chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Day 7  (April 1) I noticed red welts and hives randomly all over my body.  They are very itchy.  More pronounced after a shower or when I wash my hands.  Benadryl helps only a little.  On Day 15 (April 8) in addition I felt warmth and bloating of the ankles - more so on the left leg.
1 day p/vax pt devel an inj site rxn characterized by redness, swelling & warmth which extended tot he fingers;the reporter indicated the pt lt arm is 3 to 4 inches greater in circumference than the rt arm;
Information has been received from a physician concerning a 15 month old patient with no past medical history who on 28-Jul-2006 was vaccinated with a 0.5 ml dose of of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  On 30-Jul-2006 the patient developed a rash at the injection site which spread to the patient's torso.  Unspecified medical attention was sought.  At the time of this report the patient had not recovered.  There was no product quality complaint involved.  1/5/10 follow up - injection site rash.
Came in to show RN localized reaction to left upper arm after receiving the Zoster vaccine on 09/22/2008. Noted a hard reddened knot approximately 50 cent size on 09/24. Denies shortness of breathe, trouble swallowing etc. Encouraged to treat area with Tylenol and Benadryl for discomfort.Can use cool compress to area and anit-itch cream to site. Pt. states on blood thinners- ASA and a bruise at site also noted this day. Called daughter an RN for advise also today. DN
Patient with a history of COPD. She presented to the ED on 2/26/23 with a week's worth of symptoms including shortness of breath, cough, chills, and green phlegm. She notes she was exposed to a friend who tested positive for COVID. A COVID-19 PCR test performed in the ED resulted positive. She was placed on 2L supplemental O2 with O2 sats at 95%. Ultimately she was admitted 2/26/23-2/28/23 with discharge diagnoses including acute hypoxic respiratory failure d/t AECOPD, possible bacterial bronchitis, and COVID-19 infection. She was started on Dexamethasone 6mg daily (started 2/26) and required supplemental O2. She was eventually weaned to room air. Of note, the patient has received the primary COVID vaccine series and three boosters.
Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (Discomfort). At the time of the report, DISCOMFORT (Discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-008450 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient stated her arm swelled up from shoulder to elbow and swelling extended to breast.  Patient stated that she did not seek any medical treatment.
Generalized convulsions which required airway support and self resolved before any additional treatment in about 5 minutes while in ambulance to ER.
2/12/2020 around 2 AM. Felt really sick, achy like she had the flu, had chills, hot flashes, bad headache. Also reports bad dizzy making her almost fall.  Felt like this for 2 days. Reports "breathing has been bad", reports no energy, breathing kept getting worse,  Now on inhaler where she never was on before.
PATIENT DEVELOPED A BULLOUS BLISTERING RASH THAT STARTED ON THE PALMS AND PROGRESSIVELY WORSENED OVER THE COURSE OF A FEW WEEKS TIME.
He got his vaccine, he feel a little light headed, moderately dizzy.  He was kept for 15-30 minutes, didn't have any reaction.  AFter he got home around sunset he started feeling horrible.  He told them before he got the vaccine and Dr that he had thought that at the beginning of the pandemic that he felt that he had COVID and was reluctant to get the vaccine as he was told that he could have a reaction after getting COVID.  He then started to have chills, hot flashes, high fever, loss of appetite, could not eat.  He had really bad brain fog and an excruciating headache.  He was not able to work for 7 days after that.  He could not sleep because of the headache.  On the 21/22 he had been given a piece of paper that said to contact the healthcare team and he called that #.  He informed them and they called him back and listed everything that he was experiencing, but the main thing was the headache.   They asked some questions about red streaks and pus at injection site and did not give him any recommendations for the vaccine.  His 2nd vaccine is scheduled for the 24th, and he called on Thursday to ask if he should take the vaccine due to his reaction and felt that he should be exempted.  He spoke with employee who checked with Dr who said that no he would not give him an exemption.    He read that if you have a reaction to the vaccine, then the 2nd vaccine would be much worse.  He called back the VA after reading the info regarding this, feeling that he missed work and had to be precise and that he cannot loose another 7-10 days of work.  He spoke with the Dr. supervisor/patient advocate, and that he should document his reaction with CDC, and should seek for them to turn his reaction into an AE and they would research that info for him not to get the 2nd shot.    He is never sick, very active and healthy.
Patient contacted the State Program Operations Manger Fri., 10/24/2014, and verbalzied bruising at the RAIM site and 1/2 dollar size swelling.  The program operations mgr, immediately contacted the IZ Nurse in the NE (me), who left a message for patient to phone me back.  To date patient has not phoned back. The nurse manager has been contacted regarding this issue.
flu symptoms including up to 103 fever, aches, pains, shivers & UR problems
Pt with combined immune deficiency was exposed to OPV through daughter's vaccination in 1996. In December 2008 developed (L) calf cramping which progressed to bilateral lower extremity weakness. (see attached sheet)
CoughWheeze Thirsty, burning in mouth , losing voice, sneezing ,  Narrative:
Mom states child developed fever of 101.0 (R). 2 days after vaccines/irritable.
Pain in lower right eyelid which developed to stye-like infection oozing pus. Treated with steroid & antibiotic eye ointment which I had from similar occurrence two years ago, again right after a flu shot. Had not connected the two at that time. Now a month later, there is still redness and some swelling in the lid, but it has improved with treatment.
administering MENACTRA to a patient after a temperature excursion where product was deemed not suitable for use with no reported adverse event.; refrigerator with vaccines previously experienced a temperature excursion that reached 37.2C with no reported adverse event.; Initial information received on 07-Jun-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 11 years old female patient who experienced administering menactra to a patient after a temperature excursion where product was deemed not suitable for use with no reported adverse event and refrigerator with vaccines previously experienced a temperature excursion that reached 37.2 Celsius with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Prophylactic vaccination.  On 07-Jun-2022, the patient received a dose: 1 of 0.5 ml total once of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine lot U72688AB, 01-Jul-2023, strength: standard, via intramuscular route in left deltoid for Immunization.   On 07-Jun-2022(Latency: same day) administered menactra to a patient after a temperature excursion where product was deemed not suitable for use with no reported adverse event (Product temperature excursion issue) and refrigerator with vaccines previously experienced a temperature excursion that reached 37.2 Celsius with no reported adverse event. (product storage error).   Action taken was 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.
Puffy around the eye, cold compress no prescription administered. 2 weeks course No other symptoms.
This spontaneous report was received from a nurse prescriber (also reported as a pharmacist) concerning an 8.5 months patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VAQTA, at the age of 8.5 months rather than after 12 months of age, for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiry date were not reported). The vaccine was administered at prior pediatrician's office. Patient presented at office with parent requesting if dose needed to be repeated. No adverse effects were reported.
fever; muscle aches; body aches; This case was reported by a physician via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   On 22nd July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd July 2019, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced muscle pain and general body pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, muscle pain and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, muscle pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be between 55 or 56 years. The reporter stated that the patient developed fever, muscle aches and body aches following her first dose of Shingrix. The reporter stated that, the patient within 24 hours of vaccination called the MD stating she had a fever. The fever went up to 101 F. The patient took with good effects. The reporter stated that the fever was followed by muscle aches throughout the week. The Tylenol helped with that too. The patient also experienced body aches. Onset  and resolution time of muscle aches and body aches was unknown. The physician believed that the symptoms resolved within 24-48 hours because the patient would have called otherwise. The reporter consented to follow up. The reporter did not wish to provide patient's dob or initials.
Choking began on 4/30/22. Dysphasia. Food stuck in lower Esophageal sphincter. Passed out. Husband assisted-was able to forcibly expel. Continued choking symptoms to current day  Severe joint pain Dry eyes and Eye hemorrhage August 2021 Dry mouth, lower salivary glands became hypoplastic and noted on test in October 2021 Dry skin and glands throughout body Night cough Night sweats Swollen lymph nodes
Since second shot March 1 I have had extreme tiredness and aching joints. Next day March 2nd, was very bad and got worse as the day went along. Next morning March 3rd things were better but still tire easily, I can?t do what I usually do. Hip joints are painful when I try to get out of a chair or bend even going up stairs is hard.
horrible horrible dreams; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (horrible horrible dreams) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Dreams abnormal in 2017. Previously administered products included for Product used for unknown indication: Amlodipine in 2017. Past adverse reactions to the above products included Dreams abnormal with Amlodipine.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced NIGHTMARE (horrible horrible dreams). At the time of the report, NIGHTMARE (horrible horrible dreams) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The  patient was taking 24 hr. Tylenol to help her sleep.
Pt was immunized with FluBLOK Quadrivalent, which is indicated for patients 18 and over and this pt is 9 years old. As of 9/29/2020 pt has experienced sore arm and malaise.
VOMITING; COLD CHILLS; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a 29 year old female. 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, cold chills, headache, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, cold chills, nausea and vomiting was not reported. This report was non-serious. This case, from the same reporter is linked to 20210630836.
Vomiting; Extreme muscle cramps; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 21Apr2021 at 15:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had a unspecified medical history. 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. The patient received unspecified concomitant medications. On 22Apr2021, the patient experienced vomiting, extreme muscle cramps and extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, extreme muscle cramps and extreme fatigue was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Myalgia Employee reports: " I feel real cold, I have chills & my body is Achey."  Narrative:
Pt recvd 4 Hep B injections; 1st 2 w/Recombivax, 3rd either Recombivax or Engerix-B & 4th dose w/Engerix-B; 1 inject given GM; also recvd HBIG or ISG in 1989; 25MAR92 pt still not seroconverted;
Information has been received from other health professional concerning a 17 year old Hispanic female with no known medical condition or illness at time of vaccination, who on 19-AUG-2008, at 10:30, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot #659655/1486U) via intramuscular on her right deltoid and varicella virus vaccine live (Oka/Merck) (MSD) via subcutaneous on her left deltoid. On 19-AUG-2008, at 10:30 the patient felt light headed, looked pale and fainted right after shots given. The patient recovered a few seconds after. The patient was monitored for half an hour. The patient stated that she was nervous prior vaccine administration and did not eat in the  morning. Laboratory test were not performed. No further information is available.
Every time I get the flu shot I get sick.; Initial information received on 18-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported every time i get the (Influenza vaccine) flu shot i get sick.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (dose, strength, form, expiry number and lot number not reported) via unknown route in unknown administration site as flu (Influenza).  On an unknown date the patient reported every time i get the flu shot i get sick. (illness) (unknown latency).  It was also reported "This year had it for 9 weeks straight got better for 1 week and I am sick again. Next year I might think twice before getting it".  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
Toothache on left side (worse on teeth with pre-existing caps). General soreness at injection site and slight body soreness.
headache and chills lasting 2 hours until advil was taken.   Fatigue lasting 2 days
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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 Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, the patient did not receive any other medication in two weeks. The patient received Paxlovid from 28Aug2022 to 01Sep2022 for the treatment of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received SHINGRIX on Friday and said that he developed severe abdominal pains and cramps early Sunday morning. He said the pain was so intense that he paged his doctor. The doctor on call told him to use an enema and take milk of magnesia.
patient received dose after vaccines had been in the fridge for 79 days as opposed to the 72 days as recommended-patient had no reaction
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: patient was scared of needles. WE checked temp and vitals. All normal. Gave him water and asked him if he wanted us to call 911. He refused for us to call 911. He left the pharmacy good.
Confirmed Breakthrough Case  COVID-19 (Moderna) 1  02/25/2021  Moderna 023M20A   COVID-19 (Moderna) 2  03/25/2021 Moderna 002B21A   COVID-19 (Moderna) 3  10/25/2021 Moderna 047C21A2NDH
Itchi in The L arm just below the site of injection which became severe (7-8/10) L arm pain. Pain comes in waves at rest. Pain increases with any movement which makes L deltoid contract. Applied cortisone for itchiness with relief but pain is still significantly bad.
JOINTS HURT (ARM, BODY, AND FEET); CHILLS  (LIKE SYMPTOMS OF FLU); NAUSEA; FEVER; FEELING ACHY; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A,  expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.2 F. On 10-APR-2021 17:00, the subject experienced feeling achy. On 10-APR-2021 17:00, the subject experienced chills (like symptoms of flu). On 10-APR-2021 17:00, the subject experienced nausea. On 10-APR-2021 17:00, the subject experienced fever. On 11-APR-2021, the subject experienced joints hurt (arm, body, and feet). Laboratory data included: Body temperature (NR: not provided) 99.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 11-APR-2021, was recovering from fever, and had not recovered from feeling achy, joints hurt (arm, body, and feet), and chills (like symptoms of flu). This report was non-serious.
Received vaccine at pharmacy clinic at the Retirement Home on the morning of 05/15/2023.  Around 1145hrs a staff reported that they noted unsteady gait and balance in the resident. An RN responded and found the resident alert and oriented, sitting in a chair in her apartment, eating lunch. On assessment, the resident was found to be alert and oriented to person, time and place, with no slurred speech or facial drooping noted. Bilateral hand strength. On ambulating with her walking frame, the resident was found to be leaning towards her right side. Resident denied nausea/vomiting and visual disturbances.  Vital signs: blood pressure 177/88, heart rate 99, temperature 98.2F, SpO2 95% with no supplementary oxygen. 911 was called and EMS arrived at 1210hrs. They transferred the resident to hospital.
Very sensitive and painful injection site with scarring. Occurrence of non-vesicular red bumps associated with intense itching appearing in crops diffusely disseminated all over the body including genitalia. Bumps heal with hyperpigmented remnant scarring.
Dizzy spells; This non-serious case was reported by a consumer and described the occurrence of dizzy spells in a 72-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number D9CB9) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included losartan.   On 30-JAN-2023, the patient received Shingles vaccine. On 01-FEB-2023, 2 days after receiving Shingles vaccine, the patient experienced dizzy spells (Verbatim: Dizzy spells). The outcome of the dizzy spells was not recovered/not resolved.   It was unknown if the reporter considered the dizzy spells to be related to Shingles vaccine.     It was unknown if the company considered the dizzy spells to be related to Shingles vaccine.   Additional Information: GSK receipt date:19-MAR-2023 The Patient herself was a reporter. The vaccine details expiry date was unknown. The reporter consented to follow up.