chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm has warm, reddened sore area at sight of injection; fever of 99 on 9/22/19.  Treated with rest and ibuprofen.  Reddened area still present on 9/23/19, and still treating with ibuprofen.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PYREXIA (Fever). On 01-Feb-2021, PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details were not provided.
Headache; muscle aches; fatigue; mild upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 17Apr2021 at 10:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included grave's disease post partial thyroid ablation and mild hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), tilactase (LACTASE) and vitamin d not otherwise specified (VITAMIN D); all for an unknown indication from an unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 27Mar2021 at 10:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 15:30, the patient experienced headache, muscle aches, fatigue, fever and mild upset stomach. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, muscle aches, fatigue, fever and mild upset stomach were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Difficulty breathing Mild fever (101 degrees) Slight hand shaking (i.e. tremor)
This spontaneous report as received from a registered nurse regarding on a patient of unknown age and gender. Patient's medical history or concurrent conditions were not reported. On an unknown date, the patient received improperly stored dose of GARDASIL lot # K010574, expiration date 08-APR-2017 (dose, strength and route were unknown). There was no concomitant therapies reported. No adverse effects were reported. Additional information has been requested. This is one of several reports received from the same reporter.
Patient was having a reaction to the Varicella Vaccine, the area was inflamed and very red. It was also hot to the touch and patient said it was very itchy.
expired IPOL vaccine was administered/no AE; Initial information received on 02-Jan-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to 2020SA002268 (via same reporter).  It was reported that 6 years old female patient received expired Ipol vaccine /no AE(expired product administered) of vaccine IPV (VERO) [IPOL].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Jan-2020, the patient received a 0.5 ml dose of suspect IPV (VERO) lot N1K921M via unknown route in the left deltoid.  It was actual medication error due to expired vaccine used.  It was also a case of off label use as it was prescribed by Medical Doctor.  At the time of this 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.
Moderna Covid19 Vaccine EUA      Started feeling exhausted had chills no energy at all. Took on Tylenol. Felt fine the next day November 4th 2021
Within 24 hours, the patient collapsed and was in a shock-like state, paramedics called and the child was improving. He was monitored over night at the hospital, no treatment, CPR and pulse ox used to monitor; the patient described as white colored and non responsive for 3-4 minutes.
This literature marketed report was received and refers to a 15 month old female patient (21 month old at clinic visit). Her family history and family history were non-contributory. Antinuclear Antibody (ANA), rheumatoid factor, double-stranded DNA (dsDNA), antibody (Ab), thyroid-stimulating hormone (TSH), antithyroglobulin Ab, venereal disease research laboratory test and glucose performed on an unspecified date were normal. On an unknown date, the patient was vaccinated with her third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route, anatomical place of vaccination, lot # and expiration date were not provided), for prophylaxis. On an unknown date (also reported as "2 weeks after receiving the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) at the age of 15 months), the patient experienced hair loss. Physical examination performed on an unknown date showed 80% of hair loss of the scalp, with downy brown hair on the temples and occiput. The body was without hair, although the eyebrows and eyelashes were intact. No nail changes were noted. Diffuse alopecia of the scalp, with a few sparse hairs on the occiput. No other changes from prior examination were noted. Treatment was begun with pimecrolimus. At 3 months her examination was unchanged. The patient was instructed to continue the treatment and start amcinolone. The reporter considered alopecia areata to be related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown). This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA010505.
pt recvd vax;approx 4 wks later devel approx varicella type lesions on arm,face,neck & scalp;exp fever of 100 & general malaise;
pt was irritable 4PM for screaming, hyperventilating, shaking, sz, lt side twitching;taken to ER;hyperactive, has a temper w/high pitched screaming fits & lately has been banging head against wall;pt intubated;rt side weak;
pt recv vax 28JAN97 & pt devel a gen rash;pt was described as having a red face, sunburned looking, raised dots, swollen eyes, looked like hives;
On the same day of vaccination of Dose 2, I started having muscle tightness with difficulty moving, lockjaw, fever up to 101.0, chills and body aches. Three days after vaccination, I actually started feeling a little better but the 4th day, all symptoms came back with intensity. After 3 or 4 weeks, I was still experiencing muscle tightness but started pushing myself to move more which caused me to "convulse and fall". I passed out and my husband said it looked like a seizure. The same seizure activity happened again a week after the 1st one.  On 4-21-2021 I could not move at all. I had abd pain and loss of appetite. I put my feet on the floor and could not feel the floor due to my feet tingling. I tried to stand up and fell down.  My husband took me to the doctor that day and I was sent to the Emergency Room They did a CT scan (unsure if spine or of specific area). The ER told me that my arthritis in my lower back was inflamed. They gave me medication for inflammation in the ER but I do not recall the name of the medicine. In May, 2021 I went to the Internal Medicine and he told me it was an arthritis flare and fibromyalgia and he started me on Gabapentin, baclofen and Buspirone. I felt like I was having behavioral and mental differences with the Buspirone so I stopped taking it. In May 2021, I started hurting all over and both ears were hurting so I went to the ER and they done a head CT which showed double ear infections. In the last week of May 2021, the orthopedic doctor  started me on aquatic therapy and sent me to a pain management clinic. In June, 2021, I started going to the pain management and they upped the Gabapentin to a stronger dose and increased frequency. They started me on Cymbalta and injected a steroid into my spine. The spinal injections gave me approx 60% of my mobility back but they are wearing off now and I am having trouble sitting.
large local rxn characterized by swelling, redness, hot to touch which covered almost entire deltoid region;also had regional lymphadenopathy; tx w/Kaftab & Advil; 17JUN94 f/u pt recovered;
Pt received Flu inj on 10-30-17 in left deltoid. Pt had redness and swelling of approx 2-5" around inj site on 10-31-17. Redness and swelling became worse on 11-1-17, measured 6 in x 5 1/2 in. Pt was given BENADRYL and did ice packs overnight. Redness and swelling was better on 11-2-17. Prescribed hydroxyzine on 11-2-17.
pt recv vax AUG96 & 2wk p/ vax pt devel low fever, abd discomfort & some loose stools;pt treated for poss diverticulitis for 1wk;6SEP96 pt became more ill w/worsening sx & hosp;devel n/v, petechiae & purpura;dx thrombocytopenia;tx w/med
Fever, chills, trouble breathing, elevated heart rate, severe body aches, extreme fatigue.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-AUG-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second timer was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Initial report received from a nurse on 03 Nov 2010: This patient was vaccinated with FLUVIRIN (lot number 111773P1) 0.5 ml, intramuscularly on 02 Nov 2010. On 03 Nov 2010, the patient experienced tachycardia and elevated blood pressure of 140/100, nausea, dizziness and rash at injection site. Outcome of the events was reported as condition unchanged.
Initial misuse report received on 04 October 2013 from a doctor. A patient whose gender, age, medical history and concomitant medications were not reported, received FLUZONE (route, lot number and site of vaccination not reported) on an unspecified date.  Patient received less than 0.5 ml of FLUZONE. List of documents held by sender: none.
Patient first dose was Moderna.  Inadvertently administered Pfizer, instead of Moderna, for 2nd dose.
1 day afterward: brown patch 1' x 2" same arm she got shot few inches away from inj site showed up 2 days later: quarter sized blister on stomach 5-6 days later: burning itch progressed from waist to shoulder pimpled but not blistered. Patient on MEDROL dose pack & ZYRTEC.
The day before I was due to receive my second dose, I noticed long, silky fibers springing out of the bottom of my feet.  I'd brush them off and they'd sprout back.  There were also small, black specks emerging.  A week after the second dose, I experienced small, off-white, crescent shaped things, half the size of a maggot, emerging from every part of my body hair - scalp, chest, pubic - who h I wrangled into a bag. This continued for a few weeks. Though I saved the samples, doctors didn't want much to do with them.
Approximately 33 hours after the shot (with having a reaction to the shot within 10 hours- body aches, headaches, sore arm, flu like symptoms) I ended up having a clogged duct. I am a breastfeeding mother of 7 months and have never had a single issue. I got a clogged duct thats still trying to resolved and has significantly decreased my milk supply. There was NO other reasons why this could of happened.
Stabbing pain over left eye 1/27/2019, random severe itching over body, centering on rear shoulders, around torso at bottom of ribs and rear of hips at top of pelvic bone. Increases during day and caused sleepless nights 1/30/2019 and 1/31/2019.
Received 2nd dose Pfizer on Feb 25.  On March 1 woke up dizzy.  Dizziness  lasted 4 days, then disappeared.  Don't know if vaccine related or not.
Pt. began having injection site arm hurting at area of injection. Pain radiated up thru neck to top of head. There was also swelling/redness 1 in. below injection site. No previous sxs. Pt took 2 TYLENOL that pm but no other doses. Pt. did not use any compresses on area. Contacted pt. on 8-25-16 all sxs gone except mild swelling and soreness.
I21.4 ACUTE NON ST ELEVATION MI 7/7/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 7/7/2023 ANXIETY DISORDER, OTHER SPECIFIED
1/21 Patient wokeup dizzy, had vertigo and double vision, cough + extreme fatigue  1/28 most symptoms were resolved  Patient was prescribed Azithromycin, Meclizine, Benzonatate, Zofran
As the nurse gave the HPV vaccine, my daughter fainted and had brief muscle convulsions. She continued to have nausea, lethargy and lightheadedness for the next several hours. She continues to complain of a headache this evening (same day as event).
Severe chills Thirst Rejection to food Fever Dizzy Weak Sleepiness
Patient c/o pressure in the head. Dizziness, sleepy 3 minutes after IM injection received. V/S 139/95 HR75, R16, T97.8, SPO2 98%. Patient's legs elevated. Ice placed on back of patient's neck. 12:40PM Symptoms worsen. EMS called. Patient continues to be in observation 12:47PM. Patient reports of feeling a little better but stills feel sleepy. EMT arrives patient states she doesn't feel sleepy any longer. Refuses transport to ER. patient attempts to stand with assistance.  Patient C/o of pressure left side of chest front and back. Placed back in chair, legs elevated VS as follows: 128/74 HR73 SPO2 99% on 3L of o2. Patient states she starts to feel sleepy again and a little dizzy. Patient escorted by stretcher by medics.
Information has been received from a mother concerning her 15 month old male son, with no known drug allergies, who in approximately 200 was vaccinated SC with a dose of MMR II. The reporter noted that after the vaccination her son "went down hill from that point on." It was reported that he "has no motor skills." The mother reported that the patient recently started to speak again, and that he did ambulate well, however, he had a hard time picking things up with his hands. The patient reportedly did not have a new doctor and the reporter indicated that they would be moving to another address soon. It was reported that the patient sought medical attention and that he was recently diagnosed with "limapraxia." The reporter refused to provide the patient's doctor's information. The patient's experience wee considered to be disabling by the reporter. The patient was "recovery with sequelae." Additional information has been requested.
Headache; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history reported.    On 24-Feb-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 24-Feb-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      No relevant concomitant medications were reported.  No treatment information was provided.
ASSESSMENT and PLAN Visit Diagnoses and Orders: 1. Herpes (Primary)   2. Adverse effect of COVID-19 vaccine   3. Breast pain in female   Other orders -     valACYclovir (VALTREX) 500 mg tablet; TAKE 4 TABLETS BY MOUTH AT FIRST SIGN OF ATTACK (BURNING,TINGLING ON EDGE OF LIP) AND TAKE 4 BY MOUTH 12 HOURS LATER.  Dispense: 14 tablet; Refill: 1     Discussion: File VAERS report REfill of valtrex, Use vasline inside right nares   Questions answered and patient demonstrated understanding and instructions.     Medication Management: Patient's Medications New Prescriptions   No medications on file Modified Medications   Modified Medication Previous Medication   VALACYCLOVIR (VALTREX) 500 MG TABLET valACYclovir (VALTREX) 500 mg tablet      TAKE 4 TABLETS BY MOUTH AT FIRST SIGN OF ATTACK (BURNING,TINGLING ON EDGE OF LIP) AND TAKE 4 BY MOUTH 12 HOURS LATER.    TAKE 4 TABLETS BY MOUTH AT FIRST SIGN OF ATTACK (BURNING,TINGLING ON EDGE OF LIP) AND TAKE 4 BY MOUTH 12 HOURS LATER Discontinued Medications   FLUTICASONE (FLONASE) 50 MCG/NASAL SPRAY    2 sprays by Nasal route Daily.   Follow-up: No follow-ups on file.   SUBJECTIVE   HPI: Allergic reaction to pfizer COVID vaccine. Having mouth blisters, sore throat, bleeding blister in nose, heart palpitations, left ear swelling and itching, ear congestion and ringing.   Right lateral Breast lump, sore & change in feel.  right breast cyst, centrally at 9oclock, hard, painful > associates with start of HRT  Has follow up with clinic  Recent mammogram 3/9/2021.   COVID vaccine side effects Blister inside right nares Blisters at back of mouth (not typical allergy rxn) > painful, swollen Left ear plugs and then develops tinnitus Heart palpitations - constant - pounding, rapid > no sob or chest pain with episodes. Since vaccine all typical "allergy" symptoms are "off the charts" Dentist prescribed Valtrex 2,000mg BID x1 > for possible herpes flare, possibly helpful. No relief with benadryl
Pt devel severe viral pneumonia 12 days p/receiving Influenza vax; MD feels this ADE may not be related to the vax;
This spontaneous report was received from a healthcare worker and licensed nurse practitioner refers to a patient of unspecified age and gender. On 07-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # H018786, exp date: 15-OCT-2014, 0.5 milliliter (ml), subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Difficulty Breathing; Pain in the middle of his Back and Chest; Pain in the middle of his Back and Chest; Itching random areas of body; Bad reaction; Severe Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), BACK PAIN (Pain in the middle of his Back and Chest), CHEST PAIN (Pain in the middle of his Back and Chest), PRURITUS (Itching random areas of body) and ASTHENIA (Severe Weakness) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concomitant products included ISATUXIMAB for Immune system disorder, DEXAMETHASONE for Steroid therapy, POMALIDOMIDE (POMALYST) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ASTHENIA (Severe Weakness). On 03-Apr-2021, the patient experienced DYSPNOEA (Difficulty Breathing), BACK PAIN (Pain in the middle of his Back and Chest), CHEST PAIN (Pain in the middle of his Back and Chest), PRURITUS (Itching random areas of body) and ADVERSE REACTION (Bad reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 03-Apr-2021, DYSPNOEA (Difficulty Breathing), BACK PAIN (Pain in the middle of his Back and Chest), CHEST PAIN (Pain in the middle of his Back and Chest), PRURITUS (Itching random areas of body) and ADVERSE REACTION (Bad reaction) had resolved. On 05-Apr-2021, ASTHENIA (Severe Weakness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was told not to get the second Moderna  vaccine because they are similar. He updated his contact information   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received: Reporter information and contact information was updated
Information has been received from a registered nurse concerning a female "65 years or older", who in October 2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23. Subsequently, the patient developed swelling in the arm that encompassed most of the upper outer arm. The area was red and very painful. The patient also developed a low grade fever. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Pt. was administered 0.5 mL of Tdap in (L) delt on 4/06/12, pt. presents on 4/19/12 with red, erythematic, slightly elevated area over right upper arm. Area slightly raised, but on palpation a small lump appr. 1 inch x 1 inch can be felt, approximate rash is 2 1/2 inch x 4 1/2 inch and is in a circular shape around (R) upper arm. Pt. complains of moderate pain when moving arm.
COVID-19 PCR is positive on February 14 she has no respiratory symptoms will discuss with Infectious Disease team regarding if urticaria is possible related to COVID 19.  In review her previous COVID test on February 1st at local emergency department was negative.
A measles like rash head to toe. Ongoing of 3 days.  Being treated with a prescribed antihistamine and steroid.
Injection site pain - 3 days in length - subsided after 3 days Body aches - 1 day in length - the day after vaccination - subsided after one day - took naproxen for pain Congestion, sore throat, cough - 2 days after vaccination - still displaying these symptoms after 3 days - have been taking NyQuil, pseudoephedrine, cough drops Loss of smell - am able to feel the "burns" of certain smells (i.e. coffee grounds, peppermint oils) - developed today, 4 days after vaccination Slight loss of taste - am able to taste the sourness, bitterness, sweetness, etc., of foods, but cannot distinguish foods by their taste - developed today, 4 days after vaccination