chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 0.2ml was given IM from vial with dark pink cap instead of 0.25ml from vial with blue cap; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (0.2ml was given IM from vial with dark pink cap instead of 0.25ml from vial with blue cap) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 12-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (0.2ml was given IM from vial with dark pink cap instead of 0.25ml from vial with blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (0.2ml was given IM from vial with dark pink cap instead of 0.25ml from vial with blue cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (0.2ml was given IM from vial with dark pink cap instead of 0.25ml from vial with blue cap).    Concomitant medication was not provided. Treatment information was not reported.
Patient  came in today.  I gave her her second Shingrix shot on 3/9/20.  Her arm is red and hot to the touch.  Probably a 3 inch diameter.  I think she needs an antibiotic.  She states I should have to pay for her doctor's visit to do that.  I shared your phone number with her since she wanted money.  I followed protocol by using an alcohol swab and a the barrier bandage when I gave the immunization.
Frequent brain fog more than 5x out of a week to the point it is difficult to perform daily activities.
9 days after the 1st moderna vaccine, pt developed erythematous itchy rash, with mild swelling,  just below the injection site. Currently the rash approximately 3x5 cm wide. No other symptoms.
Pt was admitted to hospital from ED for acute cholecystitis on 4/17/21, 7 days after getting the second dose of the COVID vaccine. Per guidelines, all hospitalizations' are to be reported
Itching at site of vaccine which was given left deltoid area which extend down to the thigh area.  Also rashes noted on both arms.  B/P 105/69, Heartrate 82, O2Sat 93.
Patient was a 5 month old that received the Kinrix vaccine.  Kinrix is not approved for use in persons younger than 4 years of age. No signs or symptoms at time of vaccination noted.
Patient reported to pharmacy staff that she was feeling dizzy. Patient was observed and asked to lie flat with feet elevated for about 10 minutes. Blood pressure was 113/71 and pulse was 81 BPM. Patient felt better, sat up, and drank fluids. Pateint was observed for anohter 10 minutes. Blood pressure was checked again (118/79) and pulse (78 BPM). Pateint felt fine standing and left the pharmacy. She was advised to contact primary care provider or emergency room in the event of deteriorating condition.
GENERAL MALAISE, CHILLS, LEFT ARM PAIN, INFRAORBITAL PAIN, NAUSEA. SYMPTOMS LASTED 1 DAY.
This spontaneous report was received from a certified medical assistant referring to acurrently 13 months old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA, lot number N017094 and expiration date of 31-AUG-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1709USA011980: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Client  received the Fluarix Quadrivalent vaccine (Lot#3NA4M, exp. 06/30/22) from vaccinator  at approximately 1700 in the R deltoid. During administration of the vaccine, the client pulled his arm away abruptly causing some of the Fluarix Quadrivalent vaccine to be wasted on the clients R arm and on his chair.  RN was unable to determine the amount of vaccine that was wasted. Lead Vaccinator  elevated concern to  the Clinical Operations team. Clinical Operations received guidance from County MD that re vaccination is indicated the following day. RN  communicated this with client's mother who verbalized understanding. RN received guidance from the clinical operations team that the vaccination should still be documented as administered since the client did receive some of the Fluarix Quadrivalent vaccine dose. No adverse affects were reported during the client's observation of 15 minutes.
This is a spontaneous report from a contactable physician. A male patient of an unspecified age received PREVNAR 13 and FLUCELVAX, both via an unspecified route of administration from an unspecified date at a single dose for immunization. The patient's medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient reported a change in the biological markers for Vectra DA test, 4 weeks after receiving the vaccine on an unspecified date. The reporter wanted to know if both the vaccines can cause a change in biological markers that can affect the results of Vectra DA test. Outcome of the event was unknown. Information on batch number has been requested.
PATIENT REPORTED TO ASSISTANT WARDEN THAT SHE HAD SEEN PERSONAL PHYSICIAN WITH REACTIONS INCLUDING, BUT NOT LIMITED TO, SWOLLEN TONGUE, NAUSEA/VOMITING/DIARRHEA, SEVERE BODY ACHES AND FATIGUE. STATES SHE WAS DIRECTED BY PHYSICIAN TO REPORT TO ADMINISTERING FACILITY.
This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced Shingrix reaction that included arm swollen and redness for a period of 4 to 5 days, then the shape changed and it lasted for another 4 to 5 days. The reporter had agreed to follow up with GlaxoSmithKline.
I started having a fever by Friday ( the second day after the vaccine was administered).  I was unable to drive safely, experienced confusion.  Lost appetite.  On Monday, Sept 11, I was driven to an ER by a friend.  There all tests were negative and they concluded it was a reaction to the RSV vaccine.  I've never had any reactions to ANY vaccines, so this was a complete surprise!
Pregnancy and vaccinated; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Crohn's disease and Asthma. Concurrent medical conditions included Shellfish allergy and Drug allergy (Patient have allergy towards aspirin and ibuprofen.). Concomitant products included ASPIRINETAS for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-May-2021. On 10-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated). On 10-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy and vaccinated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Aspirinetas Treatment medications were not provided.
FEVER; LOSS OF BODY FUNCTION; CANNOT MOVE RIGHT ARM; RIGHT LEG ISN'T FUNCTIONING PROPERLY; INCAPACITATED; CANNOT TALK; DEBILITATING THROUGHOUT THE BODY; TERRIFIED; This spontaneous report received from a consumer concerned a 58 year old not female. 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included paracetamol. The patient was expecting the side effects to last for a "couple of days" but it has been a week and 1 day since the vaccination. On 19-Mar-2021, the patient has experienced "debilitation" throughout the body, that started on the right arm, side of vaccination. This then moved to the neck and now the whole body. It was still persisting. The patient "cannot move her right arm" and the "right leg isn't functioning properly" and she was "incapacitated" and "cannot talk".  On 26-MAR-2021, the subject experienced fever. The patient has stated that she has received the paracetamol. after vaccination and it was also not helping. When referred to seek HCP's attention, caller said they are in between HCPs and therefore cannot see one. Agent referred to the ER, but caller states the patient was terrified of the ER and that she "might die" there. Caller confirmed that the patient was stable and not in any medical emergency. Reminded to seek medical attention as soon as possible if condition changes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, debilitating throughout the body, loss of body function, incapacitated, cannot talk, terrified, right leg isn't functioning properly, and cannot move right arm. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210354095-Covid-19 vaccine ad26.cov2.s -INCAPACITATED. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: NATURE OF EVENT
Developed gastritis.  Gastric discomfort that prevented eating and drinking due to increased pain leading to dehydration and hospitalization.   Upper Endoscopy showed gastritis.  Treated with IV PPI and hydration.
I have pain in my; a lump in my breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (I have pain in my) and BREAST MASS (a lump in my breast) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (I have pain in my) and BREAST MASS (a lump in my breast). At the time of the report, BREAST PAIN (I have pain in my) and BREAST MASS (a lump in my breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
My breathing got worse within 5 minutes,  though didn't get to the point of having to have emergency services.  within a few hours I had constantly runny nose, headache, fever and swollen throat, exhaustion
had a major allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (hospitalization, medically significant), outcome "unknown", described as "had a major allergic reaction". The event "had a major allergic reaction" was evaluated at the physician office visit. Clinical course: Doctor from the patient's pharmacy called on behalf of the patient to confirm if the patient would need a booster shot for the Janssen COVID 19 Vaccine due to have taking the Pfizer-BioNTech COVID-19 Vaccine and not being able to complete the series of shots due to having an adverse reaction. During the call reporter stated: She received a dose of the Pfizer Biotech vaccine she had a major allergic reaction which put her in the hospital therefore her doctor advised her to switch to Janssen which she received back in October so now she's back for a booster dose of Janssen but reporter just wanted to confirm that would she not need another dose since technically she started with Pfizer even though she was not able to complete the series because of an allergic reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the event Hypersensitivity and the administration of the vaccine cannot be excluded. 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.
Fatigue. Could hardly get out of bed in the (next/second) morning. It was bad. Was a bit better by afternoon. I was at 90% by the third morning, and not quite 100% at the third evening but progressively recovering. Included muscle aches - all muscles as far as I could tell.  Very mild headache. Started same day as vaccine. Was also present second day. Gone by third day.  Mild arm soreness at injection site after both 1st and 2nd doses.
p/receiving vax pt cried hysterically all day & into the noc; mom states that nothing would soothe or calm the pt down; low grade temp; mom spoke w/MD & felt react came from DTP & encouraged mom to get DT next visit;
Client presented to Healthcare Hospital at approximately 2300, overtly anxious and hyperventilating, c/o shortness of breath and chest ; daughter translating. C/o numerous complaints after having 1st Moderna dose today. She had onset of muscle cramping, weakness in legs, then diffuse  myalgias, feeling prickling and poking sensations body-wide, chest discomfort sharp and pressure, feels anxious and short of breath. Also c/o increased itching without rash present on examination by MD.,  Hx non-ischemic cardiomyopathy, normal coronaries by agency at in Jan., managed with metoprolol and lisinopril, EF 30-35%. Cardiomyopathy attributed to thyroid disease.
pt recvd cholera/Typhoid/Hep B/Yellow fever vax the same day; the next day exp induration @ the site of inject, SOB, weakness & fatigue, upset stomach & diarrhea;
Fever 101, Sore throat, Generalized body aches and pains, chest tightness.
experiencing: red spots over her body, a warm tingling feeling in both feet and these symptoms are driving me crazy; experiencing: red spots over her body, a warm tingling feeling in both feet and these symptoms are driving me crazy; eyes also look red; Initial information regarding an unsolicited valid non-serious case from was received from a consumer (patient) via Agency (Inquiry number: 00334215) and transmitted to Sanofi on 27-Oct-2020.  This case involved a 82 yearsold female patient who was experiencing: red spots over her body (rash macular), a warm tingling feeling in both feet (paraesthesia) and these symptoms were driving the patient crazy and eyes also look red (ocular hyperaemia), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medications and family history, were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in the left arm  for prophylactic vaccination.  On an unknown date, the patient developed non-serious red spots over her body (rash macular), a warm tingling feeling in both feet (paraesthesia) and these symptoms were driving the patient crazy and eyes also look red (ocular hyperaemia), unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Mentioned that the patient's symptoms started a couple of days after the injection and she went to the hospital where they gave her a lot of medication and they believe along with her doctor that this was a result of the flu shot. Stated her symptoms were no better and did not get any other vaccines that visit.  Final diagnosis was eyes also look red, experiencing: red spots over her body, a warm tingling feeling in both feet and these symptoms are driving me crazy.  No relevant laboratory tests were reported.  The patient was treated with Methylprednisolone 4 mg.  The event outcome was reported as unknown for all the events, at the time of reporting.
Pt developed rash on both arms and part of trunk 5 day post vax.  Pt was treated with Benadryl and rash resolved.
After the shot, 4 to  5 days later, my body started aching as I noticed when I would wake up in the a.m.  I am usually "pain free" and noticed that I was in pain when getting out of bed.  My left arm was ok after injection but is now very painful to move "up and down" like a shoulder impingement.  I later noticed a problem moving my head(neck) left and right as if I had slept wrong.  I am still having that problem.  This type of problem I have experience but it usually goes away in a couple of days.  This morning  I am in whole body pain. Not debilitating but very noticeable.  I went to an orthopedic appointment Tuesday(9-7) and informed the doctor of my pains.  He prescribed muscle relaxers and told me to return if not better.  He did suggest physical therapy but am not doing that at this time.  Did not discuss if it could be injection related.
Took the shot, after waiting the allotted time my left eye began to feel abnormal and then I began seeing black wavy lines, the situation continued about 10 minutes, then my eye seemed alright but as my vision adjusted everything was blurry and distorted.  The following morning I realized I also had a floater in my eyesight.   Over the next several days I realized my central vision was distorted and was having a hard time reading.  I made an appt. with the Eye Glass Doctor thinking new glasses were needed, after seeing him he made an appt with the Opthamologist.  I saw him and he explained I had cataracts and that I needed to see a retina specialist, which I did, he thought my eye under the macula was swollen and sent me to a surgeon, after several test from these doctors they have all agreed there is a hole in my macula that was not there prior to the shot.
Patient received  0.5ml of Pfizer Bivalent Vaccination instead of the 0.3ml.  No symptoms or adverse effects
7cm X 6cm area of erythema and tenderness over left deltoid and hot to touch.
Left thigh edema and erythema which started about 2-3 hours, post vax.
Pt reported having an inject site reaction following immun; reaction included redness & swelling @ inject site; not seen by MD; recovered w/no residual sequelae;
improperly stored vaccine administered; This spontaneous report as received from a nurse refers to a 46 year old patient (gender was not reported).  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T009744, expiration date 28-JAN-2020, 0.5 milliliter for prophylaxis (route and site of administration were not reported). The vaccine underwent a temperature excursion of 48.39 degrees Fahrenheit for 1 hour and 45 minutes. The digital data logger was involved. There was no previous temperature excursion.  No additional adverse event details were available.
Patient completed 2nd dose of Moderna 07/29/2021, first dose was given 07/01/2021.  After completed dose, patient was advised to sit and wait (MINUTES).  After the timed interval was completed he would be free to leave.  A few minutes after vaccination, the patient started experiencing dizziness and fainting.   Objectively, the patient displayed fainting and minor seizure like activities.  In addition, the patient was sweating all over the body.  This happened over a period of 15-30minutes before EMT arrived to provide additional support.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received dTpa  vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant and other: serious per reporter). On an unknown date, the outcome of the vaccination failure and pertussis were unknown. It was unknown if the reporter considered the vaccination failure and pertussis to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had pertussis as an adult and was out of work for one month. The reporter was not willing for GlaxoSmithKine safety team to contact them to discuss further. This case was considered as a suspected vaccination failure case since the time to event onset and the laboratory test confirming the event was unknown at the time reporting.
Swollen lymph nodes on left side under arm and groin occurred 3 days after vaccination. Other expected symptoms day 1-2, sore arm at injection site.
THROAT SWELLED AND PT HAD DIFFICULTY BREATHING, EYES BECAME SWOLLEN & EXTREME H/A OCCURRED, PT NAUSEATED. 12/13/94 PT HAD HA & SLIGHTLY SWOLLEN EYES BUT OTHERWISE BETTER. PT TOOK 2 SUDAFED 7 HRS AFTER VAX AND FELT RELIEF W/ IN 30 MIN.
02/17/22 presents to ED for "worsening SOB". PMHx of "adrenal insufficiency (on prednisone and Florinef), iron deficiency anemia, folate deficiency, cerebral aneurysm, esophageal dysmotility, GERD, OSA (on CPAP), moyamoya, juvenile pilocystic astrocytoma x2 s/p resection x2, PCOS, HLD, arthritis, s/p Roux-en-Y gastric bypass, pleural effusion with eventual VATS"
Patient c/o cervical neck pain- on right side of spine 1 1/2 days after receiving Twinrix. Pain starts at base of skull and radiates down to shoulder blades. Pain agitated by raising right arm or turning head. Pain persisted 2-3 weeks.