chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Prevnar 13 in her right shoulder on 12/4/17. On 12/11/17 patient came to the pharmacy and stated that for the last 2 days he right shoulder had started to become tender and swollen. She presented with a light red circle roughly 3 inches in diameter around her injection site. It was noted that her shoulder felt warm to the touch and that the red area did appear to be somewhat swollen. There was no additional bruising or bleeding evident. The patient reported no other adverse effects of any kind. The pharmacist instructed the patient to seek medical attention if she noted a fever, worsening/spreading of the red mark on her shoulder or any difficulty breathing. Her primary care physician was notified via fax. The patient was asked to keep the pharmacy apprised of the situation in case anything changed in the coming days.
LEFT ARM Shingrix #2 4/23 4/25: RIGHT ARM HIVES, SWELLING, REDNESS Improved with zyrtec and benadryl by the time evaluated today, 4/26  States has had this reaction to other vaccines, not sure which ones and has had intermittent R>L arm swelling for months- negative allergist and neurologist eval. Referred to rheum, advised to hold off on covid vaccine for now
I noticed aching in my joints the evening that I received the flu shot. The swelling and pain in my joints grew worse each day until on 9/14 at 10:20 AM, I went to the Urgent Care facility. I had a fever of 101, could barely walk and could not put weight on my hands. The pain was extreme. I was given a Demerol shot and prescribed Benadryl and Tylenol. Today, 9/16, the swelling and pain have decreased so that I can move around but it is still very swollen and painful. Last night I had a fever of 99.9 but I don't have one now.
Upon waking symptoms included dizziness, abdominal aches, ringing in both ears and headache in the forehead area..  Symptoms still exists at the time of reporting.
Arm pain; All over body pain; Tirred; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PAIN (All over body pain) and FATIGUE (Tirred) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), PAIN (All over body pain) and FATIGUE (Tirred). At the time of the report, PAIN IN EXTREMITY (Arm pain), PAIN (All over body pain) and FATIGUE (Tirred) had not resolved.            Treatment medication was not provided. Action taken with mRNA-1273 in response to the event was not applicable
pt was vax 16MAR93 in the AM; 17MAR93 3AM presented to ER: pt had a WBC of 23,000; No other info available @ the report it is unk pt was hospitalized;
Nausea, weakness, fatigue paroxysms of racing heart, abdominal pain.
swelling in throat with difficulty swallowing, rapid heart rate, itching.  Within one week, also had very swollen lymph nodes across both arm pits, breasts, neck; petechiae on arm, chest, stomach, hip;  itching that spread across body, fatigue, dizziness that began 7 days later.  Two weeks later more petechiae but mild in nature
Within 1 week of 1st dose, pt developed subjective paresthesias in both hands and feet that lasted about a week, then within 2 days of the 2nd dose developed the same sx's.
POSSIBLY EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 201A21A expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced possibly expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possibly expired vaccine administered was not reported. This report was non-serious.
Five mins after vaccination, I felt tingling in my face and mouth. 15 mins after, I had numbness & tingling in mouth and throat. Lips were slightly puffy. I reported to pharmacist on duty.
2-3 months-unconsolable crying-high pitched crying lasting most of waking hrs went on 6-7months; between 4-4 1/2 months eyes started jerking; also somewhere between 2-4 months arms & legs got hypertonia in all 4 extremities; seeing speciali
Patient was asked to sit for 15minutes after vaccination. After sitting, patient  Walked approximately 15 feet and fainted onto concrete floor. Sustained head injury with laceration. Pt was alert and oriented. Was immediately attend to former EMS and nurse.  Stated he had only eaten a banana that morning. Ambulance called and received head staples at the ER.
(Twin had fever/rash morbiliform 24 hours prior). Patient had fever over 102. Less than 3 minute episode of eyes rolling back in head rocking back and forth, then stared into space. Sleepy after then fine. Febrile seizure. 14/5/16.
Pt was injection with a timed-out vial. Vial timed out on 6/23/23 and the pt was mistakenly injection on 6/29/23.
Pt came to clinic to get school shots, pt received MMRV instead of separate MMR and Varicella shot. MMRV was supposed to be for 1-12 year old. Immunization error.
flu-like fatigue and weakness, chills, no fever high blood pressure, usually have a little low pressure felt ready to pass out, several times foot went numb
Extreme nausea, vomiting, diarrhea. x 1 week.
Moderna COVID-19 Vaccine EUA Woke up with overall muscle pain and headache.  Midmorning, had chills and nausea, followed by fever 102F two hours later.  Muscle pain worsened.   By 4PM, temp down to 99 after cold compresses and fluids.    Nausea abated and was able to eat some food early evening.
Temperature, chills, headache, muscle aches, sore throat, occasional loss of taste, sinus congestion, fatigue.  These symptoms start around 4 pm every day and stop about 9 pm.  Gradually improving each day, but today is 9 days after the 2nd shot.
Initial information received on 21 January 2009 from a health care professional. Upon receipt of follow-up information on 17 February 2009, it was determined this case meets seriousness criteria. A 49 year old female patient with a history of IGA deficiency and allergies to Amoxicillin, aspirin, Prozac, Morphine, Naproxen, Motrin, Sulfa and Intron received ADACEL (lot number not known) "two weeks prior". On 29 December 2008 the patient complained of pain and swelling in her joints including fingers, knees, elbows, wrists, and ankles. During a doctor's visit (date not provided), the doctor stated that the patient had visible swelling in the proximal interphalangeal joint (PIP) joints, however no visible findings in other joints. The patient was not recovered at the time of the report. No further information was provided. Follow-up information received 23 January 2009 from a physician. According to the reporter, the patient had a similar, but worse reaction following treatment with Inferon which included urticaria. That episode required treatment with steroids and a progressive taper. The patient had a history of IgA deficiency with no demonstrated problems associated with that condition to date. Laboratory test results (date not reported) included Sed rate (15), C reactive protein, rheumatoid factor, ANA, and liver function panel which were normal. C3: 89 (ref 90-185) and C4: 4 (ref 19-55). Lyme antibody, monospot, ASO titers and culture were negative. Hepatitis profile was consistent with prior vaccination and parvovirus serology was consistent with past infection. CBC results indicated mild leukopenia at 3000, otherwise normal, no anemia. The poly arthritis interfered with the patient's ability to work and at the time of the report, the physician indicated a diagnosis had not been determined. Corrective treatments were not reported. At the time of the report, the patient had not recovered from the event. Follow-up information received 17 February 2009 from a physician. The similar type reaction previously referenced, occurred after receipt of Imferon (previously reported as Inferon), an iron dextran injection. Multiple consultations have failed to come up with an explanation for the patient's poly arthritis. The patient was noted to have a low tolerance for pain and discomfort and has not shown any improvement in her symptoms. Due to this new information received, this case has been upgraded from non-serious to serious. List of Documents held by Sender: None.
Medical Assistant in triage told the Medical Assistant in charge of the patient that Hepatitis A vaccine was needed for the 18 month check up, but she did not review patient's chart. MA in charge of the patient told the provider, but they didn't review the patient's chart and proceed with the administration and it was too early to get the vaccine.
Recurring Fever; chills; nausea; severe body aches; severe exhaustion; not clear headed; chest pressure; almost fainted right after the infections 2 & 3; respiratory issues; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Dec2021 10:00 (Lot number: Fj8762) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "covid", start date: 10Dec2020 (unspecified if ongoing), notes: Had covid 10Dec2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: Er2613, prev dose lot unknown: False, prev dose administration date: 15Apr2021, prev dose administration time: 04:00 PM, prev dose number: 2, prev dose vaccine location: Left arm), administration date: 15Apr2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Exhausted"; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: Er2613, prev dose lot unknown: False, prev dose administration date: 18Mar2021, prev dose administration time: 09:00 PM, prev dose number: 1), administration date: 18Mar2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Exhausted".  The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021 10:00, outcome "unknown", described as "Booster"; PYREXIA (non-serious), outcome "recovering", described as "Recurring Fever"; CHILLS (non-serious), outcome "recovering", described as "chills"; NAUSEA (non-serious), outcome "recovering", described as "nausea"; PAIN (non-serious), outcome "recovering", described as "severe body aches"; FATIGUE (non-serious), outcome "recovering", described as "severe exhaustion"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "not clear headed"; CHEST DISCOMFORT (non-serious), outcome "recovering", described as "chest pressure"; PRESYNCOPE (non-serious), outcome "recovering", described as "almost fainted right after the infections 2 & 3"; RESPIRATORY DISORDER (non-serious), outcome "recovering", described as "respiratory issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, nausea, pain, fatigue, feeling abnormal, chest discomfort, presyncope. Therapeutic measures were taken as a result of respiratory disorder.  No follow-up attempts are possible. No further information is expected.
Patient had known recent covid infection on 8/20/21. Admitted to hospital on 9/7/21 with SOB, abdominal distension and nausea, vomiting and diarrhea. Paracentesis was performed on 9/8 and 9/13 for continued abdominal swelling. Increasing need for 02 supplement due to swelling/volume overload. Chest xray worsening. Was being treated with combivent nebs and symibcort for COPD exacerbation and zosyn. Continued to decline with multiorgan compromise. Elected transition to comfort care and passed on 9/15.
Approximately 7.5 hours after the fist dose, at a basketball game, I began to sweat profusely, my vision blurred, and became extremely nauseated. My partner had to help me out of the venue and drive us home as I sincerely thought that I might lose consciousness at any moment and was unable to operate a vehicle. By the time we reached home, my fever had spiked to 103.1 and I was vomiting. I was severely ill for the next 48 hours. Since the having the vaccine I my vision is still blurry for things closer than about 18 inches from my face. I have never required reading glasses before, but now do.
pt recv vax & pt exp low grade fever of 99.0 & gen feeling not feeling well, devel 2 vesicles on chest w/2 small early eruptions on back of neck;also exp local rn @ inj site that was red;
pt recvd vax & became very irritable; 1st 6-8 hrs pt cried continuously; the pitch of cry was high than nl;
I received both doses of the Moderna vaccine first on 1-11-2021 and the second on 2-14-2021. Both injections were given IM in the left deltoid by the hospital I work at. After the first vaccine I noticed I was having more vivid dreams than I ever have before and have worsened since the 2nd vaccine on 2-14-2021. On 3-3-2021 I began having pain in my left armpit that is very sore and swollen like a beast lymph node
Patient developed fever up to 104 and tenderness on his right thigh. With diffuse swelling or tenderness of 5 cm x 5 cm. He developed oral lesions 2 days later. 12/19/17 well.
on 4/9/2021 I felt very fatigue and had a headache all day long my eyes where burning of my headache.  When I cough it hurts all the way  down my right arm.
An hour or so after the shot my arm started to get sore and I started to feel fatigued. During the evening the arm pain grew worse. The next morning I remained fatigued and ran a low fever. The arm pain was reduced. The low grade fever lasted until around 5 pm. The next day I felt close to back to normal until around 7 pm when fatigue set in again.
a dose of MENACTRA was inadvertently administered instead of Meningitis B with no adverse event; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old female patient who received a dose of Menactra was inadvertently administered instead of Meningitis B (wrong product administered), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. On 21-Dec-2020, the patient received a dose of 0.5 mL suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6641AB and expiry date: 30-Jul-2021) via intramuscular route in the left deltoid. Reporter stated patient had already received both (two) doses of MENACTRA, the second dose was administered 18-Jun-2020.      Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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 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.
three patients were administered with only the adjuvant part of Shingrix; three patients were administered with only the adjuvant part of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number M397F, expiry date 23rd April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: A medical assistant reported that the patient was administered with only the adjuvant part of Shingrix. The medical assistant discovered the error but she could not provide any details about the patient administered with a partial dose because that information was still not available. There were 3 patients who received only adjuvant part out of total 10 patients. This last situation made that all the patient would be revaccinated, and considering this, 7 patients would receive a third dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient was administered with only the adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case is one of 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR067807:same reporter US-GLAXOSMITHKLINE-US2022AMR071124:same reporter US-GLAXOSMITHKLINE-US2022AMR071123:same reporter
HEADACHE; FEELING HUNG OVER; BODY ACHES; PAIN BEHIND EYES; This spontaneous report received from a patient via a company representative concerned a 45 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced headache. On 2021, the subject experienced feeling hung over. On 2021, the subject experienced body aches. On 2021, the subject experienced pain behind eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, feeling hung over, body aches and pain behind eyes was not reported. This report was non-serious.
Dizziness and uncoordinated. Started 2 days after vaccine. PCP recommended evaluation at Urgent Care.  Went 12/15 and encouraged me to call if symptoms get worse.  EEG, labs and BP normal.
he started feeling pain at injection site at arm, fatigued, really tired, sleepy, body aches but no c/o of fever. He complains that his temperature is fluctuating between hot and cold. No c/o sob but he states he has upper back by shoulder blade pain (states feels like someone is stabbing him but it comes and goes). He also states a slight neck pain and c/o his bones are hurting all over. Patient stated he felt nauseous in the morning after breakfast but no longer has that feeling. Patient took Motrin on Monday @6:30am and around 12pm but didn't do anything. Advised patient to take Tylenol as directed, rest up and hydrate and monitor himself. Also informed him if feels any SOB or chest pain to seek medical attention (ER or urgent care).
Received second dose on a Thursday 2/4/2021 and started my eye side effects on Sunday 2/7/2021. Went to eye doctor on Tuesday 2/9 and doctor informed me that my conjunctivitis (viral) is from reaction to the vaccine.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Error: Infection / Cellulitis (diagnosed by MD)-
103 degree fever (day 2), muscle aches, muscle weakness, fatigue for 4+ days thus far
Mother reports tht child cried for 4 hrs straight, had staring of eyes, jerking of hands, fever and protruding of her tongue.
Covid infection on 7/27 . Developed syx 7/30  given C/I monoclonal sub Q
I received the booster Fever 101 for 36 hours with chills Malaise for 5 days  No appetite for 6 days
patient came for 2nd dose of the Moderna covid-19 vaccine, 43 day after their first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient came for 2nd dose of the Moderna covid-19 vaccine, 43 day after their first dose.) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient came for 2nd dose of the Moderna covid-19 vaccine, 43 day after their first dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient came for 2nd dose of the Moderna covid-19 vaccine, 43 day after their first dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Back Pain, body aches, extreme fatigue, fever of 102 degrees Fahrenheit, cough, sore throat that lasted 5 days. Unable to work
VACCINE INDUCED INJURY; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine induced injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine induced injury was not reported. This report was non-serious. This case, from the same reporter is linked to 20211259197.
Started noticing red itchy spots on the backs of the legs. Between 10/11 & 10/12, the hives exploded causing me to seek medical care. Dr. prescribed steroids & antihistamines.
Pt vaccinated with FLUZONE developed high fever 103+, aching, chills. No other sx. Did develop cough.
pt recv vax 30JUL98 & 930AM c/o swollen glands bilat & swollen tonsils;no sore throat or fever;trouble swallowing;better today;