chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician, via a company representative, concerning a 15 year old patient (gender not specified), with a family history of fainting post vaccination, who was vaccinated (date not specified) with the first dose of Gardasil, and fainted following the vaccination. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
given vaccine on 11/29/2022.  Tested positive for COVID with symptoms on 12/11/2022.  Respiratory decline on 12/19/2022 and intubated on 12/20/2022.  Hospitalized including ICU intubation from 12/20/2022-12/29/2022.  He released back to the nursing home with again respiratory decline on 01/16/2023 and hospitalized on 01/19/2023-01/26/2023 diagnosed with COVID pneumonia.  he did not improve during these dates and thus was discharged back to the nursing home on 01/26/2023 with hospice.  He expired 02/09/2023.
bruise @ inject site is reported in a pt who recvd flu vax 4NOV93 & the same day pt exp above sx which abated w/in several days;
Patient received Janssen vaccine and passed out approximately 10 minutes after receiving vaccine. Paramedics were called and patient was conscious immediately after. Paramedics cleared patient after evaluation.
Muscle pain,chills,vomiting,fever, weakness, diarrhea, for 24 to 48 hours
Shingles; Extreme Pain; Increased BP; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1si dose received in April 2020).   On 2nd July 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd July 2020, less than a day after receiving Shingrix, the patient experienced shingles, pain and increased blood pressure. On an unknown date, the outcome of the shingles, pain and increased blood pressure were unknown.   It was unknown if the reporter considered the shingles, pain and increased blood pressure to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced the symptoms of extreme pain, increased blood pressure and the shingles on the same day she got her 2nd dose. The patient reported her blood pressure was so high and went to the urgent care and they sent her to the hospital and they released. The reporter consent to follow up.
Suddenly became pale, cool, diaphoretic. Dizzy. Initial BP 100/60 (pulse 68). Placed in supine position. Second BP 82/44 (pulse 62). Given LAC (18g)/NS 500 mL. Final BP 104/70 (pulse 70). Refused to go to ED.
broke out in hives all night; had trouble breathing; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who broke out in hives all night and had trouble breathing after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), risk factor 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, strength, dose, form, expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient broke out in hives all night (urticaria) and had trouble breathing (dyspnoea) (unknown latency) following the administration of Influenza vaccine.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Mom reported hard knot that was red and raised about 3-4 inches in diameter top to bottom, and 6 inches toward inner thigh on left leg, and was c/o pain. Was scratching it, c/o itching, but playing normally.
An non-serious spontaneous report of tingling in nose and cheek has been received from a physician concerning a 20-year-old male, subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 15-Oct-2010. On 15-Oct-2010, two hours later FLUMIST administration, the patient experienced tingling in his nose and cheeks. The outcome of the event is unknown.
Moderate dizziness: room spinning when I rolled over in bed the night of the vaccination (Wednesday), difficulty standing in the morning (Thursday), difficulty walking.  Worse this morning.  Settles down once I am up.   I find I need to move slowly.   BP 140/78 this morning.
Currently 25 2/7 weeks; started having night terrors 1/28/21; also accompanied with ?brain zingers? small electrical shocks in my brain that last 1-2 seconds but are definitely not something I can ignore. I get approximately 4-5 zingers an evening.
I have been having irregular periods since 1-2 months after receiving the vaccine. My cycle is normally very regular and tracked in an app. Since the vaccine I?ve started my period several days early some month, several days late other months. I normally have heavy periods, especially the 2nd and 3rd days and now it is unpredictable and has been a lot lighter than normal. With this I?ve also had worse cramping and headaches each cycle, with fluctuations in body temperature feeling very hot at times during my menstrual cycle. I?ve also noticed I?ve been a lot more irritable in the week leading up to it.
1.6 mL of Normal Saline diluent was used to dilute COVID 19 Pediatric vaccine instead of the recommended 1.3 mL. Parents called and notified, information sheet to be sent to the parents. Per safety protocol called Agency and Pfizer and their instructions to give to parents were that there is no need to repeat the dose and the child is to get the second dose 21 days from the first dose.
Tiredness and exhaustion in general/exhaustion/feeling like I am completely drained of energy; muscle and joint pain; muscle and joint pain; Pain in my arms and legs; Pain in my arms, back, and legs; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiration date not provided), via an unspecified route of administration on 05Jan2021, 10:30 in right arm and then via unspecified route of administration (Lot Number: EL8982, Expiration date not provided) on 25Jan2021, 07:30 in the right arm both for COVID-19 immunization. The patient's medical history included very slight allergy to Kiwi fruit. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient had not been diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 26Jan2021, the patient experienced tiredness and exhaustion in general, performing any physical activity that requires a minor amount of effort leads to muscle and joint pain and exhaustion, while walking around the store pushing the cart has ended him calling out of work sick the next day due to pain in arms, back, and legs as well as feeling like he was completely drained of energy. It was reported that all events listed happened with the first shot and continued after the second dose but more severe. The patient had not received any treatment for the events. Outcome of the events was not recovered.
BlurredVision, Dizziness, Headache, Myalgia, Rash, Stiff neck, redness/red ring around inj site, left arm numb, red/swollen, painful joints on left hand, migraine Narrative:  From the employee: After the Covid shot was given to me, I felt fine for a few hours, around 730-800pm my left arm began to hurt more and it was numb to the touch where the shot had been given. I began to feel a bit achy and I developed a headache, that got worse as the night wore on. It was around 900pm was when I began to feel a little dizzy and had some spotty vision (white spots) often associated with a migraine, so I then went to bed. The next morning, I woke up around 6am, I felt awful. The Left side of my neck was very stiff, my left arm hurt a lot where the vaccine was given to me and a small red ring had appeared, it was maybe the size of dime. My left arm was also somewhat numb at this time and my left hand was stiff to try and move or to use. I was also sweaty, so, I took my temperature and it was 99.5 which mine is never above 99, so that was concerning. I still had a headache and felt like I had been in a car wreck when I stood up. It was then that I let my supervisor know that I wasn't going to come to work. As the day went on, I began to feel worse and this was expected as I had been told I would feel awful. Throughout the day, my headache got worse and became a full migraine, no medicine I took helped much. I had on and off blurry vision, my left hand was warm in the joints and was physically red and swollen, around my thumb and the joints in my fingers and my wrist. My Left arm and left hand were painful to use, touch, and I wasn't able to move it without concern. My hand was swollen just like an inflammatory process was underway, this sometimes happens when my fibromyalgia acts up. I would say that the shot activated the Fibromyalgia and is a worse way than I have had. I have never had severe loss of use or feeling in my hands or feet due to this condition and I wasn't able to fully use my left until Monday morning. Everything that was concerning or wrong involving numbness and loss of feeling or use was left sided and the shot was given to me in the left side. I would hate to compare it to some who had had a stroke but that it what it reminded me of. My headache however was both sides and I would say that it was a full migraine that went all the way to the back of my neck.
This is a Legacy Sanofi Pasteur case previously reported under mfg# 2017SA091146. Initial solicited report received on 17 May 2017 from an investigator (Defense Health Agency) in the trial. A 22-year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 VACCINE (lot number and route, site of administration not reported) on 19 October 2016. On 03 November 2016, 15 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified, and on 07 November 2016, 19 days post vaccination the subject was diagnosed with I31.9 disease of pericardium, unspecified. The lab data included within 30 days post vaccination on 30 October 2016, the Troponin I was abnormal (the highest value was recorded as 51.00), ECG was abnormal, Echocardiogram was normal, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported.  The events outcome was not reported. Relationship to investigational product according to company: associated. Relationship to investigational product according to investigator: not reported. List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 22 May 2017: The unit of troponin I was reported as ng/ml. Follow up information received on 21 August 2017: Additional diagnoses/symtoms were reported as 'echocardiogram normal', 'electrocardiogram abnormal' and 'troponin I increased'. Follow-up information received on 29 September 2017: Review date: 21-Sept-2017.  It is reported that initially vaccinated 80 days but no take was observed so subject was revaccinated. Lab data was updated: ECG on 30 October 2016 - STE in leads II, III AVF, V6 with HR palpable at 120 BPM and Troponin T reference range less than 0.03ng/ml on 27 September 2017. Adjudication Committee consensus received on 09JAN2018: A consensus was determined by this study protocol adjudication committee:  Based on the information received the case meets the case definition for subclinical myopericarditis, but does not meet the case definition for myocarditis or pericarditis. As a result of the adjudication committee consensus review - the event of pericarditis was removed from this case and the event of subclinical myopericarditis (myocarditis) was added to the case.
Information has been received from a registered nurse, via a company representative, concerning a 71 year old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date in March 2016 (reported as one year ago), the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PNEUMOCOCCAL 13V CONJ VACCINE (CRM197) (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On 16-MAR-2017 (also reported as within the last 2 weeks), the patient was vaccinated with PNEUMOVAX23 route of administration was reported as injection (dose, strength and anatomical location were not provided) (lot # N003997 with expiration date 20-OCT-2018), for prevention of pneumococcal disease. On 17-MAR-2017 (reported as within 1 day of receiving the vaccine), the patient experienced arms that were red, painful to touch and feverish. The patient sought medical attention and an unspecified treatment was given for adverse events. It was unknown if any laboratory diagnostics studies were performed. At the time of reporting, the patient's outcome was reported as recovered. The causality assessment between PNEUMOVAX23 and all the adverse events was not provided. Additional information has been requested.
HA starting for 1 hour after injection, lasted for 24-26 hours despite Advil, Excedrine and Fiorocet Abdominal cramps with diarrhea starting 4 hours later, lasted another 4 hours (I get diarrhea very rarely)
Pain in her armpit of the same arm she got the vaccine administered; Swollen lymph node; Tenderness from the injection site is gone; This spontaneous case was reported by an other health care professional and describes the occurrence of AXILLARY PAIN (Pain in her armpit of the same arm she got the vaccine administered), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) and VACCINATION SITE PAIN (Tenderness from the injection site is gone) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ORAL CONTRACEPTIVE NOS for Birth control.  On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 10-Jan-2021, the patient experienced AXILLARY PAIN (Pain in her armpit of the same arm she got the vaccine administered), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) and VACCINATION SITE PAIN (Tenderness from the injection site is gone). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.   At the time of the report, AXILLARY PAIN (Pain in her armpit of the same arm she got the vaccine administered) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) had not resolved and VACCINATION SITE PAIN (Tenderness from the injection site is gone) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
SEVERE FATIGUE; ANXIETY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-APR-2021, the subject experienced severe fatigue. On 12-APR-2021, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety and severe fatigue was not reported. This report was non-serious.
Day one following injection, site looked like a big, bad bug bite. Day two was hard, red and HOT, and the size of a baseball. Day three was hard, red, hot and the size of a softball. Almost like it had a bulls eye around it. Day four was same size, however less intensity on redness and heat. It never really hurt him, just annoying. Day two we applied bentonite clay. Day three he took a bath with Epsom salts and a few oils. Day four he took the same bath with some bentonite clay added to it.
Began 03/30/21 with Headaches, Blurry Vision, Racing Heart, Felt like my blood pressure went thru the roof. Following Week 04/04-04/10: Migraines, still blurry vision Following Week 04/11-04/17: Troubles Breathing catching my breath, still headaches/migraines, Developed Rashes. Following Week 04/18-04/24: Same issues as previous week no changes Following Week 04/25-05/01: Same reactions from previous week except on 04/27/21 I woke up with Massive Chest Pain, Extremely hard to breathe.
PATIENT HAD A FEVER WHICH WENT AWAY THEN SHE DEVELOPED A RED LINE WHICH STARTED FROM THE INJECT SITE AND MOVED TOWARDS THE BACK OF HER ARM WHICH WAS PAINFUL. PT WENT TO A CLINIC AND THE MD EVALUATED HER AND GAVE HER AN ANTIBIOTIC.
Patient experienced aches, low grade fever and was very tired for 24h. This was the first time that she got the high dose flu vaccine and in previous years she has never experienced these symptoms with the regular flu vaccine.
This spontaneous report was received from the patient's mother and refers to currently 23 years old male patient. The patient's medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route of administration, lot number and expire date were not reported). No concomitant therapy was reported. On an unknown date, after receiving RECOMBIVAX HB, the patient experienced fatigue, muscle ache, stiffness in the back and neck, constipation, drowsiness, and sleeplessness. The patient sought medical attention (call physician). The patient's outcome was not reported. The relatedness between the vaccination with RECOMBIVAX HB and the adverse events was not reported. Additional information has been requested.
day 3 post vaccine - left axilla pain/swelling.  day 4 post vaccine - left axilla pain/swelling and chest/left breast swelling, tenderness day 5 post vaccine - left axilla pain/swelling and chest/left breast swelling, tenderness  notified doctor - started motrin 400mg three times/day day 6 post vaccine - left axilla pain/swelling (swelling is much less in chest/breast) day 7 post vaccine - left axilla musch less pain/swelling
Shingrix Patient stated she had some Upper leg pain, Throat Pain, Swollen Throat, Stated she Can only have soft food bc throat hurts, Hard to swallow meds and food, Fever, Injection Pain Site, Headaches.
Client went out to hallway to get a drink of water where he went unconscious to the floor. Witnesses suggested client had a seizure when he awoke he vomited. Examining physician suggests client fainted
Pfizer vaccine was administered outside of facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------- G40.201 EPILEPSY, COMPLEX PARTIAL SEIZURES W STATUS EPILEPTICUS 11/3/2022 SEVERE OBESITY EQUIVALENT, BMI 35-35.9, ADULT W CO-MORBIDITY G40.201 EPILEPSY, COMPLEX PARTIAL SEIZURES W STATUS EPILEPTICUS 11/3/2022 GANGRENE OF LEFT FOOT G40.201 EPILEPSY, COMPLEX PARTIAL SEIZURES W STATUS EPILEPTICUS 11/3/2022 GANGRENE OF RIGHT FOOT G40.201 EPILEPSY, COMPLEX PARTIAL SEIZURES W STATUS EPILEPTICUS 11/3/2022 HTN (HYPERTENSION) G40.201 EPILEPSY, COMPLEX PARTIAL SEIZURES W STATUS EPILEPTICUS 11/3/2022 HYPOXIA G40.201 EPILEPSY, COMPLEX PARTIAL SEIZURES W STATUS EPILEPTICUS 11/3/2022 NAUSEA AND VOMITING G40.201 EPILEPSY, COMPLEX PARTIAL SEIZURES W STATUS EPILEPTICUS 11/3/2022 SUBDURAL EMPYEMA
No Adverse Event. Patient was given Proquad MMR/VAR vaccine and Varicella inadvertently. Which gave her two doses of varicella at same time.
Patient was given vaccine after stating not ill, etc. 12 hours later called to say diagnosed with flu. Within 48 hours pt said arm deltoid left was warm to touch and sore, red. Patient could not come to be evaluated but did take some benadryl. Patient states benadryl calmed the arm. When she returned to pharmacy, arm was red. Appeared to be injection site reaction. Patient stated did not have that issue with the first round of shingles vaccine.
Patient experienced swollen red arm for about 24 hours....dizziness for about 3 to 4 days, not to point of fainting...sweating per Dr. office but not from patient...imbalance gait...saw doctor about 12/10/2018...patient is feeling much better.
No additional AE reported; HCP calling to get T/E evaluation for GARDASIL 9. GARDASIL 9 was transferred in a cooler with ice packs without a data logger from one facility to another. Gardasil 9 was administered while it had a T/E. T/E could not be evaluated. HCP did not h; This spontaneous report was received from a nurse referring to a patient of unknown age ad gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 07-SEP-2023, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 957404, expiration date 05-OCT-2025 (dose and route of administration) for prophylaxis (product storage error). No adverse event was reported.  Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was transferred in a cooler with ice packs without a data logger from one facility to another.  Lot number 957404 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
I have shortness of breath. It?s not something that is affecting my life but I have this symptom since I got the vaccine