chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning his 15 month old daughter, with no drug reactions or allergies, who approximately on 21-DEC-2009 was vaccinated with a first dose of MMR II (lot #, route and dose not reported) and in March 2010 was vaccinated with a second dose of MMR II (lot #, route and dose not reported). The father reported that his daughter had issues when she received the vaccination. After each dose of the vaccine the patient required hospitalization for dehydration due to severe nausea and vomiting. The patient developed severe nausea and vomiting 3 to 5 days after each immunization, and was admitted to the hospital for rehydration. The first incident was on 24-DEC-2009 and the child was hospitalized for four days. The second event occurred in March 2010 and the patient was hospitalized for 6 to 7 days. The patient recovered fully each time. The patient also experienced a tic disorder that might turn into Tourette's syndrome after vaccination with VARIVAX (Merck) (WAES 1108USA00304). Additional information has been requested.
PATIENT REPORTS A RASH ON BUTTOCKS, THIGHS, HANDS & BACK BEGINNING THE DAY AFTER RECEIVING THE VACCINE
Erythema/warmth spreading over upper arm, fever and chills, T= 100.5, knot area this developed blisters
Little soreness in the arm; 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. Relevant medical history included: "Spinal stenosis" (unspecified if ongoing). Concomitant medication(s) included: NORCO taken for spinal stenosis. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Little soreness in the arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately one week after my first dose of the COVID vaccine, I noticed a large area around my where I got my shot that is red and raised. One day later it appeared to have grown a bit. It is not sore. When I touch it, it itches.
pt recvd vax & w/24hrs pt exp peripheral neuropathy (vision related);pt's vision is improving gradually;sx persist;
Patient fainted and, upon waking, was hot/sweaty and generally felt unwell with several random spells of nausea for about 45 minutes afterwards.
received the DTaP-IPV liquid component of pentacel but not the HIB lyophilized powder component; pentacel was not reconstituted with no reported adverse event; Initial information received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional via Medical Information number: 00782515.  This case involves a Four months old male patient who was received the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 23-Sep-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ529AA and expiry date: 22-JUL-2022 via intramuscular route in the left thigh Prophylactic vaccination respectively.  It was case of an actual medication error due to product preparation issue (latency: same day).  It was reported that "Office Manager reports that a 4-month old patient received the DTaP-IPV liquid component of PENTACEL but not the HIB lyophilized powder component; PENTACEL was not reconstituted. Caller would like to know if the patient can receive ACTHIB separately. Caller was encouraged to view the PENTACEL Reconstitution video".  At the time of reporting, no adverse event was reported.  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.
Vasovagal response. After receiving the Janssen COVID 19 vaccine, Patient reported she sat down in her chair. She began to feel dizzy, her palms became sweaty, and diaphoretic. She began to lie herself down on the gym floor but lost consciousness before completely lying down on the floor. LOC for for several seconds after which she began to respond to observation nurse. Fall was unwitnessed so EMS was called to evaluate the patient. She was medically cleared by EMS.
This spontaneous report was received from an office manager and refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 03-MAY-2017, the patient was vaccinated with an expired dose of M-M-R II (recombinant human albumin (rHA)), injection, subcutaneously in the left thigh, lot number M032153, expiration date: 22-APR-2017 (strength and dose were not reported) as a booster dose. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) (lot number reported as M046372, expiration date: 08-JUL-2019). The patient did not experience any adverse effects. There was no product quality complaint involved in this case. Additional information has been requested.
It was reported in a published article, title as stated above that a breast feeding woman, on unspecified dates within one month, was vaccinated with three doses of MMR II as an employment requirement. Subsequently, after vaccination, she noted that her infant son, a product of a full term uncomplicated pregnancy, who she was breast feeding seemed listless and stopped saying the few words he had previously spoken. It was reported that the infant has one sister, 2 years older than him who was in good health. When the infant was seen by the physician at the age of 17 months he had no speech, avoided being touched, even by his parents, mad repetitive motions, and exhibited all 8 of the typical signs of typical infantile autism. There was some hyperacusis in the sound of high pitch. The infants attention span could not be measured. Prior test had included comprehensive gastrointestinal analysis, which was normal. Specifically, no bacteria, yeast, or parasites were found in the pts stool. The pts parents refused further testing, other than testing mercury levels in red blood cells, because of lack of funds. The parents stated that in their native city, air and ground levels of mercury, lead and other toxic elements were very high. The infants mother had discontinued nursing at 17 months, as she realized what had happened. The pt gradually improved over 9 months but plateaued and was still subnormal at 24 months. He was placed on oral chelation, and has slowly gained speech during the last 7 months. no further information was provided. Upon internal review, the pts autism was considered to be an other important medical event (OMIC). A copy of the published article is attached as further documentation of the pts experience.
I received a flu and pneumonia shot on 11/6/03 (teacher). By 11/7/04 I had flu symptoms and a red, swollen circle on arm. That evening, I had a temperature. By following AM could not move arm. Went to ER. Arm is still sore. Cellulitis. Nurse did not swab arms with alcohol prior to giving shot.
I gave Booster dose today and it was early date, it should be Dec2022; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (patient that received the first dose of the Pfizer Covid-19 Vaccine on 02Jun2021), administration date: 02Jun2021, for COVID-19 immunization; Bnt162b2 (patient that received the first dose of the Pfizer Covid-19 Vaccine on 02Jun2021 and then received the second dose on 22Jun2021), administration date: 22Jun2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "I gave Booster dose today and it was early date, it should be Dec2022"; IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "Booster dose".  Additional Information: Transferring agent stated, "I have a Registered Nurse (reporter) on the line, and she is calling due to a patient that received the first dose of the Pfizer Covid-19 Vaccine on 02Jun2021 and then received the second dose on 22Jun2021. The patient was sent for the Booster dose and the Nurse said that when she went to enter the Booster dose it says that released dose date should be Dec2022, so she is inquiring if she gave it too early. She is inquiring about the Booster (Covid-19 Vaccine) dose being given too early, that's all the information. When paraphrased the concern, Nurse stated, "Today yes, I gave it (Booster dose) today and it was early date, it should be Dec2022." In response to further probing, Nurse stated, "Yes but I am trying to see, does she need to get another dose or is that okay because I gave it today." Nurse was provided with the number of Medical Information # and was requested to select option 3 and timings as 8 am to 8 pm from Monday to Friday as per. In response Nurse stated, "So in other words, you are not the right person that I need to talk." In response Nurse stated, "Ok, so what about the other question, I asked them, the other question for other patient, her first dose was given today, so I am going Pfizer, it says first dose "1222" (Further not clarified) and she is only 27 years old."  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
"Cluster blisters" on back of hand & inside mouth; also, mouth ulcers, taste buds on tongue swollen & painful;
REDNESS, PAIN, SWELLING AND ITCHING TO RIGHT DELTOID INJECTION SITE INITIALLY APPEARED APPROXIMATELY 24 HOURS AFTER RECEIVING VACCINE, WENT AWAY AND RETURNED 12/30/2020 WITH WORSE SYMPTOMS. SEEN BY EOH 12/31/2020 WITH 5x6cm INDURATED, WELL DEMARCATED, ERYTHEMATOUS ARE
At first, slight headache,that progressed to mild, joint ache, fever of 101.1,  fatigue.  Took 1 Advill at 11:10 P.M.  Felt better next morning until 1hr. 30 min after arising. Sudden heavy fatigue. Couldn't finish fixing breakfast. Slept 3 hours, did 1 load of laundry, slept 3hr. 30 min.. No appitite,  Did another load of laundry, slept 3 hours.  Ate fruit and a sandwich about 6:30 P.M  Took 4 Low dose aspirin then,, Took a bath and in bed at 10:25.Headache gone then. Slept til 6:00 Sun. felt fine except for fatigue which lasted into Monday,.  Also sore right arm at injection site.
Cough; Sore throat; came up positive for Covid; This is a spontaneous report from a contactable consumer (patient). This female consumer of unspecified age who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported, expiry date: not provided), dose 1 via an unspecified route of administration on 23Jan2021 as 1st dose, single for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient got a cough and sore throat. She got tested and came up positive for Covid-19 ten days after the shot. She might have had it before the shot or gotten it in-between, but she did not known. The outcome of events was unknown. The patient was supposed to get second dose of vaccine on 13Feb2021.   Follow-up attempts are completed. No further information is expected.
Patient received MMR and Hib vaccines at 4:05pm on 6/10/2020, patient left clinic.  Mother returned to clinic after physical requesting to speak with PCP at 4:15pm. Mother then stated "this is an emergency", patient started with sudden onset eye and facial swelling. , Mother left clinic, went to lab and states swelling began while at lab. No provider available in pod - patient immediately brought to clinic, roomed in room 5 and evaluated by Dr. Patient given Benadryl, Epipen Jr, and Prednisone in clinic, 911 called and patient transferred to Hospital ER.
Swelling of (L) Deltoid area with redness Pt. broke out in a rash, all over face & body (L) Deltoid area feeling hot to touch. Reaction started this morning 9/11/20 pt woke up with arm swollen and rash.
I was having very mild symptoms starting on Wednesday. I was on a trip with my softball team and someone on the trip tested positive for COVID-19, the next day I was having symptoms and so I took a test as well but that was negative. I was planning on flying home that weekend, so I did not test again. My symptoms got worse, I was having a sore throat, a slight fever, and congestion. Sunday after getting home I took another home test and it was positive, so I called my doctor, and they gave me PAXLOVID. I did take that, and my symptoms did not get worse, but I was testing positive for about six more days.
received an expired dose of the Moderna COVID19 vaccine lot number 033C21A, dose administered past the expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID19 vaccine lot number 033C21A, dose administered past the expiry date) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 30-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID19 vaccine lot number 033C21A, dose administered past the expiry date). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID19 vaccine lot number 033C21A, dose administered past the expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No Treatment was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant follow up was received and included patient identifiers (Initials, gender, DOB), dose number information.
9/19/2021- Developed ear pain with ear infection in both ears. Puss coming out of both ears. 9/23/2021- Burning sensation on bottom of feet and bottom of middle toes 9/26/2021- Head to toe complete body pain and aching at night 9/27/2021- Head to toe complete body pain and aching at night 9/28/2021- Pain and burning on bottom of feet and bottom of toes 10/07/2021- Burning sensation bottom of feet and bottom of toes 10/27/2021- Burning sensation bottom of feet and bottom of toes
Received 2nd covid vaccine (Pfizer) on Saturday, 2/20/2021.  PCP visit on 2/24/2021.  Left deltoid.  About 10 minutes after receiving vaccine, she developed sense warmth, numbness and tingling left side of her face/cheek, left lateral neck and left ear. No rash. Denies she had any tongue or lip swelling.  No difficulty breathing or swallowing. Went back to vaccine clinic and sat with the RN for 1 hour after receiving the vaccine. Was given dose of benadryl (25 mg). Still symptomatic Sunday (24 hrs after receiving vaccine). Also had headache and fatigue over the weekend, but never got any additional symptoms. Took an additional dose of benadryl. Never had any tongue or lip swelling, No scratchy throat. No fever or body aches. Yesterday was better and she was without symptoms. 2/24/2021 denies any of above symptoms.  Left upper arm slightly sore at site of injection. Did not have any reactions with prior covid vaccine. No hx of vaccine reactions.
This is a spontaneous report from a contactable consumer or other non-HCP. This is 1st of 2 reports. A 61-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Historical vaccine included the 1st dose of BNT162B2 for COVID-19 immunization. The patient experienced fever on Feb 19, 2021. The patient underwent lab tests and procedures, which included body temperature: 99-100ºF on Feb 19, 2021. The patient wanted to know if she can take Tylenol after taking the COVID-19 vaccine. She received the 2nd dose of the Pfizer COVID-19 vaccine yesterday. Today she and her husband developed a fever, one ranged from 99-100ºF (and the other ranged 100.4-100.5ºF). As per the documentation received form the facility they received the vaccine, they were advised to call their doctor if they had a fever, loss of taste, etc as they may need to take a COVID-19 test. But as for other symptoms, they make take pain medication. She asked how high a fever could go after taking the COVID-19 vaccine. The case reported non-serious, with outcome of unknown. Follow-up (Feb 19, 2021): This is a follow-up to a spontaneous report from a contactable consumer. This consumer (patient) reported no new information. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected. Sender's comments: Linked report(s): INC-2021210314 similar report from same reporter.
Pt initially when walking out of office had dizziness, blurry vision. Brought back in and was pale and slightly disoriented. BP 98/54, pulse normal. Improved within 30 sec and resolved in 5 min of sitting with cool cloth. Developed persistent diarrhea in mid-November 2015 with negative testing including GI referral with colonoscopy. Mom believes IBS and vaccine are connected. Recovered from immediate effects.
site pain on left arm; This is a spontaneous report from a contactable consumer (patient).    A 69-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318, Expiration date: Unknown), via an unspecified route of administration, administered in arm left on 03Feb2021 (age at vaccination was 69 years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 03Feb2021, the patient experienced site pain on left arm. The patient stated that the site pain started 1.5 hours after the first shot and had resolved about a day and a half later. The patient stated that if he was not getting much pain, he not getting much benefit from the Covid vaccine. Outcome of the event was recovered on an unspecified date in Feb2021.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from a nurse prescriber (NP) regarding a 4 month old female patient. The patient's pertinent medical history, drug allergies/reactions, concurrent condition and concomitant medication were not reported. On 19-MAR-2018, the patient was vaccinated with ROTATEQ, oral solution for vaccination (dose, lot#, expiry date were unknown). On 23-MAR-2018, after administration of ROTATEQ, the patient had black specks in the unspecified patient's stool (abnormal faeces). Patient was seen by NP on 25-MAR-2018. NP reported that black specks were a size of black pepper and it were hard. On the same day, a stool test was performed and the NP confirmed that there was no blood in the stool. NP reported that number of black specks decreased from the time which was initially reported on 23-MAR-2018, but it was still present in the stool. The outcome of the event was recovering. The reporter causality was not reported. Product quality complaint (PQC) was not involved.
chills; fever; arm is red; arm is swollen; arm is warm to the touch; I continue to have redness around my injection site and down my arm.; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red), PERIPHERAL SWELLING (arm is swollen), FEELING HOT (arm is warm to the touch), VACCINATION SITE ERYTHEMA (I continue to have redness around my injection site and down my arm.) and CHILLS (chills) in a 56-year-old female patient 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 was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 17-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced ERYTHEMA (arm is red), PERIPHERAL SWELLING (arm is swollen), FEELING HOT (arm is warm to the touch) and VACCINATION SITE ERYTHEMA (I continue to have redness around my injection site and down my arm.). On 18-Aug-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 18-Aug-2021, CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, ERYTHEMA (arm is red), PERIPHERAL SWELLING (arm is swollen), FEELING HOT (arm is warm to the touch) and VACCINATION SITE ERYTHEMA (I continue to have redness around my injection site and down my arm.) outcome was unknown.            It was reported that the patient had received a booster dose on 17-AUG-2021.   patient received first dose on 08-FEB-2021 and second dose on 08-MAR-2021.  No treatment information was provided.   This case was linked to MOD-2021-292485 (Patient Link).
Entire limb swelling within hours of vaccine. Tenderness, swelling, bruising at site, limping for 7 days following vaccine.
Symptoms: Fatigue, headache, nausea, joint pain, elevated  temp 100.4F, chills, sweating, difficulty breathing.  Treatment: Tylenol, water, anti-nausea, sleep.  Duration: 18hrs
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-JUN-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended. On or about 01-NOV-2011 [conflicting information: prior to vaccination with ZOSTAVAX], the patient was diagnosed with shingles, or herpes zoster. He was treated by a physician for the sudden onset of herpes zoster, or shingles. The outcome of the events is unknown. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.