chrisvoncsefalvay/vaers-outcomes huggingface dataset:
self reported hives 40 minutes after injection while back on duty.  rash not itching but face red instructed to take benadryl and  go to closest Emergency Department   follow up call >officer did not seek medical attention. states he ate lunch fine and rash self resolved by 6 PM. He did not take any medicine such as Benadryl  for rash as instructed offier denied any previous allergy to soaps, foods, detergents as well as denied seasonal allergies or allergies to any medications
Immunization of DTAP (lot 567A2( on 8/0/02 to left thigh, IM. That evening, started a 3cm blotchy, red area. On 8/10/02, it was 6cm in diameter. On 8/11/02, it was 8-9cm in diameter of swelling. On 8/12/02, 6cm X 8cm reaction with blotchy/warm/erythema on left lateral thigh localized reaction. Treated with Benadryl 1 tsp q 4-6 hours and cold compresses. Seen by a physician.
This patient was under the age of eligibility to receive the vaccine.    After calling the parent, she stated that the patient had no side effects other than some achiness for less than 24 hours.  Mom stated she called the  # on the vaccine card to acknowledge that she knew she was consenting for an underage person to receive the vaccine.  She stated that she is high risk and also has family who lives with them 6 months out of the year who are also high risk and wanted her to be vaccinated.  She stated she was an 'unemployed nurse by trade" and felt that since her daughter was big for her age ( 5'6 and 180 lb) she thought it would be ok.  She shared when she called they stated she should not have been vaccinated as this vaccine is not approved for her age group.   We have circled back with our clinic process to ensure this does not happen again,
She received the vaccine and then a couple of days it felt itchy, and it was a little red, swollen but not too much.  She then noticed that it was going down but still a little itchy.  Now it's the size of a quarter but over onto the sides of the other arm, the size of the inside of the palm and very itchy.  She thought it might have been a mosquito bite, but noticed that it has still not gone away and it has spread.  She has not taken anything for the reaction.  She has not called her doctor regarding this and it has continued to grow to where it is so large and spread today, 3/19/21.
Information has been received from a registered nurse concerning female patient with no medical history who on approximately 22-JUN-2007 was vaccinated with a dose of the Gardasil. There was no concomitant medication. Five minutes after receiving the vaccination, the patient became dizzy, nauseous and diaphoretic. The symptoms lasted for 10 minutes. Unspecified medical attention was sought. The patient recovered from the dizziness, nausea, and diaphoresis on the same day she received the Gardasil. This report is one of several reports received from the same source. Additional information has been requested.
Rashh 6/2/03, present 3 days, consistent with mild varicella.
patient rec'd 2 imz on 10/16/2020 fri . pt rec'd FLUCELVAX and PNEUMOVAX . both in the same arm. area of injection site became red and warm and swollen by the end of the day and continued on for the next 72hrs. came to the pharmacy to show me and i directed her to see a md to take a look at it since it was still very swollen and red and painful . pt did go to the md and md diagnosed it as cellulitis and pt is now on abx and ibu.
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received HAVRIX (batch number N4341, expiry date 19th February 2016). On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. One patient received HAVRIX that was exposed to temperature of 30.4F.
Patient administered lower than authorized dose. Per table: Interim recommendations for COVID-19 vaccine administration errors and deviations, patient is advised to repeat dose immediately.
12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand and face swelling, swelling and tenderness around injection site, general flu-like symptoms making it difficult to sleep. I was able to go to work the next morning despite symptoms. Symptoms, other than mild soreness in arm where injected, resolved 36 hours after onset.
Two reactions. 1. I developed shingles on my right side. 2. Injection site continues to be red and sore.
Severe right upper arm pain at site of Men B vaccine developed later on the day of vaccine. Pain radiated to right shoulder. Pain persisted and only improved minimally with acetaminophen and ibuprofen. Patient has difficulty using his right arm d/t pain. Seen by physician on 07/31/18. Treated with ibuprofen 500mg BID with resolution.
Shortness of breath, tingling in both arms to chest area, felt faint, dizziness, weak 20 minutes after the shot. Then for a week felt tired, head fog, headache, stomach bloating and diarrhea.
I have bowel irritation, diarrhea after eating, elevated CRP, elevated lymphocytes, no appetite. Sores in the nose approximately 1 week after first injection and 1 week after second injection.  I cannot tolerate any foods other than white rice, soups, crackers, bread since starting vaccinations series.
Hematoma in right eye; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EW0168), via an unspecified route of administration on 06May2021, at 16:15 hrs, on the right arm as single dose for COVID-19 immunization. No other vaccinations within four weeks prior to suspect vaccine. The patient's medical history and concomitant medications were not reported. No family medical history relevant to Adverse Event. No adverse events prior to vaccination. On 12May2021, the patient developed hematoma in her right eye after the first dose of the Covid Vaccine. Caller stated that the hematoma was barely visible now. Caller denies any medications, medical conditions, labs, testing, or treatments relevant to event. The patient did not visit any emergency room or physician office due to the events. The outcome of the event was resolving. Additional information requested.
Adverse Event: As the provider started to inject the vaccine into the patient, significant amount of leakage occurred and dripped down patient's arm. Treatment: Vaccine was lost and a second vaccine was administered.  Outcome:  We did a safety huddle and retrained vaccinators.   The same thing happened again. Each remaining syringe  was checked by the Pharmacist who found that the connection between the syringe barrel and the needle was loose and unable to be tightened,  This was determined to be a defect with the needle device.  We changed out all the remaining vaccines with our own supply of needles and had no further problems.
10/15/04 complained of excruciating pain that night in left deltoid and shoulder 10/16 : seen in office: has rash on upper left arm. 10/17: yellow blisters around the injection site (not itchy or infected appearing) 10/21: blisters still there: pain and rash gone. Better.
Shivers, then muscle ache, teeth ache on side of shot, shivers again. Pain in place of shot, warm and tenderness.
S/P cervical spinal fusion; injuries due to motor vehicle accident - deemed medically stable and was transferred to Rehabilitation Center. Hospital admission within 6 weeks of receiving the COVID vaccine.
First dose: 21Mar2021 and second dose: 02Apr2021; a breakout of granuloma annulare at injection site of 2nd dose; a breakout of granuloma annulare at injection site of 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 at 12:00 as dose 2, single (Lot number: ER530) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: Nov2018 (ongoing). Concomitant medication(s) included: TRULICITY taken for diabetes mellitus (ongoing); METFORMIN oral taken for diabetes mellitus (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Route of administration: intramuscular, Vaccine administration time: 12:00, Lot number: EN6204, Anatomical site of injection: left arm), administration date: 21Mar2021, when the patient was 53-year-old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Apr2021 at 12:00, outcome "unknown", described as "First dose: 21Mar2021 and second dose: 02Apr2021"; VACCINATION SITE GRANULOMA (non-serious), GRANULOMA ANNULARE (non-serious) all with onset 2021, outcome "unknown" and all described as "a breakout of granuloma annulare at injection site of 2nd dose".    Additional information: Prior to vaccination, the patient did not receive any other vaccination within the 4 weeks. The patient did not have any family medical history relevant to adverse event. The patient did not undergo any specific relevant test for thromboembolic events with thrombocytopenia. No appreciable adverse events from vaccines other than a breakout of granuloma annulare at injection site of 2nd dose. 4th booster received on 30Sep2022.
She received the second dose of the Pfizer Covid 19 vaccine, but she later realized it was scheduled earlier than it should have (17 days instead of 21); A little tired; Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "She received the second dose of the Pfizer Covid 19 vaccine, but she later realized it was scheduled earlier than it should have (17 days instead of 21)"; FATIGUE (non-serious), outcome "unknown", described as "A little tired"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional information: Caller stated she received the second dose of the Pfizer Covid 19 vaccine, but she later realized it was scheduled earlier than it should have (17 days instead of 21). Caller stated she had experienced the same symptoms from the list, described them as normal, she has been a little tired, and flu like symptoms, but only with the second dose, she didn't have this symptoms after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection into right arm was high up and painful upon administer. Immediate limited motion and sharp pain when moving. 4 weeks in, still painful when moving and can radiate down arm to right index finger. Constant ache.
7 days after first injection my arm became red and itchy. The next day, there is a baseball size rash, warm to touch, no swelling.
noticed swelling rt thigh;PE 2 1/2inch diameter lump noted w/sl erythema round not tender;rx augmentin;referred to surgeon-drained under local 1-2cc mucoid fluid drained;small scar w/dimple;dx poss sterile abscess secondary to DTP;
patient began experiencing nausea at 9:55AM , Dr. was notified and assessed patient. Advised monitoring an additional 30 Minutes. Gave Zofran to alleviate the nausea and provided Gatorade for  hydration.  Dr. was notified of event and vitals obtained after 30 minute of observation per Dr.  vitals are normal okay to discharge patient
My first vaccine you had all covid except short of breathe, I was very fatigued, I woke up the nest day after my second shot could not breathe and went to the ER right away.
3 days after vaccination patient got a rash on her leg (8/20/12), patient went to walk-in. Clinic 9/1/12 & MD diagnosed it as shingles.
Narrative:  65y.o. MALE with a h/o sleep apnea/narcolepsy, HTN, obesity, Gout, Vitamin D deficiency, BPH, arthritis, and T2DM presented to ER on 8/11/21 with SOB. Pt tested positive for covid-19. Pt had previously been vaccinated with covid-19 pfizer on 3/5/21 & 3/26/21 from facility (outside provider). Pt was intubated due to hypoxia and admitted to MICU. Pt was treated with covid medications (tocilizumab & remdesivir), antibiotics, corticosteroids, and anticoagulants. Pt died on 8/17/2021. Death was caused by: Acute hypoxic respiratory failure and septic shock secondary to COVID pneumonia and suspected secondary bacterial pneumonia and Staph aureus bacteremia.
Large welt around the injection site the day after shot was received. Gradually went away over a few days. Welt was the size of a tennis ball & tender to the touch.
Seizure; Vomiting; Muscle aches; Chills; Pain in my arm from shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), VOMITING (Vomiting), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in my arm from shot). At the time of the report, SEIZURE (Seizure), VOMITING (Vomiting), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in my arm from shot) outcome was unknown. Not Provided          The case pertains to one patient from chatbot. No concomitant medications were reported. The patient had these symptoms after second dose. Treatment information was not provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Began with a slight headache that eventually got worse.  Started, when treated, at a 5 of 10.  Left facility with a 7 of 10 headache.  Then I had a weird taste in my mouth (metallic like).  My tongue started to tingle and was a bit numb.  Eventually after Doctor at facility took me in, I was given benedryl 50 mg and an antacid.  After a few minutes the right side of my mouth became itchy but the tingling stopped.  The itch was not unbearable but it was getting there.  I was already having a slight difficulty breathing but that was from the morning even with inhalers.  As an instrument player  a doctor said I have super lungs so my results would be skewed due to how much air I take in.  But any loss of air, although in the safe range for others, is like breathing through a straw for me.  My blood pressure was 139/90 at the time.  My normal blood pressure is 117/70.  I went home feeling cold and just not feeling well, relatable to flu symptoms.  This is the next day after taking benedryl every 6 hours at 50mg/dose.  My breathing is slightly labored.  I feel ok but my arm hurts, I have been moving it around a lot just to get it mobile.  My chest feels like there is a slight weight on it which is weird for me.  At the moment my pulse is 81bpm and my oxygen is at around 96.  My norm is around 70bpm and oxygen at 99.    No temperature is consistent at 97.3.   I feel a little weird today.  I am stiff all over as well.  Little aches here and there but that is a norm.  Doing my stretches and exercise is not a go today.  Can't breathe as normal.
RLQ pain (without radiation), nausea, malaise and some constipation. Patient reported pain to be pressure, sharp and shooting, and 7/10 in intensity. Acute appendicitis and localized peritonitis. Patient underwent laparoscopic appendectomy.
She had  some difficulty  expressing words and remembering  names  which slowly improved over the course of several months
Rheumatoid arthritis flare up; Heart pain; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), ANGINA PECTORIS (Heart pain) and CHEST PAIN (Chest pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No medical history was provided by the reporter.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced CHEST PAIN (Chest pain). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and ANGINA PECTORIS (Heart pain). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), ANGINA PECTORIS (Heart pain) and CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient reports red, itchy, raised, swollen skin at area of injection and vicinity, roughly 3-4 inch area of left deltoid. Vaccine given 4/5/2016, patient reports 4/12/2016.
Felt full head (after first or second AND after third); This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Felt full head (after first or second AND after third)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Adverse reaction with Flu shot. Concurrent medical conditions included Sjogren's syndrome (Patient is Immunocompromised). Concomitant products included LEVOTHYROXINE, POTASSIUM CHLORIDE;SODIUM BICARBONATE and BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-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 HEAD DISCOMFORT (Felt full head (after first or second AND after third)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (Felt full head (after first or second AND after third)) outcome was unknown.            Concomitant drugs include ARDES 2 vitamin daily.Treatment drugs include steroid.   This case was linked to MOD-2022-472950 (Patient Link).
Patient had influenza and pneumonia vaccine on 8/26/2015.  Woke up the next day and his right arm was painful, red, swollen and warm.  He was not feeling well and felt feverish.  He presented to an urgent care facility and was diagnosed with a cellulitis and placed on antibiotics.
I gradually experienced joint pain in my fingers on both hands along with tightness/mild pain in my knees & right shoulder.  I thought it would eventually subside then go away but it has persisted & has gotten a bit worse.  I see my cardiologist every 6 months for a checkup & discuss my blood work. I mentioned my joint pain to him, he asked if I got the Covid vaccine.  That's when it dawned on me it was probably related.
patient that received an ipol vaccination after the temperature excursion occurred with no adverse event; excursed vaccine administered to the patient; Initial information received on 12-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old female patient that received an ipol vaccination after the temperature excursion occurred with no adverse event with excursed vaccine administered to the patient while receiving vaccine IPV (Vero) [IPOL] poliomyelitis vaccine (inactivated)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 10-Mar-2022, the patient received a dose 0.5 mL (millilitre) of suspect IPV (VERO) (lot T1E871M, expiry date: 10-Oct-2022) via intramuscular route (strength, form not reported) on an unknown administration site for Immunization    On 10-MAR-2022, it was reported as patient that received an ipol vaccination after the temperature excursion occurred with no adverse event (product administration error) and excursed vaccine administered to the patient (Product use issue) (Latency: same day)  Action taken: not applicable for both the events.  Outcome: Unknown for both the events.  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 Directive 2001/83/EC 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.; Sender's Comments:  01059755:
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Patient complaining of injection site redness and swelling, extremely red (pt will take antihistamine and make appt with provider to get further guidance)-Severe
Pediarix was given by CMA when Hepatitis A was ordered.   Hep A was also given.