chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He hasn't received his 2nd dose.; He became positive for covid after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He became positive for covid after receiving 1st dose) and PRODUCT DOSE OMISSION ISSUE (He hasn't received his 2nd dose.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced COVID-19 (He became positive for covid after receiving 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He hasn't received his 2nd dose.). At the time of the report, COVID-19 (He became positive for covid after receiving 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He hasn't received his 2nd dose.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Dizziness; Diaphoresis; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness) and HYPERHIDROSIS (Diaphoresis) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported Medical History).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and HYPERHIDROSIS (Diaphoresis). At the time of the report, DIZZINESS (Dizziness) and HYPERHIDROSIS (Diaphoresis) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 147/92 mmHg (High) 147/92 mmHg (1506) 132/86  mmHg (1520) 130/90  mmHg (1529). On 08-Jan-2021, Heart rate: 69 (Inconclusive) 69 (1506) 69 (1520) 75 (1529).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment information were reported.
Fort five minutes after having vaccine administered and waiting 20 minutes post vaccine, left and went to another department in the hospital. Health office received a call from the area stating that she had "weak legs" and could we come see her. Asessment, gait steady and all neuro checks within normal limits, no weakness in legs when asked to push against my hands.. Wanted to be seen in ED, was taken to ED , ambulated a few steps to wheelchair by Health staff. Employee requested this be reported.
This spontaneous report as received from a registered nurse refers to a 24 years old female patient with no drug reactions or allergies. The patient's medical history included knee surgery in 2001. The patient was vaccinated with dose 1 and dose 2 VARIVAX (Merck) (lot #, dose and route not reported) on 09-JUN-2004 and 09-JUL-2004 respectively as a starting nursing school requirement. No other co-suspects were reported. Concomitant medications included: ORTHO-CYCLEN. The registered nurse reported that another unspecified employer previously had the patient get a varicella titer on an unspecified date, which was found to be equivocal. No treatment was given for the event. The outcome of the event was unknown. The relatedness for varicella titer which was found to be equivocal was not provided for VARIVAX (Merck). Additional information has been requested.
Pt recvd 3 doses of Hep B vax 30AUG83, 04OCT83 & 14MAR84; In DEC85 lab eval revealed anti-HBs positive; Apr91 donated blood & tested Hep B neg; Later tested positive for antibody to HB core antigen, indicating recent infect w/Hep B virus;
I'm still feeling very tired doing the simplest tasks; Some nausea/I was also nauseous; I had a terrible headache until early afternoon today; Dizzy; Getting chills; Fevered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I'm still feeling very tired doing the simplest tasks), NAUSEA (Some nausea/I was also nauseous), HEADACHE (I had a terrible headache until early afternoon today), DIZZINESS (Dizzy) and CHILLS (Getting chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 FATIGUE (I'm still feeling very tired doing the simplest tasks), NAUSEA (Some nausea/I was also nauseous), HEADACHE (I had a terrible headache until early afternoon today), DIZZINESS (Dizzy), CHILLS (Getting chills) and PYREXIA (Fevered). At the time of the report, FATIGUE (I'm still feeling very tired doing the simplest tasks), NAUSEA (Some nausea/I was also nauseous), HEADACHE (I had a terrible headache until early afternoon today), DIZZINESS (Dizzy), CHILLS (Getting chills) and PYREXIA (Fevered) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
4 days post-vaccination, patient began to develop circular varicella-like rash on right leg and experienced muscle cramping. Rash is contained to small area on right leg and 24 hours later cramping was subsiding; rash was still present.
3:00AM morning p/vax had T, h/a all over body aches, nausea, Tx2 days, 3rd day fever broke;sx resolved;
Fatigue- Started 6 hours post-vaccine, subsided 24 hours post-vaccine Headache- Started 6 hours post-vaccine, subsided 36 hours post-vaccine Injection site pain- Started 12 hours post-vaccine, still ongoing Severe muscle pain- Started 12 hours post-vaccine, subsided 36 hours post-vaccine Severe joint pain, including spinal pain- Started 12 hours post-vaccine, subsided 36 hours post-vaccine Lymphadenopathy- Started 18 hours post-vaccine, left underarm, swollen to baseball size and painful to touch and movement. Still ongoing
NO ADVERSE EFFECTS PATIENT DID NOT REMEMBER OR REPORT VACCINE RECEIVED WHILE HOMELESS, AND RECEIVED AN EXTRA BOOSTER WHILE HERE, TOTAL 3 VACCINE DOSES.  MD MADE AWARE
pt recv vax 7FEB98 & 8FEB98 pt exp head cold;
Very lare, very painful swollen lymph node in left arm pit. Still present and painful 3 days after injection.  Actual injection site still sore and very bruised.
Patient brought to the ED by EMS on the evening of 10/28 for evaluation of low blood pressure and weakness. EMS reports patient's blood pressure was 60s/30s. While in the ED, patient tested positive for COVID by PCR. While in the ED, he was hypoxic with saturations down to 83%, was placed on 1-2L supplemental O2 with improvement. He was admitted from 10/28-10/30. Patient was able to be weaned off supplemental oxygen. He has received the COVID primary vaccine series and two boosters.
The first dose of the Pfizer vaccine was administered to the patient, within several minutes the  patient became diaphoretic, pale, dizzy,lethargic, nauseous and reported difficulty breathing.  Vital signs  BP 140/100, hr 54 beats per minute, O2 100, glucose 108 mg/dL. Assist EMS was called at 11:34am, 11:43am, and 911 was called at 11:55am. 2L Oxygen administered.  Pt. Was taken to ED.
Administered Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Treatment details were not given.
30 min after admin localized rash with itching at admin site. He denied SOB, throat itching/swelling. He was speaking in full sentences. He left with a friend after 45min. He has an Epi pen with him. He refused 911. He was informed to call 911 or seek medical attention if he has any symptoms of SOB, breathing difficulty, throat itching or swelling, or any other symptoms.
exacerbation of fibromyalgia in right arm, left arm, and hips.  Most of pain was in her right arm
Fever; chills; Vaccine administered at inappropriate site; vomiting; redness around the site; puffiness around the site; This case was reported by a physician via sales rep and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced fever, chills, vomiting, injection site erythema, injection site swelling and vaccine administered at inappropriate site. On an unknown date, the outcome of the fever, chills and vaccine administered at inappropriate site were unknown and the outcome of the vomiting, injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the fever, chills, vomiting, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient experienced Fever (102 -103) and chills about 3 hours after the dose that progressed. The patient also experienced Vomiting and redness and puffiness around the site which lasted for 3-4 days. The patient received the dose in the gluteus, which led to vaccine administered at inappropriate site.      Lab Comments: On an unknown date body temperature was noted
PENTACEL was administered to one patient 4 days after the expiration date with no reported adverse event; Initial information received on 20-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered to one patient 4 days after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  On 18-Jul-2022, the patient received a 0.5ml (dose 3) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (strength not provided) (lot UJ495AA; expiry date: 14-Jul-2022)  via intramuscular route in the left vastus lateralis for immunization 4 days after the expiration date with no reported adverse event (expired product administered).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt stated at 9 p.m. she experienced tightening in her chest, followed by swelling of the throat, minimizing her airway. The episode lasted 4 1/2 hours. Pt. did not seek medical treatment.
pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), intramuscular on 27Jan2021 (at the age of 79-years-old) as a single dose in the left shoulder for COVID-19 vaccination. Medical history included shoulder surgery about 10 years ago and she lost use of her thumb and index finger, the nerve comes from the shoulder; her hand might be numb and stiff, often but not every morning from an unknown date. Concomitant medications were reported as she is on medication but nothing she feels is relevant. On 03Feb2021, the patient experienced pain in her hand and all the lower part of each finger hurt for about 5-10 seconds, joint pain in her right hand lasting 10-15 seconds, it did not last very long; and she bled quite a bit stating she thinks she got it right in the vein on 27Jan2021. The pain happened about four different mornings but has not had pain "since Friday" and that was lighter sharp pain with no numbness. The clinical outcome of the event bleeding was unknown; pain in extremity and joint pain was recovered on 12Feb2021.
GAVE PATIENT ADACEL AND WAS ABOUT TO PREPARE SHINGRIX VACCINE. PATIENTS WIFE ALERTED ME THAT PATIENT WAS PASSING OUT. I CAME INTO ROOM AND HE WAS UNCONSCIOUS AND WAS HAVING A SEIZURE. THE SEIZURE LASTED ABOUT 30 SECONDS. AMBULANCE ARRIVED WITHIN 5 MINUTES AND TOOK CARE OF SITUATION FROM THERE.
Felt dizzy shortly after the vaccine was administered. Sat down, but continued to feel weaker. Passed out, fell out of chair and onto the floor. Regained consciousness on the floor, a minute or two after sitting down. Was given water and an ice pack. 911 was called, and responders noted that I had hit my forehead and looked pale, but otherwise seemed ok. Feeling better, I refused an offer of transport to the hospital. 10/01/2015 (a few days after vaccine): I developed a "black eye" on the right side of my face (which I presume is due to to the head injury). 10/02/2015 (date of this report): No new symptoms or changes.
Shot was on Friday morning. Right leg developed severe unmanageable muscular pain through upper hamstring and calf muscles; affecting ability to walk and put weight on the leg. Leg pain developed within 24 hours of shot; became increasingly more severe at 96 hours. Was taking Ibuprofen 400 mg 2x day. As a result I went to the emergency room Monday morning. Their diagnosis was muscle pain consistent with a slipped disk. The ran blood work to look at inflammation markers; one was slightly elevated. By Tuesday morning the pain had drastically receded; and by Wednesday (today) it is mostly back to normal.
PARALYZED; This spontaneous report received from a consumer via social media via a company representative concerned 2 patients of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination.  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 patients experienced paralysis. Reporter stated that, "I personally know of 7 cases of paralysis of which one is my neighbors daughter in law and know of 2 kids paralyzed". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralyzed was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220548149, 20220547591 and 20220548524.; Sender's Comments: V0: 20220548194-Covid-19 vaccine ad26.cov2.s- paralyzed. The event(s) has a 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.
complained of fever and chills. Temp. 101.4. Nausea and vomiting,, body aches, and headaches. Bed rest, Fluids was her treatment and Tylenol for the fever. she is feeling better today.
This spontaneous report as received from a consumer refers to a female patient of unkonwn age (the reporter's spouse). It was reported that the reporter's spouse had been exposed (date unspecified) and on an unspecified date, at age of 41 years, was vaccinated with a dose of GARDASIL injection (dose, dose number, lot/batch number, expiration date were not reported) through an obstetrics and gynecology (OB-GYN). No product quality complaint (PQC) involved. The reporter asked for guidance as stated he needed to get the vaccine but from where he contacted it was only provided to those under age 26. Additional information has been requested.
Tested positive for COVID; I had symptoms; This is a spontaneous report from a Pfizer.  This is a report from a contactable consumer (self).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced tested positive for COVID, fever is gone 'and everything' (not clear nor clarified) but still have a cough and little bit of headache on 09Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Apr2021.
Patient developed a 1/4 inch red spot at site of vaccine injection on 11/4/2011.  On 11/8/2011, initial 1/4 inch spot had blisters on it and there was a pinker ring surrounding the area.  Patient indicated there was pain at the site.  Parent took patient to doctor on 11/9/2011.  Doctor indicated that the spot was a localized reaction to Varicella vaccine.
Sore arm x2 days; This is a spontaneous report from a non-contactable other healthcare professional. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 22Apr2021 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 22Apr2021 the patient experienced a sore arm for 2 days. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm was recovered on 24Apr2021.  No follow-up attempts are possible. No further information is expected
Sore arm; Body ache; Stomach discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 11:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D3; ATORVASTATIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot no: EL3247; Location of injection: Arm right; Vaccine administration time: 10:30), administration date: 02Feb2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot no: EL3247; Location of injection: Arm right; Vaccine administration time: 10:30), administration date: 23Feb2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot no: FH8027; Anatomical location of injection: Arm right; Vaccine administration time: 10:00), administration date: 03Dec2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 16Nov2022 at 22:00, outcome "recovered" (Nov2022), described as "Body ache"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2022 at 22:00, outcome "recovered" (Nov2022), described as "Sore arm"; ABDOMINAL DISCOMFORT (non-serious) with onset 16Nov2022 at 22:00, outcome "recovered" (Nov2022), described as "Stomach discomfort". Therapeutic measures were not taken as a result of pain in extremity, pain, abdominal discomfort.  Additional information: Prior to 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 other vaccines within 4 weeks prior to the vaccination. AEs did not result in physician office visit or emergency room visit.
Head hurts Ball in throat (swollen lymph under jaw) Dizziness  Tingling in arms  Glucose 84 O2 99% Heart rate 63 Breathing and a donut and relaxing  Glucose to 83   Felt better after about 30 minutes  Daughter picked her up and told daughter to have her relax hydrate eat well and to refer her to medical attention if symptoms get worse
Presented to ER p/having a 7 minute generalized seizure @ 430PM on 14AUG92, t101.7; hx of complex febrile sz DEC89
Two days after receiving my shot, I began to experience mild dizziness. Four days after my vaccine, the dizziness began to intensify to the point where on day 5 (Sunday), I could not get out of bed.  I attempted to go to an urgent care facility, but none where open.  I called my PCP and talked to the covering doctor.  I was told that it might be BPPV and was given a prescription for meclazine.  On  day 6, I was a little better and tried to make an appointment with my PCP (I was unable to get one until this coming Friday), so I went to an urgent care.  They seemed to agree with the BPPV diagnosis and told me to look on T.V. for how to do the Epley maneuver.  It has now been 8 days since my vaccine and I am still experiencing dizziness, but am able to function with some limits (I haven't driven my car as of yet).  The Epley maneuver did not seem to help.  Besides the dizziness, my ears feel full and especially in the morning, I have a bit of a problem with my eyes focusing correctly.
This case was reported by a pharmacist via call center representative and described the occurrence of gastrointestinal pain in a 71-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 22nd December 2017, the patient received SHINGRIX. In December 2017, 1 day after receiving SHINGRIX, the patient experienced gastrointestinal pain, nausea, fatigue and dizziness. On an unknown date, the outcome of the gastrointestinal pain and nausea were recovering/resolving and the outcome of the fatigue and dizziness were unknown. It was unknown if the reporter considered the gastrointestinal pain, nausea, fatigue and dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The healthcare professional reported that about 24 hours after receiving a dose of SHINGRIX, the patient developed gastrointestinal pain, nausea, fatigue and dizziness. The patient still has gastrointestinal pain up to six days post administration of vaccine. No further information was reported regarding the event.