chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED SINGLE DOSE JOHNSON AND JOHNSON COVID 19  VACCINE ON 5/14/2021 AFTER HAVING RECEIVED FIRST DOSE MODERNA COVID 19 VACCINE ON 4/22/2021.
Back of neck & injection site started to get sore about 8-10 hours after injection.   Woke up with painful, very stiff joints.  Felt like I weighed 20 tons.  Terrible headache.  Minor chills.  Very tired.  Next day all soreness was gone but I was still very tired.  About 24 hours after 1st symptoms appeared, I felt hot but my forehead was cool & clammy.  I felt lightheaded.  When I woke up, I felt much better.  About 95% back to normal.
Red rash at injection site..very itchy. About 2 inches across. Asthma
Left shoulder 5 x 5cm induration, red rxn, nonfluctuant.
It was reported that a male pt received a Fluzone SV '99-'00 vaccination on 11/5/99. Reportedly, sometime post vax, the pt developed a red rash at the injection site. Additional information received 11/22/99, reported that the rash eventually spread from the elbow to the shoulder and that the pt's arm increased in diameter. The rash itched a lot. The symptoms cleared after 12 days. The only treatment was Benadryl OTC. Follow up #1 06/04/02: duriing internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (added some edema and pruritis)
Pt returned to clinic 1 day after immunizations (8-16) with fever as high as 103.9. Swollen (L) thigh, firm (R) thigh at site of immunizations. Pt returned for recheck on 8-17 fever high of 101.6, swelling was improved at thighs.
Patient was pregnant, and likely in the first trimester, at the time of vaccination .  Her fetus has been diagnosed with unilateral clubfoot prenatally.  She is currently still pregnant and postnatal confirmation has yet to be performed.  Estimated due date of delivery is 9/26/2021.
I received the vaccine on 01/04/21 about 230 pm. No adverse issues, just tenderness at the injection site (right deltoid) for 1 ½ days ( 1/5-1/6) No other complaints, arm showed no discoloration, tenderness, pain, nor swelling. Then a week later, 1/11 evening, the injection site became itchy. The next morning(today, 1/12) the itching continued and by mid-morning was tender too. By 1400, It was painful and I showed the area to a coworker and manager and it was noted to be red, swollen, hot to touch. Then the pain started to radiate to my right elbow and continued to ache there. My manager suggested I report to employee health which I did and it is now documented. Also the CDC symptom check-in tool ended yesterday before this happened so it was not documented there.
Rashes,itching, about 3-4 ? around injection site, warm to touch; applied ice pack 2x daily for 10 min,thereafter applied triamcinolone ointment, took fexofenadine 2nights, rash is improving
Approximately twelve days post vax, this pt became very cranky. She was crying with less intake of food. On 06/07, she had a non-itching maculopapula rash which started from her chest then to her abdomen and spread all over her body. 06/09 she returned to clinic.  06/16, rash became more extensive and she returned again to the pediatric clinic. No medication was administered. Follow up occurred on 06/19 where mother was advised to administer Benadryl if itching occurred. She subsequently recovered.
Patient reported today  that the arm that she received her Shingrix immunization in became swollen and hot to the touch two days after the shot. She went to an clinic and was provided an antibiotic by that facility but does not remember the name. The affected area of her arm was further down from the injection site closer to the elbow. The immunization was administered in the upper part of the deltoid.  The irritation progressed into an infection and Dr referred her to the ER. She was admitted to Hospital and diagnosed with cellulitis. They began iv antibiotics. The hospital had circled the area of cellulitis which was centered down near the elbow several inches from the injection site. Today she picked up an oral antibiotic, doxycycline for the same infection.
Redness/rash around neck which started from Sat 10/16/21 and finally subsided by Wed., 10/20/21. Used Tylenol, then Benadryl to ease the itching. Area was warm but I did not have any temperature-checked each day. Had a similar occurrence with a flu shot 2 or 3 years ago and reported that also.
pt recvd vax JAN95 @ 5mos & devel SC lump-tender, 1" x 1" @ Tetramune site; MD visit;
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750 (same reporter). This case involves an eight year old  patient (gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and Exp. date not reported) via intramuscular route in the right deltoid on 03-Oct-2018, which was outside of the recommended temp range (below 32F). The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any adverse event 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 and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
administered  past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-359738 (Patient Link).
COVID-19; Cough; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (Cough), HEADACHE (Headache) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (COVID-19), COUGH (Cough), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) (oral) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), COUGH (Cough), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
1/13, 1cm redness & palpable induration on both vax sites. Tenderness at both sites, possible cellulitis. Warm to touch. Tx'd with Keflex for several days.
ran titers and from the serotypes covered by Prevnar 13, there were no immunity concentration levels; This is a spontaneous report from contactable physician via Pfizer Sales Representative.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  They ran titers and from the serotypes covered by Prevnar 13, there were no immunity concentration levels  on an unspecified date with outcome of unknown.    The information on the batch number has been requested
Diarrhea; chills; Numbness in feet; stabbing lower back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 11:00 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 22Mar2021, when the patient was 20 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 05Apr2021, when the patient was 20 years old, for COVID-19 Immunization, reaction(s): "dose number=2: administration date=05Apr2021; dose number=1, administration date=22Mar2021". The following information was reported: DIARRHOEA (non-serious) with onset 12Jan2022 14:00, outcome "recovering", described as "Diarrhea"; CHILLS (non-serious) with onset 12Jan2022 14:00, outcome "recovering", described as "chills"; HYPOAESTHESIA (non-serious) with onset 12Jan2022 14:00, outcome "recovering", described as "Numbness in feet"; BACK PAIN (non-serious) with onset 12Jan2022 14:00, outcome "recovering", described as "stabbing lower back pain". The events "diarrhea", "chills", "numbness in feet" and "stabbing lower back pain" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of diarrhoea, chills, hypoaesthesia, back pain. The lot number for bnt162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.  Additional information; The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. Case was reported as non serious. Hospitalization prolonged was reported as no.  No follow-up attempts are possible. No further information is expected.
Patient presented 2 days after injection with bilateral lateral chest pain radiating to back, intermittent, sometimes at rest and sometimes with walking. Had previously been walking 2 miles twice daily, found extreme fatigue stopped her from walking more than 4 blocks with onset at same time. Evaluation included normal CBC w/ diff, ESR, CRP, CMP, LFTs. With pain no better, further eval 3/12 included RUQ U/S ddimer, NT-ProBNP. US showed dilated IVC and hepatic veins, EKG showed only bradycardia at HR 47. Patient eventually agreed to admission, workup for ACS negative with normal echo, clear coronary angiogram. Continuous monitoring showed severe bradycardia with episodes in 20s, pain improved with nitroglycerine. Pa
Patient came to pharmacy on 08/25/2015 and complained that after she received her vaccination her arm became red and swollen and was hot to the touch. She did not seek medical attention nor did she contact us at the pharmacy until 5 weeks after the receiving the vaccine.
Red, inflamed, swollen, warm to the touch. Recommended BENADRYL, anti-inflammatory. Referred to doctor. Patient had Rx from MD.
tested positive for covid after getting first dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for covid after getting first dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for covid after getting first dose). At the time of the report, COVID-19 (tested positive for covid after getting first dose) 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.   This case concerns a 60-year-old female who NS unexpected events of COVID-19.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 60-year-old female who NS unexpected events of COVID-19.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a patient of unknown age and gender. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 27-APR-2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On 02-FEB-2017, the patient was treated by a family nurse practitioner at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Started to feel flu like symptoms which proceeded to get get with severe joint pains. on 04/07/2013 appeared to get measle like looking errythema over entire body.
Two areas of (L) deltoid red, swollen, indurated after receiving vaccines in (L) arm. Pt. treated with ZYRTEC and KEFLEX.
Jittery; Nervous; felt really bad overall; bothered me in the back on my neck; headache; anxiety attack; blood pressure was around 150/90; had another attack and blood pressure was 185/100; felt like I had the flu; arm throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (arm throbbing), INFLUENZA LIKE ILLNESS (felt like I had the flu), ANXIETY (anxiety attack), BLOOD PRESSURE ABNORMAL (blood pressure was around 150/90) and HYPERTENSION (had another attack and blood pressure was 185/100) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ETANERCEPT (ENBREL), ZOLPIDEM TARTRATE (AMBIEN) and METHOTREXATE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (arm throbbing) and INFLUENZA LIKE ILLNESS (felt like I had the flu). On 13-Feb-2021, the patient experienced HYPERTENSION (had another attack and blood pressure was 185/100). On an unknown date, the patient experienced ANXIETY (anxiety attack), BLOOD PRESSURE ABNORMAL (blood pressure was around 150/90), FEELING JITTERY (Jittery), NERVOUSNESS (Nervous), FEELING ABNORMAL (felt really bad overall), HEADACHE (headache) and NECK PAIN (bothered me in the back on my neck). At the time of the report, PAIN (arm throbbing), INFLUENZA LIKE ILLNESS (felt like I had the flu), ANXIETY (anxiety attack), BLOOD PRESSURE ABNORMAL (blood pressure was around 150/90), HYPERTENSION (had another attack and blood pressure was 185/100), FEELING JITTERY (Jittery), NERVOUSNESS (Nervous), FEELING ABNORMAL (felt really bad overall), HEADACHE (headache) and NECK PAIN (bothered me in the back on my neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood pressure measurement: 185/100 (High) 185/100. In February 2021, Blood pressure measurement: 150/90 (High) 150/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received alprazolam for anxiety and atenolol for increased blood pressure.
42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    Concomitant product use was not provided by the reporter.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.   Vaccine was given to the patients for long COVID between March 2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50 % or more.  Vaccine was given within current guidelines except seven were under 65.   Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved.   No adverse reactions occurred.  Treatment information was not provided.  This case contains information for the 22nd patient out of 42 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Patient 22 out of 42
Red, swollen R thigh over injection site to present (4 days so far) no itching, no pain. Gave 1/2 tsp. Benadryl + 1 1/2 tsp. Advil q 4-6 hrs.
Vaccine reaction, got Dtap on lt arm on 4/23/19 on 4/24/19 present with redness, swelling, hot to touch, c/o fever & rash.