chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives on entire length of both arms and face.  Vaccine site swollen.  (Upper arm). Treatment:  Benadryl every 4 hours continuindv
This patient presented to ED in shock. The patient was then transported to PICU. The patient in shock requiring cardiopulmonary resuscitation. The patient expired approximately 72 hours after admission. The patient had received Prevnar the day prior to admission. Autopsy shows baby was cyanotic, not breathing
Approximately 30 hours after initial administration, patient began experiencing mild to moderate abdominal cramping and frequent runny stools. Patient believes it was most probable an autoimmune reaction to the injection, given her history of Crohn's disease. Patient continued to monitor reaction and follow a low-residue diet for 3 days until symptoms resolved.
Vaccine received on Friday 10/25/12 over noon hr. Itching began Sunday evening 10/27/13 and by Monday morning rash/hives appeared. Patient was seen by PCP and was told to take benadryl.
severe pain in his right knee; joint swelling; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (severe pain in his right knee) and JOINT SWELLING (joint swelling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Protein C deficiency (Activated Protein C deficiency). Concomitant products included METHADONE for Chronic pain.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (severe pain in his right knee) and JOINT SWELLING (joint swelling). At the time of the report, ARTHRALGIA (severe pain in his right knee) and JOINT SWELLING (joint swelling) outcome was unknown.        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.   Treatment medication included Vicodin up to 4 times a day.   Reporter did not allow further contact
Developed severe headache nausea facial and neck swelling, chest pain and respiration. Called PCP. prescribed Benadryl next day, increased swelling to include left side of face and eye. DX Bell's Palsy
Extreme itching and hives unresolved and reappearing without BENADRYL. Contained with BENADRYL while on but reoccurring.
Sore throat; I am experiencing some swelling in my arm that I got in which. I know it is normal because I had it with my first one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "recovered", described as "Sore throat"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "I am experiencing some swelling in my arm that I got in which. I know it is normal because I had it with my first one".  Additional information: It was reported that the patient had some swelling in arm with first one. Also reported that did not have any problem just sore throat from the first one for a couple of days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills; Diarrhea; hot flashes; Low grade fever; rash on the leg; Vomiting; This is a spontaneous report from a contactable consumer (patient himself) via a Pfizer-sponsored program, Covax US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on 18Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as 1st dose on 28Jan2021 for COVID-19 immunisation. The patient had both of the inoculations and he was having really bad side effects and was am not sure if these are from the vaccine or not. On 19Feb2021, the day after, it was reported that the patient experienced chills, diarrhea, vomiting, hot flashes, rash on the leg and low-grade fever. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
received an Adacel vaccine subcutaneously instead of IM; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date, site of administration were unknown) subcutaneously instead of intramuscular on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate route of vaccination.  It was unknown whether the patient had any adverse event.  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 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.  Information on the batch number was requested.  Documents held by sender: none.
Began itching about 30min to 1 hour after injection and has continued to itch, now over a week later. Has blisters on the back of his legs behind his knees and itchy whelps.
Had no reaction to 1st or 2nd Comirnaty (Pfizer COVID-19) vaccine. Received booster 11/16/2021. On 11/17/2021, severe rigors/chills/myalgias, at 9 weeks gestation. Ultrasound at 7 weeks GA was normal. Started extremely light vaginal bleeding 11/18, continued with intermittent rigors etc. through the weekend. On 11/22, felt a sudden pain ("rip") in the pelvis during a rigor, and subsequently experienced heavier bleeding/miscarriage at 10 weeks GA. No history of prior miscarriages (3 term live births).
My first dose of Covid 19 by Moderna was given on Tuesday, January 12 at about 12:15 PM.  My arm felt fine except it felt bruised at the injection site the next morning.  A day or 2 later it was a bit red and warm but went away after a couple days.  Today, 8 days after the injection, the site is inflamed.  It is red, warm, and about 3- 4 inches in diameter.  It has more discomfort today than it has in the past week although I still have mobility in my arm.
Pt received pfizer vaccines on 04/01/21 and 04/22/21. Pt presented to the ED with complaints of difficulty breathing, body aches, and cough. Pt was tested for COVID at Urgent care, which came back positive.
Information has been received concerning a pt who was vaccinated with 2 doses of varicella vaccine. Subsequently, the pt sought unspecified medical attention and was tested for antibodies. The results were negative. A third dose of varicella vaccine was administered and the pt was re-tested and found to have a negative antibody titer.
she started to feel abdominal cramps; She had the urge to go to the bathroom but the stool is described as formed; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot number and expiration date were not reported), via an unspecified route of administration on 30Apr2021 at 1st dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient started to feel abdominal cramps on 02May2021 and then it became horrendous. She described the abdominal cramps like diarrhea. She had the urge to go to the bathroom but the stool is described as formed (not watery) on 02May2021. She wanted to know if this was because of the virus or a side effect from the shot. The outcome of the events was unknown. She stated that next vaccine dose was scheduled on 29May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
One week from the vaccine injection I am getting itching hives at the injection site.  All I have done so far is put cortisone on the hives. I don't seem to have any other symptoms.  Just very itchy arm.
pt recvd vax; pt was a twin child who devel a chicken pox like rash on hands & feet p/ vax;
Day 1 - injection site pain; Day 2 - injection site pain, overall muscle soreness & headache; Day 3 - fatigue, fever, chills, overall muscle soreness & headache, hives on hand, right foot and left foot and leg; Day 4 (Saturday) - fatigue, fever, chills & headache and sinus pain on inhales; Day 5 - same as Day 4; Day 6 -  same as day 4 & 5, plus sweating AND loss of taste and smell. Today Day 7 - fatigue, fever, chills & headache and sinus pain on inhales, sweating, loss of taste and smell; ear aches, rash on chest
Redness at vaccine site R thigh, not warm to the touch.  Redness has decressed since 10/9/05. No treatment needed.  Mother applied warm compresses to reduce redness.
Localized reaction starting 6 days post injection the area about the size of a tennis ball became red, swollen, hard, hot with minimal pain and itching.
Breakthrough COVID-19 case with symptom onset 9/1/2021 (symptoms unknown). Hospitalized 8/24/2021 for unknown duration
Information was received on 04-APR-2017 from a medical assistant concerning a 14 month old male patient. No medical history or concomitant medications were reported. On 31-MAR-2017 the patient inadvertently received a dose of PNEUMOVAX 23 (lot M038359, expires 13-MAY-2018) (dose and route not reported) when the child was "14 months of age." No adverse effects reported. No other information was provided. Additional information has been requested.
Report body aches, fever with Tmax of 102, HA, fatigue and arm soreness. Treatment: Tylenol and Ibuprofen, Outcome: symptoms resolved completely by day 2.  Did not interfere with ADLs
My eyes itched; My lips itched; My eyes swollen; My tongue itched; My tongue swollen; My lips swollen; I itched all over and still itch; This is a spontaneous report from a contactable consumer or other non hcp. A 49-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: em9810) via an unspecified route of administration, administered in arm left on 08Feb2021 14:00 (at the age of 49-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, hypertension and drug hypersensitivity. Concomitant medications included telmisartan taken for blood pressure. The patient previously took Benadryl and sulfa and experienced allergies. Patient did not have COVID prior vaccination. Patient was tested for COVID post vaccination.  On 08Feb2021 at 02:00PM the patient lips tongue and eyes itched and became swollen. The patient itched all over and still itching and had to rush to the urgent care for treatment and the went to an allergist a few days later. The patient was advised not to take the second shot and was given epi pen. The patient received treatment with steroids and allergy medication. Patient underwent lab test on an unspecified date: COVID test result: negative. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
I started having problems with my vision (difficulty seeing words).  I had a slight headache and then i had trouble thinking clearly.  I could not focus or find the right words as I was trying to speak.  The whole thing lasted 20-30 minutes, and the everything was fine.
Not feeling 100%; Itching; Rash below her under arm; COVID arm; Injection site reaction that was red and raised like hives; Injection site reaction that was red and raised like hives; Sore and achy arm that extends behind her shoulder; Experiencing a reaction; Pain down into her hand/Sore and achy arm that extends behind her shoulder and upper part of her back.; Sore and achy arm that extends behind her shoulder and upper part of her back.; Has discomfort in her arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Has discomfort in her arm), MALAISE (Not feeling 100%), PAIN IN EXTREMITY (Pain down into her hand/Sore and achy arm that extends behind her shoulder and upper part of her back.), BACK PAIN (Sore and achy arm that extends behind her shoulder and upper part of her back.) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided.  Concomitant products included DENOSUMAB (PROLIA), HYDROCHLOROTHIAZIDE and VITAMIN B NOS for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced LIMB DISCOMFORT (Has discomfort in her arm), PAIN IN EXTREMITY (Pain down into her hand/Sore and achy arm that extends behind her shoulder and upper part of her back.), BACK PAIN (Sore and achy arm that extends behind her shoulder and upper part of her back.), VACCINATION SITE REACTION (Experiencing a reaction) and ARTHRALGIA (Sore and achy arm that extends behind her shoulder). On 21-Feb-2021, the patient experienced MALAISE (Not feeling 100%), PRURITUS (Itching), RASH (Rash below her under arm), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE URTICARIA (Injection site reaction that was red and raised like hives) and VACCINATION SITE ERYTHEMA (Injection site reaction that was red and raised like hives). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Has discomfort in her arm), MALAISE (Not feeling 100%), PAIN IN EXTREMITY (Pain down into her hand/Sore and achy arm that extends behind her shoulder and upper part of her back.), BACK PAIN (Sore and achy arm that extends behind her shoulder and upper part of her back.), PRURITUS (Itching), RASH (Rash below her under arm), VACCINATION SITE REACTION (COVID arm), ARTHRALGIA (Sore and achy arm that extends behind her shoulder), VACCINATION SITE URTICARIA (Injection site reaction that was red and raised like hives) and VACCINATION SITE ERYTHEMA (Injection site reaction that was red and raised like hives) outcome was unknown and VACCINATION SITE REACTION (Experiencing a reaction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information reported included ibuprofen, paracetamol.
Injection was more painful than flu shot given at same time; Pain @ injection site, lasted about 5 days (more than flu shot); injection site had some swelling and nurse reported increased temperature around injection site; tired and general not feeling well.
Red shingles looking rash around injection site on upper arm with a 3 inch radius.
Slurred speech, muscle twitching treated by numerous doctors on-going.  Doc # 203384 states that sympoms consistant with ALA after vaccine, motor neuron destruction.He is dying.
Swollen breast tissue-full feeling with the feeling on more dense area of the breast tissue. Swollen glands on left side in collarbone area same side that shot was given. Idiopathic Thrombocytopenia Purpura like symptoms-easy bruising, small red spots on feet, ankles, lower legs, waist area, and left wrist area.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concomitant therapy, concurrent condition, historical condition and drug reaction were not provided. On 21-FEB-2017 the patient was vaccinated with an expired supported dose of ZOSTAVAX (strength and dose unknown, lot # L046293, expiration date 17-FEB-2017) subcutaneously for prophylaxis (expired vaccine used). No adverse effects reported. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hyperventilation-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in fingers and toes
MUSCLE PAIN; TROUBLE BREATHING; LIGHT-HEADEDNESS/DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced trouble breathing. On 09-APR-2021, the subject experienced light-headedness/dizziness. On 14-APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headedness/dizziness on 09-APR-2021, and had not recovered from muscle pain, and trouble breathing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Nausea, severe muscle/joint pain, feelings of impending doom, redness at injection site, hot to touch.
Reported pain at the injection site as a result of a failed attempt of the patient receiving the GARDASIL 9 vaccine; syringe was put into the arm and the outside part of the syringe (flat part) broke. So she had no way to push it thru; reports that the failed attempt of receiving the GARDASIL 9 vaccine to the patient was a result of the prefilled syringe of GARDASIL 9 malfunctioning; Product difficult to administer; This spontaneous report was received from a certified medical assistant and refers to a 13 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.   On 12-JUL-2019, the patient experienced a failed attempt of vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) second dose, 0.5 milliliter, intramuscular in the right deltoid, lot # R024271, expiration date 08-MAY-2021, for prophylaxis. The medical assistant reported that the failed attempt of administering the vaccine to the patient was a result of the prefilled syringe of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) malfunctioning. The medical assistant reported the "syringe was put into the arm and the outside part of the syringe (flat part) broke. So she had no way to push it thru" (product quality issue). On the same date, the patient experienced "pain at the injection site" (also reported as "it hurt") as a result of the failed attempt of the patient receiving the vaccine.  It was reported that the patient did not receive any of the vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), as a result of the first failed attempt. However, the patient did not miss the schedule dose of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine, as he was administered another separate dose of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine. Additionally, no treatment was provided to the patient for the events. The medical assistant stated the "patient was fine and went home".   The outcome of injection site pain and product quality issue was resolved. The causality between the events and therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was unknown.
Initial report received from a health care professional on 12 April 2011. A female patient received on an unknown date an injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. lot number C3637 and sanofi pasteur Inc. lot number U3491BA. The patient developed hives. No further information was provided. The outcome was not reported. Follow-up information was received from the healthcare professional on 09 May 2011. The patient was 14 years old at the time of vaccination, and received ADACEL in the left deltoid on 15 Marcy 2011 in a school base clinic. She had no illness at the time of vaccination, and denied any history of allergies. She had no history of changes in soaps or detergents, however did have a dog which she allowed to sleep in bed with her. The event began on 20 March 2011, 5 days post-vaccination, with the patient complaining of red itchy areas on the face with no associated pain. Medications included cortisone and BENADRYL. Per the reporter, the patient had "heavy use" of cortisone cream, and had hypopigmented areas on the face and forearms. The patient was instructed to stop cortisone use, use AQUAPHOR, sunblock, AVEENO or CETAPHIL; remove dog from bed; wash all bedding thoroughly; and follow-up in 1-2 weeks. The assessment was possible dermatitis vs eczema, "unlikely secondary to Tdap given 1 month ago". The events subsequently resolved on an unspecified date. Documents held by sender: None.
Systemic: Rashes on abdomen and ear-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient states bumps/rahses on abdomen and ear and is experiencing lightening of skin, numbness and tingling on palms of both hands. No injection site reaction complaint (cant submit form with checking one)
02/04/22 presents to ED for "Intentional Ingestion". PMHx of "anxiety, depression and PTSD"
Tasted vaccine in throat, throat closed briefly, ringing in ears began immediately, hearing loss/stuffiness in right ear occurred immediately, foggy brain occurred immediately. The tinnitus is constant and persists along with the hearing loss .
Initial report was received 11 August 2010 from a health care professional which involved a cluster of eight patients who tested positive for pertussis. Patient identifiers were provided for seven patients; two who had previously received ADACEL (captured in this case 2010-04350 and case number 2010-04349); and three who had previously received an unspecified TdaP vaccine (captured in case numbers 2010-04352, 2010-04353 and 2010-04354), and two patients who had not received ADACEL, but had previously received a full DtaP vaccination series (captured in case numbers 2010-04351 and 2010-04376). At the time of the report, no information was available for the eighth unidentified patient. An 11-year-old female patient  had received an injection of ADACEL, lot number C3158AA (also reported as lot number C3507AA which corresponds to Tubersol) "at the end of April", and an unspecified amount of time later, she developed a break through case of pertussis and tested positive for pertussis. The patient's siblings, an 11 year old twin and an eight year old, had also experienced the same events. Outcome was not reported. No further information was provided at the time of the report.