chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few minutes after giving a Janssen COVID 19 vaccine, the patient was warm to the touch, visibly sweaty, and very nauseous. She sat down with her head resting on her boyfriend, eyes closed, and complained she didn't feel herself at all. I observed/verified with the patient that there was no rash, swelling, or breathing issues. She was able to speak the whole time. She does not have any allergies and did not faint. She does have a fear of needles. I called EMS to evaluate her and they took her to the hospital. When EMS arrived she stated she felt slightly better than she did ten minutes ago.
12/7/2022- 12/9/2022  HEADACHE ,ITCHY  EYES  WITH BLURRED VISION , CHILLS, HEADACHE ,  COUGH, RUNNING NOISE , ARM SORENESS A,RMPAIN, ARM REDNESS , SWELLING ON ARM, BUMP ON ARM , 12/9-12/27/2022 LEFT ARM  PARALYSIS , SEVERE AGGRESIVE NERVE PAIN  IN LEFT ARM , TINGLING IN FINGERS { LEFT }, SWOLLEN LYMPH NODES, DIFFICULTY BREATHING ,  DULL SHARP PAIN IN BREAST , SHARP PAIN IN CHEST ,  LOSS OF APPETITE , FREQUENT URINATION ,  LOSS OF MOBILITY ,
I have a red itchy painful rash in my arm and head. I used clobesol ointment but there is no effect. I took acetaminophen and the itch from my arm goes away for a few hours but the itch from my head continues to bother me. On my head I tried the clobesol and it's good for less than an an hour. when it start to itch again, I washed my head with just water then tried Vicks Vaporub to freshen the head and the itch will go away for awhile.
Patient developed urticarious rash on same site of covid-19 vaccine administration. Red, raised, itchy rashes on right shoulder.
Pfizer vaccine booster was administered to a 13-year-old child. Per Pfizer guidelines, boosters should be administered to patients 16-17 years of age and older.   No adverse effects were reported. We followed up 2 days later and still no adverse effects. The patient reported good health per the parent's admission
This is a spontaneous report received from a contactable nurse. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: for a week or 2. The patient's concomitant medications were not reported. The following information was reported: The patient had COVID pretty bad for a week or 2. Once she was COVID negative, she got the first COVID vaccine and did ok. She got the second vaccine and got pretty sick like she had COVID again (on an unspecified date). The events were reported as non-serious. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of suspected COVID-19 and drug ineffective. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Dizziness, Myalgia, Arthralgia, NauseaVomiting, sore throat, fatigue, chills, swollen glands, ear aches Narrative:
Patient called clinic with red itching of left arm, which started about 8 days after her first vaccination.  Patient proceeded to self treat with diphenhydramine and these symptoms subsided 48 hours later.   During appointment for second vaccination, patient describe additional symptoms which occurred 9 days after the appointment.  Patient describes genital itching and rash which was self treated with monistat cream.  symptoms improved within 24 hours.
After my second vaccine I had terrible joint pain starting 12 hours after the vaccine and lasted for about 36 hours.  After that the pain was less surging but took a couple more days to settle down but just had dull joint aches after that.   About 5 weeks later , the last week of April, I started getting the surges of joint pain again.  All my joints hurt.  I felt like I had the shot again.  At this time, my right starting  falling asleep from my elbow down to the my fingers mostly at night.  Then as the weeks went by it would fall asleep any time of the day, many times a day.   Over the summer months my left hand would fall asleep.  The joint pain in my right elbow area was out of control.   My joints hurt so bad in my body, I would drop things in my hands, couldn't grasp spray bottles to spray.   I would surging stabbing pain in my arms, then it would turn to a burning pain and sometimes in the same timeframe I would have a cold sensation going through my joints.  These episodes could last from several minutes to hours putting me tears.  I finally had to go to the doctor.
This spontaneous report as received from a pharmacy refers to an unspecified number of patients of unknown age and gender. In approximately August 2014, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # not reported) that were exposed to temperatures out of range and were evaluated and supported on 15-AUG-2014 and since then administered to patients. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
receiving doses after its beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022j21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported . It was reported that  3 doses from different vials were used and no temperature excursions. It was reported that the vial was initially stored in the refrigerator on 11-Jan- 2022 and beyond use date for that was  11-Feb-2022.  No treatment medication was reported.   This case was linked to MOD-2022-573737 (Patient Link).
Within 2-3 minutes after second vaccine injection(HPV) client stated that she felt hot,then did not respond to verbal stimuli, eyes open, and body began to become limp and slumped forward while sitting in chair. Client was assisted by two staff to the floor. Client placed on her back and legs were elevated. Client responsive and apple juice and granola bar given. Client tolerated juice and granola without difficulty and held appropriate conversation with staff. B/P 110/70 P-80 Resp-16. Client with this staff for 20 mins after incident and ambulated without difficulty and had no complaints upon leaving the clinic.
Caller did not report any side effects or adverse reactions; her daughter received expired GARDASIL 9 on 14OCT2022; This spontaneous report was received from the patient's mother and refers to a 13-year-old female patient. The patient's medical history, concurrent conditions, or concomitant therapies were not reported.  On 14-OCT-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, which had already expired (lot #T008101, expiration date: 01-MAY-2022,) as prophylaxis (strength, and route of administration were not provided). The patient did not experience any side effects or adverse reactions.
miscarriage; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 24Apr2021 11:00 (Batch/Lot Number: ER8736) age at vaccination of 30-years-old, as single dose, for covid-19 immunisation. Medical history was none. It was unknown if patient was pregnant and if she was pregnant at the time of vaccination.  There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Left arm on 29Mar2021 02:45 PM (Batch/Lot Number: ER8734) age at vaccination of 30-years-old, as single dose, for covid-19 immunisation.  The patient had a miscarriage on 07May2021, she found out that was pregnant on 27Apr2021. The patient believe that 2nd vaccine had something to do with miscarriage. The event was reported as serious (medically significant). Doctor visits were done and HCG testing 3 times (Unknown results). Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from miscarriage on an unspecified date.
Initial report received via a scientific literature search on 11 June 2013 via the affiliate. An unidentified 5 month old male patient was evaluated on an unreported date for raised apparently pruritic rash with episodic blisters. He was vaccinated on an unreported date with his scheduled 4 month vaccinations, including Hib; IPV; DTP and rotavirus vaccine. The vaccine manufacturers, date of vaccination, route of administration and batch numbers were not reported. Within 12 hours of vaccine administration, on an unreported date, he became colicky. A day later he began developing blisters filled with clear fluid that became confluent. The areas most affected included the back (which was covered with extensive bullae), skin fold areas of the upper arms and the lower abdomen distant from the area of injection. He had no fever and was in no acute distress. The patient history included an uncomplicated, full term pregnancy with normal delivery. At 2 months of age, the skin of his abdomen and back became progressively rough and stiff with wheal formation surrounded by "raw" red areas of flare at the site of physical stroking. A skin biopsy on an unreported date from the right flank was taken to confirm a suspected diagnosis of diffuse cutaneous mastocytosis (DCM). The patient also has a history of colicky abdominal pain. He was following his growth curve and reached all age-appropriate developmental milestones. There is no history of wheezing loss of consciousness, diarrhea, vomiting or abdominal distention. A physical examination on an unreported date showed an alert, well appearing boy in no evident distress, appropriately interactive. No lymphadenopathy or organomegaly was observed. The skin was notable for confluent skin-coloured papules and plaques with peau d'orange appearance covering his trunk with urtication on minimal touch. Hyperpigment patches of several centimeters in diameter were present on the extremities. Laboratory result on an unreported date showed a 24 hour collection urinary histamine level of 373 ug/g creatinine, total serum tryptase of 75 ng/mL and maturetryptase of 3.1 ng/mL. Blood cell counts were 12,000 white blood cell/uL, 4,690 red blood cells/uL, and 473,000 platelets/uL with mild eosinophilia of 550 cells/uL, and otherwise normal differential. Liver function tests were normal (alanine aminotransferase 23 ukat/L; aspartate aminotransferase 34 ukat/L). Lesional skin biopsy showed a patchy band-like infiltrate of mononuclear cells in the superficial dermis. Immunostaining for tryptase and CD117 was positive, confirming that the infiltrate primarily consisted of mast cells. He was treated with a 5 day course of low dose oral steroids and recovered with no residual skin changes. Since then, he has had 2 additional episodes of blistering associated with vaccination and viral illness. These episodes have become milder after initial regimen with oral and topical sodium cromolyn. The patient outcome is not recovered. Documents held by sender: None.
Nosebleed with red clots,My nose is bleeding profusely; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nosebleed with red clots,My nose is bleeding profusely) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 EPISTAXIS (Nosebleed with red clots,My nose is bleeding profusely). At the time of the report, EPISTAXIS (Nosebleed with red clots,My nose is bleeding profusely) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications mentioned blood pressure medication NOS. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI case
Pt came in for 5 yr WCC. Vacaine's DTaP #5 IPV #4 MMR #2 as well as influenza .05cc were administered. Pt 10 min later developed wheezing, dyspnea and tightness of chest
Headache, numbness of extremities, stomach ache, trouble breathing, stopped breathing, seizures, on ventilator, had CT scan, MRI, EEG, EKG, spinal tap, IV antibiotics, antivirals, blood clots, blood thinners.
This spontaneous prospective pregnancy report was received from a Midwife nurse refers to an approximately 17 years old female patient. Pertinent Medical History and drug reactions/allergies were reported as none. Concomitant therapies included Prenatal Vitamins. The patient became pregnant with Last Menstrual Period (LMP) of 05-APR-2015 and Estimated date of delivery (EDD) of 10-JAN-2016. On an unknown date in 2015, the pregnant patient was vaccinated with GARDASIL or GARDASIL 9, (strength, lot #, dose and route of administration not provided). Nurse Midwife did not know which dose this was in the GARDASIL series. The pregnancy outcome was pending. No adverse effect was reported. No treatment was given for the adverse events. Lab diagnostics studies performed were reported as none. The patient sought medical attention by office visit. No product quality complaint (PQC) was involved. No further information was available. Additional information has been requested.
Initial misuse report received from a healthcare professional on 22 October 2013 and at GPV on 21 March 2014. A 02-year-old patient of unknown gender had received FLUZONE 0.5 ml instead of 0.25 ml. The patient received an incorrect dose. No adverse event was reported. The list of documents held by sender: none
Approximately 2 minutes after vaccine was given and while in observation. Patient was observed sitting in a chair and falling over. Patient did not lose consciousness and remained on the floor for immediate care. Two providers came to assist including the clinic manager. Normal breathing and respiratory were noted. Patient remained on the floor with knees elevate, later lowering the knees to a bending position. Position was then corrected to a sitting position in a chair. Patient was moved to the school nurse's office where she was given juice and a location to lay down and be observed for 30 minutes. School nurse notified parent/guardian.
On 7/21/18 in morning- child complained with left deltoid area swollen, red and hot to touch. Mother gave her ibuprofen but it continued to bother her through the day. In the evening the parents took her to the EMS base to ask and see if they could do anything for her at the ER. They told her to do to her doctor. The next day, 7/22/18, mother took child to Urgent Care and they gave her oral steroids. On 7/23/18 grandmother reported to mother that child was fine and her arm was not swollen or red anymore.
pt recvd vax & 7 days later exp fever of 102 & pt was not able to move rt leg; pt taken to hosp; rt leg began to stiffen, irritable, swollen rt leg, pain;
Very healthy person, got the shot then that night got sudden hot sweats, chills, body ache pains everywhere, could not sleep, head ache,  legs sweating
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 25-MAY-2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, lot number, and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 04-APR-2016, the patient was again treated by this same physician for ongoing and worsening symptoms of shingles. On or about 12-APR-2016, he was treated in the Emergency Room for severe symptoms and pain resulting from the shingles infection. The patient continued to seek medical counseling from the medical facility's phone appointment line, at which time his extreme discomfort was noted and prescriptions were refilled to maintain his ability to function. He had been prescribed nystatin cream, triamcinolone cream and valacyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, he suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The lawyer felt the events were related to ZOSTAVAX. The outcome of the events was not recovered. Additional information has been requested.
No adverse events were reported at the time of discovery. The patient was informed to report any unusual symptoms to the pharmacy.
I went to the emergency room on 11/2/2019 because I could not close my left eye or move the left side of my face.  I was told I have Bell's Palsy.  My symptoms have improved, but I continue to have problems with my left eye and mouth.
numbness of the right mouth and cheek and sometimes the lower mouth also feels numb.  Feels like a novacaine shot from dentist that has never worn off.   I drool a little chewing gum, having to wipe the right side of my lips and cannot drink a glass of water without spilling from the right side of my mouth,   I have to take one sip at at time when I drink.
This spontaneous report as received from a healthcare worker (project manager at a clinical research organization) refers to her 62 year old husband. The patient had no pertinent medical history and no drug reactions/allergies. On 17-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX vial, subcutaneous, lot#, dose and frequency unspecified. Concomitant therapies included atenolol and unspecified statin. On 21-AUG-2013, the patient had shingles. The patient presented with a bubbly  blistered rash, located on the dermatome on midriff that followed a straight line. There was one cluster that hurts when the patient's shirt touched it. Ibuprofen was given as treatment for the event. The patient did not seek medical attention and no lab diagnostics studies performed. The outcome of the event was reported as not recovered/not resolved. This is one of two reports received from the same reporter. Additional information has been requested.
Felt tingling in the chest; This is a spontaneous report from a non-contactable consumer (patient) through a Pfizer sales representative. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a 2nd dose, single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On an unspecified date, the patient had felt tingling in the chest. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
FLU AND COVID VACCIANTION EFFORT FROM PUBLIC HEALTH DEPARTMENT.  LAST PATIENT OF DAY, RN REVIEWED PAPERWORK AND PREPARED MODERNA 0.25ML DOSE AND PRE-FILLED FLUARIX SYRINGE. RN MISTAKENLY NEVER DREW UP THE MODERNA VACCINE AND ACCIDENTALLY INJECTED 0.2ML OF AIR INTO THE PATIENT'S RIGHT DELTOID. RN NOTICED AFTER THE FACT AND EXPLAINED TO THE PATIENT WHAT HAPPENED AND THAT A REPORT WOULD BE FILED, ALSO APOLOGIZED. RN REVIEWED S/SX STROKE / OTHER REASONS TO SEEK EMERGENCY MEDICAL ATTENTION. ALSO GAVE CLIENT LOCAL URGENT CARE PHONE NUMBER AND RN'S DIRECT OFFICE LINE.
pt recv vax 25APR95 in rt arm; that noc felt warm; 26APR to clinic w/ 11x7 cm area of redness & swelling in rt deltoid down to elbow, w/mild swelling of lower arm & hand; no fever; rx warm wet compresses, DPH, APAP;
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No any concomitant medications were reported. No any treatment medications were reported.
This case was reported by a physician and described the occurrence of not responding to therapy in an unspecified number of subjects of unspecified ages and genders who were vaccinated with TWINRIX for prophylaxis. On an unspecified date (s) the subject (s) received the 1st, 2nd and 3rd dose of TWINRIX (unknown). On an unspecified date (s), unspecified titer (s) were tested and revealed that the subject (s) had not seroconverted. A physician reported that an unspecified number of subjects (ages and genders unspecified) completed the TWINRIX dosing series and were non-responders when post vaccination titers were tested. The physician reported that the results of the test were returning as "zero". The physician stated that post vaccination testing of the subjects occurred one month after the vaccination series was completed, and some of the subjects were tested 2 to 6 months after their dose of TWINRIX. The physician did not think the non-responders were due to a quality issue, but rather a combination vaccine issue. In addition, the physician stated that each subject has received a repeat series with monvalent Hepatitis B vaccines, and each subject and "high titers" following post vaccination testing. At the time of reporting, the outcome of the event's was unspecified.
H1N1 vaccine received on 11/2/09 at 17:13. An hour later at 18:13 both legs started itching and red bumps appeared in both legs. No medication taken. The itching and bumps lasted for 2 days.
SWOLLEN AND ERYTHEMA AT INJECTION SITE TO ELBOW SITE WAS HOT AND RED.
Pfizer 1/25/21, 2/19/21. Positive on 1/25/22