chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient contacted our facility today, 4-24-18, stating that she had tenderness and pain under her armpit near her breast that is potentially an affected lymph node. The vaccination was given on 4-22-18. There is limited information regarding adverse events involving lymph nodes in the product information. Patient will seek medical care if condition worsens or does not improve.
Patient became hypotensive and bradycardic after dose of Janssen. Patient felt light-headed and feverish. Near-syncopal episode.
Prior to event he was not too willing to eat and looking kind of sad.  After dinner he vomited and continued to throughout the night.
Initial misuse report reported from a healthcare professional on 11 June 2013. ACTHIB component from PENTACEL was reconstituted with sterile diluent not the DTAP/IPV. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Spotting for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Spotting for 2 days) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Spotting for 2 days). At the time of the report, VACCINATION COMPLICATION (Spotting for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-363522 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Added reporter information. Patient information updated. Added product information. Event information updated.
First dose on 3/16/21 - tinnitus got louder almost immediately,  8 hours later developed fever, chills, body aches for 36 hours, developed floaters in right eye. Second dose on 4/15/21 - Lot #EWO161 - tinnitus got louder immediately again, 8 hours later developed fever, chills, body aches for 36 hours, developed crescent shaped floater in left eye.  Within one week, my left ankle swelled up.  Over the past year my migraines and vertigo and dizziness have increased.  Tinnitus is still louder, floater in left eye is still present, floaters in right eye comes and goes
BUMP UNDER THE SKIN (KNOT AROUND 1/4 INCH BIG AND A LUMP); RED PATCH (RED SPOT); SWELLING; SORE ARM; This spontaneous report received from a consumer concerned a 70 year old female. The patient's weight was 200 pounds, and height was 63 inches. The patient's concurrent conditions included high blood pressure, type 2 diabetes mellitus, high cholesterol, skin cancer, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 10:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced sore arm. On 03-APR-2021, the subject experienced bump under the skin (knot around 1/4 inch big and a lump). On 03-APR-2021, the subject experienced red patch (red spot). On 03-APR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on APR-2021, and swelling on 04-APR-2021, and had not recovered from bump under the skin (knot around 1/4 inch big and a lump), and red patch (red spot). This report was non-serious.
Rt. arm lateral to vaccine injection site had a cavitous necrotic area near laterally to and at the injection site itself. spouse said 1hr after injection large blisters occurred and showed us pictures, did not seek out care. All of this was revealed at 2nd dose which was held due to discovery of the skin site.
No adverse event; Inquire about the viability of expired Moderna that was administered to two patients and the validity of their vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inquire about the viability of expired Moderna that was administered to two patients and the validity of their vaccination) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inquire about the viability of expired Moderna that was administered to two patients and the validity of their vaccination). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inquire about the viability of expired Moderna that was administered to two patients and the validity of their vaccination) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Inquire about the viability of expired Moderna that was administered to two patients and the validity of their vaccination).    Concomitant product use was not provided by the reporter.  Expiry date of suspect vaccine was reported as 12-Jun-2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-731716 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731716:Master case
Within 24 hours of the vaccination: developed red, raised large blotches on upper arm, shoulders and under arm: very hot and very sore. Raised patches lasted 3 days, but still have pain( entire body achy for 1 day).
Swelling, redness, tenderness locally arm. Treated with unk antibiotic. Resolved in 24 hrs.
Palpitation of heart; Injection site was little bit itchy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation of heart), INJECTION SITE PRURITUS (Injection site was little bit itchy) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 PALPITATIONS (Palpitation of heart), INJECTION SITE PRURITUS (Injection site was little bit itchy) and HEADACHE (Headache). At the time of the report, PALPITATIONS (Palpitation of heart), INJECTION SITE PRURITUS (Injection site was little bit itchy) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: increased incresed.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-070295 (Patient Link).
For the first few days, I had fatigue and I just rested. No medical attention for it. June 7th - severe leg cramping - both calves in the back for about five days. June 21, 02:00 am, I woke up and it felt like something was sitting on my chest and I couldn't get a regular breath or deep breath. I sought medical treatment at 07:00 - my partner took me to ER - got there at 07:30.  They gave me tests to check for blood clots and heart attack. Kept me for a few hours to re-do the Troponin test to check for blood clots a second time. 6/22 and 6/23 - continued to have shortness of breath. 6/23 - saw doctor for follow up and he ran a COVID test - negative result. I'm continuing to have intermittent shortness of breath and unless it gets worse I'm just managing it. My doctor said to wait it out. No treatment. I am not able to do the long hikes that I like. But I'm managing fine and can do daily things I need to do. They said they didn't think it was a panic attack because that usually doesn't wake you from a dead sleep.
06/07/2022, three others in my house had COVID-19. I had a sore throat and weakness. I tested positive. It barely affected me. It lasted about 3 days.
p/vax pt throat was scratchy & hoarse;w/in about 5min stated breathing felt tight & some wheezes;color pallor;tx w/epi & given DPH;
Received flu shot IM left deltoid at an off site clinic set up for city employee's. Nurses administering injections from the Public Health Dept. Patient states injection was painful, but the discomfort never dissipated and now progressed to a month later where her Left Arm ROM is being affected. She states she can only raise her arm to shoulder height and residual pain from near injection site radiates up to her shoulder causing her much discomfort.
Broke out in chicken pox 06/16/02 per mom hx of varivax vaccine 10/09/1997.
Severe Migraine, strong leg pain and arm, difficultly to walk, palpitations on the head and heart rate over 90.
03/05/2021 A 42 years old female received Janssen vaccine. Lot #1805018 Exp 05/25/2021 to left deltoid. Immediately after vaccines patient C/O left arm pain. 10:15 am patient continue to C/O left arm pain radiating up and down arm. C/O dizziness and nausea. Patient fading in and out of conscientiousness. V/S 97 BP 136/86 Left arm. O2 sats 100 %. room air. 10:30 am patient still experiencing dizziness and fading in and out of conscientiousness. Emergency services notified. Patient offered ice chips unable to consume. 10:45 am EMS arrived and resumed care for patient. Patient left facility by ambulance Lupon departure. Patient still experiencing dizziness and fading in and out of conscientiousness.
Information has been received from a physician concerning a 69 year old female with drug hypersensitivity to IMURAN (caused by diffuse swelling), lupus and  pulmonary fibrosis who 5 or more years ago was vaccinated with the first dose of PNEUMOVAX. On 27-OCT-2008 at 10:00, the patient received the second dose of PNEUMOVAX (lot #657525/0554U) 0.5 ml IM into the right deltoid and a dose of influenza virus vaccine (SANOFI PASTEUR) (lot#: 62805AA) IM into the left arm. Concomitant  therapy included vitamins (unspecified), calcium (unspecified) and oxygen at night or with exercise of physical activity. On 27-OCT-2008 at 14:00. The patient was starting to get some swelling, soreness and erythema and heat at the injection site in the upper arm on the right side. She had no systemic symptoms of any other swelling. The redness persisted on the second day. On 29-OCT-2008, the patient visited the doctor's office. Physical exam demonstrated: right arm showed some mild erythema and swelling, and warmth involving most of the posterolateral aspect of the right upper arm. The patient was prescribed BENADRYL and cold compresses. On 05-NOV-2008, the patient developed a pain just under the left breast that increased with a cough, a deep breath, but also with any kind of twisting or turning motion. On 06-NOV-2008 the patient visited the physician and complained that since she got PNEUMOVAX vaccine that her lungs had just been a little worse than usual/ She may have some wheezed. The patient felt like she had fevers and chills. She had a chronic cough, with some mild chronic sputum and that was unchanged. Physical exam showed the patient's respirations were even relaxed and no observed cough or sputum production. Her lungs sounded perfectly clear posteriorly without rales or wheezes. No dullness in the bases. Anteriorly there was faint, inspiratory squeak, but otherwise clear. The previous swelling and erythema in the right arm from the reaction to the PNEUMOVAX was totally cleared with complete resolution. The reporter felt that injection site reaction was related to therapy with PNEUMOVAX. Chest X-ray showed the pulmonary fibrotic changes which was no change at all from the X-ray of March, 2008. The physician didn't see infectious process. The patient symptoms suggested she may have some flare of her pulmonary fibrosis. The pain may be a little pleuritis as well. This is one of several reports received from the same source. All three patients developed reactions after receiving PNEUMOVAX (lot# 657525/0554U) from the same multiple dose vial. A standard lot check investigation was performed. All in-process quality checks for the lot number 657525/0554U in question were satisfactory. The lot met the requirements of the Center and was released. Additional information is not expected.
Rash and ache at lower end of rib cage from left side of belly button around to left side of spinal cord (all on left side of body). Started anti-viral on 3/19/19, Much Burning, stabbing and aching pain, which is getting better (now just intermittent abdomen aches). This is what I used from the Clinic to convince myself to wait 6 days before contacting my doctor: "Some people report a chickenpox-like rash after getting the shingles vaccine. I believe there is less than a 1 in 5,000 chance that I developed shingles without the vaccination playing a role. I would  like to hear if there are more occurrences of shingles following SHINGRIX  than would have occurred without it. I also think there should be a warning to get the anti-viral if you start to get a "chickenpox-like rash".
Mom states pt developed a high temp 102+R x 3 days; Area of inject red, swollen-blistered & skin peeled @ site; Also had runny nose; Area of inject site raised 1/2" high; Mom used APAP; Slept OK;
Initial report was received on 21 November 2007 from a nurse. A 46-year-old female patient, with no concurrent illnesses, and a history of hypertension, "MVP" with palpitations, "PAC", "PVC", and "SVT", had received a first, left deltoid, intramuscular dose of Adacel (lot number C2769AA) on 20 October 2007 at 19:00 pm. The following day, approximately eight hours post-vaccination at 03:00 am, the patient developed edema, blistering, redness, and "fiery feeling" up to the shoulder of the left arm. Her axilla was edematous and blistering as well. The patient did not seek medical attention, and no relevant diagnostic tests, or laboratory data were performed. Treatments received were not reported. The patient's symptoms lasted 19 days with recovery date calculated as approximately 09 November 2007. Follow-up information received on 22 January 2008 from a health care professional. The patient had joint involvement at the shoulder. The event did not require medical evaluation by a physician, but the patient was evaluated by the employee health coordinator. Treatment included ice packs followed by warm compresses and analgesics as needed. The patient experienced no prior similar reaction. The final diagnosis was unknown, and the patient recovered on 19 November 2007. 04 February 2008: A corrective version was created with the same latest received date as the previous version (22 January 2008) for the sole purpose of entering the treatment medication, analgesics, into the product screen structure field. No other additional relevant medically significant information was added to the case. The reporter for this case is the same as for cases 2007- 03939, 2007-03940, 2007-03941, and 2007- 03942.
Started experiencing parosmia a few days after the vaccine. Everything smelled like spoiled milk; people around confirmed that nothing smelled like that. The smells have changed (it smelled like spoiled fruit and formaldehyde for about a day, and it now smells like durian), but I have been nonstop smelling disgusting phantom smells for days now, causing me to lose my appetite.
no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 24-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981:
Significant widespread body aches starting 12 hrs after dose, felt feverish throughout night, took ibuprofen and still spiked 101.1 fever 2 hrs into motrin.
Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, I had a painful swolle lymph node on left side of neck. That same evening I developed pain, swelling, in my right armpit radiating to the right upper breast and down my right arm with a swollen lymph node under the right arm pit. The pain was about a number 7 on a scale of 1 to 10. The pain and swelling still persist today on 1/15/2021 Still painful, especially to touch. Still radiating down the arm. Lymph node still swollen The pain is about a 2 on a scale of 1 to 10
I felt sick, tired, and had fever for about a week after the vaccine. My ankle is inflamed and sore it is the soft tissue behind the left side of the right ankle.
6 days after vaccination patient developed sudden onset pain and swelling in legs. After DVT evaluation (and ruled out) was eventually seen by PCP - suspected vasculitis. CRP was elevated.
headache; neckache; diarrhea; low grade fever; muscle pain; Joint pain; bump on injection site 6inches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NECK PAIN (neckache), DIARRHOEA (diarrhea), PYREXIA (low grade fever) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (headache), NECK PAIN (neckache), DIARRHOEA (diarrhea), PYREXIA (low grade fever), MYALGIA (muscle pain), ARTHRALGIA (Joint pain) and VACCINATION SITE NODULE (bump on injection site 6inches). At the time of the report, HEADACHE (headache), NECK PAIN (neckache), DIARRHOEA (diarrhea), PYREXIA (low grade fever), MYALGIA (muscle pain), ARTHRALGIA (Joint pain) and VACCINATION SITE NODULE (bump on injection site 6inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs included No treatment drugs included
Single urticaria at omphalocele, given Benadryl lasted approx 1 1/2 hr (began 10-15 min post MMR shot). pt gets hives with eggs. No reaction at the vaccine sites. No breathing difficulty.
Numbness (tingling) in started in left arm, but now  both legs below the knee. Not constant.  sometimes skips a day, and re occurs the next day.
Pt recv vax on 2/13/99; on 2/15/99 pt exp swollen/ red vax site, sick feeling, tired in bed x 2 days
Information has been received from a physician concerning an 82 year old female patient with hypertension, hyperlipidaemia, osteopenia, gastrooesophageal reflux disease, and sulfa allergy who on 22-OCT-2007 was vaccinated IM into the right deltoid with a second 0.5ml dose of PNEUMOVAX 23 (lot # 658074/0803U).  On 22-OCT-2007, the patient experienced redness, soreness, and swelling of her shoulder where the vaccine was administered.  It was also noted that the patient has had limited movement of the affected arm and that the injection site was warm to touch.  The patient sought medical attention and was seen by the physician.  On 23-OCT-2007 in the am, it was reported that the patient developed soft tissue swelling in the right shoulder region.  At the time of this report, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Pt describes arm pain and was referred to urgent care center who recommended ibuprofen as area was inflamed. Area not getting better and pt saw orthopedist who recommended additional 2 wks of antiinflammatory. Pt states arm still not better and cannot lift it past 90 degrees. Orthopedist now recommending physical therapy.
Injection at 9:55 am. Itchy eyes and root of mouth started 15 minutes after injection.  I waited for an additional 15 minutes at facility and the symptoms went away on their own.  At 12 noon at home malaise set in.  I rested off and on for the remainder of the day.  At 4 pm,  pain and swelling in right arm.  No treatment.  Also, at the same time pain in vaginal area started.  Pain remained for remainder of the evening and night.  The next morning the pain had lessened some, however not totally.  I can not think of any cause for the vaginal pain, just that it started several hours after vaccine was administered.
This case was reported by a other health professional via call center representative and described the occurrence of eye swelling in a 21-year-old male patient who received FLUARIX (batch number 9JX2N, expiry date 16th June 2016). On an unknown date, the patient received FLUARIX. On an unknown date, 1 day after receiving FLUARIX, the patient experienced eye swelling, lip swelling, chest tightness and chest pain. The patient was treated with steroid nos. On an unknown date, the outcome of the eye swelling, lip swelling, chest tightness and chest pain were unknown. It was unknown if the reporter considered the eye swelling, lip swelling, chest tightness and chest pain to be related to FLUARIX. Additional details were provided as follows: The health care professional stated that patient received FLUARIX vaccine and the following day began to have lip and eye swelling. On an unknown date, unknown time after vaccination, the patient also experienced tightness in his chest. The patient went to onsite doctor at his college that treated him with steroid to help. At the time of reporting, patient was fine but still had some chest pains.