chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Literature report: 2016-NOV-01. It was reported in a Letter to the Editor received from the authors, referring to an 18 month old female patient who suffered from recurrent sino-pulmonary and viral infections due to varicella zoster virus (VZV) and Epstein-Barr virus (EBV) due to combined immunodeficiency (CID) with defective T cell proliferation in response to activation by antigens, anti-CD3 or anti-CD3/CD28, with weak or no impact on TCR-mediated cytokine production and homozygous CTPS1 mutations identified by exome sequencing. The patient's medical history included a hematopoietic stem cell transplant (SCT). The patient was currently I excellent health, 10 years post-transplant. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant medications were not reported. Following the administration of varicella virus vaccine live (oka/merck) (manufacturer unknown), the patient developed vesicular lesions on her legs. Then, one month later, she developed generalized varicella with VZV isolated from a typical lesion from blood (varicella zoster virus infection). Although this acute episode improved with acyclovir, as the months ensued, she suffered from recalcitrant vesicular eruptions, including one episode with corneal involvement (ophthalmic herpes zoster) and presumed varicella hepatitis (hepatitis viral). At the time of the report, the outcome of varicella zoster virus infection, ophthalmic herpes zoster and hepatitis viral was unknown. The relatedness of the aforementioned adverse events with varicella virus vaccine live (oka/merck) (manufacturer unknown) was considered as related since the events occurred followed the vaccine administration. Upon internal review, ophthalmic herpes zoster and hepatitis viral were considered to be medically significant adverse events. Additional information has been requested.
severe Fatigue/Myalgia/fever/Dizziness/Abd. Pain - s/p Kidney transplant - on immunosupp.  Recommend Emergency Dept.
Pt woke up on 9/2/01 with several lesions on the right side of her face over to her hairline. On 9/3/01, another lesion was noticed between her fingers of her left hand. Is now improving.
On 11/13/00, the mother of the patient called to say son's tongue swelled the day after his second Hepatitis B shot. It hadn't gotten worse, but had stayed the same. The parent did not give Benadryl. It was suggested the the parent call their physician and he suggested that the patient load up on Benadryl today. If the swelling not gone by tomorrow the mother should bring the patient in.
Pt woke 7/17 AM and coughed a bit of blood. On 7/18 AM, he woke and had a significant nosebleed. No hematuria, hematochezia, or melena.
The patient presents with a vasovagal syncope immediately after receiving the Moderna vaccine booster dose.
10 cm tall x 18 cm wide oval wheal, no open or draining areas. Tx with ALAVERT OTC 1 x day. Cold compress and topical cortisone.
This spontaneous report was received from a female pharmacy student of unknown age referring to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, dose number, site and route of administration, lot # and expiration date were not reported) which was not agitated thoroughly prior to administration. No adverse effect was reported.
This spontaneous report as received from a healthcare worker refers to unknown number of patients. On unknown dates the patients was vaccinated with improperly stored GARDASIL (dose and lot # not reported). No adverse effects reported. Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source.
10AM 22DEC94 pt eyes rolled back in head x 7; t100.5; evening a/ called MD office & brought pt to see MD; holding head to rt side & stiff; eyes rolled back in head while pt was being weighted; pt adm to hosp;
Pain in arm gradually got worse, pain in shoulder and arm that the patient  can't lift or move arm without pain; Pain in arm gradually got worse, pain in shoulder and arm that the patient  can't lift or move arm without pain; can't lift or move arm without pain; This is a spontaneous report from a contactable non-healthcare professional, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FW0161) via an unspecified route of administration on 13Apr2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation.  Medical history was not reported. The patient had no known allergies to medications, foods and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced pain in arm gradually got worse, pain in shoulder and arm that the patient can't lift or move arm without pain. Since the vaccination, the patient had not been tested for COVID-19. 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. The clinical outcome of the event pain in arm gradually got worse, pain in shoulder and arm that the patient can't lift or move arm without pain was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Beginning 4 a.m., extreme nausea, profusive sweating, severe body aches, head ache, muscles stiffness on right side of neck.  No fever until 4 p.m. on 12/31/20. I have been tired sleeping most of 12/31, 1/1/21 and some on 1/2/21.  Ran a fever 103.  At that point I took ibuprofen. Fever subsided. I continue with some stiffness in right neck with a mild headache.  No other known side  effects.
Patient received the COVID vaccine on 5/24/21.  On 5/31/21, patient started to experience chills, fever, and cough, which continued to progress until 6/3/21, when patient presented to the ER. He tested positive for COVID in the ER and was noted to be short of breath and satting 88% on room air.  Patient was admitted to the hospital on 6/3/21 for COVID treatment (remdesivir and dexamethasone).
According to the lot # Pt was given PCV 15 but was supposed to get HPV. No adverse effects noted
10/21/02 started oral typhoid-c/o high fever, chills, diarrhea and slight rash on face. 10/23/02 another dose of oral thphoid with c/o immediate severe diarrhea, high temp, chills and rash on face spreading. 10/24/02 advised pt to descontinue oral typhoid.  F/U both MD if needed.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: lymph node swelling was in left armpit
patient received vaccine on 1/20/2121, later that night husband found her slumped in chair, called EMS and patient was taken to Hospital where she died on 1/21/2021
Fever, Chills, Aches, Swollen Lymph Nodes, Hoarse Voice, Arm extremely sore, Large red area around site of shot
Left arm pain. In upper arm and occasionally into shoulder. Pain is where the flu shot was given. Worse with movement but is constant. Hard to turn steering wheel without sharp pain. Flu shot was in November and has had pain since then. Pain got worse last week. Tried ICYHOT without relief.
Pt recvd vax 17NOV93 jaw line itching-spread to ears & eyebrows by end of day; 18NOV93 face red like sunburn from neck up; 19NOV93 above areas had small bumps on them; drying more; 3DEC93 sx dec skin began to flake off;
was instructed to get booster dose of ENGERIX-B for low titer after series completion; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 19-year-old male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B.  Additional details were received as follows: The age at vaccination was not reported. The patient was instructed to get booster dose of Engerix-B for low titer after series completion.  It was unknown when series was completed and no details provided when titers were drawn. HCP unsure of when series was completed or any specific details. No further details were available.      Lab Comments: On an unknown date, the patient did lab test
After receiving the second dose my arm was sore for about 4 to 5 days. It wasn't as red as the first dose. I did get sick. I had to take off from work for about 4 to 5 days. I had aches and pains. All my muscles and joints hurt. When I had COVID I had chills, cough, sore throat, achiness, and I was off work for about 2 to 3 weeks. I had trouble breathing. My oxygen level was 88 to 93% for at least two weeks then it went up to 97%. Two days after I got COVID I woke up with lumps on my right breast. The doctor sad it wasn't cancer because the lumps had shrunk. They said my lymph nodes were just swollen. They saw that I had breast pain. That pain lasted for about 3 to 4 months. I had a cough that went through to January that lasted for 4 months. I was crying a lot with COVID. I was miserable. I had headaches and a chronic cough. I also caught two different funguses on my skin. The dermatologist said I got it because my immune system was low so my skin caught fungus. The fungus on my skin is still ongoing. I didn't sleep well at all. My sleeping was off. I also lost 10 lbs. I can't smell things unless it is really strong. With my taste I can only taste salty and sweet things.
Started with severe chills and severe aches, fever rose durin ghe night to @102.5. Symptoms continued 1/5 and into 1/6, with fever between 101 and 104.5. Saw doctor on 1/5/10.  Stated it was a reaction to one or both shots and that I should report.  Stay home, drink fluids, use Tylenol. 1/7 in afteroon. Fever was gone and aches much less.  !/8 - still just very fatigued and weak.
PT STARTED TO FILL DIZZY, AND LSO HAD SOME VISUAL DISTURBANCES. HIS BP AND , OXYGEN AND PULSE WERE NORMAL BP- 128/72, PULSE=-73, OXYGEN- 98
Initially  patient was noted to be unresponsive by his girlfriend and with concern of overdosing on clonazepam EMS was called.  During the evaluation patient was found to be on the floor unresponsive initially and responded to sternal rub.  His girlfriend has given him a 20 mg of intranasal Narcan and EN route he was given 4 mg of Narcan from the EMS and brought to the emergency department. He was maintaining his airway with a GCS of around 9.     On presentation to ED patient was found to have BP 215/118 with respiratory distress RR 30 with SpO2 98% on room air.   Labs showed leukocytosis 13.1 with HB 13.1 with hypokalemia 3.4 with normal troponin/lactate/procalcitonin with glucose 148 with urine drug screen positive for benzodiazepine with negative serum drug screening.  Influenza/RSV screening negative. COVID-19 positive.   Chest x-ray negative for any acute cardiopulmonary process. CT head negative for any acute intracranial process.   EKG showed NSR with QTC 456.    Patient was admitted for Klonopin overdose with accelerated hypertension with COVID-19 infection.   Patient was given IV hydralazine, potassium and Haldol in ED.   However when patient came to the floor from ED, he was awake, alert and oriented x3.  As he feels good he did not want to stay in the hospital.  He signed AMA before my arrival to see him.   Patient left the hospital against medical advise.  Patient understands that by leaving the hospital, he is placing his health and safety in peril, and can result in disability or death.
Ascending weakness in legs and arms - diagnosed as GBS. Treated with IVIG 2 gm/kg (175 gm) given over 3 days (9/30 to 10/2) and IVIG 1 gm/kg (90 gm) given over 2 days (10/4 to 10/5). 10/27/08-records received for DOS 9/29-10/8/08-DC DX: GBS. Presented to ED with 2 day history of worsening ascending lower and upper extremity weakness with abnormal sensation. Tightness and tingling of fingertip, elbow and knee. Unable to rise from squat. Episode of a fall. PE: ascending stocking glove neuropathy with weakness and decreased vibratory sensation in hands and feet. Swallowing difficulties. Treated with IVIG. 1/28/2010 Last seen in clinc 3/5/09. At that time continued to report fatigue, fine moto deficits, numbness in feet.  On exam found to have reduced reflexes and sensations. Expected to continue improvement over the next 12 months with likely no residual deficits.
Injection site was a little swollen; injection site redness; injection site itching; Injection site was mildly indurated; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE INDURATION (Injection site was mildly indurated), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (Injection site was a little swollen) and VACCINATION SITE ERYTHEMA (injection site redness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 15m2A?) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Peanut oil), Drug allergy (Relafen), Atrophic vaginitis, Prediabetes, Herpes simplex, Seasonal affective disorder and Hair loss. Concomitant products included VITAMIN D3, ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL), BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), METFORMIN and SPIRONOLACTONE (SPIRONOLACTONE A L) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Injection site was mildly indurated), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (Injection site was a little swollen) and VACCINATION SITE ERYTHEMA (injection site redness). On 28-Jan-2021, VACCINATION SITE INDURATION (Injection site was mildly indurated), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (Injection site was a little swollen) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not indicated.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Follow-up information updated medical history, concomitant medications, start date of the events, and outcome of the events. On 15-Apr-2021: Follow-up information received on 15-Apr-2021 included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I was driving in my car and my husband who I had called asked me if I had been drinking but I had not and I noticed my left hand was drooping or wanting to pill the steering wheel to the left so  my husband called my physician and she said it sounded like a stroke and I was told to seek medical attention being by a fire station I pulled in but did not go in and went to my mothers house instead and then went to sleep after going home my husband took me to the ER.
headache, tiredness, joint pain all over, muscle pain nausea, not feeling well at all
pt recvd vax w/in few hrs post vax vax began to exp prolonged fever;sx persist
pt recv vax 14NOV95 & 19MAR96 pt exp a mild case of varicella;pt recovered 28MAR96;
Patient with very watery green bowel movements with mucous with blood x 4.  1st administration of Rotateq earlier today very irritable. These symptoms started within 1hr of administration.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 14-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Fever, body aches, muscle pain, large baseball size red protrusion at injection site, hot to the touch.  Limited mobility in right arm,  couldn't use it for the next four days.
Flu-like symptoms; Welting at injection site; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and VACCINATION SITE URTICARIA (Welting at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Ankylosing spondylitis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and VACCINATION SITE URTICARIA (Welting at injection site). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved and VACCINATION SITE URTICARIA (Welting at injection site) had resolved with sequelae.        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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Information has been received from a medical assistant concerning a female patient who on an unspecified date was vaccinated with a dose of MMR II (lot number not reported). Subsequently the patient tested negative for mumps. The patient went to an office visit. At the time of the report, the patient's negative titters for mumps persisted. Follow up information was received from a medical assistant concerning a patient who over the summer, in approximately June 2009 was vaccinated with a dose of MMR II (dose, route and lot number not reported). It was reported that the patient had a titer check on 23-DEC-2009 and came back low for mumps at 0.65. The titers for VZV and rubella were good. No further information is available.
Fever symptoms (heavy chills, burning up) body ache, exhaustion, dizziness intense muscle aches, weakness, paleness. Fever ended on 4th day; rash started on 4th day -- diagnosed as cellulitis by M.D. [Rash is 4" by 7" but no red streaks or pus yet; painful & tender.]
Rapid heart rate (120-150); Headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 14:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy, depression and bladder spasms. The patient had no known allergy. The patient received unspecified other concomitant medication within 2 weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 17:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 at 10:00, the day after vaccination, the patient experienced rapid heart rate (120-150), headache and body aches.  Since the vaccination, the patient had not been tested for COVID-19. 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 reported events. The clinical outcome of the events rapid heart rate (120-150), headache and body aches were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Constant ringing in the ears.  Degree varies, can be intense and very loud.  It has been constant for nearly 3 weeks, due for 2nd dose of vaccine in 2 days.  Noise from ringing is very disruptive to sleep and disrupts hearing acuity.  Hard to keep aware of sounds around me such as motors, ebikes, running water.  Makes concentration very difficult, hard to focus and nearly impossible to distract from even with TV, music, etc.  I fear it may have caused severe hearing loss (beyond already present age related mild loss) but due to constant ringing it is hard to tell. This may lead to permanent damage.
Pt came walking in our office 10/06/06 with reaction on right arm, red, hot to the touch, big bumped, at the injection site and refused treatment/ Pt decided to go to ER. Because did not want to pay copay at our office. And walked out of office. Induration right deltoid 6in by 3in firm, hot, red.
(R) leg swelling and rash present 2 days after vaccine was given. Continued to worsen so Abx were prescribed to cover cellulitis.