chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/14 Emergency room HPI Patient is a 94 y.o. male who presents with complaint of cough that started about a week ago, and was seen by primary care provider on the 9th February 2021.  Patient was started on Augmentin and has taken it for about 5 days but said the cough is worse and productive of clear sputum.  Patient in ER to get checked for pneumonia.  Patient denies a fever or chills, shortness of breath, chest pain, nausea vomiting and no headache or dizziness. Transferred to another facility h&pHistory of Present Illness:  94-year-old former smoker with a history of paroxysmal atrial fibrillation not currently on anticoagulation, coronary artery disease, insulin-dependent diabetes, CKD 4, prostate cancer on surveillance, TAVR 2/17, with a son who is a doctor and a caregiver who is a Radiology NP by his report, who presents in transfer from previous Hospital due to a large right pleural effusion.  He has had a cough for some time now, but thinks it may have worsened, at least per his caregiver, over the last 4-5 days.  He was seen by his PCP on February 9th and placed on Augmentin, but nothing changed.  He himself denies being short of breath, having any chest pain, fevers, chills, sweats, change in appetite, abdominal pain, nausea, vomiting, dysuria, diarrhea.  Of note, on a chest x-ray in June he had bilateral pleural effusions, and on an MRI in July to investigate a renal mass, he was noted to have a small right-sided pleural effusion.        On arrival to facility this morning, he was afebrile, normotensive, had a normal heart rate, sometimes mildly bradycardic, normal respiratory rate and saturations of 97% on room air.  Labs demonstrated chronic anemia and thrombocytopenia, stable stage 4 kidney disease creatinine of 2.6, BUN 64, glucose 187.  Chest x-ray demonstrated a moderate right pleural effusion, noting that underlying consolidation cannot be excluded.  He was also felt to have bibasilar atelectasis.  CT of the chest without contrast showed a large right pleural effusion with most of the right lower lobe being collapsed.  Superimposed infection could not be excluded.  He had a small left pleural effusion with adjacent atelectasis and a small pericardial effusion as well.  EKG and procalcitonin were not performed.  He was sent to our facility for thoracentesis.         On arrival here, vitals remained stable.  His bedside RN informed me that upon returning from the bathroom, he appeared to be a bit dyspneic, but the patient himself denies any shortness of breath or ?huffing and puffing?. 2/25 admEd to hospital admission
Patient received his 2nd dose of flu vaccine for this season and his dad noticed he was wheezing a few minutes afterwards when he arrived home. Dad brought him back to the office and administered a nebulizer  treatment of albuterol sulfate inhalation. 2-23-16 This is a 9 month old here for check-up. Is doing quite well with his molding helmet per Dr. PE is otherwise normal. Immunizations up to date. Recheck in 3 months. 2-23-16 This is a 9 month old here for check-up. We just saw him earlier this morning here for his 9 month check-up. Had a molding helmet on but his exam was normal. We gave him the second flu shot and upon arriving home about half an hour later he started having a little bit of wheezing. Neither of his parents are allergic to eggs. He did not have any problems at all with his first flu shot in November 2015. Upon examination he has more of a croupy sounding voice with very, very minimal wheezing in the lower lung fields. I gave him a neb mask treatment and the wheezing cleared up. I went ahead and did an RSV test but this was negative. Thus may just be the onset of some croup. However it was certainly related from a time point of view within an hour of giving him his flu shot so it could also be a flu shot reaction but he responded well to the breathing treatment. I am going to go ahead and put him on PRELONE syrup 4 ml. Once a day for the next 3 days. They will elevate the head of the bed, use a vaporizer. They will call if symptoms worsen. 6-11-15 This is an extended visit for this 2 week old that was born at 37 weeks. Had an induced vaginal delivery because of maternal preeclampsia. Was admitted directly to the NICU where certainly after birth started having some seizure activity. We don't have the complete dictated records yet. Was sent home with the diagnosis of hypoxic ischemic encephalitis and is on KEPPRA and also Phenobarbital which are being monitored by the neonatology service. We are going to try to get an appointment in the near future with neurology. The child otherwise is taking pumped breast milk 60-90 cc's every 3 hours and is gaining weight. The child's exam does have a right turn of his head but will work with this over the next couple of weeks. May need physical therapy if it does not resolve. Neurological evaluation is normal. HEENT is negative. Neck is supple. Chest is supple to auscultation. Cardiac exam is normal. Abdominal exam is unremarkable. IMP: Seizure disorder secondary to hypoxic encephalopathy. Will get an appointment as soon as we can. Will also recheck in 1-2 weeks to make sure that his weight gain is going well. Answered numerous questions for this very nice family.
Had DTaP vaccine on 08/27/01. Redness on 08/28/01. 08/29/01, area of erythema around injection. No systemic reaction.
First dose Moderna Lot #001B21A. Second dose Pfizer Lot #EW0162
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with combined KINRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown).  At an unspecified time after vaccination with KINRIX, the subject experience erythema, hardness injection site, swelling injection site and injection site warmth.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events were possibly related to vaccination with KINRIX.  The case corresponds to a pharmaceutical product complaint.  The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX.  At the time of reporting, no additional information was available.  This is case 13 of 15 (see case IDs A0860669A, A0860688A, A0860690A - A0860699A, A0860701A, A0860702A for the other reports).
This case was reported by a nurse via call center representative and described the occurrence of chills in a 18-year-old male patient who received BEXSERO (batch number 153701, expiry date 30th April 2017). Previously administered products included BEXSERO (No trouble). On 3rd June 2016, the patient received the 2nd dose of BEXSERO .5 ml. On 3rd June 2016, 3 hours after receiving BEXSERO, the patient experienced chills, injection site swelling and tremor. On 4th June 2016, the outcome of chills and tremor were recovered/resolved. On an unknown date, the outcome of the injection site swelling was recovered/resolved. The reporter considered the chills and tremor to be probably related to BEXSERO. The reporter considered the injection site swelling to be almost certainly related to BEXSERO. Additional details were provided as follows: Less than a day after receiving BEXSERO, the patient experienced injection site swelling. The reporter stated that, the patient had no trouble with first dose of BEXSERO.
almost instantly as soon as the shot was administered I had a pain in the top of my hand that lasted the entire day. Approx 30 minutes after the vaccine I was home and had tingles like pins and needles in my body at different locations. I also had the palms of my hands were both all blotchy red and burned a little and itched a little but the biggest issue was they were blotchy red almost like hives but not. these issues lasted approx 3-4 days. I spiked a low fever which corrected on its own and had an terrible headache for 2 days. Im on day 17 post booster vaccine and approx 3 days ago i started having some numbess and or cold feeling on my buttocks as if you had been sitting for hours on a chair or a feeling as if you were outside in the cold and came inside..hard to explain. and for 2 days now i have faint constant ringing in my ears. Not sure if the most recent effects are from the booster as its been 2 weeks when these started however the first few were almost immediate.
Patient experienced labored breathing and a swollen left eye starting the day after the vaccine was given and lasted about a day.
Patient contracted COVID after being fully vaccinated Chills, dizzy, anorexia, fever, congestion, cough, headache, fatigue
4 hours after vaccine the pt became very fussy, started w/vomiting. Mother has Td allergy.
Paresthesias suddenly occurred and have been persistent, workup for stroke has been negative and while still present the sx have been slowly resolving. 11/17-11/19/2009 MR and DC summary received for 10/18-10/19/2009, Dx TIA Patient with c/o's numbness/tingling lt side of face, lt forearm and hand. Neuro exam noted loss of sensation LUE and face, Tx ASA.
Caused RA to flare after each shot to the point after the first unable to walk. After the second severe swelling in the joints of hands, feet and all over. More study should be done on people with immune disorders thinking about taking this vaccine. Very dangerous for people with immune disorders in my opinion.
Severe headache - Dizziness - fever - cough - stuffy nose, general ill feeling, oral cavity mucose Mb and upper lips - erosive reaction - ulcer - still severe headache and dizziness.
I've been having PVCs in Bigeminy. I'm currently meeting with a cardiologist who informed me it could have been the vaccine and I'm also meeting with an electrophysiologist who put me on flecainide.
Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who experienced expired DAPTACEL was administered to a patient, while she received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE for Immunisation; ACTHIB for Immunisation; and MENACTRA for Immunisation. On 03-Dec-2018, the patient received a first dose 0.5 ml dose of suspect DAPTACEL lot C5101AA, expiry date- 26-Nov-2018 via unknown route. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for expired DAPTACEL was administered to a patient. 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 and Module VI of the 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.
This case was reported by a pharmacist and described the occurrence of swelling injection site in a 30-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). Concomitant medication was not reported. The subject had no reactions to other vaccines. No allergies to medication. On 31 March 2014, the subject received an unspecified dose of BOOSTRIX (route unknown, left arm). On 31 March 2014, immediately after vaccination with BOOSTRIX, the subject experienced swelling injection site. Then, symptoms went away. After that, she started getting injection site pain when she exercised or moved the arm. At the time of reporting, injection site pain was unresolved. Follow-up information received on 29 May 2014: At the time of reporting, injection site pain was resolved.
Information has been received from a 64 year old female with an allergy to tetracycline and a history of food allergy when she was younger who on 07-AUG-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).  Concomitant therapy included EVISTA, ezetimibe (MSD), over-the-counter calcium (unspecified) and a daily multi-vitamin (unspecified).  On approximately 07-AUG-2007, the patient developed a quarter sized redness and itching at the injection site.  She also had two spots underneath her right arm on the right, one spot was two inches below the other one.  She had no pain but was wondering if it could be an outbreak of shingles.  She noted that should would contact her physician.  No medical attention was sought and no diagnostic laboratory tests were performed.  At the time of the report, she had not recovered.  A product quality complaint was not involved.  No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2023) Negative; (08Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient had no known allergies. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient took Paxlovid starting on day 1 of COVID-19 from treatment from 31Mar2023 to 05Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I had nausea at about 11:30 am the day after I had the Moderna vaccine.  It lasted into the evening.  I know longer have nausea.  I took 1 mg zofran twice to settle it down. The 3 weeks of Clindamycin had upset my stomach with the same symptom so I am not sure if it was the Moderna or residual from the Clindamycin.
Headache, Myalgia, Arthralgia, malaise Narrative: States she compares the side effects similar to those she experiences after having a Flu vaccine.
This spontaneous report was received from a patients wife refers to her 77 year old husband. The patient has cholesterol and also takes heart medicine. On an unknown date in DEC-2011, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was not reported, route was subcutaneous). On 13-MAR-2013, the patient had shingles after getting the ZOSTAVAX. The patient got it in the left eye. The rash cleared up about 2 weeks ago but the patient still continued to have headaches. Laboratory tests were not performed. Treatment was not provided. The outcome of the events were unknown. The patient sought medical attention. Additional information has been requested.
"Huge red circle" at "knot" warm to touch per mother on 7/31/13. Lt arm advised by MD to give TYL/MOTRIN seen by PCP 8/4/13 circle still present but improving.
Dizziness, tiredness. Began less than an hour after receiving vaccine. Symptoms have worsened on following day.
L swelling 10 x 12 cm with erythema of anterior thigh after DTaP 3/28/06.
After 12 hours, lost consciousness for approx 2 min, body had spasms. Had no weakness prior to the episode, arm wasn?t sore either.
Dizziness and headache immediately following the vaccine administration, and persistent dizziness the next day. Seen back, and PE was normal. Normal neurologic exam.
Expired dose given; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received Hib (Hiberix) (batch number J7CS5, expiry date 01-APR-2023) for prophylaxis.   On 28-APR-2023, the patient received Hiberix. On 28-APR-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-APR-2023 A reporter called to report that a patient received an expired dose of Hiberix.  They gave information about patient and vaccine and medical information was received. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. A patient received an expired dose of Hiberix, which led to expired vaccine used.
REC'D  immunization, the following day, December 6th, her arm was slightly swollen and itchy. She took Benadryl but did not find this to be effective. Two days following receipt of the vaccine, she reports that she developed a generalized achy feeling over her entire body and that the pain and itch at the vaccination site increased. She also began to experience pain in her left axillary area. She also reports an ongoing headache that she rates a 4/10. She reports that she took Motrin 400MG once for her symptoms but did not find this medication to be effective. on exam was found to have , left axillary adenopathy palpable and tender, slight fullness noted in supraclavicular area. difficulty with range of motion of left arm. Also, 8.5 X 6 cm area on left triceps area with warmth, erythema, and slight edema that was painful to touch.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 28-JUN-2012, was vaccinated with the third dose of GARDASIL (dose, route and lot number not reported) that could have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. No medical history was reported. On an unknown date 2 years ago approximately in May 2011, the patient was vaccinated with a dose of RECOMBIVAX HB (lot #, expiry not reported). His job in law enforcement is requiring him to take another unspecified Hepatitis B vaccine today 02-MAY-2013. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Chills then fever, difficulty breathing, hoarseness, paleness, weakness, fast heartbeat but low blood pressure (sounds impossible).
9-5-13 Redness, "bumpy rash" above site of administration; itching. 9-9-13 Reported to pharmacy; BENADRYL to help with itching per doctor's office phone call.
Mother reported that child had large swollen lympnodes under his armpit. They were visibly swollen and painful. Mother reported that they lasted about a week.
Woke up in middle of night muscle arm pain stiffness, headache, nausea. 6 hours later still has fever, 101.1.
Pt received her second covid 19 vaccine on 3/11/21 and came to the ER on 4/25 c/o sudden right sided facial weakness starting 4/24. noted to have r sided facial drooping c/w bell's palsy. pt was given antiviral, steroids and discharged home to recover from the ER.
pt recvd vax & devel f, malaise & chills; lab tests showed  anti hbs 7.8;
someone has pneumonia right now; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (someone has pneumonia right now) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (someone has pneumonia right now). At the time of the report, PNEUMONIA (someone has pneumonia right now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
no adverse effects; Temperature excursion; This spontaneous report was received from physician referring to a 2-month-old female patient. The patient's historical vaccine included hepatitis b vaccine (recombinant) (manufacture unknown) on 29-MAR-2023. Concomitant medications included hepatitis b vaccine (recombinant) (manufacture unknown), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL). The patient's concurrent condition was not reported.  On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion, and the vaccine was not viable according to manufacture. On 05-JUN-2023, the patient was vaccinated with the first dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1968386, expiration date 23-MAY-2024, administered orally (PO) by a physician in private doctor's office/hospital for prophylaxis (strength and dose were not provided) (product storage error). The vaccine was purchased with public funds. Alarm believed to be due to sensory issues, and temperatures were monitored with back up logger. Temperature was in range, new data logger was currently in use. No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
Slept most of the weekend; Spiked a fever of 102.5F; Shortness of breath; Achy all over; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Shortness of breath), PAIN (Achy all over), SOMNOLENCE (Slept most of the weekend) and PYREXIA (Spiked a fever of 102.5F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DYSPNEA (Shortness of breath), PAIN (Achy all over) and PYREXIA (Spiked a fever of 102.5F). On 02-Apr-2021, the patient experienced SOMNOLENCE (Slept most of the weekend). On 05-Apr-2021, DYSPNEA (Shortness of breath), PAIN (Achy all over), SOMNOLENCE (Slept most of the weekend) and PYREXIA (Spiked a fever of 102.5F) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-067289 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067289:
Patient completed DTaP series on 05/10/2002.  Diagnosed with Pertussis on 08/20/2003.  DFA (+) culture pending.  Cough x 2 weeks.  Treated with Zithromax.
I received dose #1 on 1/6. I had a moderate to severe headache that evening starting at approximately 9pm which was relieved by ibuprofen. 24h later 1/7 at approximately 8pm I developed a moderately sore arm covering a large area surrounding the injection site. The pain lasted approximately 36 hours.