chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Infection - swollen - diarrhea - heat and rash. Precautious - Went to my health facility for prednisone, Amoxicillin and fluconazole tablets!!
daptacel was given to 14 year old with no reported adverse event; Initial information received on 05-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 years old and unknown gender patient who was given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] to 14 year old with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the reporter reported a non-serious DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE was given to 14 year old with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) (with dose, strength, formulation, lot number and expiry date not reported) via unknown route in unknown administration site for immunization.   No relevant lab data was reported.  Action taken: Not Applicable.  Outcome: Unknown     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.
Information has been received from a physician concerning a 21 year old female with no medical history and no drug allergies, who on 13-AUG-2007 was vaccinated with a first dose of Gardasil. On 15-OCT-2007 the patient was vaccinated IM with a 0.5 mL second dose of Gardasil (Lot# 658558/1061U). There was no concomitant medication. On 21-NOV-2007 the patient experienced a seizure. The patient was seen by the physician. A computed axial tomography (CAT scan) was performed. The patient recovered on an unspecified date. No product quality complaint was involved. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
24hr p/vax site reddened, swollen, c/o SOB & c/o just don't feel well;
Initial case received on 27 January 2010 from a healthcare professional. A male patient (age and date of birth unknown) received an injection (unknown route and site) of "pediatric" FLUZONE on an unknown date. The patient experienced a full body rash and noisy breathing several hours post vaccination and was seen in the pediatric clinic. The patient had no history of an egg allergy. The chart was not available to the reporter. The patient was to have skin testing done. It was unknown if the patient recovered. Documents held by sender: None.
After about 1 hour, the customer's legs became very weak and her back started hurting.  The episode lasted a few minutes but she felt weak and tired a while after the episode.
A non-serious spontaneous report of FLUMIST was sprayed into the patient's eye was received from a Registered Nurse concerning a 24-month-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for Medical history and concomitant medications were not reported.  On 12-Nov-2008, the patient received FLUMIST.  The patient jumped while FLUMIST was being administered and the vaccine was sprayed into one eye.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. On 05-Dec-2008, the reporting nurse confirmed that there were no late - occuring advere events repoted.
c/o body aches, fever started 16JUN92; states sx cont w/diaphoresis, body aches; states pt is not getting better; states pt will not cont the vax series has been taking Advil to treat sx;
3:55 PM pt started showing a patchy rash on her chest and then up her neck and at the site of injections. No SOB, No Tachycardia provider notified. 4 PM we gave 50 mg BENADRYL IM into L delt, no SOB no tachycardia cold compress was applied to R injection site. 4:10 PM pt complained of trouble swallowing and it was observed that she had swelling in her face. Pt was given 0.3 EPI PEN into L thigh and ambulance was called. BP was 138/80 HR was 112 with O2 of 100% on room air. 4:15 PM when ambulance arrived pt was noticed to have slurred speech and was transported to ER.
Developed 15-20 vesicular lesion, scattered over body. On inhaled steroids for RAD, Acylovir 200 TID X 5d
soreness in injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in injection site arm) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in injection site arm). At the time of the report, VACCINATION SITE PAIN (soreness in injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up was attempted on 16-Apr-2021 @ 11:45am: Phone call was made but, patient declined further follow up.
Approximately 30 minutes post pt's 3rd Moderna vaccine pt developed "itching" to L upper arm with random, flat, red rash to L upper arm only. Pt denied any other symptoms but indicated that with her previous 2 Moderna vaccines, she developed itching and red rash within 24-48 hours of her vaccine to her generalized body in which she took otc Benadryl for and obtained relief. Pt was evaluated by PA-C and verbal order for Ceterizine 10mg po given. Pt tolerated very well and after monitoring, pt stated that her "itching" was "getting better". She did not develop any other symptoms and denied any acute respiratory distress. After re-evaluation, pt did not have any worsening of her symptoms and stated she was "feeling better" in which she was discharged home to follow up with PCP or seek medical care in the ED should her symptoms not improve, changes, worsens or becomes life threatening.
No adverse event; 1st dose -09-feb-2021/ 2nd dose- 02-Mar-2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -09-feb-2021/ 2nd dose- 02-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -09-feb-2021/ 2nd dose- 02-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -09-feb-2021/ 2nd dose- 02-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -09-feb-2021/ 2nd dose- 02-Mar-2021).    Concomitant medications details were not reported.  It was unknown if the patient had ever tested positive for COVID-19, or had any allergy and had any acute illness at the time of vaccination and up to 1 month before and received any vaccine one month prior to moderna covid-19 vaccine. It was unknown if the patient had taken any prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination and other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was unknown if the adverse event caused patient to seek medical care (office visit, Urgent care, ER, hospitalized), or the patient experienced a similar event in the past and the symptoms improved or worsened.  No adverse events reported.  No treatment medication were provided.   This case was linked to MOD-2022-637963 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Live follow-up appended.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult female patient who received FLUARIX QUADRIVALENT. On 6th October 2015, the patient received FLUARIX QUADRIVALENT (subcutaneous) .5 ml. On 6th October 2015, 30 min after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and intramuscular formulation administered by other route. On 7th October 2015, the patient experienced injection site nodule. On 7th October 2015, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site nodule was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the pain in arm and injection site nodule to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: Concomitant medications were unknown. The patient might had received FLUARIX QIV subcutaneously instead of intramuscular route. On the same day, about 30 minutes after the vaccination, the patient experienced diffuse pain that surged down her arm. The pain continued throughout the night. On 7th October 2015, in the morning, 1 day after receiving the vaccine, the patient noticed a knot at the injection site. At the time of reporting, the pain was resolved during the morning but the know was present. The batch number and injection site for the vaccine were unknown.
Patient reported swelling "the size of a softball" at the injection site that was hot to the touch, fever, weakness, and feeling very sleepy.
About 6 hours later, no desire to eat dinner. Was in bed by 7:30 pm. Had a terrible night. Had severe headaches, knot in stomach, leg pain felt like muscle pain from right heel to hip even though the vaccine was given in left arm. right leg looks like he was in a fire still have pain feels like the bone is bruised and has inflammation and left leg does not.  Leg hurts if it's touched or rubbed. No pain as long as it's stationary. Had 101.4 temp on Sunday morning and text it to his boss. Also had a Covid test which was negative. Woke up this morning in a pool of sweat.
Pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included PRENATAL MULTIVITAMIN + DHA for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Jun-2020 and the estimated date of delivery was 23-Mar-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2020, Pregnancy test: positive (Positive) Pregnant.     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.   No treatment information provided by Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: Internal review on 22 JUL 2021, resulted in the updates of pregnancy details.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Pt received vaccine before.  Site red, itchy, warm to touch and site swollen.  Medication: Amoxicillin 2 times a day
Patient GOT BLISTER ON HER TOE, PAINFUL RASH ON BOTH HANDS. THEN THE RASH STARTED RUNNING UP HER LEGS. THIS STARTED TUESDAY 8/8. BOTH HER PODIATRIST AND PCP DIAGNOSED THAT AS ALLERGIC REACTION THROUGH PROCESS OF ELIMINATION
Pt states she received  COVID vaccine 2/3/21 at  Hospital.  She developed redness and itching to both eyes 2/8/21.  2/11/21 pt developed redness to palms of both hands and swelling to fingers and palms making it difficult to close her hand.  2/12/21 pt woke with rash to bilateral upper thigh/groin area and to backs of upper thighs.  Rash not itchy.  Pt came to ER 2/12/21 and was seen by Dr.  Diagnosis rash and pt was given prescription for Prednisone 20mg po twice a day for 5 days PRN rash.
Information has been received from a physician who had heard from another physician concerning a child who was vaccinated with a dose of Zostavax (Oka/Merck) instead of a dose of Varivax (Oka/Merck). It was unknown if there was any adverse event involved. A product quality complaint was not involved. Additional information has been requested.
could not use arm/out of commission; Swelling under left arm pit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could not use arm/out of commission) and VACCINATION SITE LYMPHADENOPATHY (Swelling under left arm pit) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not use arm/out of commission) and VACCINATION SITE LYMPHADENOPATHY (Swelling under left arm pit). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (could not use arm/out of commission) and VACCINATION SITE LYMPHADENOPATHY (Swelling under left arm pit) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant product use was reported.  The reporter stated that the patient experienced long lasting reaction from their first dose. The patient stated that they could not use arm, out of commission and after a week experienced swelling under left arm pit. The patient spoke to doctor who said it would go away after a while.  No treatment information was provided.   This case was linked to MOD-2022-513832, MOD-2022-513833 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Follow up document contains No New Information
Weakness tired stiff neck at first migraine headaches developed on the 24th and have continued through present.  Have taked excedrine migraine prednisone 20mg for 5 days now on muscle relaxers 4xs a day.
developed fever, chills and nausea  at the 12th hour remained for two hours at which time I took 2 Ibuprofen 200 mg each to relieve symptoms, drank weak ginger tea w/honey and dry toast.  still had fever and chills until about the 16th hour after receiving vaccine. at which time I fell asleep but had disturbed rest as kept waking up throughout the night roughly 4 times until awake at 5AM at which time felt tired and had a headache,  did not resume regular activities, i/e/ work until the following day (stayed out for the 28th of April 2021.
On May 19, 1999 the pt presented with mild case of breakthrough chickenpox. It was noted that the patient was tired and irritable. Follow up information from MD reported that subsequently the patient recovered.
Whole body uritcaria, rash, itching, nausea with vomit, joint pain, fever with chills,
On 11/7/2021 the patient was observed to be in bed with absence of respirations and heartbeat.  The patient was a DNR upon admission.
Approximately 20 minutes after injection-lower leg hives, urticaria, edema, of upper lip, eyelid. No respiratory distress, Mother gave Benadryl. Epinephrine (SQ) and Orapred given at MD office.
Angioedema involving entire arm. Began within 12 hours of shot. Needed oral prednisone to resolve. Medical records states headache, hypersenativity to flu A. msv
8.5 hours after vaccination, client altered sensation in skin at arm and chest. felt like a sunburn, with a dull itch, discomfort.  Took OTC benadryl, but it did not offer relief. Went to ED  that same evening and was given Solumedrol. No epinephrine received. Next day, taking 50 mg diphenhydramine PO.  Next day, rash now at arms/legs /back . none at chest. Meds helping with discomfort.
Woke up the next morning with a very sore right wrist, didn't notice until I drove. Thought I slept on my arm therefore assumed that's why I had pain. The next day (Thursday) it had spread, all my joints were in pain. It hurt to bend my toes, fingers, neck, back, knees and ankles. My nails felt like they were going to pop off, my body felt very sensitive. I've had a headache on and off since the day after the vaccine. I've been taking ibuprofen 800 and it helps a little bit. Change in weather affects me too, pain is widespread then there are times of random stings. Every day it gets somewhat better but I will never take this vaccine again. It's been about a week now and my body is aching just sitting up while filling out this form.
Became dizzy at approximately 12:00 noon, fell on sidewalk. Weakness in legs.
Info has been received from a nurse practitioner concerning an adult female employee who approximately 2 weeks ago was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). The reporter stated that now the pt had developed a macular, papular, itchy, generalized body rash on the neck, trunk, legs and feet, with feet being the worst. There was no fever. Unspecified medical attention was sought. Follow-up info was received which indicated that the reporter was unable to remember the pt's name. It was indicated that the pt recovered. No further info is expected.
Joint swelling - started in both knees, left more than right. Then progressed to wrist/elbow/ankle swelling and hives to arms and legs only. Called doctor, told to take Benadryl and Pepcid, continued to get worse without relief. Went to ER and received steroids, Benadryl, and Pepcid. Continue to have symptoms, but now improved.
I started with cold or allergy symptoms on December 27, 2022. I had sneezing, runny nose, and head congestion. I found out I was exposed to COVID-19 over the holidays. I took a COVID-19 test on December 28, 2022. It was negative. I started taking DAYQUIL and NYQUIL to try to alleviate my symptoms. My cold symptoms seemed to get worse and moved into my head. I was congested. On January 1, 2023, I took another COVID-19 test. The result was positive. I called the doctor to see if I needed medication. He prescribed molnupiravir. I never had a fever or headache.
ADVERSE EVENT; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event was not reported. This report was non-serious. This case, from the same reporter is linked to 20210907568.; Sender's Comments: V0 : Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
her eye is also like red; Sneezing; Runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: RHINORRHOEA (non-serious) with onset 16Dec2022, outcome "not recovered", described as "Runny nose"; SNEEZING (non-serious) with onset 16Dec2022, outcome "not recovered"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "her eye is also like red".  Additional information: Reporter stated, I am calling in reference to my sister, we had her, have her COVID vaccine booster (clarified as Pfizer COVID-19 vaccine booster), the 4th one on Friday, this past Friday the 16th and as soon as she got the booster she started sneezing, I thought that was going to pass but she still sneezing, sneezing a lot and like runny nose. So I thought it was going to stop in a day or whatever but it was still going on. So I am concerned about that and now her eye was also like red. Reporter further stated, was that like Normal, was that something I should worried about.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea, extreme vomiting, a few days later facial rash, extreme fatigue, inability to move head and legs, difficulty walking.
Information has been received from a nurse practitioner concerning a 69 year old female patient who on 23-DEC-2008 was inadvertently vaccinated with a dose of VARIVAX (Merck) instead of receiving ZOSTAVAX (Merck).  No adverse effects were reported.  Additional information has been requested.
Itching, Rash to head, swelling lower lip within 30 min of receiving covid vaccine.  Treated and released in ER without any further incident.
Onset of sx started several hours after first Covid vaccine. Started with severe injection site pain, diffuse pruritis, body aches, fever 101.7 axillary, chills/sweats, and severe HA. Took acetaminophe, alternated w ibubrofen every 4 hours overnight. Next AM woke w T 99.7 axillary, HA, weakness, severe body aches, fatigue, sore throat and dry throat. Injection site swollen to ~7 mm diam with bruised appearance, extremely tender, unable to lie on L side. Able to sip sports drink; warm, clear liquids (soup) without appetite. Continued w Ibuprofen HA formula. Sleep difficult due to chills/sweating. Also frequent cough, SOB with ADLs. Recd Dose #2 Pfiz 4/5/21 - s/sx worsened significantly and CONTINUE.