chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on the arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Migraine and Allergy.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash on the arm). At the time of the report, VACCINATION SITE RASH (Rash on the arm) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
This spontaneous report as received from a licensed vocational nurse refers to a 6-week-old patient of unknown gender. Information about concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with PEDVAXHIB (dose, route, lot number and expiration date not reported). Concomitant therapies were not reported. No adverse effect reported. Additional information has been requested.
Patient reports 10-day history of generalized hives with itching.  She had taken Benadryl and allergy spray at home without improvement of symptoms.  8 days ago she was seen in urgent care and prescribed prednisone and Benadryl and Pepcid.  She reports at that time symptoms resolved.  5 days ago the symptoms returned with associated facial swelling and lower lip swelling.  She can went to urgent care while in another state and was given epinephrine as well as other IV medications and discharged home with Benadryl and Pepcid.  She reports since that time her symptoms have never gone away.  She returned last night from another state and woke up today again with facial swelling and presents at hospital.  Patient was admitted.
Stomach issues. Cramping in lower stomach. Tired. My GERD started to bother me and still not feeling well.
Narrative:  Patient received two doses of Pfizer COVID 19 Vaccine in Feb 2021. The patient tested positive for COVID 19 on 10 Jan 2022. Patient presented to the ED with malaise and was admitted to the hospital on 10 Jan 2022 with sepsis. The patient was treated with dexamethasone and empiric antibiotics. The patent was discharged in stable condition on 20 Jan 2022.
3/13- First shot of Moderna vaccine received.  3/14- Sore arm, chills and a headache.  3/15- Shortness of breath and rapid heartbeat.  3/16- Went to ER because of more severe shortness of breath and rapid heartbeat.  3/17- COVID test with negative result.  3/19- Patient messaged her PCP explaining persisted symptoms. 3/23- Chest pain and shortness of breath developed and she died at ER in PEA.   3/25- Autopsy showed pulmonary embolism with no evidence of peripheral vascular disease.              Double check COVID test with negative result.
Chills, body aches, fever exhaustion for around 24 hours after onset of symptoms.
This is a spontaneous case, initially received from other health professional on 24-Jan-2019, concerning a female neonate patient. The mother was 27-year-old female whose historical drug included SYNTHROID for thyroid. The mother's historical condition included thyroid (from an unspecified date to 31-Aug-2018). The mother had one previous pregnancy with full term live birth. The mother had no history of offspring with major congenital malformations. The mother had no relevant maternal and paternal medical history with major congenital malformations. The mother did not use tobacco, alcohol and illicit drugs during pregnancy. The mother's current condition included low iron (since an unspecified date). The mother's concomitant medications included OB complete one (as reported) for healthy pregnancy and Ferrous sulphate (reported as ferrouSul) for low iron. The mother's last menstrual period (LMP) date was 12-Apr-2018. The type of pregnancy was singleton. On 16-Oct-2018, at gestation age of 25 weeks, the fetus received FLUCELVAX QIVc [batch number: 252232, route of administration: transplacental, dose, anatomical location, and expiry date: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On an unspecified date, after vaccination, the mother had preterm labour with not resulting in live birth. 2 months and 26 days after vaccination, the mother vaginally delivered a full-term female neonate at 37.4 weeks gestation. The neonate's birth weight was 2280 grams (explicitly coded as low birth weight), head circumference was 32.5 cm and body length was 42.5 cm. The APGAR scores were 9 (one minute) and 9 (five minutes). The outcome of the event was not reported. The mother's estimated delivery date (EDD) was reported as 29-Jan-2019. This case is linked to 201805975, the corresponding maternal pregnancy report.; Reporter's Comments: A neonate female baby was delivered with low birth weight,  more than two months (2 months and 25 days) after foetal exposure of vaccine (FLUCELVAX QIVc) during pregnancy. Considering the multifactorial aetiology of the event, maternal history of low haemoglobin, thyroid disorder and long temporal relationship between vaccination to event, the company assessed causality as not related to suspect vaccine. The event foetal exposure during pregnancy was assessed as not related to suspect vaccine due to intended (prophylactic) use of the vaccine. The company assessed this case as serious (medically significant).
Both thighs had nodules - 1cm on left and about 0.5cm on R. Also has watery diarrhea.
Right arm sore; left knee/shin/calf pain; left knee/shin/calf pain; left knee/shin/calf pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm right on 30Apr2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), rabeprazole (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously took Avelox, penicillin and sulfa on unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 the patient experienced right arm sore, left knee, shin and calf pain. The patient stated that she had right arm sore but was not bad. However next morning she woke up with left knee/shin/calf pain and she could not put weight on it throughout the day and night. She further stated that her knee and shin got better on second day morning but calf was still stiff and sore. The clinical outcome of the events right arm sore, left knee pain and shin pain and calf pain was unknown.   No follow-up attempts are needed. No further information is expected.
Narrative: Patient completed COVID-19 vaccination series in March 2021. Hospitalized 8/12/21 with acute hypoxic respiratory failure and COVID-19 pneumonia and super-imposed bacterial pneumonia. Treated with dexamethasone, remdesivir, oxygen, and antibiotics. Deceased 8/22/21 from septic shock and COVID-19 pneumonia.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 08-SEP-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # I044917 which had an expiration date on 05-OCT-2018) (dose, dose number, frequency and route were not reported). No adverse effects reported. Concomitant medication information was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
This case was reported in a literature article and described the occurrence of unknown cause of death in a subject who received dTpa vaccine. Co-suspect products included human papillomavirus quadrivalent vaccine. On an unknown date, 11 days after receiving dTpa vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to dTpa vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of death in a patient of unspecified gender between the ages of 9 and 26 years who had received an unspecified tetanus-diphtheria-acellular pertussis booster and an unspecified quadrivalent HPV vaccine (manufacturers unknown). The authors identified this case while performing a retrospective review of medical records looking for deaths within 30 days of vaccination. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received an unspecified tetanus-diphtheria-acellular pertussis booster and an unspecified quadrivalent HPV vaccine. Dosages unknown; administration routes and sites unspecified; batch numbers were not provided. On an unspecified date between 1 January 2005 and 31 December 2011, 11 days after the vaccination, the patient died of unknown causes. This was a fatal case and a post-mortem was performed, but no cause of death was identified by the coroner. Treatment was unknown. According to the authors, the Vaccine Safety Datalink working group determined the relationship between the vaccines and this death to be indeterminate due to the lack of information that made impossible to confirm or discard a causal association. The authors concluded that "to our knowledge, this study currently represents the largest population-based epidemiologic investigation of the association between vaccination and death among individuals 9 to 26 years of age. Although there has been significant research conducted on deaths after vaccination in both infants and older adults, this study fills a void by investigating deaths among older children and young adults. We assessed deaths after vaccination on a population level as well as an individual level to provide a complete evaluation of vaccine safety with regard to death. This research should reassure the public with regard to the safety of quadrivalent vaccine, as well as other vaccines routinely administered to individuals 9 to 26 years of age".
Hx of Covid-19, was hospitalized on 12/23/2021 with Respiratory distress, had been at LTC d/t recent stroke.  Put under Hospice Care.
Flu like symptoms after second dose; 6 Months after develop Minimal Change Disease - rare kidney disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2021 at 11:00 as dose 2, single (Lot number: EW0185) at the age of 34 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADDERALL. Vaccination history included: BNT162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, lot number=EW0167,lot unknown=False, administration date=02May2021, administration time11:00 AM, vaccine location=Left arm), administration date: 02May2021, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: RENAL DISORDER (disability) with onset 12Dec2021, outcome "not recovered", described as "6 Months after develop Minimal Change Disease - rare kidney disease"; INFLUENZA LIKE ILLNESS (disability) with onset 12Dec2021, outcome "not recovered", described as "Flu like symptoms after second dose". The events "flu like symptoms after second dose" and "6 months after develop minimal change disease - rare kidney disease" required physician office visit. It was unknown if therapeutic measures were taken as a result of influenza like illness, renal disorder.  Clinical information: Flu like symptoms after second dose. 6 Months after develop Minimal Change Disease - rare kidney disease. Never have had any kidney disease or anything related at all, and none in family.  No follow-up attempts are possible. No further information is expected.
near syncope episode, orthostatic; feels a little foggy; This is a spontaneous report from a contactable Physician. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on unspecified date in 2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The emergency medicine physician was monitoring a patient that came in from a vaccination event, stated that it was Pfizer BioNTech Covid 19 vaccine. The patient had a near syncopal episode. They did orthostatics (unspecified) and found that she was orthostatic (near syncope episode, orthostatic). There was no anaphylaxis reaction or allergic reaction. She still felt a little foggy. The physician did a blood glucose, labwork and EKG that look good. The physician wanted to know if there was any data for things that they should looking for with the vaccination and  will direct the patient to contact Pfizer to report it. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
No adverse event; HCP called to report that a dose of PNEUMOVAX 23 that expired on 8/29/2023 was given to a patient on 9/6/2023. HCP reports no previous TEs. Permission to contact HCP given. No further AE details. No PQC.; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-SEP-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot #U032086, expiration date: 29-AUG-2023, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).
Information has been received from a healthcare worker (unspecified) concerning a patient (age and sex not reported) who on 22-DEC-2006 was vaccinated with Pneumovax 23 (lot # 655499/0988F). On 22-DEC-2006, the patient experienced swelling and pain at the injection site and fever. The outcome of the events was not reported. This is one of several reports from the same source. Additional information has been requested.
pt recv vax 25MAR97 & 2+ wk p/vax pt noted inc hyperpigmentation around the inj site w/an almost perfect 2cm ring around the site of the inj appearing like a brown tattoo on tanned skin;no induration, no indication of deep muscle rxn;
Around February of this year my daughter came up with a few ringworm's on her stomach and thigh. I bought the over-the-counter medication and was applying it 3 times a day to no avail then approximately three weeks after the initial outbreak she started getting more all over her stomach back and legs the other areas originally infected were not healing at all. I took her to our doctor and he diagnosed her with pityriasis rosea and has since put her on a steroid dose pack.. when I learned what it was I started doing some research to try and figure out how she had contracted the virus...then I read that it is possibly caused by a papilloma virus and that got me wondering if this also could be a side effect to the GARDASIL shot...my daughter got the 3rd GARDASIL shot 1/29/09 and the first hearld patch appeared less that a week later however I did not attribute it to the shot until I started doing some research... Could someone please let me know if this is a possible side effect that has just not been listed yet... I find it odd that she gets this virus, one I have never heard of before shortly after the injection...thank you
Extreme weakness in legs. Dull ache in lower back. My back still hurts. I have had chiropractic treatments. But nothing really helps. It comes back.
Imunocompromised patient that received a first, second and booster dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Imunocompromised patient that received a first, second and booster dose of the Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Imunocompromised patient that received a first, second and booster dose of the Moderna Covid-19 vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (Imunocompromised patient that received a first, second and booster dose of the Moderna Covid-19 vaccine) outcome 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 medications were reported.
Had very bad chest pains and hard to get my breath  about 45 min after the shot and it lasted 30 mi or so. I feel ok now but do I still take the 2nd shot?  Thanks
I started running a high fever (103) and aching and hurting all over the first day.  The next day I had a severe headache.  I went to the doctor that next day and she ran a blood test, flu test and chest x-ray.  She said that this was probably a response to the Covid vaccine.
Red dot at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: Unknown, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "recovered", described as "Red dot at the injection site".  Additional information: Patient who was seeking information on a adverse reaction her 12-year-old son experienced with the Pfizer Covid 19 vaccine booster dose.The mother and son both received the booster dose injection on 26Jan2022. The mother only experienced a red dot at injection site that eventually went away. Her son she states had a red dot at the injection site that was only a small red dot for 5 weeks after injection. She states that at week 5.5 or 6 the dot grew seemingly overnight. She describes the area as bright red bulbous blood blister wart type area. She states that it didn't hurt but grew. The area was nicked and began to bleed. She reports that it bled for over 2 hour straight. He was taken to the ER and has also seen his pediatrician twice since then for this issue. The pediatrician does not know what the area is. She states that everyone at the doctors over was concerned with the area and stated that they had never seen something like this. Patient had not taken any prior vaccination within 4 weeks. The patient had not taken any medication for treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Partial facial paralysis/paralysis happened on your right side of my face; Paralysis got worse; Vascular malformation of the seventh cranial nerve (a mass); Inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 25 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 02May2021 (Lot number: EW0172) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot #: EW0153), administration date: 11Apr2021, for COVID-19 immunization. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 2021, outcome "recovering", described as "Partial facial paralysis/paralysis happened on your right side of my face"; CONDITION AGGRAVATED (medically significant) with onset 2021, outcome "recovering", described as "Paralysis got worse"; VASCULAR MALFORMATION (non-serious) with onset 2021, outcome "unknown", described as "Vascular malformation of the seventh cranial nerve (a mass)"; INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "Inflammation". Therapeutic measures were taken as a result of facial paralysis, condition aggravated. It was reported that, the paralysis happened on right side of the face, the patient  increased therapy in order to counteract the increased paralysis, and it has mostly improved, but some still remains. The case was reported as non-serious.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
5 minutes, post vax, my son had a seizure, lasting approx. 60 seconds. Also, had dizziness, fatigue, weakness and was pale. I witnessed the seizure and he has had a lot of fear over this episode. He continues with fear and anxiety.
Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. At 48-hr follow-up, patient reported arm soreness. Patient received COVID vaccine on December 31
Information has been received from a medical assistant concerning a 65 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 16-JAN-2009 was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 662599/1076X) intramuscularly in her right arm.  Concomitant therapy included montelukast sodium, CRESTOR, CELEBREX, PROZAC, calcium (unspecified), vitamin D (unspecified) and iron (unspecified).  It was reported that on 16-JAN-2009 the patient experienced erythema, pain, tenderness, and swelling in her right arm and (from her elbow to upper arm) after administration of the first dose of PNEUMOVAX vaccine.  It was reported that the patient also experienced a "low grade" fever.  The patient had been recovering at the time of the report.  The patient sought medical attention with an office visit.  Follow-up information has been received from a health professional concerning a 65 year old female with no illness at time of vaccination and codeine allergy who on 16-JAN-2009, at 9:00, was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 662599/1076X) intramuscularly in her right deltoid.  On 18-JAN-2009, at 9:00, the patient developed redness, pain and swelling.  Subsequently, the patient recovered from redness, pain and swelling.  This is one of several cases from the same source.  No further information is available.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 15-SEP-2014 the patient was vaccinated with a MMR II lot # reported as J014875 (therapy type, dose, route, and expiration date were not reported) that had been improperly stored. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough case admission after 3 vaccines Moderna 4/21/21 Lot# 002C21A;  Moderna 5/19/21 Lot# 043L20A;  Moderna 12/10/21 Lot# 031H21A