chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized (11.4.21);  COVID-19 positive (11.4.21);  Fully vaccinated PLUS booster  Admission Date: 11/4/2021 Discharge Date: 11/10/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COPD exacerbation  COVID-19  HOSPITAL COURSE: Patient is a 57 y.o. male who presented with cough, chest pain and rib pain.  He has a known history of severe centrilobular emphysema with bronchospastic component and follows with Pulmonary Dr., GERD, Depression, Tobacco use (quit 5 months ago), lumbar back pain with radiculopathy that presented with shortness of breath and dry cough.  Found to be COVID positive with symptom onset 11/2.  Admitted for chronic obstructive pulmonary disease exacerbation secondary to COVID pneumonia. Patient reported to have received the JJ vaccine and most recently the Moderna Booster (11/4). CXR demonstrated no consolidation or effusion. His home prophylactic Azithromycin was held during his stay and patient was treated with Remdesivir, Solu-Medrol and Doxycyline. He completed 5 days of Doxycyline with noted negative pro-calcitonin. During his stay he never required any supplemental oxygen and was transitioned to oral steroids on 11/10. Pulmonary was consulted during his hospitalization.  He also was treated with robitussin with codeine with improvement in cough. Patient reported acute on chronic back secondary to coughing fits and was started on Norco and Flexeril during his stay. Both wife and patient insisted on continuing Robitussin, Norco and Flexeril on discharge and patient was provided a short script. MAPS was reviewed. Narcotic precautions were provided and recommended that he follow-up closely with PCP regarding pain management. He was also prescribed a stool softener given narcotic prescription. He was given a prednisone taper on discharge and recommended to follow-up with his pulmonologist.   Patient was discharged in stable condition and discharge instructions provided.
After receiving 4 vaccinations the patient had complaints of blurry vision and began dropping his head back and forth, he then began saying he was tired and started closing his eyes, his skin became pale and the patient continued stating how tired he was. Patient was placed in a wheel chair and was placed in an exam room  to lay down  first BP taken at approx. 10:35am was 79/35, Next BP taken at approx. 10:40 was 90/60. The patient was given something to drink and eat and stated he felt better before leaving the clinic.
Second booster shot, I became sick; I can hardly walk/repeats that he can't walk; He has to llive from an impairment from the vaccine; inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day; chest pain; abdominal pain; pain in my joints from the inflammation is so bad; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Second booster shot, I became sick), GAIT DISTURBANCE (I can hardly walk/repeats that he can't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He has to llive from an impairment from the vaccine), INFLAMMATION (inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day) and CHEST PAIN (chest pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Second booster shot, I became sick), GAIT DISTURBANCE (I can hardly walk/repeats that he can't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He has to llive from an impairment from the vaccine), INFLAMMATION (inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day), CHEST PAIN (chest pain), ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints from the inflammation is so bad). The patient was treated with MELOXICAM at a dose of 1 dosage form. At the time of the report, ILLNESS (Second booster shot, I became sick), GAIT DISTURBANCE (I can hardly walk/repeats that he can't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He has to llive from an impairment from the vaccine), CHEST PAIN (chest pain), ABDOMINAL PAIN (abdominal pain) and ARTHRALGIA (pain in my joints from the inflammation is so bad) outcome was unknown and INFLAMMATION (inflammation throughout my body/inflammation is so bad/ It's getting worse every day/It is systemic in my whole day) had not resolved.            No concomitant information were reported by the reporter. Patient reported that received the first two Moderna vaccinations and two Moderna booster shots and also reported that pain in his joints from the inflammation is so bad and it was a result of this vaccination. Other treatment medicine includes: Anti-inflammatory drugs.   This case was linked to MOD-2022-572009 (Patient Link).
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT THE VACCINE CLINIC ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
Flu like symptoms a day after the shot. Fever, chills, upset stomach, extreme dizziness, swollen lymph nodes, sore throat.
The area around the injection site became red; The area around the injection became swollen; The area around the injection site became itchy; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration on 05Mar2021(at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021, 4 days post the 2nd shot, the patient reported that the area around the injection site became red, swollen and itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event the area around the injection site became red, swollen and itchy was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a consumer via Pfizer (2017505484) refers to a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In 05-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for prophylaxis. Concomitant therapies included cetirizine hydrochloride(ZYRTEC). After 4 hours, the patient had worst reaction. She had not been able to lift her arm at all and bruising at the top of the deltoid muscle, the muscle right there because it was like in the joint where she got the injection and the bruising from the injection site was still there a week later but her arms had swelled up to twice the size it was and it was extremely painful but she could not even lift her shoulder, it almost made her muscle shoulder stagged down lower than her other one. She just could not do anything with her arm and since then she just get some numbness in her fingers periodically. The bruising was right where the injection was given which was actually on the very top part of her shoulder, it was not really in the middle of the deltoid where she always gotten the shot before. A week after (unknown date in October 2017), when she got her vaccine, she took blood test and they came back with low iron. All the events resolved apart from tingling and numbness. She took Aspirin when she was trying to make her arms feel better but it was done and she was taking it because of the pain. The reporter did not provide the causality for events with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
this all hit him really hard/had premature beats; heart rate skip a beat every other beat; had premature beats; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 31Jul2021 as dose 2, single for COVID-19 immunization. Medical history included feelings of premature beats around the end of May2021 or first part of Jun2021. It might have started earlier, but he didn't know for sure. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 10Jul2021 as dose 1, single for COVID-19 immunization. It was reported the patient ended up in the hospital and had premature beats (also reported as heart rate skip a beat every other beat). On 13Aug2021, all these events hit him really hard and ended up in the hospital for overnight on 14Aug2021 (presumed). As of 22Sep2021, the premature beats and heart rate skip a beat every other beat were ongoing. The outcome of the events was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever (101), bad headache, lethargy, slept for 16 hours straight, huge lump on arm with redness extending about 5" diameter, extreme soreness that has gotten a little better 5 days out.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix and the 1st dose of Shingrix. In November 2021, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingrix shots after getting shingles the first time.  The weekend before date of reporting, the patient got shingles again.  The patient stated that, the shots did nothing. This case was considered as suspected vaccination failure, since the details regarding the time to onset and laboratory confirmation for shingles were not provided.
Patient woke with severe chest pain and difficult to take deep breaths.  Chest pain extended over her shoulder and around her neck.  Pain worsened during the day, went to ER, found to have positive troponins and subsequent ecg were abnormal.  Echo was negative and angiogram showed no blocked arteries.  Cardiologist diagnosed her with pericarditis
25APR93 pt started to stare into space followed by shaking like a sz later in day had general sz; had another sz on 26APR93; taken to ER:
Patient presented to ER on 6/10 with c/o severe nausea and worsening tremors. CXray showed  a right upper lobe infiltrate. Pt was admitted to observation for vomiting with nausea, acute severe generalized weakness and pneumonia and was Covid positive upon rapid PCR.
TD 0.5cc at 4:30pm. At 4:45pm-fluttering in chest, lower limp numb, pruritus at site of injection. Benadryl 25mg po at 4:50pm. 6pm, fluttering ceased, lower lip numbness less stable. 6:30pm, to hospital.
Uncontrollable head jerking started this evening a few hours after he got the vaccine for dose on 1/11/21 which continued until he received dose 2. We were advised that that the vaccine could've triggered a tic disorder. We monitored it and have noticed that there is still ongoing symptoms of his head going backwards while walking or doing normal daily activities. We're now seeking opinion from a new primary care doctor a second opinion and for a possible referral to a neurological doctor.
a patient received Fluzone High-Dose Quadrivalent which was in extended shipping time making the vaccine not suitable for use/ No AE; a patient received Fluzone High-Dose Quadrivalent which was in extended shipping time making the vaccine not suitable for use/ No AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA272284 (sister case).  This case involves a 76 years old female patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ501AB, expiry date: 30-Jun-2021) via intramuscular route and right deltoid site on an 26-Sep-2020 for prophylactic vaccination which experienced an extended shipping time making the vaccine not suitable for use (product storage error and product distribution issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant medication was given to the patient.  It was an actual medication error due incorrect product storage.  It was a case of product shipment delay.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Severe headache, 10 days after vaccination he started having a rash at the injection site. Soreness in the arm, chills, fever, fatigue.Took tylenol.
3/22/17 Approximately at 10:37 AM patient ambulated approximately 7 minutes after GARDASIL vaccine when became dizzy light headed and had to be assisted to chair. Minimally responsive for 5 seconds, started to cry and awakened.
12/27/21 presents to ED for "multiple painful skin lesions that are draining and apparently infected". PMHx of "end-stage renal disease secondary to diabetes mellitus type 2" "personality disorder of unknown type and underlying dementia"
Bilateral hand and feet redness and itching, bilateral hand warm with burning sensation, rash/hives at injection site (right upper arm), face redness, bilateral hand swelling.
7 days. After vaccine arm started getting red, warm, and hard in a circular pattern ; became itchier as time passed; end of second day started becoming painful
Day one, appx.8 hour later intense pain in left thumb joint where there is arthritis/injury.  Did not attribute yet to shot.  Generally body and joint pain, mild first three days.  Mon eve/Tues morn extreme fatigue.  Heavy deep sleep with wild and incredibly vivid dreams.  Difficult to wake and get moving for appx 5-7 days.  Typically sleep 4-5 hours non consecutive hours and rise early without troubles.  During this time developed  sever neck and lower back pain.  Woke many times (and still ocassionally do) with both hands being numb and tingly.  Day 4-5 legs began to have pangs throughout calves and thigh unlaterally.  If felt as if every previous injury, joint and muscle, were flared badly.  Deep pain in legs.  Severe sciatica.  Severe pain and tightening of hamstrings for 3 days.  Deep bone or tissue??  pain continues still in legs.  Back and neck pain still present but with relief.  Pangs have returned to legs.  Calves and thighs.  Sometimes it is like restless leg, but then gets worse and worse.  I do suffer from fibromyalgia but unlike this.  Only one other time did I have leg pangs and pain like this August 2020 when sick with fever and fatigue for 2 weeks though tested negative for Covid at drive through swabbing.  Vaccine caused same reaction but is not going away.  Also, was directly exposed for 9 hours to Covid positive friend...kissed, ate and drank together.  Drove in car for 4 hours.  Did not catch Covid though he was very sick.  Possibly had Covid last year. ??
Erythema and Edema posterior right arm area 40 by 40 mm, with central firmness. Client reports he did not seek any medical care nor self treat at home. Denies any pain or constitutional symptoms. On 11/2 client at clinic for unrelated matter when he showed writer the site.
Spikevax produced itchy painful hot red welt 3 in across by 1.75 in high
Nurse reported VAQTA was administered after improper storage; unknown of VAQTA was prefilled syringe or vial, however it is known that it was a pediatric dose administered. The operator of the device was a healthcare professional. Requested follow up; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot number X003791, expiration date 01-JUN-2024 (dose and route of administration) for prophylaxis (product storage error).   The onset date of the event was reported as 01-JUN-2024 that is similar to the expiration date of the vaccine.  The temperature excursion was of 51 degrees Fahrenheit for 1 hour. No previous excursion were detected.
I started feeling bad around 5:00pm on 4/6 with a little nausea and sore arm.  It quickly changed around 6:30 to muscle aches, chills, fever, headache.  I took some Ibuporen and went to bed.  I still feel the same today 4/7 and its 12:45pm.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with an improperly dose of VARIVAX lot # N012618, expiration date 21-APR-2019 (also reported as 19-APR-2021), for prophylaxis (strength and route were not reported) which was reconstituted, concomitantly, with a properly stored Merck sterile diluent. The vaccine was improperly stored at a temperature between -14°C to -10°C during a time frame of 42 minutes and between -9°C to 8°C for 1 hour and 2 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.
Soon after I had the vaccine I started to have joint pain in all my major joints (knees, hips, elbows, shoulders, etc.) then I began to feel other symptoms.  Dizziness, random chest pain, shortness of breath after minimal exertion, difficulty concentrating, difficulty sleeping, heart palpitations.  Eventually I began to have high blood pressure for the first time in my life.
moderna covid19 vaccine EUA about 10 minutes after injection i was extremely dizzy, experienced brain fog in that i had trouble repeating my medication allergies. My vitals were monitored, BP i believe was 170/130 and I was in hypertensive crisis. Headache shortly thereafter. I was transfered to the ER where I stayed for 3 hours. oral Benadryl was administered. 25 mins later my left arm became numb and fingers tingled but subsided quickly. 1 hour later, I experienced oral effects - tongue and lips were burning and it felt like there was a golf ball in my throat and voice became a bit hoarse. I was given IV Prednisone and oral Pepcid and quickly recovered. Dizziness continued for the 3 hours. I was released and dizziness occured sporadically all day with headache and musle/neck soreness. At 10 PM that night I experienced a fever of 101.3 and chills. Tongue/mouth tingling remains periodically.   01/30/2021 left arm tingling and numb pinky and ring finger, shortly subsided. Swollen injection site and body aches. Trouble with asthma - used ProAir to conbat.
Redness on shoulder within 24 hours of injection, redness and burning after 30 hours, redness and swelling increasing significantly with burning itch at 42 hours
Went for routine check-up. Doctor ordered bloodwork. Liver enzymes are high. Abdominal ultrasound show a fatty liver. Hepatitis test came back negative.
redness, significant swelling of her upper arm, hot,fluid filled, mild pain, head ache, fluid is slowly leaving arm 1 week later.
got sick with mild symptoms; Initial information was received on 05-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case was linked with 2020SA351549 and 2020SA351548 (same reporter).  This case involves a male patient of unknown age who got sick with mild symptoms (illness), after being vaccinate with INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine (of unknown manufacturer) [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, patient got sick with mild symptoms (illness).   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.