chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient alerted pharmacist to feeling light headed at 12:10pm. Patient was instructed to sit down on the floor. She stated she felt hot and hadn't eaten all day. She was given a few bites of apple sauce and some Dr. Pepper to drink in case of low blood sugar. She was also given 25mg of diphenhydramine in case of an allergic reaction after the vaccine adminstration at 12:15pm. A few minutes later, she began shaking and stated she thought she was having an anxiety attack.  At this time, the patient requested we call 911 because that would make her feel better and so we did.
From an initial report dated 04/20/01, it was reported a pt vaccinated on 01/04/2001 pt had a local reaction the next day. the pt developed a slightly raised, red, rash, the size of your hand. It was painful, itchy and she had some neuritis and numbness the length of her arm radiating from vaccination site. She also had muscle soreness. Spoke with her and she had just taken Benadryl and Excedrin on day 3. That did alleviate her symptoms. She is going to try to get the lot number from her vaccine. Pt called in 01/10/2001 with lot number.
Fever 100 degrees. Continued soreness at injection site. Slight chill, Fatigue, Infrequent head pain. All within 24 hours after vaccine injection. I am currently experiencing above symptoms .
Patient was in her early first trimester for both vaccinations.  4 weeks for the first one and 8 weeks for the second one.
10 hrs after receiving 2nd dose of Moderna vaccine into L deltoid, developed pain, numbness, and tingling in L wrist, hand, and 2nd, 3rd, 4th fingers. The next day she was unable to flex mentioned digits.   She had no improvement and on 1/29/21 she was prescribed Medrol Dosepak which was effective and as of 2/3/21, patient is back to baseline.
Rash developed 2 weeks after receiving vaccine on opposite arm that was injected rash was not itchy, was splotchy and she complained of muscle soreness in that arm.
Raised red area 4.5 cm in diameter left upper posterior aspect of arm, warm to touch, itches. Symptoms started this afternoon. Treated with BENADRYL & ice.
Information has been received from the mother of a 14 month old male with no medical history and no allergies who on 29MAY2003 was vaccinated subcutaneously with a 0.5ml first dose of varicella virus vaccine live. There was no concomitant medication. On 05JUN2003, 7 days post vaccination, the mother reported that her son developed varicella breakthrough with 12 varicella like lesions. He was experiencing a "mild" varicella reaction and his pediatrician had recommended oatmeal bath as a form of treatment. No diagnostic studies were performed. At the time of report, 05JUN2003, it was reported that the patient was still recovering. No product quality complaint was involved.
Following routine vaccination of Hib, Prevnar, and DTaP at 2 and 4 months of age, child developed 105 fevers and was taken to the ER both times. Given the CDC guidance to consult with your physician following a fever of 105 or greater, parents began consulting pediatrician, functional medicine specialist, and allergist to determine if vaccination was safe to continue. At 5 months of age, patient developed moderate eczema. Child was taken for allergy screening after hives at introduction of peanut. Patient demonstrated significant allergic indication following skin prick test and follow up blood work indicated allergic presentation for ~20 foods, 10 of which warranted avoidence and to carry ephinephrine at all times. Child has no known hereditary markers for atopic presentation of eczema or allergy. Child, with medical guidance, ceased vaccination and all allergies significant declined over repeated 6 month periods. Through food trials and blood tests, by 3.5 years of age, child was eating all previous allergies freely with the exclusion of cashew which was limited in quantity but regularly given. Child was given a temporary medical exemption to vaccination based on the assumption that routine vaccination could have played a role in sensitization to certain allergens (food and environmental). When childs medical exemption lapsed, she was given the MMR at 4 years and 2 months of age to enter school legally. Labs were drawn 10 days in advance of vaccination and 4 weeks following vaccination to determine if allergic indication increased. Globally, allergic indication increased and routinely eaten foods prompted allergic response again. Following MMR vaccination, child had 3 fevers of 103 F spread across 6 days, between day 7-12 following MMR injection. No acetaminophen was given and child had no other symptoms. Child has no history of sickness that has warranted antibiotic use, no consistent use of acetaminophen or other medications.
The day after my shot around noon my underarms were in pain, my throat began to hurt and I had a really bad headache. My fever lasted for 2 days around 100 along with a stuffy head & sore muscles. I took ibuprofen only and things started to clear up about two weeks later and I am back to normal.
blurred vison; headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vison), HEADACHE (headache) and MYALGIA (muscle aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke in 2014.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (blurred vison), HEADACHE (headache) and MYALGIA (muscle aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 325 milligram. At the time of the report, VISION BLURRED (blurred vison), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. Patient took .Aspirin 325mg as a treatment drug
Pt experienced chickenpox like symptoms on left side of body. Pt also experienced redness and warmness at site of injection. On 7/17/14 instructed pt to call MD. Pt states MD stated it was chickenpox. No further medical action is required at this time.
Brain fog; rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 26Mar2021 at 14:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism, thyroidectomy and obesity. Concomitant medication included ARMOUR THYROID and multivitamin (MANUFACTURER UNKNOWN) taken for unknown indication. The patient had a history of allergy to penicillin, steroids and sulfonamides. Prior to the vaccination, patient was not diagnosed with COVID-19 and not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 7:00, the patient experienced brain fog and rapid heart rate (five days post vaccine). The patient did not receive any treatment for the events. The clinical outcome of the events brain fog and rapid heart rate were ongoing at the time of reporting.  No follow up attempts are possible. Information about batch number cannot be obtained.
Breakthrough covid-19 infection, symptoms began 10/02/2022, PCR test positive the following day. Symptoms included shaking, fever, fatigue, headache, congestion, cough. Received a prescription for Paxlovid from Dr., prescription filled 10/4/2022, 5 day course taken.
Reported a fever of 101.  Chilling and neck and arm pit swelling to right side on 1/5/2021 at 8pm.  No symptoms on 1/7/2021.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. The concurrent condition and medical history was not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (dose, route and lot details unspecified). The concomitant medications were not reported. There were no known adverse events. Additional information has been requested.
Patient who received the expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received the expired dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received the expired dose). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient who received the expired dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration given as 05/07/2021  No concomitant medications were provided. No treatment medications were reported.
Received DTAP on 3/14/13 at well visit. 3/15/13 dad went to get baby out of bed at 7AM and she was limp - went to pick baby up and could not even keep head up. Baby had flat affect. Temp 97.7, Lt arm shaking slightly. Mom gave 2 juice boxes, called 911, to ER.
sleep was restless; chills; This is a spontaneous report from a contactable consumer.(patient himself) in response to Non HCP follow-up letter sent in cross referenced case .   A 68-year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810,), via an Arm left on 03Feb2021 at 10:00 am as a single dose (Age at Vaccination: 68 years) and was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249), via Arm left on 13Jan2021 as single dose for Covid-19 immunization. Medical history included: Hypothyroidism on an unspecified date in 1990 treated with low dose levothyroxine. Concomitant medications include: Levothyroxine which the patient have been taking for many years and is still ongoing.  Dose #2 also resulted in chills 14 hours after injection on 04Feb2021. Chills lasted longer and sleep was restless on 04Feb2021, on by next day. patient felt fine. Admission to hospital due to the event was no. No Problems following initial minor side effect of chills. Second dose received 03Feb2021 at 10:00 am. During the following night sleep was fitful and chills were again experienced and they were more severe. During the day (04Feb2021). Patient  felt fine and as of 05Feb2021. there are no problems. The reported issue occur after use of a Pfizer Product was yes Therapeutic measures were none. Outcome of the events was recovered.
after 15 minutes, left arm started to hurt.  After I went to bed around 11pm I started to feel joint aches, especially in my hands and run a low grade fever 100.5.  The next day I feel body aches, joint pain, headache and my fever rose slight to 101.00.  Sunday morning 2 days after injection, all that remained was headache for most of the day.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JUN-2016 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5ml dose (rHA, lot # L024265, expiration date 01-JAN-2017, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion for four times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the second time was 16 hours with the lowest recorded temperature of 8.5 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the third time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the fourth time was 24 hours with the lowest recorded temperature of -13 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
received a dose of an expired ACT-HIB diluent with no reported adverse event; Initial information received on 15-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who received a dose of an expired act-hib (HIB (PRP/T) VACCINE) diluent with no reported adverse event after receiving vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunisation.  On 14-Jul-2022, the patient received a  dose (0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test-0.5 ML) of suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot U6999AB, expiration date: 11-Jul-2022, via intramuscular route in the left thigh as Immunization.The patient used the product for the first time.  On 14-JUL-2022 the patient received a dose of an expired act-hib diluent with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (received a dose of an expired ACT-HIB diluent with no reported adverse event).  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Tachycardia (110-120bpm), sudden elevated blood pressure (140-150 systolic/ 96-100 diastolic), over a period of 90 minutes Dizziness, nausea, feeling faint, severe headache, muscle weakness and aches, and severe fatigue over a period of three hours. After symptoms were not improving, I was taken to the ER
12 hours after dose felt pain, by 15 hours i was in severe arm pain, and lump on arm, and severe headache, chills, temperature 101.8, also tingling throughout body.   felt warmth in the internal vaginal area, i was unsure if bladder or vaginal.   Stayed in bed a couple of days and started to feel pain again in arm and I physically check and saw a whelp red rash, by then my face had a rash and i took some Benadryl for the next four days and helped.   And much better.   Now on 2/24/2021 and 2/25/2021, feeling pain again in my arm, and the itching on the injection site.   On 2/20/2021 started with left hip pain.  Had a phone visit with the Dr and she prescribed Flexaril 10mg tabs and Motrin 800 mg tabs.   And Hip pain gone.    Now all I have even after taking the Flexaril and Mortin I still have the arm pain and itching. Moderate pain on arm (injection site).
This spontaneous report as received from a Licensed Vocational Nurse refers to multiple unspecified patients of unknown ages and genders. On unspecified dates, the patient were vaccinated with a dose of VARIVAX (Merck) (Lot #, dose and route not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Information has been received from a nurse practitioner and from a physician concerning a patient who on an unspecified date, was vaccinated with the first dose of VARIVAX (Merck) (Lot# not reported) and on approximately 07-SEP-2010 "last week", the patient experienced chickenpox. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Open sores in mouth. Sores on gums, roof of mouth and tongue. Hurts to eat. Blood when brushing teeth.
At 2 am, 14 hours following the shot, I experienced sudden extreme chills, extreme body aches, involuntary jerking movements in my arms and legs, extreme tiredness, a moderate headache and moderate joint aches. These symptoms stayed consistent for approximately 8 hours at which time I had brief periods of feeling ok followed by symptoms resuming. This continued until the folding morning and for the remainder of that day I was sore and tired. In addition to the above at 2am I had a muted sense of taste for approximately 4 hours. I do exclusively nurse my 4 month old and she had no reactions.
Starting 12/20/2022, I had sinus problems and started getting a cough. I hadn't had a cold in a few years. I was congested and had a runny nose. It wasn't a bad one, but unusual for me. I took an at home COVID-19 test (12/22/2022) which was positive. I called the doctor and they decided to have me just continue treating symptoms over the counter and sent me an rx for coughing medicine (pearls). The symptoms were never really severe and I am feeling back to normal as of now. I have not tested myself again because my wife has tested positive a few days ago. I am pretty much symptom free now.
Patient received pneumococcal vaccine on 5/13/09. On 5/14/09, developed pain, redness, warmth, erythema at injection site.  WBC elevated at 11.8/cumm.  Temperature afebrile at 97.2F on 5/14, increased to a maximum of 99.1F on 5/19..  Possible cellulitis of injection site suspected, patient treated with cephalexin 500 mg po q8h x 10days.
I didn't eat after because I lost my appetite. I was nauseous with chills , sweating and vomitting and tired.
Around the 1 minutes, her daughter felt pounding and palpitations; Around the 1 minutes, her daughter felt pounding and palpitations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Dec2021 (Lot number: FF2593) at the age of 15 years 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: PALPITATIONS (non-serious), PALPITATIONS (non-serious) all with onset 10Dec2021, outcome "recovered" (10Dec2021) and all described as "Around the 1 minutes, her daughter felt pounding and palpitations".  Additional information: Parent stated that for the first dose they were supposed to wait for like 1 minutes. Around the 1 minutes, her daughter felt pounding and palpitations. At that time, it only lasted about 12 minutes and went away and her daughter didn't think anything of it.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a medical assistant refers to an 18-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 02-DEC-2016, the patient who was indicated to receive M-M-R II received in error a dose of PROQUAD, recombinant human albumin (rHA) (dose and route of administration were not reported), lot # M010478 with expiration date on 01-SEP-2017. The reporter did not know why the error occurred. No adverse effects were reported. Additional information has been requested.
Client had an order from hospital to give PPSV 23, HIB, and Menveo. Client went to ER around midnight with complaints of right arm swelling and pain. Received a phone call from local pediatrician's office today stating that this child was admitted because he bleed out from the injection site of the varicella. States it was the subclavian area but unsure what side. Was asked that we do not give her special need children any shots without her approval. This RN called the hospital and found out the following information. The child went to the ER on 01/21/2016 with complaints of right shoulder pain and swelling. Child had labs of a CBC drawn. Was admitted on 01/22/2016 and discharged home on 01/23/2016. Child was given antibiotics, steroids, and Privigen while at the hospital.
pt recvd vax 14SEP93 & 21SEP93 devel redness, itching & lumps-urticarial rash;
Member presented to the immunization clinic with swollen lymph nodes and chest tightness/pain. Patient didn't seem to be in any distress. We looked at the site which was normal and immediately brought him to our urgent care center.
injection site area is /  hot to touch; injection site area is / swollen; injection site area is now really red; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2020AMR206581).   On 12th October 2020, the patient received the 2nd dose of Shingrix. On 12th October 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix and injection site area was now really red and swollen and hot to touch.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206581:same reporter.
Severe generalized pruritic urticarial reaction with periorbital edema. Just swelling & pain.
6/26/03: In clinic mother states child complained of painful left upper arm-on exam left upper arm edematous, red, firm, warm to touch, edema from top of left shoulder to just above left elbow extending into axillary. Good ROM, painful to touch, warm moist heat and cool moist cloths.
A deltoid - red, swollen and hard at area of vaccination.  Patient given Augmentin 400/5 ml by mouth 2 times a day for 7 days.
Systemic: postive for COVID-Mild, Additional Details: pt tested positive for covid.
This spontaneous report as received from a pharmacist refers to a 53 year old male patient with no drug reactions or allergies. Patients pertinent medical history was none. On 05-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number was reported as H108091, expiry date was 04-JAN-2014 and dose was not reported), subcutaneously. Concomitant medication was none. On 05-MAR-2013, the patient experienced nausea, headaches, fever and vomiting. On 05-MAR-2013, the patient also had pain down to his left side and left arm. Laboratory test performed was none. The patient sought medical attention (saw the pharmacist) and the patient was treated with ibuprofen. The outcome of nausea, headaches, vomiting, fever, pain down to his left side and left arm was reported as not recovered/not resolved. The pharmacist also reported that last time he had seen a different patient with an adverse event with an unspecified vaccine in 1990s. Additional information has been requested.