chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs; diarrhea; felt anxious; chills; sweating; body aches; felt like her body was prickly; A spontaneous report was received from a consumer concerning a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, sweating / hyperhidrosis, body aches /pain, felt like her body was prickly, had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs / rash, diarrhea, felt anxious/anxiety.  The patient's medical history include allergies, include mold, dust and dogs. Concomitant medications reported were  cetirizine hydrochloride, mometasone furoate, vitamins nos, fish oil, for drug use for unknown indication.  On 03 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 029L20A) (unknown route) in the left arm for prophylaxis of COVID-19 infection.  On 03 Feb 2021, the patient experienced the event(s) chills, sweating, body aches, felt like her body was prickly. On 4 Feb 2021, the patient experienced the event(s) had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs, diarrhea, felt anxious.  Treatment details included acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable  The outcome of event(s), chills, sweating, body aches, felt like her body was prickly, had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs, diarrhea, felt anxious was unknown.
02/19/2021 that evening you felt fatigue, headache, muscle ache, everything hurt for about 12 hours. On May 11th, I had upper respiratory issues and coughing. No doctors visits that day. 06/06/2021 my heart started racing and having extreme back muscle pain, all till 06/20/2021 So I went to ER I was released from the ER on the same day.  On 06/22/2021 I went to see my regular MD. On 06/26/2021 next Dr appt. She sent me to hospital, they did a CT of my lungs and it sounded that I have a fungus in my left lung. My regular MD set me up with a Rheumatologist, I saw them on 08/07/2021 and I was diagnosed with Lupus.
ITCHY RASH IN NECK AND ABDOMEN AND TRUNK, IMPROVED OVER NEXT 2-3 DAYS, ON 3/19/14, FINE PAPULAR RASH ON NECK PRESENT.
Baby has eyes that vibrated or tremored, she stopped breathing for a period in my husband's arms, but quickly recovered, slept almost to the point of not waking for two weeks, even when water was applied, baby was floppy and was missing grasping reflex only on one side. She is fine now, smiling and reflexes are intact. She seems very normal now...I thought it was just related to the birth, but we had an easy birth. I truly thought this child had neurological damage at one point, not realizing it could be from shots she was given. We have a history of genetic issues on husband's side, so it may explain why she reacted poorly to shots, like with mthfr mutation or so.  She is happy now, but I don't think I will further imuunize this child. I had 10 other children, so I can tell when something was not right with this one.
Information has been received from a nurse practitioner concerning a 8 year old male with a congenital heart disorder and no known allergies who was vaccinated with a first dose of MMR. Around 2 years old (in approximately 1999) the patient was diagnosed with autism. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. It was reported that the patient's mother would not allow the second dose of MMR to be administered. The mother thinks the autism is related to MMR II. There was no product quality complaint involved. Autism was considered to be disabling. Additional information has been requested.
tested positive for COVID on 12Dec2022.; tested positive for COVID on 12Dec2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose number unknown (booster), single (Lot number: GH9694) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Dec2022, outcome "unknown" and all described as "tested positive for COVID on 12Dec2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Dec2022) Positive. Course of events: A Pfizer employee in good health (no underlying health concerns or chronic conditions) received the Pfizer/BioNTech Bivalent booster vaccine on 14Oct2022 and tested positive for COVID on 12Dec2022. Her symptoms started with a headache and dry cough and progressed to stuffy nose, sinus drainage, productive cough. Experiencing some GI issues of diarrhea and certain foods not tasting right.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200145615 same reporter/patient/product, different dose.;
This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 20-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA013686: US-009507513-1809USA013687: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA012930: US-009507513-1809USA013683.
circular lump on her; red; itching; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included latex.   On 19th May 2019, the patient received the 2nd dose of Shingrix. On 20th May 2019, 1 days after receiving Shingrix, the patient experienced erythema, pruritus and upper extremity mass. On an unknown date, the outcome of the erythema, pruritus and upper extremity mass were recovering/resolving.   It was unknown if the reporter considered the erythema, pruritus and upper extremity mass to be related to Shingrix.  Additional details were provided as follows: The patient reported no reaction after the 1st dose. The patient experienced erythema, pruritus and upper extremity mass.
Fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had Td 7/24/03. Had swelling and severe pain in left shoulder within 24 hours of vaccine. No fever. Symptoms continued until pt made appt to see Dr 8/8/03. X-ray of shoulder was done. Advised moist heat, pain med given, antiinflammatory. No numbness, weakness or loss of function.
rash over entire body seen in pediatrician office 17FEB97;vax given 2OCT95;
Migraines Increased Blood Pressure (out of the ordinary, beyond usual or customary) Irritability (out of character) Insomnia Edema (out of the ordinary, beyond usual or customary
migraines; arm swollen; arm hot; itchy; red; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   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 an unknown date, the patient experienced MIGRAINE (migraines), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and DIZZINESS (Dizzy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraines), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE WARMTH (arm hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and DIZZINESS (Dizzy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported were BP medicine for drug use for unknown indication
Entire arm (wrist to shoulder) red, hot, & swollen; Pt stated red, & swollen area had moved into underarm & breast tissue as well.
Comes in with worsening SOB and weakness, dyspnea, fatigue. Acute respiratory failure with hypoxia (HCC) -- patient with recent COVID, however repeat COVID testing here has been negative. Continued Lovenox for positive D dimer, Patient seen for respiratory complaints and thought to have COVID.  He did require oxygen for a short while.  He was able to be weaned down and did not qualify for home oxygen.  He had mild elevation in his LFTs which improved during admission.  D-dimer was high but he was negative for blood clot.  He had a positive blood culture for a contaminant.  He was covered with antibiotics while in hospital.  Patient felt better was really wanting to go home. He was discharged on oral antibiotics
Gave patient ZOSTAVAX injection, pt. started feeling week and dizzy, pt looked as if he was seizing, gave pt a dose of Epi-pen. Pt then vomited and then started feeling better. Fire Dept arrived check him out and then pt said was feeling better and didn't want to go to ED. Called pt about 1 hr later, he said he was feeling fine and did not think it was the vaccine.
nurse pulled the diluent and did not mix the powder and administered just the diluent to the patient, no AE; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six month old patient (gender not reported) who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination, on an unknown date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to active ingredient not added to diluent.  It was reported that one of the nurse pulled the diluent and did not mix the powder and administered just the diluent.  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.
temp 104.6 approx 14 hrs p/DTP,OPV; shrill cry - heard by MD over phone; irritability;                    ]
Arthritis in many joints increased  rapidly since vaccine. Sleep often 2 - 3 times in one day. Tiredness, digestion with abdominal pains, headaches, nervous, etc. Diagnosed with chest pain of unknown etiology.
This study case was received from the investigator in the trial on 18 July 2013. An 37 year-old female subject whose past medical history included headaches was found to have encephalitis following immunization procedures 11 days after the subject had received on 23 September 2009 an injection of ACAM2000 (lot number, route and site of administration not reported. Troponin I result, ECG and Echocardiogram, Lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Historically i have not gotten bloody noses.  But on Saturday 4/10/21 Morning when blowing my nose, my nose bleed quite a bit for a good 10-20 minutes.   This happened again 4/12/2021 but for a lot less.
-Anaphylaxis Reaction  -Hives -Tachycardia  -Itchy -Flushed
This case was reported by a healthcare professional and described the occurrence of expired vaccine used in a 51-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 05 September 2008, the subject received the 1st dose of FLULAVAL (.5 ml, unknown, left arm).  The FLULAVAL vaccine administered had expired (Lot # ASLLA030AA; expired July 2008).
Severe chills and body aches began in early evening and progressed to fever which became quite high (101.5) despite Advil by midnight. The fever led to overheating, near fainting and vomiting, after which fever subsided somewhat but did not return to normal temperature until another 24 hours after that.  Body aches and a feeling of "flu" accompanied the fever.  Only 48 hours after the shot (2nd morning) did I feel well again. I have rarely is ever felt so sick as an adult.
swollen lymph nodes under left arm.  lymph nodes are tender to touch.  pain in left side of neck.  swelling started the night of 10/20/2021 and is still swollen on 10/22/2021.
Pain; Shivering; Fever; Malaise; Muscle pain; Upset stomach; Moderate to severe axillary lymphedema on the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain, chills, fever, malaise, myalgia, upset stomach and lymphedema. On an unknown date, the outcome of the pain, chills, fever, malaise, myalgia, upset stomach and lymphedema were unknown.   It was unknown if the reporter considered the pain, chills, fever, malaise, myalgia, upset stomach and lymphedema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experienced pain, shivering, fever, malaise, muscle pain and upset stomach for the last 3 days. The patient also experienced moderate to severe axillary lymphedema on the injection site. The reporter consented to follow up.
Improperly stored PROQUAD were administered to 10 patients; No additional adverse symptoms reported; This spontaneous report was received from an office manager concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # S013712 and expiration date 01-NOV-2020 (dose and route were not provided), reconstituted in sterile diluent (STERILE DILUENT), for prophylaxis. It was unknown if the sterile diluent (STERILE DILUENT) used to reconstitute the vaccine was stored at proper temperature. No additional adverse events symptoms were reported. The temperature excursions were reported as follows:  measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (Lot # S013712, expiration date 01-NOV-2020)  Temperature  Total time in the range 6 degrees Fahrenheit (F) to 14 F (-14 degrees Celcius (C) to -l0 C) for 30 minutes Total time in the range 15 F to 46 F (-9 C to 8 C) for 7 hours;  Total time in the range 47 F to 77 F (9 C to 25 C) for 9 hours  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA005479:
I experienced shortness of breath, easily getting out of breath after mild physical exertion; also shortness of breath even when resting. This lasted several weeks.   Attributing this event to the vaccine, I made the choice not to get the second dose.
A report has been received from a pharmacist concerning a 3 year old, male patient, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. The patient stated inadvertent administration of full dose in one nostril which started on 12-Nov-2015. The outcome of the event of inadvertent administration of full dose in one nostril was unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between inadvertent administration of full dose in one nostril and FLUMIST Quadrivalent.
Pt reported red, wheel, hot area about 4 cm around the injection site. The reaction lasted for two days
SWELLING ON SITE OF INJECTION, RESPIRATORY SYMPTOMS: HEADACHE LOTS OF MUCUS, DIFFICULTY BREATHING.
Right deltoid area shows a 0.25 x 1 cm erythematous blister that is non tender and non-pruritic. Appears to be contact dermatitis likely from removal of Band-Aid 24 hours later.
Tested Positive for COVID-19; Tested Positive for COVID-19; stuffy nose; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0179) via an unspecified route of administration, administered anatomical location not reported, on 11May2021 (at the age of 58 years), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0170) via an unspecified route of administration, administered anatomical location not reported, on 20Apr2021 (at the age of 58 years), as a single dose for COVID-19 immunization. Prior vaccination, the patient does not have COVID-19. Post vaccination, the patient tested for COVID-19. On 01Oct2021, the patient experienced Tested Positive for COVID-19, and on 30Sep2021 stuffy nose. The patient stated, Fiance had symptoms earlier and tested positive for COVID-19 (Moderna vaccine) on 29Sep2021. On 01Oct2021, the patient underwent lab tests and procedures which included PSA, SARS-CoV-2 test: Positive, Nasal Swab. The patient did not received treatment for the events. The outcome of the events was recovering.  No Follow-up attempts are possible. No further information is expected.
I have facial fillers under my eyes.  The filler on the left eye was swollen and red.
Pulsation/pain in upper legs, swelling and burning in legs, started about 4 days after vaccine and comes and goes.  Causes her to have panic attacks.  Had symptoms with other dose(s) as well,  Does have bad varicose veins, stents, pacemaker as well.
Vaccine recipient stated that she believes the vaccine was not administered the correct route and was administered subcutaneously rather than intramuscularly.  Vaccine was administered on 1/20/21. Recipient reported that she began to develop redness and a lump under the skin where she claims vaccination occurred on 1/21/21.
Right arm red and swollen. Per Dr. "Recommend supportive care with ibuprofen 400 mg Q6-8, PRN BENADRYL 25mg Q4-6h, and icing. To call for streaking redness, fevers, increased pain, failure to improve over next week."
12 days after getting the vaccine, my upper left arm (injection site) is slightly sore, red, and inflamed.  The affected area is about 4 inches from the top to the bottom and about 2 inches side-to-side.  It feels feverish.  I seem to be okay otherwise.
pain, swelling and redness at injection site Oval shaped redness just below injection site measuring: size: 1.25 inches x 1.5 inches
Experienced anxiety; Agitated all night; Slept for 6 days straight, day and night; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Experienced anxiety), AGITATION (Agitated all night) and HYPERSOMNIA (Slept for 6 days straight, day and night) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ANXIETY (Experienced anxiety), AGITATION (Agitated all night) and HYPERSOMNIA (Slept for 6 days straight, day and night). At the time of the report, ANXIETY (Experienced anxiety), AGITATION (Agitated all night) and HYPERSOMNIA (Slept for 6 days straight, day and night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Hx. DM. Noted during observation he was forgetful but able to verbalize but speech noted to slur, Juice given 120/90, 78, 18. c/o of tightness in chest and was transported to ED for evaluation in stable condition. 140/78, 68, 18. Acu chceck 240 in ED. Di Narrative: After vaccine, during observation seemed forgetful but able to verbalize. Speech noted to slur, History of DM verbalized by pt. Juice given 120/90, 78, 18. c/o of tightness in chest and was transported to ED for evaluation in stable condition. 140/78, 68, 18. Acu chceck 240 in ED. Discharged asymptomatic from ED to f/u with PCP.
Fever x2 days. Rash x1 day. No treatment. >100 red spots - head to toe.
After 8 days a red, swollen, itchy rash/welt appeared at the injection site. Headache and fatigue were experienced the day after the welt appeared. As of time of report the affected area is approximately 1.5" in diameter.