chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 19-DEC-2012, the patient was vaccinated with the first dose of PENTACEL, but the office shortly after switched to LIQUID PEDVAXHIB, and therefore, the patient received the second 0.5 ml dose, intramuscular of LIQUID PEDVAXHIB on 29-JAN-2013 and the patient was in the office today (12-MAR-2013), to receive the third dose of LIQUID PEDVAXHIB. No concomitant medications reported. No adverse effect reported. Additional information is not expected.
Elevated temperature of 103 Massive Headache back of head (nape area ) Shivering  Muscle pain  Pain in hair follicles  Pain along top gum lines and teeth  Nausea  Congestion  Tiredness  Pain in my eyeballs (when turning left right up or down)  Soreness  Vomiting  Weakness  Skin itching ( when scratched it turned into hives)  Chest tightness/pain Excessive coughing  All symptoms lasted 12 days
Pt recvd 1st dose of Hep B 14JUL88; Immediately following vax pt devel inject site erythema w/pain traveled up into neck w/local induration; Pt reported large patches of dark pigmentation on the shoulder of inject, adenitis;
24 hours after receiving the covid vaccine Spikevax from Moderna, I developed severe orthostatic hypotension and had a pre-syncopal attack ... my blood pressure was 86/40, HR 75 (after feeling better)... I recovered about 30-45 minutes later after sitting ... the next day I felt much better with no orthostasis
Received vaccine in left arm at 7:20 am sat for 15 minutes without any incident. At approximately 7:50 am I felt an intense burning sensation to outer aspect of right eye and eyelid. My eye was burning and watering continuously.Reported back to department where vaccine was administered nurse gave my 25 mg of P.O Benadryl. No other symptoms at that time. At approximately 2:00pm same day right eye partially opens,swelling persists to right eyelid with burning sensation and eye watering.
Patient vomited without warning in sleep, called out for Mommy, Daddy. No fever. Patient slept again, very clingy in the AM, ate some oatmeal for breakfast and vomited several times after that.
got shingles after her shingles shot/suspected vaccination failure; got shingles after her shingles shot.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's comment: This case was reported by the patient's child via interactive digital media. The reporter stated that the patient got shingles a month after her Shingles shot, so the shot was pointless for her. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary immunization and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Unable to lift arm, pain makes her catch her breath/ Difficult to take a deep breath; Thought she was having a heart or panic attack; Stress, heart rate, panic; soreness from the shot; Stress, heart rate, panic; Stress, heart rate, panic; Stress, heart rate, panic; Tingling in hands and down the arm; crying; This is a spontaneous report received from contactable consumer (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 66-years-old on 22Mar2021 13:57 (Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included topiramate taken for migraine from 15Mar2021 and ongoing. The patient had her shot last Monday afternoon and had some soreness from the shot on Mar2021. On Tuesday, 23Mar2021, it began getting sore back behind her shoulder blade; it has gotten progressively worse, and now she can barely lift her arm. She does not know if it's a muscle or has to do with the vaccine, or if she pulled a muscle although she has not done anything. It's difficult to take a deep breath, she can't lift her arm, it is sore. It hurts down into her chest and around her breast; also, hurts around on her back where her shoulder blade is. She has tried heat compress, cold compress, and massage the area.  It seems like the pain will ease up but then it starts again. She becomes stressed about it and her heart rate starts panicking.  She gets tingles down the arm. Thought she was having a heart or panic attack. It has gotten worse as the week has progressed. It was worse on Sunday; even worse on Monday; worse yesterday and she was crying. She has also been stressed at work. Doesn't know whether to go to the doctor or an urgent care, or if she needs to. The patient is 66 years old and says she is in fairly good health. Right now she is unable to lift her arm and has tingles in the hand and down the arm. The pain makes her catch her breath. If this gets much worse she is going to go have it checked out. Again mentions that she has been having stress. It does seem to be a little worse. The patient experienced thought she was having a heart or panic attack on Mar2021, stress, heart rate, panic on Mar2021, soreness from the shot on Mar2021, soreness to left arm, hurts in chest around breast, back, shoulder blade on 23Mar2021, unable to lift arm, pain makes her catch her breath/ difficult to take a deep breath on Mar2021, tingling in hands and down the arm on Mar2021, and crying on Mar2021. The outcome of the event Soreness to left arm, hurts in chest around breast, back, shoulder blade was not recovered while for the rest of the events was unknown. Prior Vaccinations (within 4 weeks) was None. She had an unspecified shot but reiterated no vaccines. No AEs following prior vaccinations.
Patient presented with hematoma at injection site. Applied ice. (Size of 50 cent piece).
2nd COVID vaccine on last Wednesday afternoon 3/24/21.  Started to experience pins and needles in her right hand since late Wednesday - the same arm that the injection was in.  Now she is noticing some blisters on her right hand, those she noticed today. The following day of the injection the pain was so severe to the right arm from the shoulder all the way down the arm unable to lift the arm or movement. Pain is improving today .  Still has the blisters to the hand.    Pain in right shoulder and across the back of her neck - all on the right side. Used Tylenol and Lidocream OTC - helped very temporarily.   Also had fatigue lasting about a day and a half.
Slight redness and firmness to touch in area just below the injection site. Area is about 2.5 inches in diameter. There is no pain, dryness, or itchiness. First noticed it yesterday afternoon 28JAN, 24 hours there is no change. I've drawn a circle around the site with a sharpie marker and continuing to monitor.
After Pt. got the second dose pt. vomited clear emesis.  Pt. was diaphoretic and pale when brought to medical treatment room.  Pt. started to improve after laying down.  Pt. was observed for ten minutes.  Pt. vitals remained stable throughout treatment.  Pt. walked out after fifteen minutes without other incident.
10 days after initial vaccine, broke out in raised rash at elbow which then progressed to other arm also at elbow area. Rash progessed slowly down the arm to the wrists on both sides.  Rash slowly resolved by the time I received 2nd dose of COVID vaccine.  Approximately, 10 days after second vaccine, the rash return but more significantly and became a generalized raised rash covering most of my body from scalp down to toes. After 6 months, rash started to resolve slowly, but now my skin is intolerant of any adhesive dressings which causes welts around the edges of the dressing. I use adhesive drsng for insulin infusion sets and continuous blood glucose monitoring.  I am no longer able to tolerate an infusion set longer than 24 hrs, and not able to use CGM sensor for the same reasons.
Hospitalization - 3 hrs after immunization. Vomiting, lethargy. After 24 hrs - pt back to normal.  11/06/2007 MR received for o/n observation 10/16/2007 for c/o Lethargy and vomiting. Several hours after Hep A vax child developed redness and swelling of the R cheek.  Activity level was decreased and pt slept during the day which is unusual for her.  Later she appeared listless and pale.  Taken to PCP office where she vomited several times. Admitted to hospital for observation.  PE (+) for pallor.
Developed a rash/ developing a rash every day since vaccine/ The rash has been getting bigger and appearing on various parts of the body; The rash is red not raised, originally not itchy, but becoming more each day; This is a spontaneous report from a contactable pharmacist. A 24-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via intramuscular route of administration in the left arm on 19Apr2021 at 11:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via intramuscular route of administration in the right arm on 29Mar2021 at 11:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, the patient developed a rash. The patient was developing a rash every day since vaccine. The rash has been getting bigger and appearing on various parts of the body and the rash was red, not raised, originally not itchy, but becoming more each day. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the event developed a rash, developing a rash every day since vaccine, rash has been getting bigger and appearing on various parts of the body and the rash was red, not raised, originally not itchy, but becoming more each day were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Tested positive for Covid 19 on 9/24/2021 - asymptomatic
Patient developed severe swelling and a skin infection on the arm at the injection site. She was prescribed a seven day course of Cephalexin.
Intussusception, hospitalized til 7/3/14, air enema to treat.
Swelling, redness and warm to touch around injection site of left arm. Administered 50mg po diphenhydramine caps, applied 2% topical diphenhydramine cream to injection site area, and gave ice pack approximately 25 to 30 minutes post vaccination.
This spontaneous report was received from a Registered Nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of M-M-R II (lot # L015282, expiration date on 30-APR-2017 (dose number, strength and anatomical location were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 52F during 30 minutes, 46.9F during 12 minutes and 47.1 F during 16 minutes (cumulative total time out of range was 70 minutes). No previous temperature excursion was reported. NO adverse events were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
fever of 102, unconsolable crying for about 6-8 hrs on & off; in spite of APAP;
Congestion; slight headache; Patient is in Treatment for COVID-19 with Paxlovid/rebound COVID-19 symptoms/Tested positive again; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient is in Treatment for COVID-19 with Paxlovid/rebound COVID-19 symptoms/Tested positive again), NASAL CONGESTION (Congestion) and HEADACHE (slight headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No other medical history reported.  Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2022, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. In April 2022, the patient experienced COVID-19 (Patient is in Treatment for COVID-19 with Paxlovid/rebound COVID-19 symptoms/Tested positive again). On 05-May-2022, the patient experienced NASAL CONGESTION (Congestion) and HEADACHE (slight headache). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-Apr-2022 to 29-Apr-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient is in Treatment for COVID-19 with Paxlovid/rebound COVID-19 symptoms/Tested positive again) had not resolved and NASAL CONGESTION (Congestion) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2022, SARS-CoV-2 test: (Negative) negative. On 06-May-2022, SARS-CoV-2 test: (Positive) Positive.         Patient Date of birth was reported.  It was reported that On 05-May-2022, the patient developed rebound COVID-19 symptoms. Congestion and slight headache. Patient had tested negative via BinaxNOW antigen home test after Paxlovid dosing finished and again tested positive with BinaxNOW antigen home test.  This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation.
Information has been received from a medical assistant for the Pregnancy Registry for GARDASIL concerning a 23 year old female with no pertinent medical history reported and no known drug allergies who on 21-MAY-2009 and 29-JUL-2009 was vaccinated intramuscularly with her first 0.5mL dose and second 0.5mL dose, respectively of GARDASIL (lot numbers not reported). There was no concomitant medication. The medical assistant reported that after being administered her second dose, it was determined that the patient was pregnant. The patient was seen on 07-AUG-2009 and had a positive pregnancy test on that date. No problems were reported. The patient sought medical attention by contacting office by phone. Follow up information has been received from a medical assistant concerning a 23 year old female with Sickle cell trait and no previous pregnancies who on 29-JUL-2009 was vaccinated with her second dose of GARDASIL (lot number 662300/0100Y). Concomitant therapy included YASMIN for contraception (frequency reported as inconsistent). The patient's LMP was on 07-JUL-2009 and the estimated conception date was on 20-JUL-2009. The estimated delivery date is 13-APR-2010. Follow up information received from the medical assistant indicated that the patient's concomitant medications also included CONCEPT and "INTERJCA". On an unspecified date during her pregnancy the patient experienced anemia, genital warts, yeast infection and urinary tract infection. On 13-APR-2010 at 40 weeks from her last menstrual period, the patient gave birth to a female, who weighed 6 lb and 10 ounces. The baby's length was 20 3/4 inches; her Apgar score were 8/9. The baby was born with the following congenital anomalies pericardial effusion, intracranial ventriculomegaly, stomach duodenum, possible aneuploidy, alpha thalassemia trait ("after baby born no abnormalities"). The outcome of the patient's genital warts, yeast infection and urinary tract infection was unknown. The baby's experience has been captured on WAES # 0909USA01458B1. No further information is available.
Pt c/o swelling in throat and difficulty breathing approximately 5min after vaccine was recieved. Pts voice was noticably hoarse after recieving vaccine. Epi and Benadryl administered, vital signs were documented.
(L) arm pain, soreness, began immediately after vaccination, persisting, 2 meds for swelling, went to ER on 11/14/2019 Improved, still having pain
On 08/16/01, this patient's mother called and stated the child developed "heat like" rash on both arms, elbows to hands, and on left side of face the evening after the vaccine was given. No redness. soreness, or swelling at the injection site. No rash at the injection site. Rash was gone the next AM.
the day after the vaccine was given the patient noticed, redness, swelling, itching and pain of her right arm.  Dizziness and sleepiness notices as well., vomited x 2, on day 2 the area increased in erythema, elbow was painful., directed to take Motrin, Benadryl and apple cool compresses
Left deltoid with swelling, redness, hard, no tenderness, no limitation of movement. Motrin/HC cream 1% BID/ warm compresses.
it was worst than the 1st dose; she felt really bad,felt crappy all day long; she had a major headache that Tylenol wouldn't even make go away,super bad headache; body aches; the injection site ached for a few days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (it was worst than the 1st dose), FEELING ABNORMAL (she felt really bad,felt crappy all day long), HEADACHE (she had a major headache that Tylenol wouldn't even make go away,super bad headache), MYALGIA (body aches) and VACCINATION SITE PAIN (the injection site ached for a few days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, LAMOTRIGINE for Antidepressant therapy, CLONAZEPAM for Anxiety, HYDROCHLOROTHIAZIDE for Blood pressure high, LISINOPRIL for Blood pressure management, TIZANIDINE for Muscle relaxant.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (it was worst than the 1st dose), FEELING ABNORMAL (she felt really bad,felt crappy all day long), HEADACHE (she had a major headache that Tylenol wouldn't even make go away,super bad headache), MYALGIA (body aches) and VACCINATION SITE PAIN (the injection site ached for a few days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Apr-2021, FEELING ABNORMAL (it was worst than the 1st dose), FEELING ABNORMAL (she felt really bad,felt crappy all day long), HEADACHE (she had a major headache that Tylenol wouldn't even make go away,super bad headache), MYALGIA (body aches) and VACCINATION SITE PAIN (the injection site ached for a few days) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable. No treatment medication provided by the reporter.
I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 12/14/2021 CHRONIC RENAL INSUFFICIENCY I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 12/14/2021 DM 2 W RENAL MANIFESTATION
On December 12th I started with a headache, my whole head hurt but it wasn't a migraine. The next day I didn't have the headache but I had a runny nose that just wouldn't stop. The third day I had a violent cough that I couldn't control and a sore throat. I tested 3x and they all came back COVID-19 and I just couldn't believe it. I called my doctor but she wasn't able to see me until 12/16. She prescribed PAXLOVID pills and I stayed in isolation up until I tested negative on 12/21, but I am still quarantining myself because I don't want to get anyone else sick. I'm still having a cough, a deep in my lungs kind of cough. Its not persistent just once in a while.
temperature excursion involving PROQUAD / Several patients were administered PROQUAD during this temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 07-DEC-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T021302, expiration date: 19-DEC-2020) as prophylaxis, that experienced a temperature excursion (product storage error).  On an unknown date, the vaccine underwent a temperature excursion of minus 5 degrees Celsius (C) for 20 hours, as recorded by a data logger. There was no previous temperature excursion.
THE JAB KILLED HER; This spontaneous report received from a patient via social media (J&J corporate) a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, dose 1 (01 total) administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died after taking vaccine from unknown cause of death. It was unknown if an autopsy was performed or not. The reporter reported that, "the jab killed her" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220948266, 20220946006 and 20220946018.; Sender's Comments: V0: 20220948144-COVID-19 VACCINE AD26.COV2.S- the jab killed her-The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH