chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild fever; Tired; headaches; A spontaneous report was received from a consumer concerning himself, who is a 56-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild fever, tired, headaches.  The patient's medical history was not provided. Concomitant medications reported were insulin, gavapentin for drug use for unknown indication.  On 07 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient experienced the events mild fever, tired, headaches.  Treatment details included ibuprofen.  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable  On 09 Feb 2021 the outcome of events mild fever, tired, headaches was resolved.
Erythema, warmth at injection site plus 4 inches surrounding. Advised BENADRYL and see MD. Left deltoid.
Experiencing redness on left arm of vaccination as well as itching. Itching spread to mid-rib area as well as up arm, neck and left side of face. She took Benadryl, which did help symptoms. She has a call into her doctor and will receive call back in the morning. She will proceed to ER if any serious anaphylactic reactions occur.
Patient had a vasovagal response to the needle after being vaccinated with the Pfizer -Biontech vaccine dose #1.. EMS personnel were at the site, she was given the appropriate care. Patient's vitals were Pulse ox read 99% in room air, heart rate 72,blood pressure 128/86. Patient was awake and alert. after few seconds of  the syncope spell. . No signs of head trauma ,denies, head and neck pain. Small abrasion noted on nasal bridge no bleeding noted.  Patient was observed  for an hour. Patient went home in stable condition.
10/7/99 4cm local rxn;treat ice & Ibuprofen;
Initial misuse report received from a healthcare professional on 06 January 2014. A child (date of birth and gender was not reported) had received a dose of FLUZONE. It was reported the patient had received 3 doses of FLUZONE instead of 2 doses. No adverse event was reported. Documents held by sender: none.
Pt ran temp of 105 & cried unconsolably for several hrs. Temp was the following morning. Pt seen by PMD that morning & diagnosed with double ear infection.
I received the moderna COVID vaccine. 13 hours later I woke up with a leg cramp. While walking downstairs I became very dizzy and sweaty chills. I sat in a chair. My husband came down a minute later and I was passed out in the chair. He was saying my name and rubbing my arms to wake me. It took him about one minute to get me to open my eyes and then another minute before I could coherently respond. He said my chin was tucked into my neck and I was pale and making noises for less than a minute. He said then I relaxed and responded coherently. My temperature was 94-95 for about an hour while I had chills but also was drenched in sweat. I was also throwing up clear fluid for about two hours. I felt nauseous for about 3 more hours. After that I just felt tired.
Tingling in mouth, lips; Slight swelling of lips; Weird feeling in throat; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0171, at the age of 33-year, on 06May2021 12:30 at single dose in left arm for COVID-19 immunization. Medical history included Irritable bowel syndrome (IBS). The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included ergocalciferol (VIT D), ascorbic acid (VIT C), vitamin b complex (VIT B COMPLEX) and zinc chloride. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received Hyoscyamine and Gantrisin and experienced allergy. On 06May2021 12:45, the patient experienced Tingling in mouth, lips; Weird feeling in throat; Slight swelling of lips. Nurses administered Benadryl on site. The outcome of the events was resolved in May2021.
1/08 - school reported she was very weak - 03/09 leg weakness/tired 03/09 pain started. Please see attached.  Patient continuity codes to 353037 and 353069. VAERS report received with MR and notes from PCP. Pt developed weakness and fatigue shortly after 2nd HPV vax on 12/2908.  ADLs greatly reduced due to lethargy and fatigue. Developed joint pain and pins & needles shin pain and loss of muscle control in 5/2009  Walked with a limp 2' to pain. See ER notes. Neuro consults with no specific dx. Referred to another neuro and will be seen 8/2009. In June 2009 developed hair loss. Following 3rd HPV shot 7/14/09 developed sharp chest and shoulder pain, fever, nausea and stomach pain, worsening pain in fingers, thrumb, wrist, elbow and arm. 8/28/09 ER records rec'd for DOS 5/31/09 with DX:  Acute lower extremity sense of weakness.  Acute LE paresthesias. Presented with c/o joint pain and weakness in legs since 5/18/09.  Unable to walk. sharp pains in shins and thighs.  Occ feels like airway is closing. PE (+) stiff-legged, wide-based gait.  Referral notes EKG abnormality, lower extremity strength 3/5, upper extremity 4/5.  Referral made for outpt PT.  10/8/09 Neurology consult, rheumatology consult, pediatric pain service records received, service dates 8/14/09 to 10/1/09 Assessment: Diffuse musculoskeletal pain, amplified pain. Abnormal ESR. Chronic steroid use. Patient presents for evaluation of diffuse pain. Intermittent activity-dependent fatigue and generalized weakness, Aching pain entire body. Transient swelling of face and hands. Jaw aches after chewing. Activities limited. Uses cane or wheelchair for walking more than a few steps. Occipital headaches. "Crouched" gait. Brief cervical lymphadenopathy. On corticosteroids - Cushingoid face and 30 lb undesired weight gain, sleep disturbances. Muscle tenderness and tender points. Antalgic gait. Episode of severe chest pain.
Approximately 1 week after my 4th dose vaccination I experienced the following symptoms: Occasional PDC and it became frequent as weeks have come by and I had some shortness of breath and chest tightness. My heart felt swollen and inflamed. I saw my nurse practitioner and was prescribed with atenolol 25mg/1x day and it did settle down my PDC. I will be seeing a cardiologist on 07/15/22 for a follow up.
12/28/17 Hepatitis B vaccine pulled from private stock which was pediatric dose and given to patient. (GSK) GlaxoSmithKline called. Summary of Immunogenicity and Safety of 10 mcg dose of ENGERIX B in Adults. Health Commissioner notified. No treatment needed.
Information has been received from a licensed practical nurse concerning a newborn infant whose 18 year old mother with a history of varicella who on 20-JAN-2009 was vaccinated intramuscularly (IM) in the left deltoid with first dose of GARDASIL (dose not reported, lot number 661703/0651X). Concomitant therapy included ADACEL (lot number C773AA), MENACTRA (lot number U2734AA) and EMERFLU (lot number U2840AA). Subsequently on 20-MAR-2009, the patient was vaccinated IM with second dose of GARDASIL (lot number 661766/0652X). It was reported that on an unspecified date at 34 weeks of gestation, the patient delivered a normal infant with no congenital anomalies due to premature rupture of membranes. The mother's experience is captured in WAES 0904USA00268. Additional information is not expected.
Heavy bleeding & bruising only days after the Gardasil Vaccine. Extreme fatigue, blood platelet count decreased to 20,000 and I was referred to a Hematologist. Diagnosed with ITP after several tests for other causes and biopsy.
I did and I still have shingles/Suspected vaccination failure; I did and I still have shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination. The patient said that vaccine did not work for everyone. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Information has been received from a physician concerning a 15 year old female patient who on 01-NOV-2010 was vaccinated with the third dose of GARDASIL (lot # 662518/0087Y, expire date not reported), intramuscularly. On 01-NOV-2010 the patient's blood pressure went to 41/18 following her third dose of GARDASIL. Patient stayed at the doctor's office for about 30 minutes until the blood pressure went back to normal. On 01-NOV-2010 the patient recovered. The patient's blood pressure went to 41/18 was considered to be other important medical event by the physician because the patient was "kept in office monitored". Additional information is not expected.
Information has been received from a mother concerning her 15 month old son with no drug allergy and no pertinent medical history who "when 15 months old" was vaccinated subcutaneously with a 0.5mL dose of MMR II (LOT# not reported).  There was no concomitant medication.  The mother reported that a week after the vaccination, her son experienced redness and rash all over his body that looked like rubella.  She brought him to a nurse who verified that the rash was rubella.  Patient had recovered about a week after the adverse events started.  Additional information has been requested.
Mild itchy rash on neck and chest; This is a spontaneous report from a contactable healthcare professional (patient). This 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration in the right arm on 21Jan2021 at 10:30 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have any allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine, omeprazole, and birth control. The patient did not have any other vaccines within 4 weeks prior to the vaccine. On 22Jan2021, the patient experienced a mild itchy rash on the neck and chest. The patient did not receive any treatment for the event. The outcome of the rash was recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
After Hep A, he experienced fever, abd pain, and now headache while standing & "twitching in the jaw and leg".
A 15 yo was inadvertently given ProQuad, a combination MMR/Varicella vaccine, instead of separate MMR + Varicella. ProQuad is licensed through 12 years of age.
Difficulty breathing (short and shallow breathes), vomiting, increased heart rate, nausea, dizziness, numbness in extremities, headache and weakness and tiredness. Symptoms arose approximately 8 hours after vaccination (between midnight and 1 AM, 4/9/21) and persisted until approximately 5 AM, coinciding with sleeplessness. Throughout the entirety of the next day nausea, headache, and weakness persisted. After 36 hours, mostly bedridden, and 12 hours of sleep the following night symptoms have dissipated as of 10 AM 4/10/21.
Worsening fever, body aches, and headaches but the swelling in my vaccinated deltoid got significantly larger and had redness and heat coming from it. As the swelling got worse I experienced pain in my right shoulder, elbow and wrist with some mild swelling. On February 13 (Sunday night) the swelling went up to my collar bone up and neck and that caused some difficulty swallowing. I went to the ER on February 14 (Monday morning) and they started letting me take steroids and it helped ease the swelling, prior to me going to the ER I tried the following solutions: Ice/Cold compress, Tylenol, and Motrin but none of them worked. As of today 02/16 the swelling has mostly gone down and I have seen a lot of improvement.
PATIENT HAD NO ADVERSE EVENTS, BUT RECEIVED THE INCORRECT PFIZER PRODUCT. PATIENT RECEIVED LOWER DOSE FOR PEDIATRIC (5-11YO) INSTEAD OF ADULT DOSE.
Tdap injection given in (R) deltoid on 11/26/12 at 4PM. Pt noted discomfort at base of neck at (R) clavicle on 11/28/12 10AM. There is small lump at above noted area on 11/28/12 1:30PM.
Pt states he started developing rash around trunk, arms, legs but not on face/feet and genital area.  Pt presented to Urgent Care Clinic and is taking Benadryl and Allegra.
Information has been received from a consumer concerning a 22 year old female who on 09-JUL-2009 was vaccinated with a dose of GARDASIL (lot no. not reported). Concomitant therapy included hormonal contraceptives (unspecified). The consumer reported that the patient had not had her period since getting GARDASIL. The consumer also stated that the patient "was a little woozy" after she was vaccinated. The patient's did not have a doctor but she was vaccinated in a local agency. The patient did not seek medical attention. Additional information has been requested.
Bell's Palsy diagnosed 3-31-21 by Dr. (Name). Started on Valtrex and Prednisone.
I had Covid confirmed with a PCR test in late Dec2021; I had Covid confirmed with a PCR test in late Dec21; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", described as "I had Covid confirmed with a PCR test in late Dec2021"; COVID-19 (medically significant) with onset Dec2021, outcome "unknown", described as "I had Covid confirmed with a PCR test in late Dec21". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive, notes: 'tested positive on 12Apr'; (21Apr2022) Negative, notes: '21Apr tested negative with a nasal rapid test'; (Dec2021) Positive, notes: 'I had Covid confirmed with a test in late Dec2021'; (25Apr2022) Positive, notes: 'tested positive on 25Apr with PCR'; (26Apr2022) Positive, notes: 'tested positive on 25Apr with PCR and again on 26Apr with rapid antigen test'; (18Apr2022) Negative, notes: 'On 18Apr I tested negative with salivary PCR'. Therapeutic measures were taken as a result of covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200633295 Same patient diiferent drug
Had a drastically different echocardiogram- his ejection fraction dropped 20%.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 (Batch/Lot Number: EN6201) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included heart history of heart failure and said that 'he died' on 09FEB2016. The patient's concomitant medications were not reported. The patient had a drastically different echocardiogram- his ejection fraction dropped 20% on an unspecified date with outcome of unknown. The patient reported about the Pfizer BioNTech Vaccine clarified as the COVID-19 vaccine. He thought that there were links. He added that he was fine on the vaccine. He wanted to report data he had a medical background in the medical field clarified as health administration. Since he had a heart history they do echocardiograms. The heart failure team at the hospital. He mentioned a drastically different echocardiogram. They did an echocardiogram the year before he got the Pfizer vaccine and then he had an echocardiogram after he got the Pfizer vaccine, the day before last. His ejection fraction dropped 20 percent day before last on an unknown date. He doesn't know why and was establishing a link between myocardia, clarified as inflammation of the heart muscle. He commented that it may not be, could be totally unrelated. The ejection fraction dropped with the Covid vaccine in the middle and a major drop in the ejection fraction. His went from 50% to 25-30%. He wanted to bring it to our attention. The more data it helps, a 20% ejection fraction drop in a heart failure patient is bad but he doesn't feel bad or any different to report. It was mentioned that the second dose of the vaccine was given on 12MAR2021  (lot number: 12MAR2021).   No follow-up attempts are needed. No further information is expected.
vasculitic/purpuric rash to the face and behind the left ear; right groin pain
This spontaneous report as received from a nurse and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 13-FEB-2017, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (route, lot #, expiration date and dosage number were not reported), for prophylaxis. Nevertheless, no adverse effects were noted. The vaccines experienced the following temperature excursions during 6 hours of more than 8 degree celsius (C) but less than 25 degree C. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001139: US-009507513-1703USA001137: US-009507513-1702USA009844: US-009507513-1703USA001135: US-009507513-1703USA001135:
Reason for Admission: dyspnea 2/2 COVID vs. Bacterial pneumonia   Brief Summary of Hospital Stay: patient is a 66 YO male with h/o lung transplant for IPF, MDS, CKD IV, HTN, hypothyroidism, OSA, CHF presenting for evaluation of subjective dyspnea without the need of oxygen. Found to be COVID positive and pancytopenic. He is following with facility and Dr. Per facility transplant specialist ok to be treated here and may be transferred there any time the need would arise or if he would worsen. Got one unite of irradiated PRBCs, was treated with Remdesivir (discussed with Dr. - transplant specialist, that in spite of his CKD stage IV ok to give; 3 days per protocol if not needing oxygen, if needing oxygen, then total of 5 days, completed 5 days prior to discharge), Rocephin and doxycycline - as discussed with facility specialist; Still the patient continued to decline clinically and started requiring oxygen. Chest x-ray showed likely increased infiltrates vs atelectasis. Regimen was switched to Doxy, vanc and zosyn and decadron added. ABG showed mild respirator alkalosis. Changes were made in discussion with Dr. On day 3, due to worsening clinical status decision was made to transfer to transplant service and he was gracefully accepted there. A bed was available the same night, however patient decided to wait until the morning due to being extremely tired, however the bed was not available in the morning any more. On day 5 a bed became available again and patient was discharged. D-dimer elevated on arrival, but about his baseline and improved on day 3, troponins elevated but downtrending during the stay. Kidney function stable. Due to worsening thrombocytopenia and anemia he received irradiated platelet and PRBC transfusions prior to discharge in discussion with hem/onc on call Dr.
May 14th, 2021 at approximately 23:00 I started getting a rash/raised lesion on my left arm at the injection site, which wasn't painful-just itchy. It went away after a while and is fine now.
Information has been received concerning a male pt who was vaccinated with 2 prior doses of varicella virus vaccine live and had a titer drawn 2 years after the 2nd dose and failed to seroconvert. Unspecified medical attention was sought. Additional information has been requested.
This literature report was received from the authors of a published literature article concerning a 49 year old patient of unknown gender who was classified to be a Reinfected Case (RIC). On an unknown date, the patient was vaccinated with the third dose of M-M-R II (route and lot # not reported). Despite the continued importations of measles virus into the article country, the elimination of indigenous measles had been maintained for over 15 years because of sustained high coverage with two doses of M-M-R II. Many countries have eliminated measles or have made significant progress toward achieving goals for measles elimination. However, measles remained endemic in many parts of the world and both sporadic cases and large outbreaks have occurred in this country following importations of the virus. Although most measles cases in the country have occurred among unvaccinated individuals, some confirmed cases have occurred among vaccinated and presumptively immune individuals. A suspected measles case in a previously vaccinated individual could be classified as a primary vaccine failure (PVF) by measurement of low-avidity measles IgG antibody. Individuals with confirmed measles and a prior immunologic response to measles virus (reinfection) from either vaccination or natural disease that occurred at least 4 months before symptom onset can be identified by the presence of high-avidity measles IgG antibody. A measles virus reinfection that occurs in an individual who had measurable specific antibodies after documented vaccination constitutes a secondary vaccine failure (SVF). However, the vaccination history of some persons with confirmed reinfections could be unknown, and among those with higher or equal to 1 documented doses of vaccine, evidence of a protective titer of antibody to measles following vaccination is rarely available. Therefore, the term reinfection case (RIC) can be universally applied to a confirmed measles case in a person with high-avidity measles IgG antibody. In this study, persons suspected of having measles with high avidity measles IgG antibody in serum were tested by standard laboratory methods and were classified as having either a RIC or a rash illness not attributable to measles (noncase). On an unknown date, the patient was reported to have had no detectable IgG despite the receipt of three doses of M-M-R II vaccine. It was reported that the IgG concentrations in this reinfected case increased rapidly after rash onset and reached peak titers before 10 days after rash onset. Between 1 and 2 months after rash onset, the elevated concentrations had fallen below 40,000 mIU/mL. In conclusion, although high coverage with two doses of M-M-R II vaccine has eliminated measles, vaccination may fail to stimulate a protective level of antibody in some individuals, even after two doses of M-M-R II. Additional information has been requested.
Vomiting copious mucousy green fluid. Extreme lethargy. Pale and listless.
(L) thigh, swollen and spreading cellulitis. Seen 4/22/11 in UC at clinic by PA.