chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 8/26/2021. Patient presented to ED on 10/2/2021 for shortness of breath, coughing and wheezing. Patient has a week of feeling unwell, saying she has had worsening dyspnea on exertion, PND and orthopnea. She also mentions stopping all of her medications for two days when that happened because she was feeling too unwell. 4 days ago, her shortness of breath acutely worsened. She had been dusting and the dust made her wheezing and coughing worse. Shortness of breath became severe enough that she needed to come to the ED. The patient was admitted on 10/3 for COPD exacerbation and COVID pneumonia. She developed worsening hypoxemic respiratory failure with increasing HFNC requirements and was subsequently transferred to the ICU on 10/11. Her renal failure worsened so a femoral quinton was placed but the patient became very hypotensive and hypoxic with every attempt at HD or CRRT. The patient decided that she would not want to pursue intubation in the setting of further respiratory deterioration. Code status was changed to DNAR-COT. Since dialysis made the patient too hypoxic while already on HFNC, the decision was made to not pursue further dialysis and the quinton was removed. Then, the patient's pneumonia panel came back positive for pseudomonas and her respiratory culture indicated the presence of mold. She was started on cefepime and cresemba. Her oxygen requirements decreased and she was transferred back to the floor on 10/19. However, on 10/20 she was brought back to the ICU once again for worsening hypoxia requiring 60L/90% on HFNC. She also developed hemoptysis, anemia, and thrombocytopenia requiring transfusion of platelets and pRBCs. V/Q scan was negative for PE. On 10/23, the patient developed acute word finding difficulty while speaking with family member in the setting of a brief run of afib and ongoing thrombocytopenia. CT brain was ordered to assess for stroke/bleed. However, after discussion with the patient and her daughter, the decision was made to withdraw all support. She was made DNAR-AND and was started on comfort care.  On 10/24/2021, patient was pronounced deceased.
complex febrile seizure lasting over 45 min, medical helicopter to hospital, 102 fever in ER, seizure stopped in ER when given Ativan, had second seizure 8/09/19 with no fever, clinic tonic lasted 5-6 min
Injection site red. Left arm discoloration to elbow; Left-arm inflammation, left supra clavicular inflammation of the lymph node. Bowel movement x3 5/10/08. General body ache. Temp 101.0 deg F, chills - Flu-like Symptoms.
sore arm local to injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm local to injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm local to injection site). At the time of the report, VACCINATION SITE PAIN (sore arm local to injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Speech impaired; Dominance difficulty in understanding speech,; Tired; Eyes hurting; I feel like I want to go to sleep; Eyes flashing; Breathing problems; Cramps in legs and buttocks; Hair problems; Throat is bothering me; My neck and joints is bothering me; My armpits are bothering me; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathing problems), MUSCLE SPASMS (Cramps in legs and buttocks), HAIR DISORDER (Hair problems), OROPHARYNGEAL DISCOMFORT (Throat is bothering me) and MUSCULOSKELETAL DISCOMFORT (My neck and joints is bothering me) 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 was provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] and SIMETICONE (GAS RELIEF) for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced DYSPNOEA (Breathing problems), MUSCLE SPASMS (Cramps in legs and buttocks), HAIR DISORDER (Hair problems), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), MUSCULOSKELETAL DISCOMFORT (My neck and joints is bothering me) and DISCOMFORT (My armpits are bothering me). On 07-Jun-2021, the patient experienced EYE PAIN (Eyes hurting), SOMNOLENCE (I feel like I want to go to sleep), PHOTOPSIA (Eyes flashing) and FATIGUE (Tired). On an unknown date, the patient experienced SPEECH DISORDER (Speech impaired) and MOTOR DYSFUNCTION (Dominance difficulty in understanding speech,). At the time of the report, DYSPNOEA (Breathing problems), MUSCLE SPASMS (Cramps in legs and buttocks), HAIR DISORDER (Hair problems), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), MUSCULOSKELETAL DISCOMFORT (My neck and joints is bothering me), DISCOMFORT (My armpits are bothering me), EYE PAIN (Eyes hurting), SOMNOLENCE (I feel like I want to go to sleep), PHOTOPSIA (Eyes flashing), SPEECH DISORDER (Speech impaired), MOTOR DYSFUNCTION (Dominance difficulty in understanding speech,) and FATIGUE (Tired) was resolving.        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.   The patient states she was taking some medications for her mind, for breathing. The patient gave medications that are prescribed to her, which were not specified.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021:  updated
fever; shivering; wheezing; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 21st June 2021) for prophylaxis.   Concurrent medical conditions included asthma.   On 10th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than 3 weeks after receiving Shingrix, the patient experienced fever, shivering and wheezing. On an unknown date, the outcome of the fever, shivering and wheezing were unknown.   It was unknown if the reporter considered the fever, shivering and wheezing to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on the left deltoid. The patient experienced fever, shivering and wheezing that resolved and then went back about one week later. This case has been linked with case US2019140579, reported by the same reporter.
I went to see my doctor for a routine check up in October 2021. They saw that I had clogged arteries. I got a stent put in my heart. My blood pressure has also gotten high. I was prescribed Lipitor, blood thinners, and high blood pressure medications.
This spontaneous report as received from a Certified Medical Assistant (C.M.A.) refers to 4 patients of unknown age and gender. On an unknown date the 4 patients received improperly stored PROQUAD (lot #, strength, dose, frequency, route unspecified). Temperature excursions for the vaccine were supported with in-house stability data. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Shoulder, elbow, wrist and arm pain began following the injection and has not subsided.
Pt was reportedly standing with mom and noted to spontaneously drop to the floor (hitting her head with a subsequent forehead hematoma).  Pt was noted to be rigid with extended extremities, a blank stare, and no response for 15 to 30 seconds.  She was drowsy thereafter but returned to her baseline within 1/2 hour.
Patient was admitted to observation level of care on 10-9 for hyponatremia. Patient is noted to have tested positive for covid on 10-7.
This case was reported by a nurse and described the occurrence of allergic reaction in a 25-year-old male patient who received MENVEO (batch number M14071, expiry date unknown). On 22nd January 2015 14:40, the patient received MENVEO (intramuscular) .5 ml. In January 2015, 15 hrs 20 min after receiving MENVEO, the patient experienced allergic reaction, generalized pruritus, burning sensation, generalized rash, generalized erythema and generalized urticaria. The patient was treated with SOLU MEDROL and BENADRYL (nos). On 23rd January 2015, the outcome of the allergic reaction, generalized pruritus, burning sensation, generalized rash, generalized erythema and generalizes urticaria were recovered/resolved. It was unknown if the reporter considered the allergic reaction, generalized pruritus, burning sensation, generalized rash, generalized erythema and generalized urticaria to be related to MENVEO. Additional details were received as follows: On 22nd January 2015, at 2:40 pm, the patient received a dose of MENVEO. On 23rd January 2015, at 6 am, the patient wake up with allergy, all over body rash, itching, burning sensation, urticaria when he scratch his skin and specially when he had contact with cold water. On 23rd January 2015, at 11:30. 5 hours and 30 minutes after starting the events, the patient was recovered. The patient visited to emergency room but was not admitted for prolonged time. On 23rd January 2015, at 11:30 the patient was recovered.
14 days after vaccination postular rash on hands/feet - No systemic signs/symptoms, vaccine site healed normally. Treated with antihistamine.
Pt recvd 1 dose Engerix-B 31MAR92 @ 1130AM &  30mins post vax, pt felt blood rushing to head, felt hot & cold, mouth dry, felt windpipe swelling, hyperventilating, tingling in hands, couldn't walk; Pt seen by MD who felt was allerg react;
First noticed area of swelling and redness @ L upper arm evening of 10/13/15.  Site was larger in morning of 10/14/2015, so patient went to ER.  Patient was given steroids shots and 5 day steroid.
Fever, chills-several hours.  Headache-1 day.  Sore arm-3 days. Swelling and redness around injection site-4 days ,
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 05-NOV-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 1.11 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
pulmonary embolism; short of breath; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative.  A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died of pulmonary embolism 2 days after 2nd vaccine dose. She had been short of breath the day after the shot, called the pharmacy where she'd received it, and they told her to go to ER. The reporter thought that she did not go to the ER, and then later died at home. It was unknown if an autopsy was performed. Outcome of the event short of breath at the time of death was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pulmonary embolism
Patient's throat was swollen, had difficulty breathing, was dizzy, said his mind felt "foggy". Said he should've gone to ER but was too stubborn. 99.2 degree fever.
Have had a headache daily since vaccination. Took a while to realize that it has been since the vaccination that this has been ongoing. Have always had problems with headaches, and migraines. This has been ongoing, first attributed it to allergies/sinus problems/stress, gave the ongoing headache many excuses. Last night realized that this is likely an adverse reaction to vaccination. Ibuprofen, Tylenol, Tylenol Migraine, Aleve: None Work. Have not yet been to PCP to seek treatment, as I was attempting to resolve on my own. Will be making an appointment with PCP to seek further treatment.
Immunization on 09/17/2001. Fever 104 09/26/2001 decrease to 102 09/28/2001, Temperature 99. Pt has 2 fluid filled vesicles on neck; shoulder, chest and back, has red dots. Cutting teeth now and has had running nose flux with yellow drainage.
Patient had reaction to Varicella vaccine at the site of vaccination. Patient was previously given 1 vaccine in 1997, and has previously had chickenpox.  Patient developed a rash that was slightly itchy, warm to touch, with redness, 30mmx20mm induration. No other symptoms.
No additional AE reported; Caller states an expired dose of PNEUMOVAX 23 (pfs) [ lot: T035379; exp: 5/31/2022] was administered to a patient; This spontaneous report was received from an office manager (also reported as a health care business professional) and referred to a 73 years old female patient. The medical history, current conditions and concomitant medications were not provided.  On 29-JUN-2022, the patient was administered with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose: 1 (unit not provided), lot # T035379, expiration date: 31-MAY-2022; strength and route were unknown) for prophylaxis (expired product administered).  The vaccine was stored at the recommended storage range until administration. The reporter was provided with supported disclaimer per article guidance and post expiry memo. No additional AE reported.
Patient was received her Covid vaccination in her right arm approximately 9:15am.  With about 5 minutes she became shaky, sweaty, flushed, and stated she had a ?medication taste in mouth?.  She had eaten breakfast, but was given a snack & juice.  Nurse reported slightly elevated BP (exact numbers not given).  Patient was taken to ER for care.
left neck mass.   CT neck showed: IMPRESSION: 1.  Left axillary and left supraclavicular lymphadenopathy, most likely related to recent ipsilateral COVID vaccination. The left supraclavicular lymph node corresponds to the finding on ultrasound. Recommend continued clinical follow-up for the palpable abnormality. If the palpable lymph node persists or enlarges, follow-up imaging may be considered. 2.  Hepatic steatosis.  3.  Mild paranasal sinus disease.
cold like symptoms; tired; has soreness at vaccination site; has hot and cold flashes; has hot and cold flashes; coughing; wheezing/Mild Wheezing; arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 06Aug2021 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: use her asthma inhalers if needed. The patient's concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious) with onset 07Aug2021, outcome "unknown", described as "tired"; VACCINATION SITE PAIN (non-serious) with onset 07Aug2021, outcome "unknown", described as "has soreness at vaccination site"; HOT FLUSH (non-serious), FEELING COLD (non-serious) all with onset 07Aug2021, outcome "unknown" and all described as "has hot and cold flashes"; COUGH (non-serious) with onset 07Aug2021, outcome "unknown", described as "coughing"; WHEEZING (non-serious) with onset 07Aug2021, outcome "unknown", described as "wheezing/Mild Wheezing"; PAIN IN EXTREMITY (non-serious) with onset 07Aug2021, outcome "unknown", described as "arm soreness"; NASOPHARYNGITIS (non-serious) with onset 08Aug2021, outcome "unknown", described as "cold like symptoms". The events "tired", "has soreness at vaccination site", "has hot and cold flashes", "has hot and cold flashes", "coughing", "wheezing/mild wheezing", "arm soreness" and "cold like symptoms" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fatigue, vaccination site pain, hot flush, feeling cold, cough, wheezing, pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Reporter cousin called tonight to report that she took the Pfizer vaccine on Friday at her doctor's office and is not feeling. She stated she was very tired, has soreness at vaccination site, has hot and cold flashes, coughing and wheezing. She called her doctor who advised her to go to urgent care tonight. She said symptoms started Saturday morning when she woke up tired and with arm soreness. She was seen by a physician at urgent care last night. She was tested for COVID and the results were negative. The physician stated that she had cold like symptoms, her blood pressure was normal and had mild wheezing. She was instructed to rest, drink plenty of fluids and use her asthma inhalers if needed. She has a history of asthma.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red for 2 days, induration in both areas for approx. 1 month. As per mother, the pt is up-to-date with his vaccinations but there is no record. She further stated that this is the 1st time that the pt had a reaction of this sort. There are no other siblings in the household.
The next two days I had a sore arm. But a week later, the following Monday and Tuesday, I had fatigue and headaches. I put the date as Wednesday because that is when the concerning possible reactions began. I woke with clogged ears feeling very sick. I took Advil Cold and Sinus and arranged to miss work. It felt like a possible ear infection in my left ear. Also my forearms were painfully sore. I had lifted a heavy box up the stairs the afternoon before but the pain in my arms was immeasurably more than ever expected. My ankles were also very tender as I had done a little jogging the day before and I normally walk. As the day progressed I was barely able to get out of bed. Sleeping and just laying there. My highest temperature was 101.25 at 2:45 pm. I had severe chills on and off. I reported these afflictions and was mailed a covid test by Thursday. The test came back negative by Friday evening. Wednesday night my whole body was tender and I had no appetite. I took tons of vitamins and drank tonic tea and took advil and nasal allergy medication. I am still using all of those. Thursday I woke drenched in sweat. My head was mostly cleared just a wet ear and I had a low grade fever on and off through the day. Just touching my body against a surface was painful. Or putting my hand on my hip. My forearms and ankles were no longer worse than the rest. I received my covid kit and taking it to be mailed was the only time I left my house. I was surprised to find extreme difficulty walking down the stairs with muscle strain and pain in my joints. I was not nauseous but had no appetite. Friday I woke up hungry and felt better. No fever. Fatigue and body tenderness but it was better. Saturday my body is only sore on my glands and jaw and back of head. And my muscle is sore in my left arm. The oddness of that being where my shot was given is what makes me wonder if it was an extreme reaction to the vaccine. Maybe it is a flu. I have never had the body pains I try to describe before.
Pt. forgot she had already received a PREVENAR - 13 shot from her MD and received another one from us on 8/29/16. The one from the MD was administered on 11/4/15.
Middle of Jan. 15, 2022, pain in arm and concerned with it. Went to primary care doctor, Dr. took an x-ray and made arrangement for therapy referral and she called and received the referral and still in therapy. Six weeks issue with arm and been in therapy for three weeks.
Initial unsolicited report received from a Physician via partner company Pfizer (manufacturer reference Number: 2017021955) on 01-FEB-2017. This case involves a 76-year-old female patient who was vaccinated with doses of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose and dose in series, site of administration were not reported) on an unknown date. Patient's medical history were reported as patient had arthritis, tumor or cancer, depression, hypertension, high cholesterol, had rotator cuff repair in the right side on 2013 and left knee on 2016. The patient was non-smoker and also had codeine allergy and patient's family history reported as Headache or migraines and Stroke. Patient had developed blotted sensation in bowels with distension of the stomach. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had stomach flu in the interim, leading to vomiting, weakness in the intercostal muscle, feeling upset, snapping sensation in the neck, muscle spasm which leading to head twitch, stress and headache. The patient had doctor visit on 08-Dec-2016. Laboratory investigations was reported as patient's body mass index 28.36, blood pressure 120/89 millimeter mercury and pulse rate 118 beats per minutes. Corrective treatment was not reported. On an unspecified date, patient recovered from headache. The outcome of other events was not reported. List of documents held by sender: none.
Outbreak case of COVID diagnosed using a PRC test  12/29/2021 ; prescriptions were called in was really sick.
Sore for 3-4 days. Took Band Aid Off and saw blister. Blister - with red liquid.
Narrative:  Covid +, Moderna #2 vaccine, confusion, cough, weakness, fever, dec appetite, SOB x 2 weeks, decadron. d/c home
pt. started having diarrhea exactly one week after recieving the vaccine and it continued for 19 days; diarrhea was brown liquid with mucous in it occasionally; diarrhea also had a strong odor; the first 6 days she had at least 5 stools/ day sometimes 6 or 7; the diarrhea would sometimes be green and mucousy not pure liquid
I felt fine the rest of yesterday but started to feel really tired and worn down late last night. I took my sleeping pill like normal and went to bed. I woke up feeling really achy and cold so I went to take some Tylenol in case I had a fever. Started feeling dizzy and light headed and I passed out. I cut my foot on the glass I dropped and scraped my back as I fell. I don?t remember being blacked out very long. I just remember sitting on the floor feeling really lethargic. My whole body felt tingly and my ears were ringing really bad. Was able to get up and get back to bed. Decided to go back to sleep and not go to the ER. This morning I?m still a little dizzy but mostly just have a headache and am extremely tired. I plan to get into my doctor today so I will keep you updated. Just wanted to let you know what happened so you could report it.