chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for COVID-19; stopped smelling; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) and ANOSMIA (stopped smelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19) and ANOSMIA (stopped smelling). At the time of the report, COVID-19 (tested positive for COVID-19) and ANOSMIA (stopped smelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         In concomitant medications high blood pressure medicine was reported. No treatment details were reported.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old male patient who received SHINGRIX (batch number 29RR4?, expiry date June 2019) for prophylaxis. On 14th June 2018 15:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th June 2018, 1 days after receiving SHINGRIX, the patient experienced shingles and rash. The patient was treated with VALTREX and Steroid Injection. On an unknown date, the outcome of the shingles and rash were recovered/resolved. The reporter considered the shingles and rash to be possibly related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that the patient developed a rash on his right calf and shin the morning after receiving his first dose of SHINGRIX. Four days, after the vaccination, the patient visited his doctor who diagnosed shingles, administered a steroid injection and prescribed VALTREX. On the fifth day after the vaccination, the rash was gone. The healthcare professional stated that the patient was told by his doctor that the vaccination gave the patient shingles.
Son having a fever; A spontaneous report was received from a consumer concerning of an unknown age male patient, who received Moderna's COVID-19 vaccine and developed a fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patient received their first of two doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.     On 01 Jan 2021, after receiving his vaccination, the patient began to develop a fever. The exact temperature of the fever was not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, fever, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of fever, a causal relationship cannot be excluded.
pt recvd vax & had rash; red pimply; 1 diam around area lasted till monday;
Pain at time of injection that lasted 2-3 weeks. 8 months later, pain developed in right humerous that led to X-ray, bone biospy with dx of necrotic bone. 2 years later, pain continues. Repeated bone biopsy on 4/12/00 with a dx of necrotic bone. Continued pain and muscle weakness in right arm. Per doc 198038, annual follow up received on 08/23/2001: patient continues to have pain in Rt humerous, Rt shoulder. Pain has led to 2 shoulder scopes. Re biopsy of rt humerous showed necrosis. This event has led to the loss of patient's job, continuous pain even after multiple surgery.
pt recv vax & 2hr post vax pt felt dizzy & was staggering;pt woke up during the noc & still felt dizzy;by the next morning pt felt fine;
10 hours later at 10 PM, I was experiencing a severe headache accompanied by chills. Then my extremities became so cold that I couldn't warm them up the entire night. My entire body was experiencing the worse flu-like symptoms with severe muscle and joint aches for the next 24 hours. That next day, I noticed that my feet and hands were now feeling a noticeable warmth.
2.5 hours after vaccination she had a follow up appointment with her doctor and when she went to the restroom the she had no symptoms, she did not feel anything when she urinated; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC BACTERIURIA (2.5 hours after vaccination she had a follow up appointment with her doctor and when she went to the restroom the she had no symptoms, she did not feel anything when she urinated) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination.     Concurrent medical conditions included UTI.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ASYMPTOMATIC BACTERIURIA (2.5 hours after vaccination she had a follow up appointment with her doctor and when she went to the restroom the she had no symptoms, she did not feel anything when she urinated). At the time of the report, ASYMPTOMATIC BACTERIURIA (2.5 hours after vaccination she had a follow up appointment with her doctor and when she went to the restroom the she had no symptoms, she did not feel anything when she urinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: TCR form- Non significant info- Contact info updated
Vaccine administered without any noted problems or concerns. 9/16/09 soreness noted. By 9/17/09 noted swelling ~2" diameter, redness, heat over triceps area. Noted headache 9/16/09 which has persisted and mitigated with sleep. No swelling, redness or other localized symptoms noted at flu shot site on deltoid. Did not see health care provider evaluation. Will seek care if concerns
Started at 430pm with hives and swollen lips, writer took 50 mg benadryl.  Next morning 6:00 AM started with  nausea, vomiting, fever 101.5f, swollen joints and very weak muscles.
Pt. called and stated had temp up to 103 degrees F, on/off for 3 days, body aches. Also stated arm, where got vaccine, was red & warm to touch 24h after vaccine.
Two days after routine tetanus toxiod immunization administered by  health nurse patient complained of swollen arm, erythema, induration, deltoid to elbow.  Patient seen by MD - working diagnosis of allergic or other reaction or possible cellulitis.  Patient prescribed dicloxacillin, returned to clinic following day (after two doses antibiotic)with noticable improvement of symptoms.
Severe Nausea vomiting chills with sudden onset lasting 5 hours and then gone.
Ear is achy.; runny nose/nose is kind of runny; left arm is sore; Headache; very tired; muscle tension; This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on 03May2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first vaccine on Monday 03May2021 and wanted to ask a question about something she was experiencing. The patient had noticed especially yesterday my left ear started bothering me. My doctor looked at the ear there was no wax or infection. I received the vaccine on the same side. My left arm was sore, and ear was achy. I also have a runny nose with a headache. When I take Claritin, it goes away but when the medicine wear of it starts again. I also feel very tired. Caller clarified that she has allergies and got her first dose and next dose is due at the end of the month. The caller said that her left ear has been bothering her. She thought maybe that it was wax or maybe an infection in her ear. She said that she went to Instacare and the doctor there saw no wax build up or infection in her ear. It was bothering her. She said that they told her could be muscle tension that it could be causing her symptom. Caller said that her nose is kind of runny, but she feels better than she did. She said that she also had headaches along with it. Caller said that her ear aches and she forgot to ask the doctor if it could be a swollen gland. The outcome of the event runny nose/nose is kind of runny was recovering/resolving and outcome for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I am now having the worst, heaviest periods and cramps I have ever experienced in my life. I am completely exhausted when I am on my period and sleep for hours, which is extremely unusual for me. I have experienced 3 menstrual cycles since receiving the vaccine.
Patients daughter reported the following:  Palpitations.  Member was seen in clinic on 9/28/2020.  Member reports palpitations had improved since 9/26 and no longer having symptoms.
Sudden stiffness and pain in rightlower armpit approx. 50 hours after injection in left arm muscle.; Sudden stiffness and pain in rightlower armpit approx. 50 hours after injection in left arm muscle.; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 03Sep2021 at 10:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. On 05Sep2021 at 12:00, 50 hours after the injection in left arm muscle, the patient experienced sudden stiffness and pain in right lower armpit which lasted for several hours. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sudden stiffness and pain in right lower armpit approx. 50 hours after injection in left arm muscle was resolving at the time of report.   No follow-up attempts are possible. No further information is expected.
L upper arm swelling, redness, induration. Treatment for cellulitis w/Bactrim x 10 d
I had the chills; cold sensation; This spontaneous case was reported by a non-health professional and describes the occurrence of CHILLS (I had the chills) and NASOPHARYNGITIS (cold sensation) in a 67-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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (I had the chills) and NASOPHARYNGITIS (cold sensation). At the time of the report, CHILLS (I had the chills) and NASOPHARYNGITIS (cold sensation) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-311211, MOD-2021-311061 (Patient Link).
Patient complained of stomach ache, muscle ache, malaise, runny nose and headache. She got vaccine Saturday near 6 PM and starting feeling bad that night around 2 or 3 AM. She called pharmacy Tuesday night, said Monday and Tuesday were less severe, but still not feeling back to normal. Sunday was the worst of the symptoms, which started to subside around 8:30 PM or 9 PM. Symptoms lingered Monday and Tuesday. She did not require emergency medical attention.
pt recv vax & 10 days later pt devel a fever to 107; pt also devel febrile sz; No further details were provided;
Patient arrived anxious.  While standing in line to book her second appointment she suffered a syncopal event.  There was concern about potential airway stridor with LOC.  She was transferred to ED by EMS.  Treated for anxiety with complete resolution to baseline.
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided
Left arm very sore for more than one week; red  area on arm below injection site.  One month later. still have discolored area below the injection site and a redness in both cheeks and chin on my face and a discolored large area below my neck on my chest.  My personal physician advised to not get the second shot.  I went to my Dermatologist regarding the rash like discolored skin areas and was told it could take 6+weeks to clear.  The Dermatologist also advised not getting the second shot.
6 year old patient being behind on vaccination schedule and being administered QUADRACEL as her 4th DTAP dose instead of her 5th DTAP dose with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old female patient who was being behind on vaccination schedule and being administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] as her 4th dtap dose instead of her 5th dtap dose with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPA [HEPATITIS A VACCINE]) for Prophylactic vaccination; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 27-Jul-2022, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE(formulation, strength was unknown, lot UJ570AA and expiry date was unknown) via intramuscular (Vastus lateralis ) route (unsure of which side) in the thigh nos for Immunization. Information regarding batch and expiry date was unknown.  On 27-Jul-2022 the patient developed a non-serious 6 year old patient being behind on vaccination schedule and being administered quadracel as her 4th dtap dose instead of her 5th dtap dose with no reported adverse event (inappropriate schedule of product administration, latency: unknown) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  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 guidelines. 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.
12:08 Patient began to c/o tingling in throat. Patient also noted to have red blotchy skin on chest. Benadryl 25 mg P.O given with water; vitals; 12:10  170/100,87,18,97% lungs clear; 12:17  150/94,78,18,97% lungs clear; 12:24   150/94,78,18,97%  lungs clear. Patient stating that throat sensation is improving, red blotchy skin is also less evident; 12:35 150/86,75,18,97%: 12:45 symptoms have completely resolved. Patient states she feels normal. Patient departs the building.
3-24 to 4-2, Mild Flu-like symptoms (headache, sleepy), all joints painful, any previously broken bones very noticeable. No hard work or  4-1 to 4-10, Rt shoulder (shot arm)  joint continues to be VERY painful, felt like rotator cuff injury (that I have had on left shoulder), then it was suddenly almost gone (unlike normal rotator cuff injury pain).  4-12 I can feel it but minimal now
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (strength: 0.5ml, lot # L012190, expire date 13-APR-2017; dose and route unknown). The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 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.
On 11/22/10, this patient notified me that she had been diagnosed with Guillain-Barre syndrome and was hospitalized for a period of time.  It is unclear whether the vaccine (combined seasonal and H1N1 vaccine) contributed to the onset of the syndrome.  When we screened the patient for the vaccine, she had no previous reaction to any vaccine and no history of Guillain-Barre.
He doesn't feel his normal self; His heart was pounding and racing on the day he received his 1st dose.; On same day, he felt very tired; He felt nauseous; He felt shortness of breathe.; He lost his appetite; He was feeling dizzy.; He had chest pain that came and went away for 3 to 4 times; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (He felt shortness of breathe.), DECREASED APPETITE (He lost his appetite), DIZZINESS (He was feeling dizzy.), CHEST PAIN (He had chest pain that came and went away for 3 to 4 times) and FEELING ABNORMAL (He doesn't feel his normal self) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SALBUTAMOL (ALBUTEROL HFA) and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced DYSPNOEA (He felt shortness of breathe.), DECREASED APPETITE (He lost his appetite), DIZZINESS (He was feeling dizzy.), CHEST PAIN (He had chest pain that came and went away for 3 to 4 times), FATIGUE (On same day, he felt very tired) and NAUSEA (He felt nauseous). On an unknown date, the patient experienced FEELING ABNORMAL (He doesn't feel his normal self) and PALPITATIONS (His heart was pounding and racing on the day he received his 1st dose.). At the time of the report, DYSPNOEA (He felt shortness of breathe.), DECREASED APPETITE (He lost his appetite), DIZZINESS (He was feeling dizzy.), CHEST PAIN (He had chest pain that came and went away for 3 to 4 times), FEELING ABNORMAL (He doesn't feel his normal self), PALPITATIONS (His heart was pounding and racing on the day he received his 1st dose.), FATIGUE (On same day, he felt very tired) and NAUSEA (He felt nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medication were provided.
Contracted Covid-19, probably on 11/24/2022.  Day Zero was 11/19:  sore throat, malaise, "brain fog."   Tested positive on 11/30 and began 5-day treatment.  Ended isolation on 12/9/2022.
Information has been received from a registered nurse and a physician concerning a 18 month old male with an amoxicillin allergy who on 12 FEB 2002 was vaccinated with the first dose of MMR. Concomitant vaccination the same day included varicella virus vaccine live and Streptococcus pneumoniae vaccine. On 25 FEB 2002, the patient developed a rash on trunk, face, arms, legs and a fever. Subsequently on 28 FEB 2002, the patient recovered from the rash on trunk, face, arms, legs and fever. Unspecified medical attention was sought. No further information is expected.
Patient noted swelling and tenderness above left clavicle 2 days after receiving first Pfizer COVID-19 vaccine in the left shoulder. Also reported swelling and tenderness behind ears. No other symptoms.  On my exam on 1/17, I appreciated mobile nontender areas of swelling without overlying redness or fluctuance above left clavicle and behind left ear. Exam otherwise normal.
Patient noticed red patches on both arms (about 3 patches on each arm on 07/21/19 after receiving the vaccine on 07/19/19. The patches were described as having a burning irritating effect. The patches were not itching at all. Patches were nearly resolved by 08/10/19, but the outline was still evident at this point.  Patient self treated with Ivarest.
Splotchy rash on trunk and extremities appearing 6 days after vaccination.  One lesion vesicular (left pretibia) one pruritic.  On exam day 10, blanching rash compatible with erythema multiforme.
Fever of 101.2 Body aches Chills Nausea Vomiting  Headache
Patient developed right frontal and left parietal stroke on 7/22/2021 after developing A.fib and NSTEMI around 7/19//2021. Was treated with IV heparin, BP management. She completed physical rehabilitation program.
pt previously received one moderna monovalent vaccine 3/21/23 for first dose in series.  then received moderna bivalent vaccine on 5/16/23 (10mcg, pink cap).  should have received higher dose of moderna bivalent vaccine (25mcg, blue cap) instead.  no symptoms reported.  error noted on 7/18/23 after chart review.   I called moderna for guidance, and was directed to call the CDC.  CDC recommended pt receive a dose of the moderna bivalent vaccine (25mcg, blue cap) since lower than recommended bivalent dose previously received.  no minimum time interval required. family notified.  pt received moderna bivalent vaccine (25mcg, blue cap) on 7/25/23