chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 days after 1st dose patient experienced 2 days of blood in urine.2 days after 2nd dose experienced 2 days of blood in urine; This is a spontaneous report from a contactable consumer (Patient) via COVID-19 reporting through Regulatory Authority.  A 32-years-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0179), dose 1 via an unspecified route of administration, administered in Arm Left on 05May2021 13:00 as (At the age of 32-years) dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Left on 27May2021 13:30 (Batch/Lot Number: Ew0191) as dose 2, single at Doctor's office/urgent care, both doses for COVID-19 immunization. The patient medical history included depression, anxiety, herpes simplex, obesity, seasonal allergies and gastrooesophageal reflux disease. The patient previously took ceclor and experienced drug hypersensitivity. The patient concomitant medication(s) included paracetamol (TYLENOL) and ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. On May2021, 7 days after 1st dose patient experienced 2 days of blood in urine and 2 days after 2nd dose experienced, 2 days of blood in urine. Adverse event resulted into emergency room visit to the patient. Treatment not received for the event. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Rash on cheeks bilaterally - stated itching after shots given - rash appeared on Saturday. Has not changed since Saturday. No difficulty breathing.
Patient received Moderna vaccination on 3/11 and was starting to lose vision like a curtain coming across his eye. Made appointment with Doctor and he determined it was a detached retina.
12/13/21 Pt presents today for cough, generalized body aches x 1 day.  She has not lost taste and smell Denies known ill contacts She has been vaccinated against Covid-19 She does work as a restaurant server Review of Systems  Constitutional: Positive for activity change, chills, fatigue and fever. Negative for appetite change.  HENT: Positive for congestion, postnasal drip and sore throat. Negative for ear discharge, ear pain, rhinorrhea, sinus pressure, sinus pain and trouble swallowing.   Eyes: Negative for visual disturbance.  Respiratory: Positive for cough. Negative for chest tightness, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Positive for diarrhea. Negative for abdominal pain, nausea and vomiting.  Skin: Negative for rash.  Neurological: Positive for headaches. Negative for dizziness, weakness, light-headedness and numbness.
Back pain started after first dose. I did not initially attribute it to the vaccine. After the second dose: dizziness, migraine, ear ache, tinnitus, inner ear pain, adrenaline rushes, high heart rate
within 7 days of vaccination patient had relaps of afib requiring medical intervention. Has been otherwise controlled for extended period of time.
Diarrhea, NauseaVomiting, Tachycardia, tachycardia, NVD approximately 12 hours post injection Narrative:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-MAY-2012 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-NOV-2016 the patient was treated by a physician for severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was treated with valacyclovir hydrochloride (VALTREX) for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment, with monetary damages. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses,and pain and suffering, and other damages. Additional information has been requested.
C/O redness, warmth and swelling of (R) arm - 6cm x 4cm - posterior aspect of (R) arm. Dx - cellulitis vs. immunization rxn of (R) arm, Keflex 250mg/5ml tsp po BID x 10 days.
Night sweats, Rash over torso and back, heart palpitations, PVC?s, heart arythmia, increased heart rate, shallow breathing .  Still being treated but currently on Atenalol and aspirin daily regimen.  Also on atrial dialater  called Ranolazine ER
Pt. displayed redness at the site of injections, several minutes after administration.  Provider monitored pt. for any other adverse reaction after administration of BENDARYL 2 tsp P.O.  Redness cleared during observation.  Pt. released with no s/s of distress.
Information has been received from a registered nurse concerning a 44 year old female hospital employee who in approximately august 2001 experienced a lack of response after being vaccinated with a series of hep b vaccine recombinant. On 08/24/2001, the pt was vaccinated in the left arm with a booster dose of hep b vaccine recombinant. Subsequently, the pt developed shortness of breath, a fever of 99.4 F, confusion, change in cognitive status, lightheadedness and nausea. It was reported that pt also had numbness in her left arm. The pt was taken to the ER and was treated with an IV antihistamine. It was noted that the pt was not hospitalized. She was released from the ER. Subsequently, the pt recovered from shortness of breath, fever of 99.4 F, confusion, change in cognitive status, lightheadedness, nausea and numbness in left arm. It was reported that "now her only complaints are some alteration in cognitive status (some forgetfulness) and tightness and pressure in her neck." It was noted that her physician had her on restricted work, with no lifting allowed. Additionally, pt's alteration in cognitive status and tightness and pressure in her neck persisted. The pt's shortness of breath was considered by the reporter to be immediately life threatening. The tightness and pressure in her neck was considered by the reporter to be disabling. Additional info has been requested.
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) 1 dosage form. On 01-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported. Pharmacist is unaware if patient is taking medication. Pharmacist is unaware if patient had the side effects. Safety consent to follow up with the pharmacist received.
Lung transplant recipient from 9/2018, stable lung function and no significant rejection episodes.  Underwent first dose of COVID19 (Moderna) vaccination 3/22/21 and second dose 4/19/2021.  Developed progressive shortness of breath and presented to transplant clinic 4/26/21 with 30% decline in pulmonary function tests.  Transbronchial biopsies and extensive evaluation for infectious and known immunologic causes of rejection were negative.  Patient had progressive decline in lung function despite high dose augmented immunosuppression and was diagnosed with rapid onset chronic lung allograft dysfunction (bronchiolitis obliterans phenoytpe).  Lung function continued to worsen and she was transitioned to hospice 6/2021.  Spike protein antibody testing showed significant IgG and IgA response.  VAERS reporting being filed given chronologic and potential physiologic association between vaccination and onset of BOS.
Patient received a second bivalent booster. Patient was made aware by staff before leaving the clinic.  No adverse events occurred during  vaccine wait time.
Patient was transferred from a county jail to Corrections facility. He requested a COVID Vaccine. He did not tell us he was previously vaccinated at his county jail. He was given a Moderna vaccine on 6/10/2021 by the Health Department. On 6/22/2021 he received a Janssen (J&J) vaccine from us, 12 days later. Health Department was notified. Our instructions were to repeat the vaccine in 28 days from his last dose, and that the Janssen on 6/22 is invalid due to it being given to soon from the initial Moderna dose on 6/10.
10 cm erythematous area around vaccine admin. site with induration. (+) cluster of vesicles that are Varicella Zoster Virus PCR positive.
About 7:25 chills, shakes. About 7:30 passed out (about 10 seconds) pavement, about 5 mins. vomit and bowel movement - family called 911.
Erythema, induration and severe pain at injection site. Pt also reported pain in shoulder joint as well as at injection site that lasted for 3-4 days.
This spontaneous report was received from a physician assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 22-FEB-2018, the patient was vaccinated with one dose of M-M-R II injection, lot M029230, expiration date 08-JUN-2018, for prophylaxis (anatomical location were not provided). This dose was reconstituted with an unspecified sterile diluent (manufacturer, lot # and expiration date were not provided) that was not the recommended sterile diluent to be used for reconstitution as per the prescribing information. No adverse effects reported.
I had 3 doses of Pfizer prior to this Moderna Booster. Starting the evening of 04/23/2022 - 04/24/2022 I had a headache unlike any I had before. That morning I had a runny nose and felt like something was wrong (general malaise). I tested positive that day. On 04/25/2022, I contacted my doctor and he recommended that I go on antivirals (PAXLOVID). I wasn't feeling to badly but due to my age he thought it would be good to take it. I started PAXLOVID that night and the symptoms started to diminish. I was able to work and I did not have chest congestion. I mainly felt that my head was full (like a cold without any other cold symptoms). I took the PAXLOVID for 5 days and on day 7-8 the symptoms came back but not as bad as before. I took some immune support supplements that I would normally take if I had a cold and some aspirin. This lasted another week or so then resolved on their own. About a month later I had some joint pain flare up for a few weeks in my knees, ankles and shoulders which had never happened before and it resolved on its own.
Arm felt like was kicked by a mule; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was recovered/resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date- 25-FEB-2023 Reporter's Comments-The case was received from the patient via interactive digital media. The patient reported that while the shot itself was not painful, his/her arm felt like he/she was kicked by a mule, for almost a week.  The patient not looking forward to the second shot. Additional supportive information: The follow-up could not be possible as no contact details were available. As no vaccination details were provided therefore case was kept valid for only 1st dose.
pt recv vax 1DEC97 & exp an allerg rxn described as urticaria & swelling of lips;there was no laryngeal edema;
Pt states next morning 4/21/16, awoke with HA, dizzy, stomach pains. No increased T. Same PM c/o confusion. Friday 4/22/16, c/o HA, vomiting "several times". Went to ER Sat 4/23/16 AM, states tested for meningitis (neg), received IV, nausea meds. C/O continued tenderness in upper quadrant abd.
Patient is 9 years of age and received the 12+ vaccine. No harm to patient at this time
This spontaneous report was received from a 78 years old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) in early 2011. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that around 05-OCT-2012 she developed shingles after receiving ZOSTAVAX. The patient sought unspecified medical attention and was given VALTREX and prednisone (manufacturer unknown) as treatment for shingles. No lab diagnostic tests were performed. The outcome of shingles was reported as recovering (also reported as event did not improve). The relatedness for the reported event was not provided for ZOSTAVAX. Additional information is not expected.
I had a huge half a grapefruit size swelling in arm. It lasted about a week. It felt like whooping cough and still feels like whooping cough. My back behind the lungs feels like a horse kicked me in the back, dizzy spells. Strange feeling in my feet and my hands that I didnt have before. One of my fingers feel like there is a bee stinging it. I have been fighting phlegm, this was as bad if not worse that the whooping cough. I have learned not to lay down while sick, the more I sit up the better it is.  I am still having coughing symptoms. The Doctor put me on antibiotics. I felt so bad, all of my tubes were just full of mucus.
Injection side sore night of injection and following morning with redness. On 11/19 noted soreness under left arm. 11/20 left lower axilla edematous and tender. Afebrile - Painful with movement. Saw MD on 12/20/02, advised Ibuprofen 200mg every 8 hours. Took Ibuprofen for 2 days. Swelling and redness gone in 2 days.
Treatment of COVID-19; Treatment of COVID-19; Moderna/ Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: 652529) at the age of 71 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9267), on 09Mar2021 as dose 2, single (Lot number: EN6199) and on 25Sep2021 as dose 3 (booster), single (Lot number: 30145BA) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 033K21-2A) and on 28Apr2023 as dose 6 (booster), single (Lot number: 045H22A) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "recovered", described as "Moderna/ Interchange of vaccine products"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 29Sep2023 to 03Oct2023 for treatment of COVID-19. Patient tested negative for covid on day after the course of Paxlovid and again 2 days later. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300325158 Same patient, different drug/events;
approximately 10 min after receiving the vaccine I became very itchy. I notified the nurse and was given 50 mg of oral benydrl and then taken to the Emergency department. In the ED I was given Epinephrine, Medrol prednisone IV , benydrl, famotidine, and nebulizer treatments. I was also placed on )2 due to falling saturation levels.
I had the pain from the back of my "neck (hip)" (not clarified) although the way down to my "toes" (not clarified) all, except my left arm where I got the shot; I had the pain from the back of my "neck (hip)" (not clarified) although the way down to my "toes" (not clarified) all, except my left arm where I got the shot; I had the pain from the back of my "neck (hip)" (not clarified) although the way down to my "toes" (not clarified) all, except my left arm where I got the shot; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration, in arm left on unspecified date as DOSE 1, SINGLE for covid-19 immunization at hospital.. The patient medical history included hard of hearing problem and concomitant medications were not reported. On an unspecified date the patient had experienced the pain from the back of my "neck (hip)" (not clarified) although the way down to my "toes" (not clarified) all, except my left arm where got the shot .Therapeutics measures were taken with AE and treatment included two different pills one was stronger and one was like "buffers" (not clarified the name), they gave two different pills when patient got home It was okay. The clinical outcome of the events were recovered.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
This spontaneous report was received from a physician via a company representative refers to a 8 years old female patient. On 24-APR-2005 the patient was vaccinated with (Oka/Merck) VARIVAX dose 2, 0.5 ml, subcutaneous (lot # was not reported). On 17-JUN-2008 the patient was also vaccinated with (Oka/Merck) VARIVAX dose 2, 0.5 ml, subcutaneous (lot # was not reported). Concomitant medications were not reported. In Dec-2012 the patient developed chicken pox after receiving two doses of (Oka/Merck) VARIVAX. The outcome of patient developed chicken pox was reported as recovered/resolved on unknown date. This is one of several reports received from the same reporter. Additional information has been requested.
I had usual soreness, but immediately after IM injection I had a lot of itching and redness.  The soreness was worsening by Sunday evening.  Now the pain is in my back around my shoulder blade, shoulder, down my arm into the elbow and wrist.  The pain also radiates up the side of my neck.  Even my hand and fingers ache.  The pain ranges from a 6-8.  I am also experiencing tingling in those fingers and hand.  The entire arm feels heavy and weak although I have not lost any function in it.
Fever in the early morning, leading into dehydration, though after words i had extreme chest pain that turned out to be Pericarditis
flu-like symptoms; This is a spontaneous report from a contactable nurse. A female patient of unspecified age received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on unknown date as DOSE Number UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had experienced flu-like symptoms. The clinical outcome of the event was unknown.  Information on lot number/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected
started 4OCT95AM w/rt arm, red, swollen, warm to touch, used ice w/o relief, called consulting nurse 5OCT95 & told to come for eval, dx cellulitis rt arm;
Oral and lip swelling, painful. Went and received steroid prescription. Also realized, I had this same reaction last year after my flu shot (last yr vaccine GSK AFLLA734AA). The lip symptoms last year lasted 6-7 months.
Late onset of side effects started on day 6 with mild sluggishness.  Progressed to severe mental confusion and incoherence.  Fever of 100 this morning (Feb/5) and  wet cough with  lots of mucous. Still going on and we are trying to control with Tylenol and Coricidine
Report on admission: Patient is a 78 y.o. year-old female, who presented with weakness to ER. Patient admitted to ICU for pneumonia and anemia. Covid +. She did receive blood transfusion. Chronically on Coumadin. CT scan reveals ground glass opacities in upper lobes. Did have episodes of hypotension in ED with decreased responsiveness. She is chronically on midodrine    Infectious disease followed during stay for COVID and C. difficile.  Home Ambien discontinued in setting of falls.  Patient received blood transfusion for anemia.  Coumadin was safely restarted once guaiac was negative.  Palliative care followed during stay.  Patient improved with medical treatment and was discharged home in stable condition.
Clt. called in on 8/17 to report that Tdap injection site was swollen to the size of a golf ball, but swelling was coming down, clt. stated that on 8/14 AM she had stomach upset-nausea, felt dizzy, short of breath, had wheezing cough & pain to inj. site. Stated that after doing a breathing treatment her shortness of breath and wheezing stopped and she felt better. She stated she had not sought medical care.
Within 4 hours of the 2nd shot, I notice that I experienced fatigue. Within 12 hours of taking the 2nd shot I had minor body aches and chills with a low grade fever.  This lasted approximately 12 hours. I took Ibuprofen and it helped with the minor symptoms.
night before (second dose) she was in atrial fibrillation; was tired but she didn't sleep the night before second dose/exhausted; was tired but she didn't sleep the night before second dose/exhausted; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269; Expiration Date: 31May2021), intramuscularly, administered in left arm on 29Jan2021 as single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation (has a pre existing atrial fibrillation), patient also has under active thyroid from unspecified date. The patient's concomitant medications included magnesium taken daily from an unspecified date and for unknown indication, an unspecified medication for atrial fibrillation and an unspecified low dose medicine for cholesterol. The patient previously received the second dose of unspecified shingles vaccine on an unspecified date for immunization and felt sore arm maybe a little under the weather. On 22Feb2021, the night before the second dose of vaccine, patient reported she was in atrial fibrillation, she was tired but she didn't sleep the night before second dose because she was in atrial fibrillation and was exhausted. She took extra of her atrial fibrillation medications. She does not think she took Tylenol after first one. Does not think arm was sore after the first one. The patient was vaccinated at a mass vaccination site. The events did not require emergency room or physician's office visit. The outcome of the events was unknown.