chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child received H1N1 nasal mist on 11/04 around 11 am, her symptoms  began on 11/07/09 around noon. Child was running fever and cough.  Her brother just got over virus. The 5 year old child seen by her physician on Monday 11/9/2009 because fever left and came back.  She is now back at school Tuesday 11/10/2209 and doing well. MD has set up for her to been seen at an asthma clinic. The child is on Singular.
Information has been received from a mother concerning a 3 year old male with a penicillin allergy who in July 2004 was vaccinated with Proquad. There was no concomitant medication. In July 2004 the patient had stomach cramps. The patient sought unspecified medical attention. As of 19 Sep 2006 the patient was recovering. It was also noted that the patient's brother experienced an adverse reaction after vaccination with Proquad. (WAES#0609USA05264). Additional info is not expected.
Pain in arm; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Pain in arm". Additional Information: While reporting for himself, the reporter mentioned a guy who had both of his shots of the Covid-19 vaccine and just had pain in his arm. His arm hurt for 2 -3 days but it got better, that's all.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021441411 same reporter, different patient.
She lost the sense of taste this morning; This is a spontaneous report received from a contactable consumer (Patient mother) via medical information team. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Jun2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. No adverse events reported with the first dose. On 04Jun2021, the patient had lost the sense of taste. The consumer stated that "My adult daughter received the second dose of the Pfizer COVID-19 vaccine two days ago. She lost the sense of taste this morning. I have seen people reported a loss of taste but along with a metallic taste in the mouth. But my daughter doesn't have a metallic taste in her mouth". The reporter has been reading some of the questions and articles and none of them talk about a loss of a sense of taste. They talk about a metallic taste, but her daughter doesn't have a metallic taste. The reporter wanted to know that if loss of a sense of taste was common after the Covid vaccine and if this was a side effect reported.  Information on lot/batch number has been requested.
Within 23 minutes of receiving the vaccine I had a strong metallic taste in my mouth.  That same day I had headaches, diarrhea, was ice cold.  By early evening I had a fever, was fatigued, and was beginning to get a body ache that seemed to outline my lungs in my back.  The next morning I had severe body aches and joint pain, and intermittent headaches throughout the day.  On the next day I felt much better.  Mid-day I became ice cold again and continued with headaches that were dull.  The metallic taste remains constant and has altered my perception of "sweet."  Fruits taste very sour and inedible.  The injection site pain was what I had expected and paled in comparison to the other side effects.
dizziness and seizures. 4/16/09 MR received from PCP from 2/18/09 to 4/13/09. Pt presented on 2/18/09 for 3rd Gardasil vaccine 1757U. RTO for f/u for  recent grand mal seizure on 3/14/09, as well as c/o fatigue, stomach pain and dizziness. Pt also reports blurry vision and heaviness all over.  PE (+) for bruising L shin. DX:  Syncope and collapse.  Very likely combination of hypoglycemia and vasovagal response. Syncopla episode with seizure-like activity. Returns 3/26/09 with continued c/o dizziness, H/A, arm heaviness and sharp pains, some congestion. PE (+) for vertigo with extraocular testing. DX:  Syncope and collapse.  Malaise and fatigue.  H/A. Sinusitis-chronic.  EEG and labs ordered.  F/U 4/13/09 with c/o severe H/A which comes and goes x 3 days with photophobia and phonphobia, mild nausea, seeing spots prior to H/A and other visual disturbances. PE (+) for H/A and joint pain. MUscle tightness and tenderness of bilat pericervical and upper perithoracic tissues. To see chiropractor.  Follow-up: Still dizzy, vision problems and loss of concentration.
My right arm has been extremely painful ever since.  To date I have been to 4 Dr's. I have had a MRI, steroid injections, 4 medications. All with no relief.  My arm shoots numbess feeling, tingling, tightness from shoulder to fingertips. It is getting worse. I am unable to do my job and household work.
pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site).   At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Acute pain (L) deltoid with pain radiating to chest down (L) arm - mild swelling.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient of an unknown age who received a dose of YF-VAX lot number not reported via unknown route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage and wrong technique in product usage process. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: None.
Patient expired on 9/08/2012 at 4:00 AM, in her home.
Fever, "Pounding" headache, Body aches, Arm administered in ached, Slight nausea, Palpitations.
pt recv vax; cyanosis devel; resp arrest; rescue breathing instituted; to hosp; Acute viral Upper resp infect;
pt recvd vax & 20 mins p/inject & again 24 hrs p/inject pt exp dizziness & weakness;
Neck pain and could not turn his head all the way,  left arm pain.  Treated with Tylenol
3.5 x 4.0 cm, light red,raised, moderately soft area, left upper lateral arm.
Patient was in office and receive his 3rd dose of Pfizer vaccine. patient started having  tingling in his throat and lightheaded 3 to 4 minutes after the vaccine was given. Patient was give 1 tablet of Allegra 60 mg .  Patient started feeling better after he took the Allegra. Patient was kept in observation for additional 30 min.
Seven days after receiving DTAP, HIB, Prevnar, MMR, and Varicella, began to vomit, have diarrhea approximately 10 times daily, fever up to 104, lethargy.  Went to ER received antiematic supposatories antipyrestic.  Recovered 05/29/2005.  Mother states was told by PMD was probably MMR and not to get any more.
3 ulcerated dark centered lesions, 2 papular lesions.  Right leg at vaccine administration site.  Rash on 10/24/2003.  1 papular lesion on lower right leg.  Itchy/some redness at site.  Prescribed Benadryl for itching; Calamine lotion; Neosporin ointment
Was administering vaccine while patient was sitting in the lap of the MOC of care.  Both myself and the mother of care were holding on to  the child to stabilize the leg and properly administer the vaccine.  Both the grips of myself and the mother of care were not tight enough.  Patient slipped loose and the needle scratched the leg of the patient.  No reactions other than slight bleeding and scratch on leg.
Follow up information received from the pt MD included illness at the time of vaccination, past vaccinations, and recovery status. Information regarding Prevnar ( pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injeciton) was received from a healthcare professional regarding an 18 month old male pt. who experienced fever of 103-104 degrees. At 18 months, the pt received the 4th dose on 11/08/04. Medical History: the pt's concurrent illness includes viral pharyngitis. Past therapies included Fluzone. Event Details: The pt experienced fever of 103-104 degrees on 11/09/04. The pt recovered.
Patient received Pfizer vaccine with 1st dose on 03/11/2021 and 2nd dose on 04/01/2021 Per ED Note: Patient is an 83-year-old male with past medical history coronary artery disease and coronary artery bypass graft, diabetes mellitus, hyperlipidemia and hypertension presenting to emergency department chief complaint of difficulty breathing.  Patient states that his symptoms began approximately 1 week ago and subsequently tested positive for COVID-19 viral illness.  He denies any associated chest pain.  He states that the shortness of breath has been worsening since the onset of symptoms and is constant, no significant improvement at rest.  He is not normally on home oxygen.  Patient denies fever, chills, headache, blurry vision, nausea, vomiting, diarrhea, chest pain, abdominal pain, numbness, weakness or tingling in his extremities.
soreness in the arm (left arm); tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the arm (left arm)) and FATIGUE (tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 007M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Allergy.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness in the arm (left arm)) and FATIGUE (tired). On 04-Feb-2021, FATIGUE (tired) had resolved. On 05-Feb-2021, VACCINATION SITE PAIN (soreness in the arm (left arm)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-009093, MOD-2021-076768 (Patient Link).
Noticed redness after injection Monday, swelling Tuesday night. By noon on 08/29/2011 her thigh had swelled so much her shorts could not fit over and she was running a fever. Went to pediatricians, then to ER. She was admitted with cellulitis and received IV antibiotics through 09/02/2011. Currently on a 7 day oral course and a recheck with the pediatrician next week.
PT received a Typhoid vaccination Monday 4 August 2008 at 0900. Roughly 5 hours later PT began to feel ill and started to have diarrhea and vomiting symptoms with a temperature of 101 about 5 hours after the vaccination. By Wednesday 6 Aug 2008 PT temperature increased to 104. PT went to Hospital in at 1800 the same day 6 AUG 2008 to address the temperature and nausea symptoms. PT received IV therapy and was given pain and nausea medication. PT c/o severe weight loss approx. 10 lbs. PT was discharged from the ER at 2330. PT reports major symptom relief beginning Thrusday 7 Aug 2008.
This spontaneous report was received from a certified medical assistant refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored VAQTA. No adverse events were reported. Temperature of 49.3 F for 24 hours and there was no previous temperature excursion. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Pt administered 1-2 drops, started coughing & salivating. Pt suctioned, lasted approx 5-10 minutes. Baby massaged briefly & then fell asleep. Checked with mom in the afternoon baby doing OK.
Covid arm; Redness (3 inches wide, 2 inches long); Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), ERYTHEMA (Redness (3 inches wide, 2 inches long)) and SWELLING (Swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 11-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), ERYTHEMA (Redness (3 inches wide, 2 inches long)) and SWELLING (Swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), ERYTHEMA (Redness (3 inches wide, 2 inches long)) and SWELLING (Swelling) outcome was unknown.            Concomitant product use was not provided  by the reporter. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
1) Myocarditis 2) Dyslipidema 3) Essential Hypertension 4) Shortness of breath 5) Chest presure 6) Chronic Systolic congestive heart failure 7) Dilated cardiomyopathy 8) PVC  contractions 9) Left ventrial EV 16-30% 10) Biatrial Enlargement  RV dysfunction also noted
The patient reported a rash on the trunk and up the chest. She was also very red on the neck chin. The patient took 50 mg of Benadryl, and the rash has now gone away.
Patient received the flu shot given at 8:00 am. on Tuesday, October 6th, 2020 at the High School. She had no issues with it until 3:00 pm. Wednesday, October 7th, 2020.  She felt nauseated and she thought she was going to faint, that?s when she put her head down between her legs.  Also, later that evening her left breast was hot and hurting where she had a lumpectomy and 2 lymph nodes removed earlier in January and had radiation 16 treatments in March and April.  Her right arm where she had the injection was also hurting. Patient contacted her oncologist and radiologist who were unsure if it was all related.  Patient is symptom free now.
With in 24 Hours, had fatigue, chills, muscle soreness. 32 hours later a rash had developed on chest. The rash occurred after the first vaccine as well. Also on my chest.  I didn't report it due to not being 100% sure they were related. The rash is more spread this time than the first time.
PARTIAL DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: 01-AUG-2021) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced partial dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose of vaccine administered was not reported. This report was non-serious.
Fever, coughing er visit bronchitis 3/4/21 Sore throat, pus on sides of tongue and tonsils unable to swallow, pain in both ears 3/13/2021 return to er, fever both times 101. I was doing good until I got the shot
developed rash at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (developed rash at the injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (developed rash at the injection site). At the time of the report, VACCINATION SITE RASH (developed rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No relevant concomitant medications were reported. No treatment information was provided.
A report has been received from a Health Professional concerning a 9 year old, Female subject who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The patient experienced gave expired FLUMIST which started on 14-Dec-2013. The outcome of the event of gave expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Rash started a few hours after first pill of VIVOTIF. Rash, with itch worsened. Had headache also. On 6/7, started having stomach pain and vomiting.
02/15/22 presents to Birth Center Triage for "labor" "39w4d". PMHx of "COVID+ 2/13" "Abnormal Pap smear of cervix"
After receiving the first Moderna vaccination in my Left arm, I started feeling pain in the area of the vaccination site on the evening of 03/22/21. As time progressed I started to realize I was losing all motion in my arm and weakness on my entire left side of my body, but assumed this was a side-effect of the vaccination .  I was not concerned until my wife alarmed me in the morning when she looked at me and noticed the left side of my face drooped and had that I had difficulty standing, no balance, little use of my left leg and no use of my left arm and hand.  At that point, 7:00am 03/23/21, my wife drove me to the ER.  I was admitted and an inpatient for 15 days including PT/OT/ST therapies at the hospital for Stroke.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 15-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N017698, expiration date: 09-JUN-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
A patient asked for B12 shot and received the flu vaccine/ no AE; The patient received a flu vaccine had a flu vaccine a month ago too/ no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00811175) and transmitted to Sanofi on 13-Oct-2021.  This case is linked to case 2021SA342362 (same reporter).  This case involves a 64-year-old female patient who received a 0.5 mL (once) dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ7725AA, expiry date 30-Jun-2022) via intramuscular route in the right arm on 12-Oct-2021 for prophylactic vaccination instead of CYANOCOBALAMIN [B12 shot] (wrong product administered) and she had a flu vaccine a month ago too (extra dose administered).  The patient's medical history included Renal transplant.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of an actual medication error due to wrong vaccine administered and extra dose administered (latency was on same day).  It was reported "Medical assistant reports two patients who are husband and wife came in for B12 shot and received the flu vaccine. They both had the flu vaccine a month ago. She asks for appropriate follow-up."  No other 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.
pt recvd vax 25OCT95 & parents report high fever (104-105) & irritability not controlled w/APAP/Advil;began vomiting 26OCT95 PM & more irritable;ER visit & 27OCT95 for fever, vomiting, irritability & dehydration;green nasal discharge
used the wrong solution / mixed vaccine with saline; used the wrong solution / mixed vaccine with saline; This case was reported by a other health professional and described the occurrence of wrong solution used in drug reconstitution in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2021, the patient received Shingrix. On 17th August 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was the Glaxosmithkline vaccine specialist. The reporter called to report adverse event provided by the nurse that, used the wrong solution and administered the vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter stated that, the nurse mixed vaccine with saline instead of provided adjuvant. The health care professional follow up for nurse that administered vaccine to the patient.