chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Onset of erythema 4x4cm & induration 3x3cm at injection site beginning 12 hrs after vaccine. Progressed to 11cmx11cm erythema induration unchanged within 24 hrs - resolved by 72 hrs. Also c/o itching/tenderness at injection site and itching on upper chest.  Denies fever, ?, SOB,throat swelling.
Patient required hospitalization due to breakthrough infection. She received J&J vaccine on 05/25/21. Hospitalized from 07/23/21 - 08/21/21 (death). Below is copied from discharge (death) summary:   Patient 47 y.o. female with PMH of asthma, MAC PNA, and MRSA PNA (treatment course above) admitted to Hospital on 07/24/2021 for evaluation of progressive fatigue of 2 weeks, generalized weakness limiting activities of daily living. Found to be COVID positive. She recived J&J COVID-19 vaccination 5/25/21. Pt also noted to have a fever of 101, chills, and sore throat. Patient has been followed by pulmonary service for pulmonary cavitary lesions, MRSA, and MAC. Pt went to PCP and told her to go to ED. Patient admitted to Hospital North campus. Pulm and ID consulted this admission. CT chest with mycetomas noted. IV abx given per ID recs. BAL done 07/27 cx growing MRSA put on Bactrim, which was transitioned to Vanc, Zosyn, and minocycline given worsening thrombocytopenia. MICU consulted for worsening respiratory status and increasing oxygen requirements. 8/10/2021 ED Intubated in the setting of respiratory failure and transferred to MICU for further management. On 8/12 CT Head showed 3.4mm thickness subdural hematoma in the R frontal with occipital infarcts. S/p BAL with MRSA, started on linezold. 8/15 Transitioned from Zyvox to Bactrim due to rash, for treatment of superimposed pneumonia with MRSA on BAL. Pt transitioned to PS 8/16 and tolerated well. After discussion w family, they would like to proceed with tracheostomy.  Pt has increasing WBC this AM. Respiratory cultures.  Tracheostomy placed 8/20 with minimal blood loss   8/20, 95/39 MAP 59 200mcg phenylephrine given plus 100 more   Pt was found to be bleeding through her tracheostomy tube, surgery consulted and placed sutures, bleeding slightly decrease   Hbg 6.8 1U blood trans   8/21/2021: Patient's family visited at bedside, and then proceeded to the family counseling room. After an extensive discussion regarding the patients status and prognosis, the family (Pt's mother, father, and daughter) decided to compassionately wean the patient.  A morphine drip was started, pressors, and O2 were weaned. The patient expired shortly after.
VERTIGO; CLOGGED AND HOLLOW EARS; SUPERFICIAL THROMBOSIS OF LEG; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's past medical history included right leg amputated below the knee, and concurrent conditions included varicose veins in legs. The patient was previously treated with acetylsalicylic acid for right leg amputated below the knee. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced superficial thrombosis of leg. On 12-APR-2021, Laboratory data included: Ultrasonography (NR: not provided) no deep vein thrombosis. had a "superficial thrombosis. On 13-APR-2021, the subject experienced vertigo. On 13-APR-2021, the subject experienced clogged and hollow ears. Treatment medications (dates unspecified) included: meclozine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo on 04-MAY-2021, and had not recovered from superficial thrombosis of leg, and clogged and hollow ears. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious
Skin Rash, Rash, Urticaria Pruritis, VESICULAR RASH. Tx: DIPHENHYDRAMINE, HYDROCORTISONE, PREDNISONE  Follow up information received - Patient's date of birth 04/28/47, manufacturer: Novartis, vaccine lot number 102132P1, IM, left deltoid, doses.
Swelling on the arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling on the arm) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling on the arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. On 07-Mar-2021, VACCINATION SITE SWELLING (Swelling on the arm) and HEADACHE (Headache) had resolved.            Treatment information included generic for tylenol and naproxen.   This case was linked to MOD21-042548 (Patient Link).
Fever ranging from 100-101 F lasting 24 hours. Chills, muscle pain all over, joint pain all joints, fatigue, somnolence, very sore arm of injection site, all lasting 24 hours.  Missed 1 day of work. Took Tylenol 1000 mg every 8 hours. Was perfectly fine after 24 hours with slight soreness of injection site lasting a few more days.
Injection site edema 9x6 right arm.  Given BENADRYL po at office & q 8 hours PRN.
This spontaneous report was received from a medical assistant and refers to a 3-year-old male patient. The patient's pertinent medical history included an unspecified reaction to PREVNAR 13. On 09-AUG-2018, the patient was vaccinated with (Oka/Merck) VARIVAX injection, into left arm (lot # R002506, expiration date: 25-JAN-2020, indication was reported as vaccination, dose and route of administration were not provided). On 10-AUG-2018, the patient experienced swelling and a rash in left arm with small little bumps around the injection site. The physician sent the patient to an unspecified emergency room on 10-AUG-2018, where patient received unspecified BENADRYL. The patient was treated and released from emergency room the same night. No laboratory diagnostics or studies were performed. The outcome of the events was reported as recovering. The relatedness between the events and (Oka/Merck) VARIVAX was not reported.
Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA001853: US-009507513-2107USA008730: US-009507513-2107USA008731: US-009507513-2107USA008732: US-009507513-2107USA008733: US-009507513-2107USA008728: US-009507513-2107USA008727:
She got her vaccine, started the next day her arm was sore and it is now gradually gotten worse.  She had excruciating pain when she moved her arm, raise her arm or move it to the left.  She cannot take her left arm and put it around her back.  When she goes to wash her hair to raise her arm it hurts.  To take her arm out of her clothes it hurts.  To sleep it hurts when she lays on it.  When she is driving to take her left arm to turn the blinker on it hurts.  It's almost a constant pain at times.    She has seen an orthopedist for this, she has had three steroid shots and PT.  He diagnosed her with a frozen shoulder.  She said that none of the treatments or medicine has helped her symptoms.   Her dr. said that he has had several patient's that have come in with the same symptoms she has had.    She had an x-ray or MRI.    She did get her 2nd vaccine, and has worsened over a period of time.
Acute CVA with some permanent loss of left arm functionality. Heart Failure with evidence of myocarditis. 51% LV ejection fraction. Frequent Supraventricular Tachycardia events resulting in dizziness.
Prolonged pain at injection site and progressive loss of range of motion of left shoulder. Currently under care of Orthopedist; getting physical therapy.
rash and edema in LUE 8"X5" area around and including injection site. It is red and itchy.
This spontaneous report as received from a Registered Nurse refers to a 15 anonymous patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with PEDVAXHIB lot # K025005, expiration date 07-JUN-2017 (dose was not reported). The patients received a doses of PEDVAXHIB that was stored improperly. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Approx 12 hrs after PNEUMOVAX administration, patient developed redness, swelling and pain in (R) upper arm. Also reported fever, chills, headache and lethargy.
At around 3 am, the day after getting the vaccine, I woke up having severe chills, running a fever and achy all over especially my back. At around 7 am I could not move the arm I got the vaccine in without major pain and my entire body was very sore especially my back. I was extremely fatigued with a headache and had virago. This lasted all day Friday, then on Saturday I still had a mild temperature and still sore but not as severe except for my back and still I had a headache. I noticed a little swelling under my arm.  On Sunday, I felt a lot better but still a little fatigued and my back is still hurting. It was just like having Covid 19 again but a shorter version.
1st does no adverse effects. 2nd dose first 12 hours  OK. But for next 24 hours felt sick nausea and weak. Flu like symptoms. Then shortly after that got Tinnitus right ear. Still now after 2 weeks. Will not go away. Unbearable. Never ever had tinnitus. My eara always in good shape. No Tinnitus in my family on both sides.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 56-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 29Mar2021 at 15:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 22Apr2021, the patient developed shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measure was taken as a result of the event shingles and included treatment with valacyclovir (VALTREX) on an unknown date. The clinical outcome of the event shingles was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient came in complaining of severe pain at the injection site, very warm to touch, and patient states that the vaccine may have been administered too high above the recommended site. She states that she works for a physician office and has some clinical knowledge. She was prescribed AUGMENTIN for her possible infection.
Patient presented for a covid booster. Vaccine being administered in left deltoid and needle and syringe separated. Unknown amount administered. Consulted with MD and order received to repeat half dose.
First injection on 3/2/21 I developed Eustachian tube dysfunction with significant hearing loss in bilateral ears. Treated with Rx ear drops. No infection noted on exam findings. Symptoms nearly resolved w/in 2 weeks. Second injection on 3/23/21, I did not have any reaction or adverse symptoms until 2 days after. The ETD restarted. I was treated with Prednisone with a positive response w/in 2-3 after treatment, while tapering the Prednisone my ETD got more severe. I am scheduled for an ENT visit on 4/6/21. My symptoms are progressing to the point of inability to tolerate hearing my voice or any other noises.
in ??aug/98 pt recv vax & on 05sept/98 pt devel swelling of lt eyelid & 9-10 small vesicles/papules on an erythematous base. treated w/zyrtec & calamine. zyrtec was sedating & changed to claritin. by 10sept vesicles crusting over.
got the flu; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who got the flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient was required to take it for 10 years at the job and got the flu every year and starting the year after retirement (20) years ago and never had the flu shot nor the flu.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Developed red mosquito like rash to neck, bilateral arms, chest, thighs. Only itching noted to neck area. Rash onset 3/10/17 and has been taking BENADRYL with no improvement. Encouraged to cont. taking BENADRYL and notify PCP or urgent care. 3/21/17 - Call to patient, left msg to return call for follow up on reaction. 3/23/17 - Call to patient. States she did not go to PCP/urgent care but kept taking BENADRYL and rash resolved 3/18/17. She reports no further problems or questions at this time.
The patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician and refers to a 4-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 14-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S032355, expiration date 14-OCT-2021 as prophylaxis (Product storage error); which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT), lot # S032591, expiration date 16-AUG-2022 (dose, frequency and route of administration were not reported) (Product storage error).  The improperly stored suspect vaccine experienced a temperature excursion of 6 Fahrenheit degrees (6°F) to 14°F (average 13.6°F) for 12 hours (multiple excursions); and 15°F to 46°F ( average 16.0°F )  for 30 minutes. No previous temperature excursion was reported. The call was made due to a digital data logger.
Information has been received from a physician and a registered nurse concerning an 8 month old male with a history of cardiac murmur at birth (ECHO showed heart OK) and no known drug allergies and no concurrent conditions who on 20-JAN-2010 was vaccinated with the first dose of ROTATEQ (Lot# 664650/1098Y). On 17-MAR-2010 the patient was vaccinated with the second dose of ROTATEQ (Lot# 664872/1212Y) and on 26-MAY-2010 received his third dose of ROTATEQ (Lot #665272/0203Z). Concomitant therapy included other vaccines given on 26-MAY-2010 PENTACEL, PREVNAR 13 and hepatitis B virus vaccine (unspecified). It was reported that on 29-JUL-2010, the patient experienced dehydration, vomiting and diarrhea and was hospitalized. The patient was treated with IV fluid; laboratory tests performed on 29-JUL-2010 showed an increased RBC of 4.83, a decreased CO2 of 13, a decreased glucose of 52, and a decreased BUN of 4. No stool samples were tested for rotavirus. The patient recovered, was "all better" and on 03-AUG-2010 the patient was discharged from the hospital; labs back to normal by time of discharge. No discharge diagnosis available. Dehydration, vomiting and diarrhea were considered to be disabling. No further information is available.
immed p/vax pt devel inj site rxn characterized by induration & erythema;pt recovered @ the date of this report;this is 1 of 4 pt from this site to devel an inj site rxn following vax;
Pt developed infection in injection arm (right arm) but it's around the bicep and inner arm.  The infection seems to be seperate from the deltoid where the PNEUMOVAX was administered.
Patient developed nausea immediately after the administration of the IPV vaccine. He ran to the adjoining restroom and vomited once in the toilet. He returned to the exam room table and laid down on the table. He returned to baseline in 5 minutes. He was observed for 15 minutes and remained stable without any new symptoms. He declined offer of pretzels and juice.
This is an initial report of an Adverse Event, received on 30/Sep/2015, for FLUBLOK. The female subject received FLUBLOK Intramuscular on 28/Sep/2015. The day after receiving FLUBLOK, 29/Sep/2015 (FLUBLOK administered on 28/Sep/2015 at an unknown time (Lot #: 550603F)), the subject experienced redness, a mild rash 3 cm by 5 cm, and itchiness at the injection site. At the time of this report, the outcome of the events was not reported; however, the itchiness was improving. Medical/surgical history for the subject reported that the subject had multiple allergies to penicillin and sulfa. Concomitant medications were not reported. Causality information was not provided. The company's assessment of the causal relationship between redness, mild rash, and itchiness at the injection site and FLUBLOK is a possible relationship in light of the safety profile information that injection site reaction is an expected event. In summary, this case report does not change the known safety profile of FLUBLOK.
I was vaccinated approximately 1 year ago. In the intervening period, I have never had COVID. I have not even had a sickness that maybe could have been COVID. I have remained 100% healthy ever since this vaccine.  On April 5th at ~3am, I woke up to stabbing chest pain from my sternum to right clavicle. I took ibuprofen, stretched, and returned to sleep. I worked through moderate pain the follow day and slept through the night. I woke up on April 6th to even worse pain. I sat up in bed, coughed, walked to the bathroom sink, and spat out a mouthful of blood. I immediately went to the ER.  I was diagnosed via CT scan by noon of April 6th with a pulmonary embolism. I have no prior medical history to speak of, and unprovoked pulmonary embolisms have no history in my family. I was given a Lovenox shot in the early afternoon and started on an IV bag of heparin, which I remained on until the following afternoon (April 7th). I was sent home with a prescription for Eliquis.  I am a healthy 25 year old male with no medical history, and spent the last 3 1/2 years in the job. I have maintained a healthy weight, eating habits, sleeping habits, and exercise habits. I was in perfect health until now.
On a pain scale of 1 to 10, inner aspect of right leg 7 or 8. So weird! Limping. Awakened throughout night with every movement in sleep. This lasted about 48 hours. Pressing inside aspect of right knee shot pain up to 10, radiating down to ankle and up inner thigh. Also had injection site redness, tenderness, and a raised lump, not unexpected.  Had some brain fogginess two days post injection as well. No treatment; just time. Note: I'm sure I had Covid-19 in February 2020. No test available then.
ARRHYTHMIA; VACCINE DID ABSOLUTELY NOTHING TO PROTECT ME; FLU LIKE SYMPTOMS; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was sick with a 4 day high fever and sweats and experienced flu like symptoms. Patient also had heart palpitations (arrhythmia). Patient had to be treated by a cardiologist for arrhythmia. Patient got covid twice (suspected covid-19 infection) and also reported that vaccine did absolutely nothing to protect the patient (Lack of drug effect). Laboratory data (dates unspecified) included: Body temperature high fever. It was reported as "One and done. I was done with all vaccines. Sick with a 4 day high fever, sweats, flu like symptoms along with heart palpitations. I had to be treated by a cardiologist for arrhythmia. I got Covid twice so this vaccine did absolutely nothing to protect me. Just some bad chemicals put in your body". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, arrhythmia, suspected covid-19 infection and vaccine did absolutely nothing to protect me was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000263680.; Sender's Comments: V0: 20221238362- Arrhythmia. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221238362-Vaccine did absolutely nothing to protect me. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/3/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R09.02 HYPOXIA 12/23/2022 NONTRAUMATIC ACUTE KIDNEY INJURY