Liver function test, Loss of consciousness, Metabolic function test
Clinical narrative: Sleepy, continuous strong lower abdominal cramps, loose bowel movements with abdominal pain, cold sweat nausea, dizzy, symptoms of blacking out,  blacked out - loss of consciousness, slow speech - hard to speak, shakiness and weakness, hard to walk, slow heart rate at Emergency Room between 37-47 bpm. IV, benadryl and prednisone, sodium choloride and Iopamidol treatments provided during Emergency Care.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Slow speech, Somnolence, Tremor, Urine analysis
Clinical narrative: Sleepy, continuous strong lower abdominal cramps, loose bowel movements with abdominal pain, cold sweat nausea, dizzy, symptoms of blacking out,  blacked out - loss of consciousness, slow speech - hard to speak, shakiness and weakness, hard to walk, slow heart rate at Emergency Room between 37-47 bpm. IV, benadryl and prednisone, sodium choloride and Iopamidol treatments provided during Emergency Care.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Hives. No vomiting, respiratory distress, or other signs/symptoms of anaphylaxis
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: There is no additional AE or PQC associated with this case; given MMR-II intramuscularly vs. subcutaneously; Expired vaccine administered (Expiration date 31-MAR-2018); This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 05-NOV-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) intramuscularly, once, for prophylaxis (lot # S039309 was verified to be valid, expiration date reported as 04-DEC-2021, but upon internal validation established as 31-MAR-2018), (strength and dose were not provided).  The patient did not experience any additional adverse reactions. The reporter wanted to know if there was any safety data that they need to know about the intramuscular versus subcutaneous vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II).
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Mobility decreased, Nausea, Pain
Clinical narrative: limited mobility; body aches; pain at injection site; nausea headaches; headaches; This spontaneous report was received from a female patient of unknown age who was reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 08-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) singe dose vial (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis.   On the same date, she had serious pain at injection site, body aches, nausea headaches, and limited mobility. She did not see a physician in reference to the events. No treatment was given. The outcome of the events was not provided.   The causality assessment between the events and therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Feeling abnormal, Influenza like illness, Pain in extremity
Clinical narrative: major arm pain; feels awful; flu-like symptoms; This spontaneous report was received from a consumer and refers to a 25-year-old female patient. The patient concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were ot provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23), intramuscularly, (dose, strength, lot # and expiration date were not provided) as a prophylaxis. On the same day the patient was vaccinated with unspecified influenza virus vaccine intramuscularly (dose, strength, lot # and expiration date were not provided) as a prophylaxis. The patient had" major arm pain in the arm in which pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) injection was given (although which arm cannot be determined at this time). The patient felt awful, had flu-like symptoms since about 2 days then. The outcome of the events was reported as recovering.  The causal relationship between the adverse events and the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No patients reported any additional adverse experiences as a result of receiving the improperly stored vaccine; Since the receipt of the late shipment, the vaccine has been administered to 6 patients; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T014309, expiration date on 24-APR-2022, 0.5 milliliter (administration route and anatomical location were not reporter) for prophylaxis. The reporter stated when she first received the vaccines, she for some reason thought the current date of receipt was actually 27-OCT-2020 and not 29-OCT-2020 and that the product was received on time. She immediately placed the product into the freezer. Since then, the reporter stated that she let them know what happened and that the product was actually received 2 days late. Since the receipt of the late shipment, the vaccines has been administered to a 6 patients. No patients reported any additional adverse experiences as a result of receiving the improperly stored vaccine. The reporter stated that when she opened the package, the information and logger inside the package stated the product was "ok" but she does not have any of that paperwork at this time as when it was found "ok". This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2011USA013293: US-009507513-2011USA013200: US-009507513-2011USA013620: US-009507513-2011USA013163: US-009507513-2011USA013851:
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Feeling sick; Information received from a case in litigation (case# 2003USA009785) regarding with a male concerning a patient of unknown age. In 2018, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown)  for prophylaxis (dose, route of administration, lot number and expiration date were not reported). It was reported that the patient was really sick for 24 hours. The outcome was recovered on unspecified date in 2018. The causal relationship between the event and therapy with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown)  were not reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA009785:
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sicker; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sicker (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sicker (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that Pump up the vitamin C and fluids.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: fever of 104.5; Based on information received on 20-Nov-2020, the report previously considered as non-valid became valid: [suspect product corrected from SANOFI PRODUCT NOS to INFLUENZA VACCINE].  Initial information was received on 11-Nov-2020 regarding an unsolicited non-valid serious social media  case from a consumer/non-healthcare professional.  This case involves a patient (with demographics unknown) who had fever of 104.5 (pyrexia), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed fever of 104.5 (pyrexia) (unit not reported)(unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for 10 days.   No other relevant test was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  The information on lot number was requested for this case.  Follow up information was received on 20-Nov-2020 regarding an unsolicited valid serious social media.  Case upgraded to valid from non-valid. Suspect product corrected from SANOFI PRODUCT NOS to INFLUENZA VACCINE.; Sender's Comments: Follow up information reported on 20-Nov-2020: This case concerns a patient (with unknown demographics) who had pyrexia after vaccination with INFLUENZA VACCINE. The time to onset was unknown. However, patient's medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, IPV, VARCEL
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via the agency (Reference number-00363512) and transmitted to Sanofi on 18-Nov-2020.  This case involves a 12 year-old male patient who received 0.5 mL expired dose of POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) (lot P1E70, expiry date- 09-Nov-2020) via an unknown route in an unknown administration site for prophylactic vaccination, on 17-Nov-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided.  concomitant medications included varicella vaccine, hepatitis A vaccine and hepatitis B vaccine.  This was an actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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: 18.0
Sex: M
Vaccine: FLUX, HEP, HEPA, IPV, VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient was admnistered with an expired dose of Ipol with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via The Agency (Reference number- 00363528) and transmitted to Sanofi on 18-Nov-2020.  This case involves an 18 year old male patient who received an expired dose of POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) once (batch no: P1E70 and expiry date: 09-Nov -2020) via an unknown route in right upper arm for prophylactic vaccination, on 17-Nov-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLU), HEPATITIS A VACCINE, HEPATITIS B VACCINE and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  This was an actual medication error case due to expired vaccine used (latency same day).  The reporter asked for guidance on how to proceed and if patient needed revaccination. The reporter informed that product was not been used and there was no product technical complaint.  At the time of reporting, no adverse event was reported.  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 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: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Mobility decreased, Sleep disorder
Clinical narrative: Representative from a Pharmacy came to my place of work to do the Flu clinic. I was the first one that day that the representative injected. The representative never "Landmarked" my arm for proper injection site and I truly believe he went to high.. When he began to administer the flu shot I felt immediate pain as he injected. The pain was nothing like I ever felt with ANY injection. I figured it would be the "usual" 2-3 day sore arm but it never got better but instead got worse. I am not sleeping well at night, trouble lifting , pain in upper arm and shoulder. Seen by Dr. on November 24th 2020 and she gave me tapering steroids. Steroids are done and pain persist.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: We gave this young man a flu shot in our office and he had already recieved one elsewhere this season from a pharmacy. There was no adverse reaction .
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu flu vaccine was not administered correctly. The dose was not injected into the muscle of the arm as recommended.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Epilepsy, Seizure
Clinical narrative: Patient had HPV vaccination on 6/4/2014 had a seizure in the doctor's office. She has been hospitalized 4th times since stated by mother and has exp 9 seizures. The reporter provided the name of all tx'g facilities 1st Hospital, 2nd&3rd Hospital, 4th Hospital. Just recently in 2020 she was hospitalized in April and in October. Since being hospitalized patient has been diagnosed with epilepsy. She is currently seeing Dr. (Neurology).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Patient states she" was in bed 72 hours with Fever of 100:5, chills, shaking, extreme body aches headache and nausea. Her left arm literally felt broken and I could not move without severe pain for 3 days but today I can move a few inches. The same thing happened with my first shot."
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Patient states she" was in bed 72 hours with Fever of 100:5, chills, shaking, extreme body aches headache and nausea. Her left arm literally felt broken and I could not move without severe pain for 3 days but today I can move a few inches. The same thing happened with my first shot."
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chills, Diarrhoea
Clinical narrative: Patient awakened at 4am on Monday 11/23/2020 with major reaction; severe hiccups, intense body shivers, severe lower right back pain, muscle and joint pain, leg pain, stomach pain with loose stools, headache, fever at 0415am was 99.3. At 4:30 temp was 100.2. At 5am temp was 101.5. Vomiting event, temp dropped to 99.9, relief of most symptoms. At 5:15 temp went up to 100.3 and the body chills started again. At 5:25, 100.2 temp. 6 am 101.0 temp and same at 6:15am. At 8am 100.3 temp, upon waking. At 0815 100.4, 10:33 am 99.6 temp. Patient still feeling feverish, drove to clinic. No temp at clinic @ 1300. Symptoms had subsided, feeling of exhaustion. Testing done; 4th COVID test, flu test, PSA checked, labs. All lab work 'within  All lab work 'within normal range'. Patient feeling better but upon 11/30/2020 started to have fever at 99. On 12/1/2020 temp was within normal range.  Flu shot done on 09/10/2020 lot #UJ461AA - High dose quad. Administered at same pharmacy, unknown which arm.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Hiccups, Influenza virus test, Laboratory test
Clinical narrative: Patient awakened at 4am on Monday 11/23/2020 with major reaction; severe hiccups, intense body shivers, severe lower right back pain, muscle and joint pain, leg pain, stomach pain with loose stools, headache, fever at 0415am was 99.3. At 4:30 temp was 100.2. At 5am temp was 101.5. Vomiting event, temp dropped to 99.9, relief of most symptoms. At 5:15 temp went up to 100.3 and the body chills started again. At 5:25, 100.2 temp. 6 am 101.0 temp and same at 6:15am. At 8am 100.3 temp, upon waking. At 0815 100.4, 10:33 am 99.6 temp. Patient still feeling feverish, drove to clinic. No temp at clinic @ 1300. Symptoms had subsided, feeling of exhaustion. Testing done; 4th COVID test, flu test, PSA checked, labs. All lab work 'within  All lab work 'within normal range'. Patient feeling better but upon 11/30/2020 started to have fever at 99. On 12/1/2020 temp was within normal range.  Flu shot done on 09/10/2020 lot #UJ461AA - High dose quad. Administered at same pharmacy, unknown which arm.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity, Prostatic specific antigen, Pyrexia, SARS-CoV-2 test
Clinical narrative: Patient awakened at 4am on Monday 11/23/2020 with major reaction; severe hiccups, intense body shivers, severe lower right back pain, muscle and joint pain, leg pain, stomach pain with loose stools, headache, fever at 0415am was 99.3. At 4:30 temp was 100.2. At 5am temp was 101.5. Vomiting event, temp dropped to 99.9, relief of most symptoms. At 5:15 temp went up to 100.3 and the body chills started again. At 5:25, 100.2 temp. 6 am 101.0 temp and same at 6:15am. At 8am 100.3 temp, upon waking. At 0815 100.4, 10:33 am 99.6 temp. Patient still feeling feverish, drove to clinic. No temp at clinic @ 1300. Symptoms had subsided, feeling of exhaustion. Testing done; 4th COVID test, flu test, PSA checked, labs. All lab work 'within  All lab work 'within normal range'. Patient feeling better but upon 11/30/2020 started to have fever at 99. On 12/1/2020 temp was within normal range.  Flu shot done on 09/10/2020 lot #UJ461AA - High dose quad. Administered at same pharmacy, unknown which arm.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Patient awakened at 4am on Monday 11/23/2020 with major reaction; severe hiccups, intense body shivers, severe lower right back pain, muscle and joint pain, leg pain, stomach pain with loose stools, headache, fever at 0415am was 99.3. At 4:30 temp was 100.2. At 5am temp was 101.5. Vomiting event, temp dropped to 99.9, relief of most symptoms. At 5:15 temp went up to 100.3 and the body chills started again. At 5:25, 100.2 temp. 6 am 101.0 temp and same at 6:15am. At 8am 100.3 temp, upon waking. At 0815 100.4, 10:33 am 99.6 temp. Patient still feeling feverish, drove to clinic. No temp at clinic @ 1300. Symptoms had subsided, feeling of exhaustion. Testing done; 4th COVID test, flu test, PSA checked, labs. All lab work 'within  All lab work 'within normal range'. Patient feeling better but upon 11/30/2020 started to have fever at 99. On 12/1/2020 temp was within normal range.  Flu shot done on 09/10/2020 lot #UJ461AA - High dose quad. Administered at same pharmacy, unknown which arm.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu flu vaccine was not administered correctly. The dose was not injected into the muscle of the arm as recommended.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Infection, Peripheral swelling
Clinical narrative: Patient had no immediate reaction, she said her symptoms started in the evening. Her upper arm felt swollen and hard all the way down to her elbow. She went to the dr who thinks its an infection so she was prescribed Keflex 500mg 1 capsule tid for 10 days. I did see her arm dec 1 at 1pm and it was red and swollen - but clearly not at the injection site but lowed and moving towards her elbow.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient attended a drive-thru flu clinic hosted by the Health Center and was mistakenly given Flublock, which is licensed for 18 and older. Patient turns 18 on 12/9/2020. Attempt was made to contact patient's mother of the error. Message was left on voice mail to call the Health Clinic. Patient tolerated vaccination well at the site of the clinic. To date, no known symptoms or adverse reactions occurred as  the Mom did not return the call.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: patient reports intermittent burning sensation in muscle of injection, started today - 10 days post vaccine
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient received vaccination 11/25. On 11/28, localized reaction with swelling, warmth, soreness at site. Swollen and sore supraclavicular lymph node on left side. Localized reaction at injection site resolved. Lymph node remains swollen.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Abulia, Arthralgia, Cardiac stress test, Dyspnoea, Feeling cold
Clinical narrative: The following is what I sent to doctor: I sent the following to cardiology Sunday night and received an answered Monday night. I have yet to receive any communications whatsoever namely an appt for this covid test.  I woke up Friday morning with my left shoulder which had arthroscopy in June was hurting excruciatingly. I thought maybe it was slept on it wrong. Now not so sure. The pain lasted all day and I had taken prescribed doses of Tramdol(50mg). About 6:45 Saturday morning I was writhing in pain i never felt this bad before. I was waffling back and forth sweating profusely and freezingly cold. My heart was pounding so very fast and rapid crazy beats. Not only my shoulder in pain but now the tips of my fingers became numb. Believe me i was wishing it would end and I would just maybe die. Labored breathing also mixed with a whole lot of Panic. I took a metropolol ASAP and put a nitro under my tongue. It took just a minute to subside. Pain was gone and no numbness but I was freezing. Took about 20 minutes and 3 blankets before feeling warm again and ok. Fell back to sleep and felt groggy but OK about a hour and a half later. Did not want to call emergency, thinking this is just a passing episode and on the weekends the Doctors are steretypically on the golf course. Will not hesitate calling 911 if this happens again before seeing you hopefully first of Nov 16 week. I just took my BP (10:00 pm Saturday) and was 111/50 with a rather high pulse of 74.   Your symptoms do not fit well with heart symptoms. Pain which lasts all day would not be heart attack pain. Fever and chills suggest infection, not heart disease. Your response to medications also does not fit with heart symptoms. Metoprolol would not even have been absorbed in your stomach within 1 minute. Nitroglycerin generally does not work within 1 minute either. We must exclude infection, particularly COVID. I have ordered COVID testing. You will be called to schedule this within the next 1-2 days. Follow up as planned, but GO TO THE ER IMMEDIATELY if this recurs.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Heart rate increased, Hyperhidrosis, Hypoaesthesia, Palpitations, Panic reaction
Clinical narrative: The following is what I sent to doctor: I sent the following to cardiology Sunday night and received an answered Monday night. I have yet to receive any communications whatsoever namely an appt for this covid test.  I woke up Friday morning with my left shoulder which had arthroscopy in June was hurting excruciatingly. I thought maybe it was slept on it wrong. Now not so sure. The pain lasted all day and I had taken prescribed doses of Tramdol(50mg). About 6:45 Saturday morning I was writhing in pain i never felt this bad before. I was waffling back and forth sweating profusely and freezingly cold. My heart was pounding so very fast and rapid crazy beats. Not only my shoulder in pain but now the tips of my fingers became numb. Believe me i was wishing it would end and I would just maybe die. Labored breathing also mixed with a whole lot of Panic. I took a metropolol ASAP and put a nitro under my tongue. It took just a minute to subside. Pain was gone and no numbness but I was freezing. Took about 20 minutes and 3 blankets before feeling warm again and ok. Fell back to sleep and felt groggy but OK about a hour and a half later. Did not want to call emergency, thinking this is just a passing episode and on the weekends the Doctors are steretypically on the golf course. Will not hesitate calling 911 if this happens again before seeing you hopefully first of Nov 16 week. I just took my BP (10:00 pm Saturday) and was 111/50 with a rather high pulse of 74.   Your symptoms do not fit well with heart symptoms. Pain which lasts all day would not be heart attack pain. Fever and chills suggest infection, not heart disease. Your response to medications also does not fit with heart symptoms. Metoprolol would not even have been absorbed in your stomach within 1 minute. Nitroglycerin generally does not work within 1 minute either. We must exclude infection, particularly COVID. I have ordered COVID testing. You will be called to schedule this within the next 1-2 days. Follow up as planned, but GO TO THE ER IMMEDIATELY if this recurs.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: SARS-CoV-2 test negative, Somnolence
Clinical narrative: The following is what I sent to doctor: I sent the following to cardiology Sunday night and received an answered Monday night. I have yet to receive any communications whatsoever namely an appt for this covid test.  I woke up Friday morning with my left shoulder which had arthroscopy in June was hurting excruciatingly. I thought maybe it was slept on it wrong. Now not so sure. The pain lasted all day and I had taken prescribed doses of Tramdol(50mg). About 6:45 Saturday morning I was writhing in pain i never felt this bad before. I was waffling back and forth sweating profusely and freezingly cold. My heart was pounding so very fast and rapid crazy beats. Not only my shoulder in pain but now the tips of my fingers became numb. Believe me i was wishing it would end and I would just maybe die. Labored breathing also mixed with a whole lot of Panic. I took a metropolol ASAP and put a nitro under my tongue. It took just a minute to subside. Pain was gone and no numbness but I was freezing. Took about 20 minutes and 3 blankets before feeling warm again and ok. Fell back to sleep and felt groggy but OK about a hour and a half later. Did not want to call emergency, thinking this is just a passing episode and on the weekends the Doctors are steretypically on the golf course. Will not hesitate calling 911 if this happens again before seeing you hopefully first of Nov 16 week. I just took my BP (10:00 pm Saturday) and was 111/50 with a rather high pulse of 74.   Your symptoms do not fit well with heart symptoms. Pain which lasts all day would not be heart attack pain. Fever and chills suggest infection, not heart disease. Your response to medications also does not fit with heart symptoms. Metoprolol would not even have been absorbed in your stomach within 1 minute. Nitroglycerin generally does not work within 1 minute either. We must exclude infection, particularly COVID. I have ordered COVID testing. You will be called to schedule this within the next 1-2 days. Follow up as planned, but GO TO THE ER IMMEDIATELY if this recurs.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: rash antihistamine 2-3 days
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a patient of unknown age and gender.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a medical office (dosage regimen, route of administration, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for the following injuries resulting from Plaintiffs ZOSTAVAX use: shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient claimed had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event of shingles was considered as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Head titubation, Neurological symptom
Clinical narrative: neurological issues; uncontrollable shaking of her head; autoimmune disease; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 28-NOV-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered neurological issues, uncontrollable shaking of her head and autoimmune disease. As a result of these symptoms, the patient was seen and treated by health care professional. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations that were not present prior to using zoster vaccine live (ZOSTAVAX), the patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Furthermore, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered as not recovered. Causality assessment was reported as related. At the reporting time, the patient was still under health professional care.  Upon internal review, the event of autoimmune disease was determined to be medically significant.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who got flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: still had a severely sore arm; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involved a 47 year old female patient who still had a severely sore arm (Pain in extremity), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On 12-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number UT7073NA and unknown expiration date) via intramuscular route at the left deltoid.  On an unknown date, the patient still had a severely sore arm (Pain in extremity), unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was not resolved at the time of reporting.
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: fatigue; Fever; Chills; Malaise; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involved a 72 year old male patient who experienced fatigue, fever (Pyrexia), chills and malaise, while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23).  On 28-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number- UJ470AB and unknown expiration date) via unknown route at unknown administration site.  On an unknown date, the patient experienced fatigue, fever (Pyrexia), chills and malaise, unknown latency following administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  No relevant laboratory data was reporting.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for fatigue all the events at the time of reporting.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports morning of vaccination that left arm was sore and all red and shiny and swollen, hard.  Patient reports it as one large area. It was raised and sore for over 2 days and by the 3rd day was able to raise arm up and not as sore.  Patient also reports fever for 2 days.  Patient took Tylenol and ibuprofen regularly for 2 days to help with pain and fever.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reports morning of vaccination that left arm was sore and all red and shiny and swollen, hard.  Patient reports it as one large area. It was raised and sore for over 2 days and by the 3rd day was able to raise arm up and not as sore.  Patient also reports fever for 2 days.  Patient took Tylenol and ibuprofen regularly for 2 days to help with pain and fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Confusional state, Dyskinesia, Eye movement disorder, Loss of consciousness, Urinary incontinence
Clinical narrative: Patients mother stated the child's eyes rolled back, the patient lost consciousness, started "jerking", and had urinary incontinence. Pt woke up after about 30 seconds confused. Mother brought patient back into the clinic where the patient was evaluated, and then transferred to the ER for evaluation.
Age: 97.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Broke out in rash, itching, bumps all over body. Patient lives at a nursing home
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Redness and swelling at injection site for 3 days. Fever, chills, muscle aches.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Abnormal behaviour, Diet refusal, Fatigue, Skin warm, Sleep disorder
Clinical narrative: Felt warm, clingy, out of character, would not eat, laid on floor in hallway. Would not sleep, stayed up until 3 am in the morning. Tiredness for the next few days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Pyrexia
Clinical narrative: Patient said that it feels hot at the left side of her neck. She noted that after the injection she felt fatigued and had to head home and lay down. Told her that usually feel fatigue after the vaccine.  She described whenever she yawns she cannot control it. Currently has a fever the next morning 100.4F.  Told her to have primary care provider to look at it.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Woke up next morning with low grade fever 100.3, and congestion which lasted a little over 12hrs. Then had mild cough which lasted 24hrs.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Myalgia
Clinical narrative: muscle aches,  swelling in right arm Headache slightly elevated temperature weakness shivering
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: muscle aches,  swelling in right arm Headache slightly elevated temperature weakness shivering