chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right side and I took Advil late at night time because it was so painful I couldn't sleep. My arm was not sore but that muscle was.  That seemed to calm it down (Advil). The next morning, I was very swollen under my right armpit - I figured it was my lymph node. It was uncomfortable and very noticeable - quite swollen for three days. It took about a week to go back to normal. I also had abnormal fatigue and that took longer to resolve - that took about two weeks to be resolved.
Mother reports that within 2 hrs of vaccine injection pt develops erythema, swelling and pain. On exam, left anterior thigh area was indurated, warm, hot and tender and erythema 10cm diameter
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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced insomnia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of insomnia was not reported. This report was non-serious. This case, from the same reporter is linked to 20210422183 and 20210439461.
Severe Body aches, temp 102.2F, headache, dizziness, redness and induration at injection site which progressed over one week to involve the entire anterior and antecubital surface of right upper arm, bubbles/blister-like rash at injection site, severe arm pain for 10 days, induration remains at 2 weeks post injection
Patient with erythema near site of injection and extending around upper arm with associated axillary TTP and lymphadenopathy (reactive).
Red rash which was warm to touch; Red rash which was warm to touch; Itching on the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE WARMTH (Red rash which was warm to touch) and VACCINATION SITE ERYTHEMA (Red rash which was warm to touch) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the injection site). On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red rash which was warm to touch) and VACCINATION SITE ERYTHEMA (Red rash which was warm to touch). At the time of the report, VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE WARMTH (Red rash which was warm to touch) and VACCINATION SITE ERYTHEMA (Red rash which was warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Conmeds not provided. Treatment information not provided.; 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.
Vaccine given after expiration date due to temperature change in storage; Vaccine given after expiration date due to temperature change in storage; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date due to temperature change in storage), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine given after expiration date due to temperature change in storage) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine given after expiration date due to temperature change in storage) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine given after expiration date due to temperature change in storage).    No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2023: Follow up added with no new information received.
Redness/erythema and warmth of right thigh where immunization was given, progressive affected area for about 1-2 days. Not indurated and not tender on physician exam.
Information has been received from a physician concerning her 16 year old daughter, who on 12-OCT-2007 was vaccinated in her left arm with a second dose of Gardasil vaccine. Subsequently, the patient developed swollen lymph nodes under her left arm. The patient was seen in the office. The patient was treated with Motrin. The patient recovered on an unspecified date. No product quality complaint was involved. This report is on of two reports from the same source. Additional information has been requested.
11-30-16 ZOSTAVAX given "Sq" Lt arm. Patient states soreness after injection which continues. No redness noted. 07-15-10 Patient diagnosed with Herpes Zoster.
Fever Severe joint and muscle pain Worsening of arthritis pain Chills, Headache Inability to get out of bed Rash on second after after shot on both arms, legs and leg side of torso
Symptoms began 9:30pm on 12/28. Malaise, nausea, cough, night sweats, intermittent mild shortness of breath. Red, swollen, warm, and itchy lump one inch from the site of injection, almost gone now. The malaise was bad enough that I had to call out of work.
Migraine and hives all over body for 1 week. Hives on elbows, knees, ankles, feet, hands.
they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days; they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days; 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 PRODUCT STORAGE ERROR (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days) and EXPIRED PRODUCT ADMINISTERED (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) 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 PRODUCT STORAGE ERROR (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days) and EXPIRED PRODUCT ADMINISTERED (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days). On 18-Oct-2021, PRODUCT STORAGE ERROR (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days) and EXPIRED PRODUCT ADMINISTERED (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant drugs were reported. no treatment drugs were reported
By 8pm I had a fever and felt very tired. I took Temp at 830, it was 99.8, I took tylenol and went to bed,I got my shot in the left arm, it was very sore. I woke around 2am, still had fever and my left side was sore, my neck,hip and leg, but only left side.  took more tylenol went back to bed. I woke at 930am,  still fever, still sore down left side, and a headache.  I went back to sleep around 1230 and didn't wake up till 430 pm. I was still with fever, 99.4, my face, though not red, felt like it was on fire most the day. I was very tired, fatigued, headache, and starting to feel slightly nausous. I dozed off and on for a few hours. drinking often and taking tylenol every 4 hours. I was up around 1:30 am on the 21, took more tylenol, the soreness from my left side was now also across the back of my neck. When i woke on march 21 around 8 my temp was down to 98.4 {my normal temp is 97.4}. my face no longer felt like it was on fire, most of the soreness gone from left side, but still headache and sore across the back of my neck., still very tired. I dozed most of the early day. When i woke around 1pm , my temp was back to normal 97.4. and the headache was all but  gone.  by 7 pm the headache was gone and most of the soreness across the back of my neck, still felt slightly nausous all day, never puked,  Waking march 22, headache was gone, temp normal, soreness all but gone. still slightly nausous.   by 330 pm the nausous was gone.  And symptom free.   I had positive tested covid in Dec of 2019.  I do not have a doctor,
Pt reports last evening after the shot experiencing a fever of 101 degrees. She says she was shaking so bad from chills that she had difficulty breathing. She also reports having a headache and muscle pain in neck, arm, and back. This am fever was gone but headache and muscular fatigue still present.
SWELLING AT INJECTION SITE ALONG WITH RASH. WENT TO SEE FAMILY DOCTOR AND WAS GIVEN A STERIOD SHOT TO HELP WITH THE REACTION.
This spontaneous report was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, albumin status HSA (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
I tested positive for covid 19 on April 28, 2022.  I had headache congestion and low grade fever.  I spoke with a Doctor and because of my age I was prescribed Paxlovid.  I have one day left of the 5 day course.
fever; sore arm; nausea; achy legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy legs), PAIN IN EXTREMITY (sore arm), NAUSEA (nausea) and PYREXIA (fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (achy legs). On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea). On 28-Mar-2021, the patient experienced PYREXIA (fever). On 26-Mar-2021, PAIN IN EXTREMITY (achy legs) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Uti day after getting vaccine and I don?t normally get them. Sore throat heart palpitations fast heart rate fever chills severe migraine
This case was reported by a healthcare professional, via a sales representative, and described the occurrence of rash on hands and feet in a male subject aged between 20 and 29 years old who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 7 December 2011 the subject received a dose of BOOSTRIX (unknown route). In December 2011, less than one week after vaccination with BOOSTRIX, the subject experienced rash on hands and feet. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was unrelated to vaccination with BOOSTRIX. Follow-up information was received on 04 January 2012 via nurse who is the immunization provider. The 26-year-old male subject previously received DTaP and Td form; no adverse events followed previous vaccinations. On 14 December 2011, seven days after the initial dose of BOOSTRIX the subject experienced the rash on hands and feet that resolved on 19 December 2012. The reporting nurse considered the rash on hands and feet unrelated to vaccination with BOOSTRIX. At the time of the report no additional information was provided.
Pt. developed vesicular rash on (L) arm same day as vaccine then vesicular rash on forehead day 2, progression to abdomen/chest days 3-4, scalp day 5. No fever, no cough, no coryza, no exposure to varicella milk-type.
chills, nausea, arm pain.  took ibruprofen felt a little bit better
administered a dose that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 38-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 11th January 2023, the patient received the 1st dose of Havrix. On 11th January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The medical assistant reported that the patient was administered with expired dose of Havrix. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
No adverse event occurred, patient observed for 30 minutes.  Patient received Moderna Covid-19 vaccine 2nd dose on day # 16 instead of recommended date of day #28
14-16 days post Varivax immunization ( 1st dose) Employee developed itching rash on arms & legs , tiny, raised " pimple like" ,fluid filled rash Employee denied fever or any other known exposure to a varicella virus. Some areas were dried and others as above. Denied headache or malaise
Positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for Covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F, 302M208 and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive for Covid). The patient was treated with MOLNUPIRAVIR ongoing from 14-Feb-2022 for COVID-19, at a dose of every 12 hours. At the time of the report, COVID-19 (Positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications was reported.  Company Comment: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious, and AESI of COVID-19. The event occurred 3 months and 13 days after the third dose of mRNA-1273 vaccine. Primary vaccination against COVID-19 completed with mRNA-1273 vaccine, with and inappropriate schedule, as doses were given 66 days apart. Patient reports that he visited his doctor and tested positive for COVID-19. He was asymptomatic, and received treatment with molnupiravir. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-486840 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious, and AESI of COVID-19. The event occurred 3 months and 13 days after the third dose of mRNA-1273 vaccine. Primary vaccination against COVID-19 completed with mRNA-1273 vaccine, with and inappropriate schedule, as doses were given 66 days apart. Patient reports that he visited his doctor and tested positive for COVID-19. He was asymptomatic, and received treatment with molnupiravir. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
developed a severe bladder infection; her husband was peeing blood; Initial information was received on 10-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (Reference number- 00764114) and transmitted to Sanofi on 10-Sep-2021.  This case involves a 92-year-old male patient who experienced severe bladder infection (Cystitis) and peeing blood (Blood urine present) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. At the time of the event, the patient had ongoing Chronic kidney disease and Cardiac failure congestive.  On 16-Sep-2020, the patient received a (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date the patient developed non-serious severe bladder infection (Cystitis) peeing blood (Blood urine present) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, "Her husband received the FLUZONE HIGH-DOSE QUADRIVALENT vaccine last year on 16SEP2020 and developed a severe bladder infection that required an ER visit on 18SEP2020. Caller states that her husband was peeing blood when taken to the ER. Caller states that her husband has chronic kidney disease with a GFR of 34 or 35 in addition to congestive heart failure and asked how FLUZONE HIGH-DOSE QUADRIVALENT was metabolized. Caller states that her husband has never had a reaction like this before. Caller asked for a comparison of Sanofi flu vaccines to see if the FLUZONE HIGH-DOSE QUADRIVALENT was "too strong for her husband".Caller states that pharmacist could not locate any information on the metabolism of FLUZONE HIGH-DOSE QUADRIVALENT and suggested that she contact Medical Information".  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, patient had recovered from the events.  There will be no information available on batch number for this case.ea
No adverse event reported. Immunization given 9-20-17. Upon review, it was discovered the vaccine had an expiration of 8-18-17.
Within 10 minutes of receiving vaccine, patient reported excessive sweating, blurred vision, light headedness while seated in observation area. Patient then walked to bathroom. She came back stating she remained sitting for about 20 minutes with nausea and chills. Patient states she experienced diarrhea as well.  Patient returned to observation area for another 10 minutes for observation before feeling better and well enough to leave. Patient was advised to state hydrated and take acetaminophen if she experiences fevers and body aches later in the day.
Intense pain where shot was given and extended around entire area of upper arm, including shoulder and under arm area. There is swelling and a lump under my armpit that is very painful. Shot was given Friday Mar 15, 2019 at approximately 2pm and it's now Monday Mar 18, 2019 at 12:19 and I still have the same pain in same areas, including the swelling and lump under my arm put.
Initial misuse report received from a healthcare professional on 20 February 2014. The cases were received on 21 March 2014 at GPV. A patient had received an expired dose of YF Vax on an unspecified date. No adverse events were reported. List of documents held by sender: none.
My entire body broke out in hives mostly around my chest and right arm (where I was vaccinated) which lasted throughout the evening and into the next day. My legs then went numb for just over 30 minutes.
1813: reported feeling nauseated and was noted to diaphoretic. HR 110. BP 142/82. Room Air sat 100%. 1830: reports feeling better HR 89. BP 141/75. Room air Sat 100% 1840: symptoms resolved. associate sent home per request. HR 86 no interventions done.
body aches-hands, arms, legs;vomiting 5hr;onset w/in4hr duration 12hr;
C/O BODY ACHES 5 DAYS AFTER RECEIVING STAMARIL VACCINE FOR 2 DAYS- TOOK EXCEDRIN AND BODY ACHES BETTER. THEN HYPOTENSION WITH NAUSEA 8/6/18 AND 8/7/2018. CT IS ON HYPERTENSIVE MEDS AND ANTI CHOLESTEROL MEDS. ADVISED CT TO SEEK MEDICAL ATTENTION.
Information has been received from a physician concerning a 15 year old female who on 04-DEC-2007 was vaccinated with the second dose of Gardasil (Lot# 656050/0245U) and fainted.  It was reported that the patient was fine before leaving the office and had fully recovered on 04-DEC-2007.  The patient sought unspecified medical attention.  It was reported that the patient did not have this experience after receiving the first dose (date unspecified).  Additional information has been requested. This is in follow-up to report(s) previously on 1/7/2008. Information has been received from a physician concerning a 15 year old female (88 lbs., 63 in.) who on 04-DEC-2007 was vaccinated with the second dose of GARDASIL (Lot# 656050/0245U) and fainted. The episode lasted about 2 seconds and the patient got up and was doing well. The patient was placed on observation for about 10 minutes and was sent home doing well. No additional information is expected.
Fever of 101 for about 24 hours. Lower fever for another18 hours. Cough Asthma attack 24 hours after shot. Had to use rescue unhaler two different times 4 days later I still have somewhat of a cough