chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 12/28/2021; COVID-19 positive 12/28/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 12/28/2021 Discharge Date: 12/30/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia  Acute kidney injury (AKI) with acute tubular necrosis (ATN) (HCC)  COVID-19    HOSPITAL COURSE: Patient is a 75 y.o. male with a past medical history of congestive heart failure, chronic obstructive pulmonary disease, type 2 diabetes, hypertension, tobacco use, coronary disease and obstructive sleep apnea who presented to ER with  shortness of breath.  Patient was seen earlier today in the emergency department and sent home on home oxygen, he did return this evening feeling that his condition was worsening.  Patient states his symptoms started 12/27 and has since worsened feeling short of breath, coughing, weakness and lightheadedness.  Patient is producing a white productive cough. Pt feels when he lays down he cannot breathe and needs to be propped up in bed.  Patient does admit that his ex-wife, whom he lives with is currently COVID positive.  Patient has been previously vaccinated but has not had his booster.  Patient is baseline on 2 L by nasal cannula, which she has since started couple weeks ago, but patient does admit to not wearing at all times. Patient was admitted to the hospital and started on IV steroids, lasix, remdesnivir, and azithromycin.  After 48 hours, patient's oxygen was weaned down to 2 L (baseline) and patient felt significantly improved.  Patient to be discharged home in stable, improved conditon.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine quadrivalent. On an unknown date, unknown after receiving Influenza vaccine quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product. This case was one of the 7 cases, reported by the same reporter.
Skin writing Helps with I use cortizone-10 (1%) and allergy medicine (loratadine 10mg antihistamine)
generalized pruritus; This is a spontaneous report from a contactable other healthcare professional. A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206), via an unspecified route of administration on his left arm on 08Mar2021 at 02:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient was allergic to latex. Prior to vaccination patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and also within 2 weeks of vaccination. On 15Mar2021 the patient experienced generalized pruritus. The clinical outcome of generalized pruritus was not recovered. No treatment was received for the adverse event.   No follow-up attempts are needed. No further information is expected.
VACCINE  ADMINISTERED AFTER TEMPERATURE  EXCURSION OCCURRED; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A  expiry: 07-AUG-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced vaccine administered after temperature excursion occurred. On 25-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after temperature excursion occurred and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210701990.
Within minutes (2-3) post vax, child broke out in welts on face, neck and arms. Epinephrine 0.15mg, intramuscularly, right deltoid muscle (1:1000) at 11:35 AM. Benadryl 0.6mg (50mg/1ml), intramuscularly, left thigh at 11:47 AM. No wheezing. Pt recovered.
Mandatory anthrax vaccine while deployed O/F rash on R arm (site of injection) that spread across chest and L arm. Given Benadryl and oral steroid - SX resolved in 5 days.
Breakthrough case admission after 2 vaccines moderan 3/7/21 Lot# 030A21A;  Moderna 12/10/21 Lot# 01321A
Very sore  and swollen arm. Light headed, dizzy.  Ankle swelling,  which I had never had before. Headaches, lethargy
Weakness and fatigue for over a month, headache off and on for 3 weeks on the right side of my head.  Was so tired I kept laying down during the day to rest.
Decrease in amount of menstruation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOMENORRHOEA (non-serious), outcome "unknown", described as "Decrease in amount of menstruation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021450627 same reporter, drug, event/different patients
FIRST THE SITE SWELLED, APPROXIMATLY 2" WELT.  FOLLOWED BY NAUSEA AND DIARRHEA THE NEXT DAY AND A FEVER OF 101.0, CHILLS AND THE SWELLING INCLEASED AND MY ARM BECAME WARM AND TENDER TO THE TOUCH.  THE 3RD DAY I STILL HAD THE FEVER AND CHILLS, NO MORE NAUSEA, BUT THE SWELLING INCREASED TO APPROXAMATELY FOUR INCHES IN DIAMETER. TODAY THE FEVER AND CHILLS ARE GONE, THE SWELLING INCREASED TO APPROXAMATELY SIX INCHES IN DIAMETER AND THE LYMPH GLANDS IN MY LEFT BREAST AND AXILLA ARE SWOLLEN.
Left thigh red and swollen, warm to touch, redness size of approx 3cm x 3cm. No fever/treatment-symptom care.
Headaches, muscle ache at injection site, nausea, and vomiting last night, this am pt had temperature 102.5 and not feeling well.
fever began 29JUL & cont into 30JUL; became very lethargic & was taken to ER where had 1 febrile seizure; pt was transferred to the hosp & kept overnight for observation; 1AUG & 2AUG broke out in a rash;
Pt states that she started feeling fatigued, slightly nauseous and had a headache within a few hours after receiving the vaccine. The symptoms, along with feeling "foggy brained" went on for the remainder of the evening and into the next day. Pt reports leaving work on 10/27 as a result. Pt states that now, on 10/28 at 1500, she is feeling back to normal.
3/6/23  My left eye started getting puffy like a stye was forming. By the time I had an appointment, 4 days later, the area under my eye had became puffy and I looked like I had been punched in the eye. I was diagnosed with allergic conjunctivitis in both eyes. I did not have itching at the time. started Lastaeaft eye drops At my normal visit, a month later, I still had the conjunctivitis.   A cold compress makes the swelling go away.  On 5/14/23, my eyes were red, swollen and itchy, but not swollen as before.
Information has been received from a registered nurse concerning a 2 year old patient who on 06/19/00 was vaccinated with a dose of Varivax. Subsequently, the patient developed chicken pox. The reporter indicated that there was a chicken pox breakout at a day care in her area. It was reported on 01/04/-2 that 15 children had developed chicken pox since the end of 12/01. The first onset date was12/31/01 and the last was 01/03.2002. The number of lesions were reported to be unknown. It was also reported that 7 of the children were vaccinated with Varivax (WAES0201USA00755, 0201USA00756, 0201USA00757, 0201USA1038, 0201USA1039 and 0201USA01041). Additional information has been requested.
About 4 hours later, I had a severe headache and I started feeling very tired. My body was very itchy, and I had fever off and on with chills for about 3 or 4 days. So, I went home from work and had the reaction for about two weeks total. I took Tylenol and plenty of fluids.
An Expired Vaccine Was Administered; Patient received second dose of Heplisav-B four months after first dose; Initial Report Received on 02-Mar-2023.    A registered nurse reported that a 59-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was expired.     Medical history and allergies were not reported at the time of vaccination. The patient was not on any concomitant medications.    On 01-Nov-2022, the patient received the first dose of HEPLISAV-B vaccine (no details were reported).    On 02-Mar-2023, the patient received the second dose of HEPLISAV-B vaccine (Lot # 937231, expiration date 30Jan-2023, NDC # 43528-003-05) intramuscularly in the right deltoid. The second dose of HEPLISAV-B vaccine that the patient received expired on 30-Jan-2023. The patient did not experience any adverse effects from the first or second dose of HEPLISAV-B.     Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
No adverse effects; multiple patients were administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information concerning the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies provided. On 22-APR-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R023513, expiration date: 16-AUG-2020, subcutaneously)(exact dose was not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The administered dose of vaccine experienced a temperature excursion between -9 degrees Celsius (°C) to 8°C (-3.2C) for 5 hours 30 minutes. Digital data logger was involved in capturing the temperature excursion. There were no previous temperature excursions reported. No adverse effect was reported. This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA009817:
no adverse effects; Product reported as GARDASIL but lot # valid for GARDASIL 9; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-MAR-2020 at 11:23 hours, the patinet was vaccinated with an improperly stored dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) with a lot # reported as 1621931 (Reporter reported Gardasil with lot # 1621931 which was not valid for Gardasil. However, lot# 1621931 is valid for Gardasil 9) at a dose of 0.5 mL intramuscularly (IM) on the right arm (RA) and with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) at a dose of 0.5 mL intramuscularly (IM) on the right arm, with a lot # reported as 747P5, and an improperly stored dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, influenza virus split virion 4v vaccine inactivated (FLUZONE) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA).  Administered doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) and Hepatitis A Vaccine, Inactivated (VAQTA) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  Lot # 747P5 is not a valid lot # for Hepatitis A Vaccine, Inactivated.    This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient. ; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008890: US-009507513-2008USA008889: US-009507513-2003USA002275: US-009507513-2008USA008877: US-009507513-2008USA008875: US-009507513-2008USA008885: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008883: US-009507513-2008USA008882: US-009507513-2008USA008879: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008887: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008890: US-009507513-2008USA008920: US-009507513-2008USA008904: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008896: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008898: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008909: US-009507513-2008USA008907: US-009507513-2008USA008906: US-009507513-2008USA008921: US-009507513-2008USA008903: US-009507513-2008USA008901: US-009507513-2008USA008933:
Chest tightness and arm heaviness starting from the left arm to the right arm, with a burning sensation  in the chest. Brought to the ER.
Patient developed itching and pain involving the posterior pharynx. Treated with bendryl liquid 50mg PO.  Resolved within 45 minutes.
No other AE ocurred; Administered to a patient after a temperature excursion; This spontaneous report was received from an office manager concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 07-MAR-2022, in March 2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) 1 dose (lot number T033815 with expiration date on 05-OCT-2022) and with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose (lot number U020239 with expiration date on 28-JUN-2023) both for prophylaxis (route of administration, vaccination scheme frequency and anatomical location were not provided).  Before administration, the doses of the vaccines experienced a temperature excursion on 07-MAR-2022 since they were stored at a temperature of -14 degrees Celsius (C) up to -10 degrees C for the time frame of 30 minutes, from -10 degrees C up to 8 degrees C for 2 hours and 15 minutes, and from 9 degrees C up to 25 degrees C for 20 minutes (product storage error). There was no previous temperature excursion.  No adverse events were reported.
delirious with the fever; had something in her stomach; nausea with no diarrhea; shortness of breath; a little bit of palpitation; just a little bit of high blood pressure.; a little bit delirious with the fever; armpit swollen near her breast and hurts really bad/ lymph nodes; armpit swollen near her breast and hurts really bad/ lymph nodes; third dose of bnt162b2; third dose of bnt162b2; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route on 12Oct2021 single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient said her armpit was swollen near her breast and it hurt really bad and the lymph nodes was bothering her from 14Oct2021. The patient also added that she had a fever and was a little bit delirious with the fever. She didn't have fever but maybe a very very low grade. In addition to that, she also had something in her stomach and was nausea with no diarrhea. The patient had a shortness of breath and a little bit of palpitation. The patient said that there was nothing wrong in her heart, just a little bit of high blood pressure. Her symptoms now was not as severe as yesterday but still have it now and was not feeling better. The patient took an oxygen yesterday, which she was reserving for cases of emergency. Outcome of the event third dose of bnt162b2 was unknown, outcome of the other events was resolving.  The lot number for BNT162B2, was not provided and will be requested during follow up.
This is a spontaneous report from  a contactable pharmacist. A 88-year-old female patient of an unknown race received PREVNAR 13, (NDC number: 00005197102, UPC number: 30005197102, lot R45377, exp. date Dec2017) via intramuscular route at 0.5ml single dose for immunization on 12Nov2016. Relevant medical history included Chronic obstructive pulmonary disease and Hypothyroidism, ongoing. Concomitant medication included levothyroxine for hypothyroidism at 50 mg, 1x/day. On 13Nov2016 the patient experienced mild fever, redness and swelling at the vaccination site. The outcome was reported as not recovered. The patient has not taken any treatment.
Patient given a 5th IPV erroneously. Patient came to office 9-30-10 for 4 yr old vaccine. Received DTAP, IPV, MMR, and VAR. This was documented in the wrong patients chart. When MA pulled up this child it showed him missing the "4 yr old shot series" so she drew up 4 shots. MA took vaccines in to give and mom informed her that patient had his shots on 9-30-10. MA still gave an IPV - that was not needed.
This spontaneous report was receive from a pharmacist via company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient's grandfather was subcutaneously vaccinated with ZOSTAVAX (dose, anatomical location, lot# and expiration date were not reported). The patient's grandfather did not experience any adverse effects. On an unknown date, the patient was diagnosed with shingles. The outcome of the event was unknown. The relatedness between ZOSTAVAX and the event was not reported. Additional information is not expected, the reporter did not wish to be contacted.
Patient was given incorrect dose of Moderna. She is immunocompromised and needed to receive a 3rd full dose to complete her primary vaccination series but instead was given 0.25mL as a booster
Had headache not all the time but every once in a while; Have chills every once in a while; tired; This is a spontaneous report received from a contactable consumer or other non hcp. A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EL9265, Pfizer NTEC), via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that she had some reactions and that is not that they were but she concerned about herself and she had headache not all the time but every once in a while, have chills every once in a while and she tired, unusually tired on an unspecified date. Therapeutic measures were taken as a result of Had headache not all the time but every once in a while, Have chills every once in a while and tired and treatment included TYLENOL. The outcome of the events was reported as recovered on an unspecified date.
Parent found pt laying on floor. He was blue, jerking, and then listless. 911 called and transported to ER. No resuscitation needed. Dr stated he had a seizure. Discharged to home.
I experienced urinary retention and muscle spasms in my torso/midsection. It lasted about 1-2 weeks. I visited many doctors. The doctors did not find anything unusual.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. the patient's medical history, current conditions and concomitant medications were not reported. On 11-JUL-2017, the patient was vaccinated with ZOSTAVAX (batch# N015628, expiry date: 30-JUL-2018) for prophylaxis. On 14-JUL-2017, the patient experienced injection site pruritus and injection site erythema which were resolved on 17-JUL-2017 without any treatment.  On an unknown date in July 2017 (reported as 2 weeks after receiving the vaccination), the patient experienced head and neck itchiness which was ongoing. The causality was not reported.  Additional information has been requested.
c/o feeling faint right after vaccine admin. slumped over. and the had a seizure lasting 5 sec. arms and head jerking. then disoriented for 3 min or so.
Father states child had a silver dollar size red lump to injection site. Redness now gone lump still present.
Nausea, vomiting, chills, diarrhea, dry mouth, headache, dizzy, weak
11 months without menstruation, in menopause phase; four days just after the shot, I got it back; Very strong pain in left arm started 3 or 4 hours after the shot and lasted 48 hours; Area of shot swelled; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 01Mar2021 09:30 as single dose for covid-19 immunization. Medical history included retinal operation, surgery, cataract operation, appendicitis, reflux gastritis (retina detachments and surgeries on both eyes as well as cataracts). No chronic condition reported for Appendicitis. Concomitant medication(s) included pantoprazole sodium 40mg on unspecified date. On 01Mar2021 at 13:00, patient experienced very strong pain in left arm started, area of shot swelled and the patient was 11 months without menstruation, in menopause phase; four days just after the shot, I got it back. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination and post vaccination, patient had not tested with covid 19. No known allergies reported for patient. No treatment received for these events. The outcome of event was recovered on an unknown date. Upon follow-up on 29Mar2021, query response received regarding confirmation on patient and awareness date of events as: Yes, I am the patient in the report. I got the vaccine in the left arm.