chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left side supraclavicular lymph node swelling and tenderness. The swelling was visually evident over my clavicle.  The pain and visual swelling resolved within about two days.   The lymph node persists to this day.  It is pea sized, non-tender, superficial, moveable.
10/28/21 and 10/29/21=temp 99.9 oral, headache,achy, fatigue,.Mild swelling, soreness injection site. This was Booster shot
3-month old female patient received both pentacel and pediarix today, the patient accidentally received a double dose of DTaP-IPV vaccine with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA236480.  This case involves a 3 months old female patient for whom both Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (YEAST), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3V (VERO), Tetanus Vaccine Toxoid [Pediarix] on the same day, the patient accidentally received a double dose of dtap-ipv vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine and Pneumococcal Vaccine CONJ 13v (CRM 197) (Prevnar 13) for Prophylactic vaccination.  On 01-Aug-2023, the patient received a dose 1 of 0.5 ml (frequency: once) of standard strength of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] suspension for injection (lot: UJ84LAA) via intramuscular route in the right thigh and and dose of suspect PEDIARIX (strength, formulation, expiry date and lot number not reported) not produced by Sanofi Pasteur via unknown route in unknown administration site, both for prophylactic vaccination (immunization), the patient accidentally received a double dose of dtap-ipv vaccine with no reported adverse event (extra dose administered) (latency: same day).  Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was 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.
This is a 60 y.o. patient with a past medical history significant for DLBCL, hypogammaglobulinemia, anemia, COPD, peripheral neuropathy, chronic back pain, and tobacco abuse who presented to ED for symptoms of fevers, chills, malaise.  Pt states that she has been fevering since the beginning of April, when she was diagnosed with COVID.
1/28/23 Client reports swelling, discomfort, and redness at right arm, site of vaccine administration on 1/24/23. Client took arm from shirt sleeve and showed arm. Right deltoid area is swollen, red, with an approximate 3" wide area affected. It is slightly warm to touch. It was painful 1/25, 1/26 but client reports it is "better". Advised acetaminophen or ibuprofen for pain relief, applying ice packs as needed. Option to check in with primary care. Requested report back if symptoms worsen or do not resolve on own. Encouraged to try not to rub or itch as could exacerbate. Explained typical side effects and that this looked like a known reaction that is self-limited and resolves that can be associated with Moderna.
Red, swollen, itchy, hot at injection site first appeared 8 days after first vaccine dose, about the diameter of two quarters. 14 days after first dose the area is larger, but the discoloration is a paler pink, the swelling has disappeared, the heat has lessened, and the itching has lessened.
Left Shoulder soft tissue infection with tender indurated area central eschar surrounding cellulitis. Treateed with  Zithromax and Bactrim.Cultured area with 4+ Staph aureus.
Absence of period; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Absence of period) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-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 MENSTRUATION DELAYED (Absence of period). At the time of the report, MENSTRUATION DELAYED (Absence of period) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: negative (Negative) negative.         No concomitant medications reported.  No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-034448 (Patient Link).
left leg went numb; tingling; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21May2021 at 11:15(at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disorder, asthma and allergy to penicillin. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21May2021 at 13:15, within 2 hours of the shot all of a sudden, the patient experienced left leg went numb and tingling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events left leg went numb and tingling were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shortly after receiving the vaccine, my arm was sore. All the typical side effects in the paperwork I had. The next day I had a low fever of 99.9 and I noticed my arm was red. It is still red as of today it is about 3 inches in width. I went back to the pharmacist to let them look at it and they referred me to contact VAERS. It is not bothering or anything like that.
I had excruciating headache, stuffy nose, mild cough and immediately after day of symptoms no sense of taste and smell. A week later I woke up with difficulty breathing and went into MD Now was tested. They gave me toradol for headache. My heart rate was low and my BP was low.
General symptoms- chills, headache, joint pains, muscle pains, fatigue, nausea, loss of appetite, sweating itching,, 2.5 inch lump in right armpit area. Narrative:
ARM HURT A LONG TIME AFTER THE ORIGINAL SHOT IN LEFT ARM, COULD FEEL THE NEEDLE STICKING IN ARM; This spontaneous report received from a patient concerned a 57 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 was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAR-2021, the patient experienced arm hurt a long time after the original shot in left arm, could feel the needle sticking in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm hurt a long time after the original shot in left arm, could feel the needle sticking in arm was not reported. This report was non-serious. This case, involving the same patient is linked to 20211124742.
Pain starting upper left arm around shoulder to left wrist that lasted about 1 week.  Next 3 weeks range of motion was limited and pain with movement of left arm. Though slowing recovering.  First appointment with an orthopedic was 9/20, MRI was done 9/25, and I was diagnosed with subacromial bursitis in left shoulder.  No previous pain in the area prior to this incident.
Mild swelling and redness, pain and itching for 24-36 hours after injection. 7 days later, after getting out of the shower, I noticed my arm at injection site was very red, swollen and itchy. It had a knot on it and a red ring about 3 inches around the injection site. I placed a cold pack on my arm for 15-20 minutes. The area was still hot to touch for another 12-24 hours. The hotness has subsided and most of the itching, but my arm still feels sore and has about a 2.5 inch red area around it. Note that my swelling, redness and itching had completely subsided before this particular shower. I did not use any different products in my shower than I had used the days previously following my injection.
This spontaneous case reported by a patient family member or friend and describes the occurrence of somnolence (sleepy patient) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# AS1416B) for COVID-19 immunization. No chronic disease reported. On Jul 25, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced somnolence (sleepy patient). At the time of the report, somnolence (sleepy patient) outcome unknown. The reporter did not provide any causality assessments or treatment information. Patient received the vaccine in right leg. Concomitant medication included vitamin D with probiotic for weekly once. No other adverse reactions reported. This case linked to MOD-2022-638968 (patient link).
Information has been received from a physician concerning a 5 year old male with seasonal allergies who on 24-JUN-2004 was vaccinated subcutaneously with the first 0.5 ml dose of VARIVAX (Merck). On 14-MAY-2008 the patient received the second 0.5 ml dose of VARIVAX (Merck) subcutaneously. On the same day the patient also received secondary suspect vaccination of MMR II. Concomitant therapy included DTaP (unspecified) (+) Tetanus toxoid, Poliovirus vaccine and CLARITIN. On 01-JUN-2008 the patient developed quite a few pustules and papules generalized on his body. As the time of the report, no other symptoms noted, no treatment required. The patient's events persisted. The patient's mother contacted the office by phone. Additional information has been requested.
breakout w/pox #5 18FEB98 c/o h/a-confirmed chickenpox on 29FEB97 by MD;no known exposure;23FEB98 had 70 pox 1 on tongue;all crusted over;
lymphocyte is elevated; This is a spontaneous report from a contactable consumer (Patient). An 85-year-old male patient received second dose of BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Historical Vaccination included Patient already received first dose of BNT162B2 for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced elevated lymphocyte levels after the second dose of the vaccination. The patient stated that the vaccine activates the B cells, so he didn't know if that has something to do with it. The patient also stated he had no information on elevated lymphocyte levels after vaccination and referred to HCP. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Within the first 5 minutes of vaccine I started feeling weak. Within 10 minutes I was feeling weak and a little out of it. My blood pressure was taken. I had to come home from work and stay home for 2 days. I ended up with severe weakness and a fever (100.4F). I had a headache and vomiting. I missed 2 days of work due to that. It took me a month to start feeling better.
Experienced normal soreness the evening of 4/9/2021. At 2:30 pm on 4/10/21, started having generalized soreness. Temp at that point was 98.6. Within ten minutes, started having congestion in chest (rattles). This caused strong bouts of coughing with pain radiation through my lungs. I then started vomiting (x3). I started feeling fatigued so I went to lie down, when I had a cold chill. At 3:00 pm, my temp was 102 F. At 3:15, it was 102.5 F, and then crested at 103 F at 3:30. In the past five hours, the only symptom to subside was vomiting; all the others are still present with my current temp 102.1 F at 8:41 pm.
Approx 16 hrs after injection, low fever, chills, fatigue, and muscle aches set in.  Took two tylenol and symptons lessened.  About 6 hrs after taking tylenol, fever and chills started returning.  Took 2 more tylenol went to bed and woke up fine.  But the symptons I experienced after the injection was similar to my symptons during the time I had Covid.
EE received Covid 19 Booster (Dose #3) of Pfizer on 09/25/2021 at facility. She reported swollen lymph nodes and swollen redness of arm at the injection site, body aches, chills,  a  fever of 102 no  others stated. She was advised to take Tylenol or ibuprofen with a cold compress to help alleviate pain and assist with fever  drink fluids and rest. Adhere to the illness in the work place at facility for work return.
I received first dose of COVID-19 vaccine Pfizer on 4/5/21 and had only minor reaction of tiredness. However, I discovered a lump under my left arm around mid April 2021. I received 2nd dose on 4/26/21 and a few days later, a 2nd lump appeared what I thought was the Lymph node in my groin area (that's very painful) for a couple of weeks. The 2nd lump in the groin area eventually went away. But the lump under my left arm persisted and sometimes the area is a little sore. I went for a physical exam on 5/17/21 and Dr. ordered an ultrasound.  I went for the ultrasound on 8/27/21 which rendered no result and continued on to take an MRI on 9/27/21 and the technician and PCP recommended a biopsy which I scheduled for 11/1/21.
Right thigh with erythema, swelling, pain the morning after vaccines were administered. No symptoms to left thigh. Patient also with rash to back although mom reports could also be heat related d/t air conditioning issues currently. Itching to rash areas also. OTC BENADRYL was given at home with improvement although patient reported to office with continued swelling and redness surrounding injection sites to right thigh. Minimal pain on palpation, no fluid collection or concern for abscess or infection at the time of assessment in office. Recommended another dose of BENADRYL, cool compresses to area, and starting PO cetirizine today to be taken for 1 week. Mother to return for any changes in patient condition.
Severe headache (9/15-today), pain in injection site(9/15-today), chills (24 hrs post injection), loss of appetite (72 hrs post injection), eyes twitching (9/15-today), very lethargic (9/15-today), ringing in ears (9/15-today).
This spontaneous report was received from a medical assistant, concerning a twin patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with an inappropriate storage dose of PROQUAD (dose, frequency and route not reported), lot # reported as M037652 with expiration date of 28-FEB-2018 for prophylaxis. No adverse effects were reported. The temperature excursion of the vaccine was greater than -15 °C degrees but less than -10 °C degrees with a highest temperature of -12.97 °C, for a time frame of 4.5 hours. There was no previous temperature excursion. No product quality complaint (PQC) was involved. Data logger was involved. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Aug2022) Negative, notes: Positive rapid antigen test 48hrs after negative test; (19Aug2022) Positive, notes: Positive rapid antigen test 48hrs after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received no Other medication in 2 weeks. Patient received treatment with paxlovid from 09Aug2022 to 14Aug2022.
Severe outbreak of shingles across abdomen on or about 2/13/2021.  It got progressively worse to the point where the lesions/rash were covering most of her abdominal area and was quite severe and painful.  Then came the uncontrollable shaking of arms and legs - more neurological that just "feeling shaky".  Feeling very unwell and concerned.  On March 12, 2021 while driving to the urgent care because of how ill she felt, she crossed the divider and went into on-coming traffic and was involved in a serious car accident.  She died 5 days later from complications of the injuries sustained in the accident , including heart failure,  It is highly likely that the vaccine was likely a contributing factor to all of the above - -the shingles, shaking, unwell feelings and most importantly,   the accident and incidents of heart failure.
Developed swelling about 4 inches further down in their inner arm; Tenderness about 4 inches further down and in their inner arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (Developed swelling about 4 inches further down in their inner arm) and VACCINATION SITE PAIN (Tenderness about 4 inches further down and in their inner arm) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE HIGH DOSE QUADRIVALENT) for an unknown indication.    Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Hypertension.   On 15-Sep-2022, 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 and dose of INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE HIGH DOSE QUADRIVALENT) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced VACCINATION SITE SWELLING (Developed swelling about 4 inches further down in their inner arm) and VACCINATION SITE PAIN (Tenderness about 4 inches further down and in their inner arm). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Developed swelling about 4 inches further down in their inner arm) and VACCINATION SITE PAIN (Tenderness about 4 inches further down and in their inner arm) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient had a location reaction to one of the vaccines. The patient had received Flu shot: Fluzone Highdose along with Moderna COVID bivalent on 15-Sep-2022 on the upper left arm. Then not right away but later that day she developed swelling and tenderness about 4 inches further down and in their inner arm. Patient mentioned that it did go away. Patient took Aleve after the reaction and it helped.
The day after the second dose, I felt flu-like symptoms including body aches, lack of energy, and nausea.  The following day, the body aches and lack of energy persisted.   By day three these symptoms had disappeared.  I had a very sore arm (around site of the injection) for the first three days then a slightly sore arm for another three days.  Unlike the first dose, I did not have a rash around the injection site with the second dose.
PT-therapy popping noise in left upper arm where I had flu shot - very very sore - dull ache since Oct. 27 28 2 weeks after flu vaccine. Left upper arm to elbow not normal since flu vac.
Same day experienced fever, cough, lethargy. Fever continued for 3 days. 8/24/2014 wheezing, saw MD on 8/25/2014 was given breathing treatment, steroid injection and antibiotic injection. Rx for steroid and antibiotics also. Rash on torso 3 weeks after immunization symptoms continue.
Vomiting, severe headache, body aches, extreme fatigue, slight fever, extreme anxiety. Lasted approximately 72 hours
sudden onset of regional anesthesia of hands, bilaterally, & of the nose & cheeks; resolved spon w/in minutes;
Seizure lasting approximately 10 seconds, starting 5 mins after injection. We had her lay down for at least 15-20 mins following seizure. When she sat up, she felt nauseated, but no vomiting. Pt. laid down for another 10 mins, and felt ok sitting up the next time. A few minutes following first HPV vaccination, I responded to a call for help inside exam room. Mom stated that pt. was seizing. Pt had eyes closed, supine with legs hanging off the side of the bed and head next to the wall. Brought legs onto the bed and held her head away from the wall to protect it, and had the MA get the doctor. No visual shaking at this time, but she was non responsive while mom called to her three times. I called her name and touched the front of her shoulder and within a couple seconds she opened her eyes, looking suddenly alert. She looked around to the people in the room and spoke normally. No apparent tiredness or pallor. Mom reports she called for help as soon as she recognized what looked to her like seizure activity. Episode lasted approximately 5-10 seconds, Dr. entered the room just after she became responsive again, and spoke with mom regarding the episode, and the plan going forward. Pt. rested in the exam room for at least an hour and blood pressure was checked twice, supine and sitting, with no change from the initial BP taken today. ER precautions given. She was scheduled for an EEG on 7/26/17. Hx: Mom stated that she had 3-4 seizures when she was younger, non febrile. After first seizure, she was taken to the ER, where doctors witnessed another seizure. She had 1-2 more seizures 1-2 weeks after that. Pt was seen by a Neurologist, and took medication: LAMICTAL for 1 year. No more seizures after that, so she was taken off the medication. Mom reports that she also had a fainting episode when getting blood drawn on 10/26/13. Pt was sitting in her lap and she felt patient slump back into her chair. She was pale, and had no apparent seizure activity that mom recognized. In both cases: today, and for the blood draw in 2013, she was very nervous.
Swelling and soreness around vaccination site, swelling on bilateral thighs around size of half dollar, itching of arms and legs.