chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Large, red, warm, itchy rash at vaccination site on left arm appeared on about 2/12/21.  Contacted PCP, she suggested I see an allergist to be safe, met with Dr. on 2/18/21, he prescribed a cortisone cream to use immediateley.  He also prescribed prednisone to use after second vaccine if reaction was worse, and an epinephrine auto-injector in case of severe reaction.  He also suggested switching arms.  Redness and itch have finally faded to almost nothing as of 2/22/21.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Days 15 persistent 2" red circle at injection site
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: tennis ball size hard lump with itching at injection site, sore and hot to the touch 7 days after 1st vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Day 8 itching at injection site Day 9 red raised warm tender lump at injection site resolved over 48 hours
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching shot site
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: ?Moderna COVID-19 Vaccine EUA?  Rash, itching and warmth at and around the injection sight.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: nausa, aches, headache, tired
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Low grade fever which reached 99.8 degrees joint ache
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Headache, Injection site pain
Clinical narrative: Mild headache, lasted only 2 hours.  Injected arm was sore starting 3 hours after injection until the next day at 5pm.  (pain comparison, felt bruised)
Age: 0.08
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, fever, chills, body aches 48 hours
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: 25 minutes after the vaccine was given I noticed hives on my arms and chest and my throat was tight. I went to urgent care, they administered iv Benadryl and pepcid. this did not stop the reaction, so they gave me an EpiPen IM and sent me to the hospital by ambulance. At the hospital, I was given Solu-Medrol IV, observed for about 4 hours, and sent home with prescriptions for 10 days of pepcid and Claritin and 4 days of prednisone. The allergic symptoms have not come back as of this reporting.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Antithrombin III, Back pain, Blood immunoglobulin G normal, Blood immunoglobulin M
Clinical narrative: Soreness in the back started on 2/5/2021 and eventually moved to the abdominal area on 2/12/2021.  Went to the doctor and got a CT scan and found an Acute right common iliac vein and infrarenal IVC thrombus.  Many blood tests were run and no common factors were located to cause the thrombus.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin M normal, Blood test normal, C-reactive protein normal, Computerised tomogram abdomen, Computerised tomogram pancreas normal
Clinical narrative: Soreness in the back started on 2/5/2021 and eventually moved to the abdominal area on 2/12/2021.  Went to the doctor and got a CT scan and found an Acute right common iliac vein and infrarenal IVC thrombus.  Many blood tests were run and no common factors were located to cause the thrombus.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count normal, Hepatic cyst, Hepatic lesion, May-Thurner syndrome, Metabolic function test
Clinical narrative: Soreness in the back started on 2/5/2021 and eventually moved to the abdominal area on 2/12/2021.  Went to the doctor and got a CT scan and found an Acute right common iliac vein and infrarenal IVC thrombus.  Many blood tests were run and no common factors were located to cause the thrombus.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pelvic venous thrombosis, Protein C, Protein S normal, Prothrombin level normal, Scan with contrast
Clinical narrative: Soreness in the back started on 2/5/2021 and eventually moved to the abdominal area on 2/12/2021.  Went to the doctor and got a CT scan and found an Acute right common iliac vein and infrarenal IVC thrombus.  Many blood tests were run and no common factors were located to cause the thrombus.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Spleen scan normal, Thrombin-antithrombin III complex normal
Clinical narrative: Soreness in the back started on 2/5/2021 and eventually moved to the abdominal area on 2/12/2021.  Went to the doctor and got a CT scan and found an Acute right common iliac vein and infrarenal IVC thrombus.  Many blood tests were run and no common factors were located to cause the thrombus.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Myalgia, Nausea, Tremor
Clinical narrative: dizziness, hypotensive, nausea, tremors, muscle aches, light headed
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: Got the 2nd dose of Corona Vaccine Moderna at 12:45pm yesterday - at 6p, started to feel weak/dizzy - then this am on 2/22/21 at approx 6:30, pt had a syncopal episode with preceding dizziness, denies cp/fever.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Pt. in tent 23 at 2:05 pm at observation line.  Complained of light headed and increased blood pressure.  Paramedics assessed pt.  They monitored her until her symptoms subsided.  Pt. was released.  Husband drove her home.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I noticed that I had hives on my right forearm. I took 25 mg of benadryl, and the hives went away. This occured at 10:00 PM, approximately 12 hours after the vaccination.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pruritus, Rash erythematous, Swelling
Clinical narrative: Swelling, itching, red rash, some pain
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Headache, fever, nausea. Dizziness, sore at injection site, chills and sweats, body ache, trouble sleeping. Took Advil for the fever and headache - helped with fever but not the headache.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Sleep disorder
Clinical narrative: Headache, fever, nausea. Dizziness, sore at injection site, chills and sweats, body ache, trouble sleeping. Took Advil for the fever and headache - helped with fever but not the headache.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: I got Covid Arm big red itchy circle on arm the next day after injection and now it is 9 days later, I still have it. I took a picture today. I'm not allergic to anything. But I did have Epstein-Barr Syndrome about 30 years ago...directly after 3rd dose of a vaccine. So I am worried about shot #2.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood glucose normal, Dizziness, Headache
Clinical narrative: Approximately 45 minutes after receiving the vaccine, patient returned reporting sharp back pain and headache. Patient denied difficulty breathing or swallowing. Denied chest pain or palpitations. Patient reports dizziness began 3 weeks ago. Glucose was 167.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Facial pain, Headache, Hypoaesthesia oral, Injection site bruising
Clinical narrative: Bell's Palsy like symptoms.  Initially post dose soreness at injection site and arm muscle as expected.  Gradually arm soreness continued down the length of the arm and up the neck into the face and head.  Left side (injection side) facial pain in the jaw accompanied with feeling of numbness in lips and headache on left side.  Symptoms progressed thru 5:30 that evening when shortness of breath developed and heart palpitations.  Symptoms gradually subsided.  Facial feeling returned to normal.  Headache, shortness of breath, palpitations, neck and arm soreness subsided by 9:00 PM.  All symptoms except expected injection site soreness and a small bruise at injection site subsided by 9:00PM
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain, Pain in jaw, Palpitations
Clinical narrative: Bell's Palsy like symptoms.  Initially post dose soreness at injection site and arm muscle as expected.  Gradually arm soreness continued down the length of the arm and up the neck into the face and head.  Left side (injection side) facial pain in the jaw accompanied with feeling of numbness in lips and headache on left side.  Symptoms progressed thru 5:30 that evening when shortness of breath developed and heart palpitations.  Symptoms gradually subsided.  Facial feeling returned to normal.  Headache, shortness of breath, palpitations, neck and arm soreness subsided by 9:00 PM.  All symptoms except expected injection site soreness and a small bruise at injection site subsided by 9:00PM
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Joint vibration
Clinical narrative: Intermittent vibration (buzzing) in arch of right foot started approximately 23 minutes after the injection of the vaccine, and it is still occuring.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Pain at injection site within hour after injection Felt spread down arm to elbow & up arm to neck It felt tender for a couple of weeks  On 2/15/21 started feeling burning pain at back of injection arm & in scapula radiates down to wrist & small finger
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin
Clinical narrative: Pain at injection site within hour after injection Felt spread down arm to elbow & up arm to neck It felt tender for a couple of weeks  On 2/15/21 started feeling burning pain at back of injection arm & in scapula radiates down to wrist & small finger
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient felt light headed. Denies SOPB, chest pain, palpitations, V/V, or visual changes.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Huge delayed rash one week after - about 8 to 10 long and ten inches wide. Itchy and raised. Day four of rash, has gotten slightly bigger. No fever.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: SORENESS AT THE SITE, MALAISE, FATIGUE, HEADACHE, SORE THROAT, CHILLS AND FEVER.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: SORENESS AT THE SITE, MALAISE, FATIGUE, HEADACHE, SORE THROAT, CHILLS AND FEVER.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy, Malaise, Pyrexia, Retching
Clinical narrative: The day after booster shot extremely lethargic, malaise, dry heaves and diarrhea with low grade fever. I'm now seven days out with continued extreme lethargy and diarrhea.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: The day after booster shot extremely lethargic, malaise, dry heaves and diarrhea with low grade fever. I'm now seven days out with continued extreme lethargy and diarrhea.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Moderna COVID-19 Vaccine  - rash on torso
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Oral pruritus
Clinical narrative: Itchy sore red patch about 2 1/2 inches round on arm at injection site.  Also experiencing itchy mouth which I get when I eat something I to which I am allergic.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: Dizziness that is continuing, fatigue, arm soreness, swelling of lymph nodes
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Incoherent, Pyrexia
Clinical narrative: 103 fever, difficulty breathing, chest cough, not coherent
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypotension
Clinical narrative: She felt hypotensive. She states that she felt that her BP was increasing. Average range is 160/170 systolic. Felt anxious prior to vaccine. Denied SOB, difficulty breathing, denied chest pain or dizziness. 15:35 VS 187/72 and HR 69. 16:17 VS 212/94 HR 71 RR 14 and o2 sat 100%. Brought patient to our express symptom management unit.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Reported Fever 103F, fatigue, chills, sweats, and muscle aches.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain of skin, Rash pruritic, Skin lesion
Clinical narrative: Shingles after receiving the vaccine / received shingles vaccine on 1/23/2021 / developed shingles on 1/26/2021 /  Shingles as diagnosed; painful itching lesions on her right arm / lesions continue to be painful; painful itching lesions on her right arm; dry itchy spots on her right arm turning into blisters; This case was reported by a consumer and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd January 2021, the patient received the 1st dose of Shingrix. On 26th January 2021, 3 days after receiving Shingrix, the patient experienced shingles, skin pain, itchy rash and blister. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the skin pain, itchy rash and blister were unknown.   The reporter considered the shingles, skin pain, itchy rash and blister to be related to Shingrix.  Additional information was provided as follows: On 23rd January 2021, the patient received 1st dose of Shingrix in left arm. On 26th January 2021, the patient experienced shingles which was confirmed by a dermatologist. She also experienced painful itching lesions on her right arm and noticed dry itchy spots on her right arm that were turning into blisters. The lesions continued to be painful but no longer had itch. The patient had been taking Valtrex, prescribed by her dermatologist as a treatment. All the information was not available. The reporter consented to follow up.; Reporter's Comments: Patient called back to provide additional details to AE that was filed. She reports that she received the shingles vaccine on 1/23/2021; she got the vaccine in her left arm. She developed shingles on 1/26/2021. It was confirmed that it was actually shingles by a dermatologist; she had painful itching lesions on her right arm, and was started on valtrex. The lesions continue to be painful, but no longer itch. She did not want to provide HCP information.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient self reported the case. The patient got shingles. For tolerance of 2nd dose refer case US2021AMR041514.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041514:1-shingles case
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Pruritus, Rash, Rash papular
Clinical narrative: Chickenpox-like reaction / chickenpox-like spots occur 5-7 spots at a time/back, thigh, butt, backside of calf, and; small fiery, red marks/described the size of the marks as "bigger than the top of a pen, but smaller than a dime.; Itchiness /  "itch like crazy"; bumps / Tiny bit raised; skin looks like dry skin; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hives (as child) and staphylococcal infection (as child).   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 15th December 2020, 34 days after receiving Shingrix, the patient experienced varicella-like rash, erythema, pruritus, papular rash and dry skin. The patient was treated with triamcinolone acetonide (Triamcinolone Ointment). On an unknown date, the outcome of the varicella-like rash, erythema, pruritus and papular rash were not recovered/not resolved and the outcome of the dry skin was unknown.   It was unknown if the reporter considered the varicella-like rash, erythema, pruritus, papular rash and dry skin to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left deltoid. The patient experienced a chickenpox-like reaction, small fiery, red marks, and itchiness. The reaction started roughly six weeks after getting the shot.  The chickenpox-like spots occured 5 to 7 spots at a time throughout his body (e.g. back, thigh, butt, backside of calf, and other random places). The patient described the size of the marks as bigger than the top of a pen, but smaller than a dime and reports there were bumps that were a tiny bit raised when ran finger across them. The skin looks like dry skin, and they itch like crazy around a 3 inch diameter.  The reporter prescribed Triamcinolone ointment to control the itching. The reporter consented to follow up and not all information was available.  The patient gave permission to follow-up with their HCP. The patient was unable to provide HCP's email at the time of report.  Discrepancy: Reported Date and TTO information are discrepant. Vx on 11Nov2020 and narrative states TTO of approx 6 weeks, however the date is captured as 15Dec2020 which is in 5th weeks after vaccinatin.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Varicella
Clinical narrative: Chickenpox-like reaction / chickenpox-like spots occur 5-7 spots at a time/back, thigh, butt, backside of calf, and; small fiery, red marks/described the size of the marks as "bigger than the top of a pen, but smaller than a dime.; Itchiness /  "itch like crazy"; bumps / Tiny bit raised; skin looks like dry skin; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hives (as child) and staphylococcal infection (as child).   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 15th December 2020, 34 days after receiving Shingrix, the patient experienced varicella-like rash, erythema, pruritus, papular rash and dry skin. The patient was treated with triamcinolone acetonide (Triamcinolone Ointment). On an unknown date, the outcome of the varicella-like rash, erythema, pruritus and papular rash were not recovered/not resolved and the outcome of the dry skin was unknown.   It was unknown if the reporter considered the varicella-like rash, erythema, pruritus, papular rash and dry skin to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left deltoid. The patient experienced a chickenpox-like reaction, small fiery, red marks, and itchiness. The reaction started roughly six weeks after getting the shot.  The chickenpox-like spots occured 5 to 7 spots at a time throughout his body (e.g. back, thigh, butt, backside of calf, and other random places). The patient described the size of the marks as bigger than the top of a pen, but smaller than a dime and reports there were bumps that were a tiny bit raised when ran finger across them. The skin looks like dry skin, and they itch like crazy around a 3 inch diameter.  The reporter prescribed Triamcinolone ointment to control the itching. The reporter consented to follow up and not all information was available.  The patient gave permission to follow-up with their HCP. The patient was unable to provide HCP's email at the time of report.  Discrepancy: Reported Date and TTO information are discrepant. Vx on 11Nov2020 and narrative states TTO of approx 6 weeks, however the date is captured as 15Dec2020 which is in 5th weeks after vaccinatin.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: a week of insomnia; This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to plants. Concomitant products included temazepam (Restoril).   On 13th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced insomnia. On an unknown date, the outcome of the insomnia was recovered/resolved.   It was unknown if the reporter considered the insomnia to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced a week of insomnia. The patient was allergic to several plants. The reporter believed that the plant extract contained in the Shingrix vaccine was the source of the insomnia. The patient was on Restoril for treatment of insomnia and that medication being effective in the management of the insomnia for over 7 years.  The patient reported believed that Shingrix reduced or completely overrode the efficacy of the Restoril. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Feverish; This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 13th January 2021, 12 hrs after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were reported as follows: About 12 hours after receiving the Shingrix patient began to feel feverish and developed a headache. The symptoms were not resolved till the time of reporting. The reporter gives permission to contact his physician.  The patient asked how long the side effects should last.  The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given less than a quarter of the dose; A spontaneous report was received from a pharmacist concerning a unknown patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and patient was given less than a quarter of the dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly prophylaxis of COVID-19 infection.  Reporter who was a pharmacist stated patient was given less than a quarter of the dose. Pharmacist was wondering if another dose should be given. This was the patient's second dose of the series. No further information was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273 (lot # unknown) with no associated AEs.
Sex: U
Vaccine: TDAP
Symptoms: Syringe issue, Underdose
Clinical narrative: Adacel syringe described as having a cracked hub allowing the vaccine to leak from the hub and not flow into the syringe; The nurse reported that the leak was noted while injecting into a patient; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves patient  (unknown demography) who while injection with a dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6737AA and expiration date 09-Jul-2022) had the leak that was noted by nurse while injecting and also adacel syringe described as having a cracked hub allowing the vaccine to leak from the hub and not flow into the syringe via unknown route in unknown administration site for prophylactic vaccination on an unknown date (underdose).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of syringe leak (syringe issue) and vaccine underdose.  Also reported that: How purchased: Direct ;Number of units affected: 1- Adacel ; dose not used or not available: not used ; Whether product was available for return: Yes ; Leaking ; Where is it leaking from? Tip of the needle ;Diluent or vaccine leaking? Vaccine; During withdrawal from vial? NA  (not applicable) ;Sanofi Pasteur prefilled syringe or your syringe? Pasteur prefilled syringe; Was air injected into vial? NA (not applicable) ; Was there a vacuum in the vial? Yes ;Was vial punctured multiple times? not applicable;  Did the product spray out of the vial? not applicable; Any signs of damage or tampering with the vial, stopper, flip seal or carton? No ; How often was vial punctured? not applicable.  No laboratory data reported.  No information on the corrective treatment was reported.  Outcome for both the reported events were not applicable.
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Dizziness, Meniere's disease, Nausea
Clinical narrative: Dizziness; Nausea; This spontaneous case was received on 08-Jan-2020 from other non-health professional via Med Communications (reference number: SEQW21-00015) and concerned a female patient of unspecified age.  The patient's concurrent conditions included vertigo and Meniere's disease. The patient's concomitant medications included Melasin (fluocinolone acetonide, hydroquinone, tretinoin) for nauseas.  On 20-Sep-2020, the patient was vaccinated with Afluria Quadrivalent vaccine (influenza vaccine; dose: 0.5 ml, route of administration, anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in the middle of Sep-2020, unknown amount of time after Afluria Quadrivalent, the patient experienced inner issues, dizziness and nausea.  On an unspecified date, the patient had called her doctor, which prescribed unspecified antibiotics and antiemetics but the symptoms have not improved.  At the time of initial reporting on 08-Jan-2020, the patient had not recovered from the events. The patient reported that she was having vertigo, Meniere's disease, but the symptoms never lasted this long.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: The events of 'dizziness' and 'nausea' are assessed as related to Afluria Quadrivalent vaccine.; Sender's Comments: The events of 'dizziness' and 'nausea' are assessed as related to Afluria Quadrivalent vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was received on 08-Jan-2021 from physician via regulatory authority (reference number: SEQW21-00112) and concerned a female patient of an unknown age.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included Flucelvax Quadrivalent on 25-Oct-2018, after which the patient developed rash.  On 04-Oct-2019, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number reported was P100109697 and expiry date was 22-May-2020.  On an unspecified date, unknown amount of time after receiving Afluria Quadrivalent, the patient developed rash.  The outcome of the event was not reported.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  This case is linked with cases 202100471 and 202100473 (the same patient).  Company comment: The event of 'rash' is considered as related to Afluria Quadrivalent.; Sender's Comments: The event of 'rash' is considered as related to Afluria Quadrivalent.
Age: 70.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Allergy to chemicals, Blood pressure diastolic decreased, Blood pressure systolic increased, Product intolerance
Clinical narrative: Blood pressure went from 120 to 189/35 too high and too low; Blood pressure went from 120 to 189/35 too high and too low; Chemical reaction/diagnosed with chemical intolerance; This spontaneous case was received on 08-Feb-2021 from other non-health professional (consumer) via Agency (reference number: NUS2021US019543) and concerned a 70-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine monovalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). The batch number was not reported.  On an unknown date, an unknown amount of time after receiving influenza virus vaccine monovalent, the patient had chemical reaction and he was diagnosed with chemical intolerance. The patient's blood pressure went from 120 to 189/35 too high and too low.  The outcome of the events was not reported.  The reporter assessed the events as related to receiving influenza virus vaccine monovalent. The patient took the Novartis H1N1 vaccine and it caused a chemical reaction and he was diagnosed with chemical intolerance and his blood pressure went from 120 to 189/35 too high and too low.  The events of 'blood pressure diastolic decreased' and 'blood pressure systolic increased' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment:The patient developed blood pressure diastolic decreased, blood pressure systolic increased and allergy to chemicals on an unknown date and unknown amount of time after receiving the suspect product, influenza virus vaccine monovalent. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality for all events is assessed as unassessable due to lack of information.; Reporter's Comments: The patient took the Novartis H1N1 vaccine and it caused a chemical reaction and he was diagnosed with chemical intolerance and his blood pressure went from 120 to 189/35 too high and too low.; Sender's Comments: The patient developed blood pressure diastolic decreased, blood pressure systolic increased and allergy to chemicals on an unknown date and unknown amount of time after receiving the suspect product, influenza virus vaccine monovalent. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality for all events is assessed as unassessable due to lack of information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypertension
Clinical narrative: About ten days after the first dose I began to have "brain fog". When I arrived at the donor center to give a monthly platelet donation my blood pressure was extremely high, 184/104.  My average blood pressure varies with an average of 135/80.  Never above 150/90.  It has stayed relatively high, though a late-day glass of red wine seems to bring the blood pressure lower.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Hot, red, itchy front of upper arm from injection site to elbow
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Pt complains of experiencing bilateral burning from toes to ankles 2 days after receiving 2nd dose of Moderna. Plan per MD: trial 100mg gabapentin at bedtime; consider lab draw, B12 supplementation d/t low levels from previous blood draw
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Skin warm
Clinical narrative: Red Rash  3 inch circle raised hot to touch
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Lip swelling, Pruritus, Rash
Clinical narrative: Immediate itch in the head  and arm fifteen minutes after shot along with slight swelling of the lip. Then 2 weeks after 2nd dose the same itch has returned all over the body along with some open rashes on the skin.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: Covid arm 9 days following vaccine.  Tenderness, itching, round red patch approx 2 inches in diameter at injection site.  Injection site warm to the touch.  Itchy arm and shoulder same side as injection.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus
Clinical narrative: Warm feeling bilateral to the legs. Itching to plantar left foot. VS 197/89 HR 114 at 13:38. VS at 13:46 150/78 HR 106. Denies SOB, palpitation, no N/V.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling hot, Lymphadenopathy, Musculoskeletal chest pain
Clinical narrative: Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary region on same side as vaccination given, muscle soreness and pain of chest wall on same side as vaccination given, felt hot and prickly all over but not measuring fever, nausea. Symptoms started late Friday night after vaccination and are ongoing still as of Monday after receiving.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Rhinorrhoea
Clinical narrative: Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary region on same side as vaccination given, muscle soreness and pain of chest wall on same side as vaccination given, felt hot and prickly all over but not measuring fever, nausea. Symptoms started late Friday night after vaccination and are ongoing still as of Monday after receiving.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Nausea, Pain
Clinical narrative: Severe chills & trembling, fever (101.5), nausea, , achiness, feeling of malaise, severe fatigue. Started 7 hours after vaccine administration, and lasted 15-16 hours, with ongoing residual fatigue - it was bad.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Severe chills & trembling, fever (101.5), nausea, , achiness, feeling of malaise, severe fatigue. Started 7 hours after vaccine administration, and lasted 15-16 hours, with ongoing residual fatigue - it was bad.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Sore arm, reddened site 4 cm square 2 days after. Redness continues 6 days after
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Throat irritation
Clinical narrative: Patient came to us with complaints of her heart racing, feeling like she needed "fresh air" and slight itch to throat.  NP and RN on sight assessed patient and had her sit in reclining chair with some water.  50 mg of Benadryl were administered orally at 1630.  By 1720 patient was feeling better and her husband came to pick her up
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Neck pain, Pyrexia, Secretion discharge
Clinical narrative: Neck ache, upper body muscle ache, severe  headache/sinus ache,  production of mucus, fever of 100 on and off.  This was from 12 hours after vaccine, and lasted 24 hours. Tylenol was effective to reduce both headache and fever.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: Neck ache, upper body muscle ache, severe  headache/sinus ache,  production of mucus, fever of 100 on and off.  This was from 12 hours after vaccine, and lasted 24 hours. Tylenol was effective to reduce both headache and fever.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Gastrointestinal sounds abnormal, Hypophagia, Nausea
Clinical narrative: Extreme stomach distress:  Nausea, diarrhea, stomach unsettled/growling, afraid to eat.  Gradually better by 02/21/2021 (light eating all day) and feeling pretty well today (02/22/2021)
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Rash
Clinical narrative: Itching and rash to the injection site, left deltoid. Down left arm shoulder and chest. After a few minutes patient was stable and sent home after monitoring patient. Benadryl was administered at 12:17pm. Patient advised to take Benadryl prior to 2nd dose.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Injection site pain, Injection site swelling, Myalgia, Oropharyngeal pain
Clinical narrative: Injection site very sore continues  ; injection site swollen continues; extreme muscle ache throughout body; sore throat the morning after injection; temperature 101 first day after; second day 99 (normal 98.4); third day 98.9.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching neat vaccine site.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Condition aggravated, Death, Fatigue, Nausea
Clinical narrative: Patient was found with no pulse no heart rate by a staff member around 11 pm.  Earlier that day seen by myself for fatigue, sorethroat, nausea.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pulse absent, Urine analysis
Clinical narrative: Patient was found with no pulse no heart rate by a staff member around 11 pm.  Earlier that day seen by myself for fatigue, sorethroat, nausea.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives primarily on left side of face/cheek.  Just observed, about 4 hours after it diminished 75%,  I took one Benadryl at bedtime just in case, next morning it was gone.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Generalized  Pruritic hives
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Hypertension
Clinical narrative: One side effect I still have,  I now have very high blood pressure. I?ve been to my cardiologist,  wore a heart monitor for 5 days, follow up appointment in 2 weeks.  I?ve quadrupled my BP dosage, blood pressure is still high.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncope
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Livedo reticularis
Clinical narrative: After 5-7 days I noticed a mottling in the arm that was vaccinated  and  veins in that arm appeared pronounced and bluish and sore arm  noticed after a hot shower and disappeared about an hour later. This reaction persisted several days
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Partial seizures
Clinical narrative: Approximately 14 hours of shot I suffered 3 partial seizures (20-30 second duration) in short succession with 5-10 minutes of each other.  I was awake and aware during all 3 events.  After 3rd, I had a severe headache lasting 24-36 hours.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hip arthroplasty, Myalgia, Pain in extremity
Clinical narrative: Right hip leg muscles and joint pain
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site swelling, Myalgia
Clinical narrative: Extreme muscle pain. Twisting and tightening feeling. Unable to relax. swelling at injection site and bruising
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Patient began coughing immediately after sitting down for her observation. Patient had a dry cough. Vitals every 5 minutes. No acute distress, lungs were clear.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 6 days after vaccination, large, red, hot, itchy painful swelling on shoulder at vaccine site. Consistent with online reporting of "covid arm"
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Quarter sized inflammation next to the injection site. Round, swollen, painful
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Vomiting
Clinical narrative: vomiting, diarrhea, chills and body aches. Treatment: Phenergan, advil Time Course: 36 hrs.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: AFTER RECEIVING THE VACCINE, SHE COMPLAINED OF BEING TIRED. ONSITE EMS RESPONDED. HER VITAL ARE BELOW.  SHE REFUSED ADDITIONAL EVALUATION AND CARE.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paresis, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness in face, could not move face, resolved after a day
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Pruritus
Clinical narrative: Patient reported chest discomfort and itchiness, resolved within 5 min.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Had seizure 2/5/21 .  Does have dx of seizures disorder
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Developed a raised red rash at injection site. It is itchy and about 7 inches in diameter
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: Chills, fatigue, body aches, headache, malaise
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Fever (Sweats and Chills) - 6 hours Severe Headache - 12 hours Body Aches - 18 hours
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Upper back rash and rash below injection site, low fever day 10.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Patient indicated she had tingling neck, throat, mouth.  Provided oral diphenhydramine (Benadryl) 50 mg at 0625 and monitored.  At approximately 0650 patient indicated the tingling was gone and she was ready to return to work. Vitals were WNL through this period. Patient worked for the medical hub, believed to be run by Contract employees.  Her supervisor was notified of situation and cleared to return to work.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Non-stop body aches for the past 16 days.  Headaches at least once per day lasting a few hours per day, without prior history of headaches, still occurring.  Chills for 2 days afterwards.  Constant fatigue since getting the vaccine.  CDC will not accept my comments.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Chills, headache, low grade fever, fatigue and muscle weakness  and sore arm. Taking Tylenol.  Symptoms lasted around  42 hours .
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, headache, low grade fever, fatigue and muscle weakness  and sore arm. Taking Tylenol.  Symptoms lasted around  42 hours .
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Redness, swelling,  itchy and tender to the touch after 7 days of vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: fever, chills, headache, nausea, muslce, joint aches, fatiue
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: fever, chills, headache, nausea, muslce, joint aches, fatiue
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Headache, Influenza like illness, Pain
Clinical narrative: Flu symptoms:  chills, fever, body aches, headache, cold sweats
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Flu symptoms:  chills, fever, body aches, headache, cold sweats
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness & soreness at injection site R forearm for 1 week. Felt generalized muscle aches and fatigue on   2/20- developed cold sore on mouth. Took famcyclovir. 2/21  Woke up with redness & soreness increased, site itched and area became swollen size of large grape. Armpit and neck on left side was sore with raise lymph nodes.-Took Tylenol and applied ice to arm.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy, Neck pain, Oral herpes, Pain
Clinical narrative: Redness & soreness at injection site R forearm for 1 week. Felt generalized muscle aches and fatigue on   2/20- developed cold sore on mouth. Took famcyclovir. 2/21  Woke up with redness & soreness increased, site itched and area became swollen size of large grape. Armpit and neck on left side was sore with raise lymph nodes.-Took Tylenol and applied ice to arm.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: AFTER RECEIVING THE VACCINE, SHE STARTED HAVING DIFFICULTY BREATHING. ONSITE EMS/PHYSICIAN RESPONDED. VITALS ARE BELOW. EMS WANTED TO TRANSFER HER TO EMERGENCY ROOM BUT SHE REFUSED AND WENT HOME AGAINST MEDICAL ADVICE.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site streaking, Injection site warmth
Clinical narrative: patient states she received injection on 1/27/21 with no issues at time of injection. On 2/8/21 she noticed tenderness at site of injection, fine rash with redness, red streaks down the arm and heat noticed to area. States she has been putting ice packs and Benadryl cream to area. 2/12/21 PCP Dr  notified of signs & symptoms per patient and also via me.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: Chills, fever, body aches, headache, fatigue, malaise
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, fever, body aches, headache, fatigue, malaise
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: I have numbness on the left lower side of my face. It is faint, however, noticeably different from the right side with no symptoms.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache, chills, and fever
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Muscular weakness, Oral discomfort, Pharyngeal swelling, Swollen tongue
Clinical narrative: about 30 to 40  minutes after shot on my way home. my lips, tongue, and throat was swelling. Lasted until after 5 pm . the next day through the following day i had burning on my  tongue and mouth. Strange sensation. Slight weakness in my legs through Monday and then i was fine.  On Monday i called my doctor and the doctor suggested that i go for my second shot and let them know of my reaction and let them decide if i should take my second shot.