chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None- vaccine given 16 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 16 days post expiry) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 16 days post expiry). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 16 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-395985 (Patient Link).
pt was given boostrix in stead of infanrix. pt had no adverse effects of this injections. The CDC and poison control center was notified and they stated that pt will have no adverse effects of this and since it was her fifth dose she dose not need any more of the DTAP injections. It was given in the vastus laterus left. on 12-28-07 at 2:oopm.
nauseous 1-2 days p/vax; vomited 3rd day post; vomiting severe 5th day post vax; ER Phenergan Im;
Discharge Provider: MD Primary Care Provider: DO Admission Date: 9/22/2022 Discharge Date: Oct 2, 2022   PRESENTING PROBLEM: Weakness generalized  Severe sepsis (HCC)  AKI (acute kidney injury)  Other closed fracture of twelfth thoracic vertebra, initial encounter (HCC)    HOSPITAL COURSE: Patient is a 70 y.o. male patient with past medical history of type 2 diabetes, hypertension ,class 3 obesity, obstructive sleep apnea, coronary artery disease, chronic daily alcohol use in remission since Labor Day, chronic kidney disease and generalized debilitation.  He was discharged a day prior to admission from Hospital.  Per family patient sustained a fall at home.  The patient also endorsed he fell against his bedside table attempting to get out of bed.   Patient presented with mild leukocytosis at 10.79 and was found to have a positive SARS-CoV-2 PCR test.  Patient did not endorse shortness of breath but did describe exertional dyspnea.  He had a left heart catheterization done August 29 which showed significant occlusions of the LAD and mid circumflex but no stenting was done due to his anemia and need to be on dual anti-platelet agents.  On arrival, His son states that he fell and hit his head on a piece of furniture without loss of consciousness.  His unenhanced CT head did not show any acute process however his CT lumbar spine shows a T12 nondisplaced superior endplate fracture and would be a subacute to chronic L2 transverse process fracture.  CT cervical spine did not show any acute fracture or dislocation, but did show a right apical nodule which appears unchanged and will need follow-up at 3 months.     During the hospital stay patient did not require any remdesivir or dexamethasone for patient's COVID-19.  He was continued on his home CPAP device.  In regards to presenting diarrhea and GI bleeding, enteric pathogen panel was benign including C difficile.  GI was consulted for need for endoscopic evaluation and GI recommended monitoring clinical stability and did not recommend endoscopic evaluation inpatient.   Spine service was also consulted for patient's T12 superior endplate an L2 fracture-nonoperative management with DLCO brace.  PT/OT were consulted to assess need for subacute rehab.
Syncope, Pallor, and Vomiting. Applied cold compress, laid with feet elevated. Due to concern with persistent vomiting and possible concussion, transferred patient to ER.
This infant was extremely irritable, with unconsolable crying for 12-15 hours. Febrile off and on for 12 hours, hives for 4 hours. Given Tylenol and Benadryl.
Vaccine administered 9/4/20 - the following day patient had low grade fever 99.9 & Red, sore arm, body aches for 2 days.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018, and lot #L038018, expiration date 13-SEP-2017, (dose and route of administration were not provided). The RECOMBIVAX HB was stored in a temperature of 50.8 degrees F for a cumulative period of 38 hours. No adverse effects were reported for any patient. Additional information has been requested.
Pain, tightness & swelling R neck/shoulder about 30 min after received meningococcal vaccine.
Rec'd call from EE that his Day 5 post travel testing resulted Covid POSITIVE, 11/20/21. EE returned . EE has returned to work on campus since travelling. EE asymptomatic.   Discussed EE will need to quarantine at least 10 days, likely end date 11/30/21
patient had anaphylactic reaction; labored breathing; Initial information received on 02-Mar-2021 regarding an unsolicited valid serious case from physician and consumer.  This case involves a 56 years old female patient who had anaphylactic reaction with labored breathing (dyspnoea), after receiving INFLUENZA VACCINE.  The patient's past medical history included other anaphylactic reactions but didn't clarify to what products.  The patient's past medical treatment(s), vaccination(s) and family history were not provided and no Concomitant Medication(s).   On an unknown date in 2014 at 3 in the evening, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in 2014, the patient developed a serious anaphylactic reaction, while patient went to dinner at 5 in the evening with friends started having labored breathing (dyspnoea), (exact latency unknown) following INFLUENZA VACCINE. These events were assessed as medically significant.  Patient states that the influenza vaccine that she had by Sanofi back in 2014 caused her to have an anaphylactic reaction and allergist was trying to find out what was in the flu shot to narrow down the reaction to what she was allergic to.   Doctor office states that the patient received the Fluzone for under 65 years of age back in 2014 but that office did not have records of exactly what vaccine she used.   Patient did not seek any medical care until the next day when she went to the office and physician subsequently sent her for test and to an allergist.  Patient was not sure of any other details of the injection from 2014.   In Dec 2020 her allergist gave her a skin test from Afluria and she had a "bad skin reaction" so then he gave her a "watered down" version of Afluria and she had redness with raised areas so he told her that she could not have further flu shots.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for the reported events.  Information regarding the batch number should be requested.; Sender's Comments: This case concerns a 56 years old female patient who presented with anaphylactic reaction and dyspnoea, after vaccination with INFLUENZA VACCINE .The time to onset is compatible. Past medical history included anaphylactic reactions. There is, however, no information regarding patient's condition at time of vaccination, past medical treatment, family history and  other relevant laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Worsening left arm deltoid pain, initial swelling without erythema resolved, pain has worsened over past few days, interfering with sleep.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified (Oka/Merck) VARIVAX that were improperly stored. No adverse effects reported. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Vesicular rash x 1 days on face, shoulders, right foot, forearms, forehead (probable varicella infection). Rx-Hydrocortisone cream 1% tid and Benadryl sinus 25/5ml q 6 prn, itching.
Large wheal with erythema; continued to enlarge for several days. Painful initially. Eventually began to itch.
felt a little off after her second Moderna Covid-19 vaccine dose. , Felt like she was removed; felt like she had a hangover; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little off after her second Moderna Covid-19 vaccine dose. , Felt like she was removed) and HANGOVER (felt like she had a hangover) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A, 007M20A and 039D21A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma (non-Hodgkin's) (Active case of Non Hodgkin's Lymphoma).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (felt a little off after her second Moderna Covid-19 vaccine dose. , Felt like she was removed) and HANGOVER (felt like she had a hangover). At the time of the report, FEELING ABNORMAL (felt a little off after her second Moderna Covid-19 vaccine dose. , Felt like she was removed) and HANGOVER (felt like she had a hangover) was resolving.            The  concomitant medications on use were not provided.  The patient was considered to be immune compromised and received a third full dose of the vaccine after her first two full doses. The patient reported no adverse reactions or side effects to the first dose and third dose.   No treatment information was provided.   This case was linked to MOD-2022-511194 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2022: Follow up  information included no new information.
Reports numbness, tingling feeling on and off, especially in the evening on left arm 2 days after receiving vaccination. She did not seek any medical attention.
This case is a part of two cluster cases and linked to the case 2013SA100252. this case is invalid as the individual patient identifiers were not reported. Initial spontaneous report  received from Healthcare professional on 03 October 2013. This case included 3 patiens, whose demographic details including initials, date of birth and gender were not reported. The patient had received a dose FLUZONE (batch number UH898AA and site of vaccination was not reported) intramuscularly on an unspecified date in September 2013. The medical history of the individual patients and concomitant medications were not reported. The illness at the time of vaccination and pre-existing, physician diagnosed allergies, medical conditions and birth defects were unknown. It was reported that three patients had experienced tenderness at the injection site. Corrective treatment was not reported and the patient has no laboratory test. The patient was recovered on an unspecified date. Documents held by sender: none.
Heavier menstrual cycle with increased cramping and pain about 3 weeks after second pfizer dose
No adverse event, but patient received Moderna Bivalent as second dose instead of Pfizer second dose.  Patient requested a booster, but should have been second dose
1.  painful, golfball size lump in right breast - not previously present ( 5-6 days after shot given in left arm). 2.  Menstrual bleeding and strong menstrual cramping in lower back after 1.5 years into menopause (1 week after shot). 3.  Sleep disturbances, waking multiple times per night, and awful nightmares / night terrors every night for past week following shot.  4. Metallic taste from 30 mins after shot, lasting up to 3 hours.
This is a 88 yr old male pt with a hx significant for -stage renal disease on hemodialysis, hypertension hypertensive heart disease and kidney disease, CAD, history of acute MI, dementia, GERD, gout, prostate cancer who is admitted with complaints of chest reviewed and back pain.  Pr records patient was noted to be grunting and hyperventilating while in the emergency department.  Imaging done was negative for a pulmonary embolism, showed minimal interstitial upper lobe and peripheral lower lobe interstitial and groundglass lung opacities which are nonspecific.  Patient was tested for COVID-19 and has tested positive.
Pt. returned to clinic 2 days after receiving vaccine. (L) arm swollen from deltoid to elbow. Warm to touch-reddened. Dx: Urticaria. Tx: BENADRYL and Hydroxyzine Hcl.
extreme pain in left arm, shoulder, back of shoulder and left side of neck, was giving muscle relaxers.  appt to see an otho dr Monday Jan 3
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 20-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
At 3:20pm, c/o face flushing & tingling in (R) leg approx. 10 min. after flu shot. B/P 120/100, P 72 x 2, at 5 min apart. No nausea or resp. distress. Diphenhydramine hydrochloride (tabs 25 mg) x 2 po given. B/P - 110/78, P 68. No further c/o's.
Reached out to my Doctor thru app because of UTI and was seen by the doctor 03/11 and after a physical (lower back pain and abdominal pain, nausea, urgently needing restroom often) and a Urine Sample, I was diagnosed with simple UTI and was given Cipromyacin and told to drink plenty of water.
Pt noticed 20mins-1hr p/recvd vax redness & swelling but didn't return to clinic for reevaluation; on 27MAR92 visit @ clinic noted 5x6 cm erythematous swollen area lt deltoid; instructed pt not to recvd DT;
pt recv vax 23OCT96 & on 9NOV96 pt exp sl greater than 50 lesions on scalp, torso, & face, h/a & cough;some lesions were papular, some crusted umbilicated & some crusted vesicles;
Case number PHEH2014US025019, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 39 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml of 18 Nov 2014. The nurse reported that before administration, the FLUVIRIN had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperatures were in between 46 to 49 degree F. No adverse event was reported following this mal administration.
Day after receiving Guardasil noted hives throughout body which increased over weekend. Prescribed Keflex and Benadryl.
sweating, clammy, not quite right, dizziness, felt lousy; No local reaction; felt bad evening of 9AUG93, but better 10AUG93;
Fever of 102.3, alternated Tylenol and Motrin every 4 hours. At 3:30 AM patient started throwing up. She threw up one time. 24 hours after vaccinations still has 101 fever and very tender and red at injection site.
This case was reported by a health professional on 17 September 2007.  A 24-year-old male patient received an intramuscular left deltoid injection of Adacel (lot number C2769AA) on 14 September 2007.  The following day, he developed a blister at the injection site, in addition to a "dull pain" and numbness.  He presented to the emergency room on 17 September 2007; treatment was not provided.  At the time of the report, the patient had not yet recovered.  Additionally, the patient had also received an injection of Tubersol intradermally in the right forearm on 08 August 2007.  Follow-up information received on 24 October 2007 from a health care professional.  The patient received no treatment.  In response to a query asking when the events resolved, the reporter responded "unknown".
Information has been received from a RN concerning a 13 year old female patient who on 15-Jan-2007 was vaccinated IM with a dose of Gardasil, lot #6536978/0955F. Several hours later, the patient experienced pain and swelling at injection site and extending into her hand. There were no other symptoms noted. Medical attention was sought. At the time of the report the patient was recovering. Additional information has been requested. 5/14/10 Follow up information has been received from a physician concerning the female student with no medical history who on 15-JAN-2007 was vaccinated IM in right deltoid with her first dose of GARDASIL, lot #653978/0955F. 24 hours later the patient presented with complaints of numbness and swollen thumb at the arm where shot was given. The physician stated "No reaction at the site of injection. Also itching." The patient recovered from numbness and swollen thumb at the arm where shot was given and itching. Additional information is not expected.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity needed to protect against  covid 19  at time of administration of vaccine.  Also patient did not call in to advise of adverse event.  This is administrative error without adverse event.
Red blood cell counts took a dump; he was bleeding internally; almost died after the Covid Vaccine; This is a spontaneous report from a contactable consumer (patient's daughter). An 85-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had the Covid Vaccine and his red blood cell counts took a dump afterwards. He was bleeding internally and almost died after the Covid Vaccine. Patient's cardiologist told him not to get the booster dose of the vaccine.  The patient was not the same since the vaccine, he cannot go grocery shopping anymore. He was receiving iron transfusions. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
arm is much more sore than her arm.; This is a spontaneous report from a contactable consumer (patient) via medical information team reported similar events for two patients. This report is for the patient self. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 07Feb2021 as 1st dose single for COVID-19 immunisation. The medical history of the patient included sinus infection. The concomitant medications of the patient azithromycin for sinus infection on 05Feb2021. On an unspecified date in 2021, the patient experienced sore arm. The patient was concerned because on Friday, 05Feb2021, she went to see an Healthcare professional at an urgent care and was given azithromycin for a sinus infection. She informed the provider she would be receiving the Pfizer COVID-19 vaccine and the provider did not give her an instructions to alter her plans. She reports concern and questioned if the azithromycin would have potentially interacted with the vaccine and made it less effective. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021170289 same drug/reporter/event, different patient
8/18/21: Admitted to hospital with breakthrough COVID-19.  Presented to ED secondary to onset respiratory distress, nasal congestion, right-sided substernal pain, and nonproductive cough, which began on 08/12/2021. Patient's oxygen saturation was found to be 88% at home, prompting her to seek emergency department treatment. Hx right thoracotomy 7/12/2021.  Diagnosed with Acute COVID-19 pneumonia, hypoxia and pleuritic chest pain. Note: patient recently vaccinated with J&J COVID-19 vaccine on 7/2/21. 8/20/21: Discharged home on home O2.
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. The reporter considered the influenza-like symptoms to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter had stated that after they provided the 1st dose of BEXSERO to the patient, they experienced flu like symptoms. Although, the reporter believed that the event was related to the BEXSERO, the reporter explicitly stressed that GlaxoSmithKline (GSK) not follow up and contact them as they did not want to deal with the paper work and information related to the incident. The reporter did not agree to follow up. This case was linked with US2019GSK030180, reported by the same reporter.
PATIENT HAS A RED RASH ON SHOULDER AROUND THE INJECTION SITE, PATIENT STATES THAT THE RASH IS SPREADING. THE AREA IS VERY WARM TO THE TOUCH. PATIENT SAYS ARM THAT WAS INJECTED IS SORE AND HURTS TO MOVE. SHE ALSO NOTES THAT SHE FEELS VERY LETHARGIC, PATIENT FEELS MENTALLY CLOUDY. SHE STATES THAT THIS IS NOT NORMAL FOR HER.