chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: He can barely little walk/He can't barely even stand as just fine; He just have muscle pain.; Chills; His whole body is actually, fever degree high; Swelling; My brother is feeling very sick; This is a spontaneous report from a contactable consumer reported for a male patient (reporter's brother). A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0167; Expiration Date: Aug2021, NDC number, UPC number: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated was actually calling on behalf of brother because he (patient) recently just got his 2nd shot of the vaccine and reporter was looking at all the side effects that was but just found out that patient had muscle pain but he, like he can barely little walk/ cannot barely even stand as just fine (on an unspecified date). Reporter was taking the patient to the hospital, but he was. The reporter asked to tell because patient just have muscle pain, rest have chills. Reporter check his temperature his whole body was actually, fever degree high, he was swelling (on an unspecified date). When confirmed the name of vaccine as Pfizer Covid 19 vaccine: Reporter stated believe that this was 2nd shot, checked the paper for they gave him it said not, somebody was going to taking to but, what had right now was the Pfizer, looking at the paper that they gave him and just trying (Further clarification was unknown hence was captured as Unspecified medication) Reporter stated just wanted to make sure brother (patient) was okay. Asked if patient should be taken to the hospital, do not need to waste 8 minutes of this time. Well, need to take him hospital. That what reporter said, have been on phone with you from almost 11 minutes now, and needed confirmation was very upset because brother was feeling very sick right (on an unspecified date) was super upset and had number. Reporter was informed about the Medical Information department and Reporter said that Yes, they knew to take him (patient) to the hospital, How could their phone number when supposed to be the 1st person that was supposed to take care of this situation, would go ahead and take the patient to hospital rather that stay her and dial number and wait 8 minutes. Outcome of all events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: only time ever got the flu; Initial information received on 24-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves patient who experienced only time ever got the flu (influenza) while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious only time ever got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event (only time ever got the flu).  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Decreased immune responsiveness
Clinical narrative: from a consumer/non-health care. totally lowered my immunity; caught literally everything; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case This case involves an unknown age female patient who had totally lowered my immunity (decreased immune responsiveness) and caught literally everything (unevaluable event) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient medical treatment(s), vaccination(s)concomitant medication 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 unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious totally lowered my immunity (decreased immune responsiveness) and caught literally everything (unevaluable event) (unknown latency) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Eczema
Clinical narrative: eczema; Initial information was received on 24-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves a patient (unknown age and unknown gender) who experienced eczema while receiving 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 not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious eczema (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "When I stopped getting flu Vax my eczema stopped.5 years ago!".  It was unknown if patient's physician provided consent to be contacted   It was unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: tingling; numbness; pain in my arm; Initial information received on 25-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves Adult patient (unknown gender) who had tingling (paraesthesia), numbness (hypoaesthesia) and pain in my arm (pain in extremity) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious tingling (paraesthesia), numbness (hypoaesthesia) and pain in my arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Had a flu shot three years ago had tingling, numbness and pain in my arm for three months. Doctor (Dr) said I must be allergic."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the events.  There will be no information on the batch number for this case.
Age: 32.0
Sex: M
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: YF-VAX was administered to patient using an expired diluent with no reported adverse event; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a other healthcare professional via information (under the reference:00826342).  This case is linked to cases 2021SA356701 and 2021SA356051 (same reporter).  This case involves a 32-year-old male patient who was administered YELLOW FEVER VACCINE - US [YF-VAX] using an expired diluent (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US (0.5mL, lot U6428AA, expiry date: 30-Sep-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency: same day)  It was reported "Operations manager is following-up, providing additional information on expired YF-VAX administered to 5 patients."  At time of reporting, the 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2021SA354616: US-SA-2021SA354618:
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Injection site bruising, Injection site erythema, Injection site mass
Clinical narrative: injection site lump; injection site redness; injection site bruise; Patient got a subqutaneous injection instead of Intramuscular; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Media Information (under the reference 00826944).  This case involves a 65-year-old female patient who experienced injection site lump (vaccination site mass), injection site redness (vaccination site erythema) and injection site bruise (vaccination site bruising) after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] she got a subqutaneous injection instead of Intramuscular (incorrect route of product administration).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2021, the patient received a 0.5 mL total dosage form of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for Tuberculin (TB) skin test 0.5ML strength: standard except for Fluzone high dose, lot U66846AA, expiry date 16-Oct-2022] via subcutaneous route in the left arm for prophylactic vaccination.  On 02-Oct-2021, the patient developed a non-serious injection site lump (vaccination site mass), injection site redness (vaccination site erythema), injection site bruise (vaccination site bruising) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was an actual medication error due to incorrect route of vaccine administration (latency same day). No other vaccine.   It was reported "The caller stated that they administered ADACEL to a patient in the deltoid muscle of the arm on 21-Oct-2021. The caller stated that the patient called and reported injection site lump, brise and redness. She also said that the needle that was on the syringe did not go all the way in, so she believes she got a subqutaneous injection instead of Intramuscular."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered the PENTACEL, then came and told her it was expired  no reported adverse event; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and non-health care professional via Medical Information number: 00826991.   This case involves a 24 months old male patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number: UJ411AA and expiry date not reported via intramuscular route in the right thigh prophylactic vaccination.  It was case of an actual medication error 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 holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an expired vaccine/ no AE; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (MI) (Reference number- 00829192) and transmitted to Sanofi on 26-Oct-2021.  This case involves a 69-year-old female patient who received an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided   On 26-Oct-2021, the patient received a 0.5 ml (total) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot C5657AA and expiry date 26-Sep-2021] via intramuscular route in left arm for prophylactic vaccination.  Product used: Used. Still using product : No.  It was a case of actual medication error due to Expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Extreme pain at injection site, preventing movement of arm above heard, swelling at injection site, redness at injection site, hot to the touch at injection site
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Pain in extremity, Pain in jaw
Clinical narrative: Chest pain. Started in sternum then moved to left side, eventually caused pain down left arm as well as jaw pain.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Chest pain. Started in sternum then moved to left side, eventually caused pain down left arm as well as jaw pain.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Blister, Herpes zoster
Clinical narrative: On 10/23/21, nine days after the Pfizer COVID booster and flu shot on (10/14/21) I had an outbreak of shingles on my right face.  I was seen in urgent care on 10/25 and started on valcyclovir, I was seen on 10/26 by an optometrist who determined there was no ocular involvement despite vesicles on my lower eyelid.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: First menstral cycle after second shot is going on 10 days now.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Painful respiration, Troponin increased
Clinical narrative: Patient began to have chest pain the day after 2nd dose of Moderna Vaccine.  Evaluation 28 Oct showed continued pain with troponin elevation.  She has sharp substernal chest pain as well as pain with breathing.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Decreased appetite, Extra dose administered, Fatigue, Injection site pain
Clinical narrative: extreme pain at injection site & traveling down entire arm including fingers.  Pain moved on to all muscles i ncluding my back & right arm.  Extreme fatigue. loss of appetite.  This was a booster shot.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: extreme pain at injection site & traveling down entire arm including fingers.  Pain moved on to all muscles i ncluding my back & right arm.  Extreme fatigue. loss of appetite.  This was a booster shot.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest pain, Palpitations, Psychotic disorder
Clinical narrative: Blood pressure spiked to 188/103 and remained at high levels for two to three days Felt a bit of psychosis mentally Heart Palpitations and slight chest pain
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Chest pain, Electrocardiogram, Heart rate irregular, Human rhinovirus test positive
Clinical narrative: Common cold symptoms began 10/11/21 then chest pains began on 10/14/21. On 10/19 I took the patient to urgent care who prescribed Motrin. The pain became more severe so I took the patient to Hospital Emergency Room where he was admitted. Troponin was a 9 and patient was diagnosed with Myocarditis.  He was given Motrin for pain and inflammation. Doctors treated with IVIG once the troponin levels continued to stay at a 7. He stayed in the hospital for 12 days and was released on steroids and a heart monitor. Also during this time his heart rate became irregular.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Inflammation, Magnetic resonance imaging heart, Myocarditis, Nasopharyngitis
Clinical narrative: Common cold symptoms began 10/11/21 then chest pains began on 10/14/21. On 10/19 I took the patient to urgent care who prescribed Motrin. The pain became more severe so I took the patient to Hospital Emergency Room where he was admitted. Troponin was a 9 and patient was diagnosed with Myocarditis.  He was given Motrin for pain and inflammation. Doctors treated with IVIG once the troponin levels continued to stay at a 7. He stayed in the hospital for 12 days and was released on steroids and a heart monitor. Also during this time his heart rate became irregular.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test negative, Troponin increased, Ultrasound scan, Viral test
Clinical narrative: Common cold symptoms began 10/11/21 then chest pains began on 10/14/21. On 10/19 I took the patient to urgent care who prescribed Motrin. The pain became more severe so I took the patient to Hospital Emergency Room where he was admitted. Troponin was a 9 and patient was diagnosed with Myocarditis.  He was given Motrin for pain and inflammation. Doctors treated with IVIG once the troponin levels continued to stay at a 7. He stayed in the hospital for 12 days and was released on steroids and a heart monitor. Also during this time his heart rate became irregular.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Myocarditis, Troponin increased
Clinical narrative: Common cold symptoms began 10/11/21 then chest pains began on 10/14/21. On 10/19 I took the patient to urgent care who prescribed Motrin. The pain became more severe so I took the patient to Hospital Emergency Room where he was admitted. Troponin was a 9 and patient was diagnosed with Myocarditis.  He was given Motrin for pain and inflammation. Doctors treated with IVIG once the troponin levels continued to stay at a 7. He stayed in the hospital for 12 days and was released on steroids and a heart monitor. Also during this time his heart rate became irregular.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported no symptoms day of the vaccination. The patient did note that the vaccine was given lower than normal in the muscle of the arm. When he awoke the next morning the area around the vaccine was warm to the touch, red, swollen and painful. The patient reported a "goose egg" was on his arm. Since Saturday (10/30/2021) the swelling has gone down, but not entirely away. Patient also reported some muscle weakness, but not more than normal reactions to vaccines in the past.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Patient reported no symptoms day of the vaccination. The patient did note that the vaccine was given lower than normal in the muscle of the arm. When he awoke the next morning the area around the vaccine was warm to the touch, red, swollen and painful. The patient reported a "goose egg" was on his arm. Since Saturday (10/30/2021) the swelling has gone down, but not entirely away. Patient also reported some muscle weakness, but not more than normal reactions to vaccines in the past.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Eyelid pain, Lacrimation increased, Swelling of eyelid
Clinical narrative: About 4 hours after injection in left arm, left eye became itchy, watery and the upper eyelid began to swell. Swelling increased over the next day and the eyelid was very sore. 4 days later it isn't sore and swelling is about 25% of what it was. I expect it will be normal tomorrow.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Dosage 1 had heart palpitations; anxiety and jittery feeling; tired. Slept it off. Heart palpitations (benign) lingered for at least a few weeks. Had not experienced them for months before the vaccine.  Dosage 2: Received dosage 2 on 04/07/2021 and developed Shingles on 04/24/2021. Notified healthcare provider that I had shingles, and was prescribed medicine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Ventricular extrasystoles
Clinical narrative: Needed an ultrasound of heart. I started having Premature ventricular contractions (PVCs)
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Choking, Diarrhoea, Diplegia
Clinical narrative: the following day after the vaccine patient developed paralysis of legs 2 days in row causing patient to fall, legs like wet noodle, very weak upper body strength (Guillame Barre syndrome), fever, profuse diarrhea for at least 2 days, urinary incontinence, bowel incontinence, fever for 2-3 days, extreme weakness, nausea, nonstop gagging and choking on saliva in throat for 2 weeks
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Guillain-Barre syndrome, Metabolic function test, Muscular weakness, Nausea
Clinical narrative: the following day after the vaccine patient developed paralysis of legs 2 days in row causing patient to fall, legs like wet noodle, very weak upper body strength (Guillame Barre syndrome), fever, profuse diarrhea for at least 2 days, urinary incontinence, bowel incontinence, fever for 2-3 days, extreme weakness, nausea, nonstop gagging and choking on saliva in throat for 2 weeks
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Retching, Urinary incontinence
Clinical narrative: the following day after the vaccine patient developed paralysis of legs 2 days in row causing patient to fall, legs like wet noodle, very weak upper body strength (Guillame Barre syndrome), fever, profuse diarrhea for at least 2 days, urinary incontinence, bowel incontinence, fever for 2-3 days, extreme weakness, nausea, nonstop gagging and choking on saliva in throat for 2 weeks
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest pain
Clinical narrative: New onset Afib with chest pain
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dyspepsia, Head discomfort, Impaired work ability
Clinical narrative: Got vaccine on May 11, exactly 2 weeks later on 25 of May out of nowhere while sitting in my car my heart started to race, vision became blurry, it felt like i was going to pass out. First two months were the worst - i could not go to work, i could not go to the store, even for a short walk around the house. Symptoms are - dizziness, feeling of pressure in my head, tinnitus, insomnia, heart palpitations, panic attacks (that iv never experienced before getting this vaccine), vision in my left eye was blurry (it resolved in 2 moths), indigestion, anxiety (again i have never experienced such thing). Its been 6 months now - last month i was somewhat ok (this symptoms come and go in waves), but they came back beginning of the last week. This experience is horrible - its hell on earth.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Palpitations, Panic attack, Tinnitus, Vision blurred
Clinical narrative: Got vaccine on May 11, exactly 2 weeks later on 25 of May out of nowhere while sitting in my car my heart started to race, vision became blurry, it felt like i was going to pass out. First two months were the worst - i could not go to work, i could not go to the store, even for a short walk around the house. Symptoms are - dizziness, feeling of pressure in my head, tinnitus, insomnia, heart palpitations, panic attacks (that iv never experienced before getting this vaccine), vision in my left eye was blurry (it resolved in 2 moths), indigestion, anxiety (again i have never experienced such thing). Its been 6 months now - last month i was somewhat ok (this symptoms come and go in waves), but they came back beginning of the last week. This experience is horrible - its hell on earth.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Injection site warmth, Urticaria
Clinical narrative: Redness in the Left thigh, Hot to touch, Rash, Hives, Welts from hives. Started 24 hours after shot.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Euphoric mood, Feeling abnormal, Gait disturbance, Gaze palsy
Clinical narrative: Client reports having a reaction to her first two doses of Moderna vaccine but medically advised she could get the booster dose but keep in mind she may have a similar reaction. She expressed understanding this risk but felt the booster was necessary in order to complete an upcoming trip to visit her sister who has cancer and is immunocompromised.   With both previous doses, client reports feeling the medicine come over her body rapidly, with a sensation of being "drugged." Client reports PMH of addiction. 22 years sober. In both of those doses, the sensation was weak enough that she was able to drive home after each dose, waiting 15 minutes for first dose and 30 minutes for second dose. With the first dose, she reports feeling at baseline for the most part but developed swelling and redness at the vaccine site 10 days after administration, along with redness and swelling at her palms of hands and soles of feet. With second dose, she felt feeling of being drugged but was able to drive home before symptoms worsened at 45 minutes. Those symptoms continued for 48 hours then self resolved.  Today - Received dose at 1520. Notable shooting pain from vaccine site at L deltoid down arm to L hand. Within 10 seconds, reported numbness and tingling in LUE. Within 1 minute of administration, client felt a daze that decreased level of consciousness similar to a feeling of being "high."  Arm numbness continued along with HA that started at back of neck and move to bilateral temples of head after 20 minutes. Pt declined heat, ice, water or lotion. RN provided lymph massage to increase sensation and blood flow to L hand. VS stable at 120-130/80s with HR 70-90. Pulses +2 bilaterally with increased warmth and redness to bilateral palms.  Benadryl administered at 1550. Decreased fine motor skills noted while patient trying to hold and take pill. Notable difference in sensation between upper extremities with 3-4/5 strength and numbness in LUE and 5/5 strength with normal sensation in RUE. No change in symptoms after 45 minutes post Benadryl administration.  At 1620, patient stated she wants to go home and noted that she would decline an ambulance if one was provided.   Dr. assessed patient at 1640. Observed decreased LOC, strength and unstable gait. Offered to   She has two coworkers who volunteered to drive her home in her car from her appointment. 1710 declined transport to hospital. Discussed rule out for COVID vaccine reaction vs TIA  Spoke to fiancee regarding assuming responsibilities if brought home instead of ED. Fiancee agreed to assuming care.  Patient signed AMA form at 1715 against instruction by medical team to seek emergent care for symptoms. Escorted by clinic director and RN in wheelchair to patient's ride at 1730.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Hypoaesthesia, Impaired driving ability, Injection site pain, Neck pain
Clinical narrative: Client reports having a reaction to her first two doses of Moderna vaccine but medically advised she could get the booster dose but keep in mind she may have a similar reaction. She expressed understanding this risk but felt the booster was necessary in order to complete an upcoming trip to visit her sister who has cancer and is immunocompromised.   With both previous doses, client reports feeling the medicine come over her body rapidly, with a sensation of being "drugged." Client reports PMH of addiction. 22 years sober. In both of those doses, the sensation was weak enough that she was able to drive home after each dose, waiting 15 minutes for first dose and 30 minutes for second dose. With the first dose, she reports feeling at baseline for the most part but developed swelling and redness at the vaccine site 10 days after administration, along with redness and swelling at her palms of hands and soles of feet. With second dose, she felt feeling of being drugged but was able to drive home before symptoms worsened at 45 minutes. Those symptoms continued for 48 hours then self resolved.  Today - Received dose at 1520. Notable shooting pain from vaccine site at L deltoid down arm to L hand. Within 10 seconds, reported numbness and tingling in LUE. Within 1 minute of administration, client felt a daze that decreased level of consciousness similar to a feeling of being "high."  Arm numbness continued along with HA that started at back of neck and move to bilateral temples of head after 20 minutes. Pt declined heat, ice, water or lotion. RN provided lymph massage to increase sensation and blood flow to L hand. VS stable at 120-130/80s with HR 70-90. Pulses +2 bilaterally with increased warmth and redness to bilateral palms.  Benadryl administered at 1550. Decreased fine motor skills noted while patient trying to hold and take pill. Notable difference in sensation between upper extremities with 3-4/5 strength and numbness in LUE and 5/5 strength with normal sensation in RUE. No change in symptoms after 45 minutes post Benadryl administration.  At 1620, patient stated she wants to go home and noted that she would decline an ambulance if one was provided.   Dr. assessed patient at 1640. Observed decreased LOC, strength and unstable gait. Offered to   She has two coworkers who volunteered to drive her home in her car from her appointment. 1710 declined transport to hospital. Discussed rule out for COVID vaccine reaction vs TIA  Spoke to fiancee regarding assuming responsibilities if brought home instead of ED. Fiancee agreed to assuming care.  Patient signed AMA form at 1715 against instruction by medical team to seek emergent care for symptoms. Escorted by clinic director and RN in wheelchair to patient's ride at 1730.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Client reports having a reaction to her first two doses of Moderna vaccine but medically advised she could get the booster dose but keep in mind she may have a similar reaction. She expressed understanding this risk but felt the booster was necessary in order to complete an upcoming trip to visit her sister who has cancer and is immunocompromised.   With both previous doses, client reports feeling the medicine come over her body rapidly, with a sensation of being "drugged." Client reports PMH of addiction. 22 years sober. In both of those doses, the sensation was weak enough that she was able to drive home after each dose, waiting 15 minutes for first dose and 30 minutes for second dose. With the first dose, she reports feeling at baseline for the most part but developed swelling and redness at the vaccine site 10 days after administration, along with redness and swelling at her palms of hands and soles of feet. With second dose, she felt feeling of being drugged but was able to drive home before symptoms worsened at 45 minutes. Those symptoms continued for 48 hours then self resolved.  Today - Received dose at 1520. Notable shooting pain from vaccine site at L deltoid down arm to L hand. Within 10 seconds, reported numbness and tingling in LUE. Within 1 minute of administration, client felt a daze that decreased level of consciousness similar to a feeling of being "high."  Arm numbness continued along with HA that started at back of neck and move to bilateral temples of head after 20 minutes. Pt declined heat, ice, water or lotion. RN provided lymph massage to increase sensation and blood flow to L hand. VS stable at 120-130/80s with HR 70-90. Pulses +2 bilaterally with increased warmth and redness to bilateral palms.  Benadryl administered at 1550. Decreased fine motor skills noted while patient trying to hold and take pill. Notable difference in sensation between upper extremities with 3-4/5 strength and numbness in LUE and 5/5 strength with normal sensation in RUE. No change in symptoms after 45 minutes post Benadryl administration.  At 1620, patient stated she wants to go home and noted that she would decline an ambulance if one was provided.   Dr. assessed patient at 1640. Observed decreased LOC, strength and unstable gait. Offered to   She has two coworkers who volunteered to drive her home in her car from her appointment. 1710 declined transport to hospital. Discussed rule out for COVID vaccine reaction vs TIA  Spoke to fiancee regarding assuming responsibilities if brought home instead of ED. Fiancee agreed to assuming care.  Patient signed AMA form at 1715 against instruction by medical team to seek emergent care for symptoms. Escorted by clinic director and RN in wheelchair to patient's ride at 1730.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Pain in extremity
Clinical narrative: Sore arm, heavy bleeding for a week following despite not menstruating in years due to IUD placed.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Dysstasia, Gait disturbance, Joint range of motion decreased
Clinical narrative: Unable to move arm 12 hours after getting shot.  Range of motion improved after 24 hours.  Slight lower back pain 18 hours after shot however the pain intensified over the next few hours.  24 hours after shot, unable to stand or walk.  48 hours after shot, can sit or walk for short periods of time.  96 hours after shot, can sit and walk with very little pain.  Stomach cramps 12 hours after shot, able to keep food down 24 hours after shot.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Unable to move arm 12 hours after getting shot.  Range of motion improved after 24 hours.  Slight lower back pain 18 hours after shot however the pain intensified over the next few hours.  24 hours after shot, unable to stand or walk.  48 hours after shot, can sit or walk for short periods of time.  96 hours after shot, can sit and walk with very little pain.  Stomach cramps 12 hours after shot, able to keep food down 24 hours after shot.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: After my first vaccination, I experienced swelling of my feet and ankles.  I'm not sure when it started in relation to the vaccination, but it went away after my second shot. On my third booster shot, both feet and ankles swelled--nothing grotesque, but definitely puffy.  I'm not sure if it started the same evening or next day.  My left foot and leg are still a little puffy a week and a half later.  My ankles feel tight when I rotate my foot, especially on the left leg.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, swelling near injection site
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Chest pain, Dizziness, Erythema, Hypersensitivity
Clinical narrative: Burning sensation as shot was administered. Sensation traveled up the arm to the chest. Once it reached the chest, vision was compromised by spots and there was a tingling sensation throughout the whole body. Face swelling, entire body turning red. Severe nausea and lightheadedness. Time course was about 1 minute for everything. Treatment was going to be epi, but a Zyrtec pill was given instead as well as other nurses using ice packs to cool down body temperature.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia, Swelling face, Visual impairment
Clinical narrative: Burning sensation as shot was administered. Sensation traveled up the arm to the chest. Once it reached the chest, vision was compromised by spots and there was a tingling sensation throughout the whole body. Face swelling, entire body turning red. Severe nausea and lightheadedness. Time course was about 1 minute for everything. Treatment was going to be epi, but a Zyrtec pill was given instead as well as other nurses using ice packs to cool down body temperature.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest discomfort, Erythema, Flushing, Hyperhidrosis
Clinical narrative: Burning sensation as shot was administered. Sensation traveled up the arm to the chest. Once it reached the chest, vision was compromised by spots and there was a tingling sensation throughout the whole body. Face swelling, entire body turning red. Severe nausea and lightheadedness. Time course was about 1 minute for everything. Treatment was going to be epi, but a Zyrtec pill was given instead as well as other nurses using ice packs to cool down body temperature.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Nausea, Oral mucosal erythema, Paraesthesia, Skin reaction
Clinical narrative: Burning sensation as shot was administered. Sensation traveled up the arm to the chest. Once it reached the chest, vision was compromised by spots and there was a tingling sensation throughout the whole body. Face swelling, entire body turning red. Severe nausea and lightheadedness. Time course was about 1 minute for everything. Treatment was going to be epi, but a Zyrtec pill was given instead as well as other nurses using ice packs to cool down body temperature.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Burning sensation as shot was administered. Sensation traveled up the arm to the chest. Once it reached the chest, vision was compromised by spots and there was a tingling sensation throughout the whole body. Face swelling, entire body turning red. Severe nausea and lightheadedness. Time course was about 1 minute for everything. Treatment was going to be epi, but a Zyrtec pill was given instead as well as other nurses using ice packs to cool down body temperature.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pain
Clinical narrative: I?ve been to 4 different emergency rooms on different days in the past 4 months and they don?t know what the problem is . My primary doctor referred me to an RA who said what I had was weird and he couldn?t help. My pains are so severe that I don?t sleep for days .
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest X-ray, Electrocardiogram, Palpitations
Clinical narrative: 45 minutes after shot heart start to race and atrial fibrillation took place for the next five hours
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood pressure increased, Blood test, Chest pain, Computerised tomogram
Clinical narrative: Spontaneous Coronary Artery Dissection and Takotsubo cardiomyopathy    detected with severe chest pain, elevated blood pressure and arm pain.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery dissection, Electrocardiogram, Pain in extremity, Stress cardiomyopathy, Ultrasound scan
Clinical narrative: Spontaneous Coronary Artery Dissection and Takotsubo cardiomyopathy    detected with severe chest pain, elevated blood pressure and arm pain.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Computerised tomogram, Dyspnoea, Fibrin D dimer increased
Clinical narrative: Pain in right upper chest and ribs, unavailable to move or breath normally for 3 days, a month after getting the shot. It?s been 2 weeks with the same problem and nothing seems to improve.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Musculoskeletal chest pain
Clinical narrative: Pain in right upper chest and ribs, unavailable to move or breath normally for 3 days, a month after getting the shot. It?s been 2 weeks with the same problem and nothing seems to improve.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: painful swollen arm; painful swollen arm/very sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingle vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were recovered/resolved.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got 2 shots years ago then had another two more recently which was supposed to be better.  The patient waited 3 months for 2nd instead of 4 and had a painful swollen arm for a week. Probably should have waited 4 months. Worth it though my cousin died from later complications.  It seemed to destroy his immune system. The patient had the same reaction. Very sore arm for days but well worth it.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles; Missed 2nd shingles dose; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself/himself. The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. The patient missed the 2nd dose, which led to incomplete course of vaccination. At the time of reporting, the patient had shingles. The patient asked if he/she needed to start over again with the 1st dose. Follow-up would not be possible as no contact details available.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered a dose of Shingrix one month too early.; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On 25th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 25th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The medical assistant administered dose of Shingrix to a patient one month too earlier than the recommended interval, which led to shortening of vaccination schedule. Number for GSK Medical Information given for future reference and warm transfer provided.  The reporter did not consent to follow-up.
Age: 50.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Off label use
Clinical narrative: received during the same clinical day a shingrix and varicella shot; This case was reported by a other health professional via call center representative and described the occurrence of off label use in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number mx7ma, expiry date unknown) for prophylaxis.   Co-suspect products included Varicella (Varicella vaccine) for prophylaxis.   On 26th October 2021, the patient received Shingrix and Varicella vaccine. On 26th October 2021, unknown after receiving Shingrix and Varicella vaccine, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The patient received during the same clinical day a Shingrix and a Varicella shot, which led to off label use. It had been considered that having co-administration of the Varicella and the Shingrix vaccine would be a "off label use" as CDC recommended to wait a minimum of 8 weeks after a person received varicella/chickenpox vaccine to give Shingrix. The reporter consent to follow up.