chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received regarding a case in litigation from information obtained from a published article concerning a female who on 09-JAN-2002 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). Three days post vaccination a routine examination showed elevated liver enzymes attributed to the vaccination. It was reported that the patient alleged that the vaccination caused her to experience an onset of pain on 16-MAR-2002. On 17-MAR-2002 the patient was admitted to the hospital for "severe stabbing back pain radiating to both legs for five days." The patient's liver enzymes were five to six times the normal limit. On 22-MAR-2002 the patient was diagnosed with transverse myelitis. On 24-MAY-2004 the patient was diagnosed with multiple sclerosis. The patient also had prominent pain syndrome. The patient's outcome was unknown. The multiple sclerosis, transverse myelitis, and elevated liver enzymes were considered to be related to the vaccination. Upon internal review, the multiple sclerosis was determined to be an other important medical event. No further information is available.
Muscle soreness, 102.7 fever, tiredness, headache. Started around 4 pm day of shot. Took 2 Tylenol at 9:30 pm that night.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-FEB-2019 the patient was vaccinated with expired dose of RECOMBIVAX HB (lot # M037248, expiry date: 21-FEB-2019) (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. It was reported that, the RECOMBIVAX HB did not have any temperature excursions prior to administration. No adverse effects were reported. No product quality complaint was involved.
titers drawn for MMR II and employee was immune to mumps and rubella but not measles; This spontaneous report was received from a nurse regarding a female adult patient of unknown age. The patient's historical drug included unspecified penicillin, historical condition included rubella and allergy to penicillin. The patient's concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route of administration, lot # and expiration date were not provided by the reporter) for prophylaxis. On an unknown date, an employee (patient) at the office had Igg antibody titers test and the employee was immune to mumps and rubella but not to measles (measles antibody negative).  Reporter stated that the patient thought she was vaccinated and was uncertain if she had illness as a child. Patient sought medical attention. Patient had not recovered from the event, measles antibody negative. Causality assessment was not provided by the reporter. There was no involvement of product quality complaint (PQC).
Approximately 6 weeks of muscle weakness and fatigue. After that, gradually went back to walking, brisk walking, running. Did fine until Sept 11, where I could not continue 2 miles into my run. Extreme shortness of breath, weakness, fatigue. Transported to ED; could not get breath. Sent home from ED after 5 hours. Had another episode the following week on Sept 17th from a brisk walk while talking on the phone. Was admitted to ED with full cardiac work up. Found no problem with my heart and was discharged next day. I CONTINUE to have sob issues while walking up stairs or talking during exercise. Have managed the onset and stop when I feel it coming on, taking deep slow breaths.
pt recvd vax;11jul95 devel T &1 sore in mouth& side of tongue was swollen;few mins p/ using benzocaine-phenol-providone-iodine alcohol pt felt lightheadedness;reporter felt rxn was felt to be related to the aphthous ulcer & not rxn to vax;
On approximately 01/15/2001 the patient developed full blown chicken pox with more than 50 lesions covering her arms, hands, lips, mouth, under eyes, legs and stomach. Also noted, the patient had a low grade fever of 101F. The patient was treated with Benadryl and Tylenol on 01/15/2001 for the itching. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSSTASIA (Difficulty in standing), FATIGUE (Tiredness/ She can't stand up to cook) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIZZINESS (Dizziness), DYSSTASIA (Difficulty in standing) and FATIGUE (Tiredness/ She can't stand up to cook). On 17-Mar-2021, the patient experienced NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), DYSSTASIA (Difficulty in standing), FATIGUE (Tiredness/ She can't stand up to cook) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D: 18 (Low) Decreased.         No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD-2021-092285 (Patient Link).
Received Td Left deltoid with problems, next day area was sore, on Friday woke up with redness and warm to touch. (area size of silver dollar) (events and description per phone, per mother.
Patient had SHINGRIX #2 8/24/18 at pharmacy. Noticed warmth, swelling, and pain today at injection site on (L) arm. Area 6 cm x 10 cm on (L) arm. Tenderness. No fever or chill. Prescribed prednisone today.
Two days after receiving my second dose I experienced an elevated heart rate and heart palpitations. Happened randomly, saw my doctor after a week. EKG was done, and anti anxiety medication was prescribed to lower heart rate. Two days later palpitations stopped, and Heart rate leveled out.
The patient's mother reports the patient developed a runny nose, sneezing and a cough the morning after the vaccine. The patient was seen at the ER with a complaint of rapid breathing and wheezing. The patient was given respiratory inhalation treatments and admitted for 24 hours.
Patient is an inmate at the local jail. Patient signed consent form and indicated on consent form that he had never received a covid vaccine. Consents were reveiwed in office and patient only had 1 previous covid vaccine in the system. Patient was given dose of Moderna as a 2nd dose. When the vaccine administered went to patients record, the patient had received a 2nd dose of Moderna bivalent previously.
There was no adverse reaction, vaccine was administered on 02/23/22 and vaccine expired on 02/17.
This spontaneous report was received from a physician refers to a patient of age 5 (unspecified units) (unknown gender). No pertinent medical history was reported. On 06-OCT-2014, the patient was vaccinated with VARIVAX (Merck) (lot # K002920 and expiration date was 26-FEB-2016) dose 0.5 ml, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure of -3.9C for 110 hours affecting VARIVAX (Merck) with lot # K002920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of the several patients from the same source. Additional information has been requested.
Pain in left shoulder, throbbing at night, rotator cuff injury, clicking noise when rolling shoulder, weakness, scapula protruding. Have had physical therapy - pain in left arm, weakness in left hand. Thyroid problems increased - goiter started to form, muscle spasms, peripheral neuropathy.
Swollen lymph node in right armpit.; Tender to touch and doubled in size when compared to left armpit.; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3249) at single dose on 15Jan2021 at 02:45 PM on right arm for COVID-19 immunisation. The first dose was on 28Dec2020 at 03:00 PM at age of 30 years old, on right arm, lot number: EL0140. Medical history included Crohn's disease. Known allergies was Tegaderm. Concomitant medications in two weeks included azathioprine, verapamil. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient experienced swollen lymph node in right armpit on 17Jan2021 at 01:00 AM. Tender to touch and doubled in size when compared to left armpit. There was no treatment received. The outcome of events was recovering.
diarrhea; sore arm at the site of injection; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea) and INJECTION SITE PAIN (sore arm at the site of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIARRHOEA (diarrhea) and INJECTION SITE PAIN (sore arm at the site of injection). The patient was treated with DIPHENOXYLATE for Diarrhea, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. On 17-Jan-2021, INJECTION SITE PAIN (sore arm at the site of injection) had resolved. At the time of the report, DIARRHOEA (diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Dizziness, Headache, Arthralgia, Fever, CoughWheeze, chills, lymphadenopathy, sore throat Narrative;
Chills, fever, muscle aches, sweating, headache, tiredness, tightening or swelling in throat
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX in June 2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-JUL-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as herpes zoster (shingles). As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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.
ED to Hosp-Admission Discharged   9/13/2021 - 9/15/2021 (2 days)  MD  Last attending ? Treatment team Syncope and collapse  Principal problem Presenting Problem/History of Present Illness/Reason for Admission Syncope and collapse [R55] AKI (acute kidney injury) (CMS/HCC) [N17.9] Syncope, unspecified syncope type [R55] COVID-19 virus infection [U07.1] 74-year-old female past medical history of stable cerebral aneurysm, routinely follows in the outpatient setting, COPD, essential hypertension, polymyalgia rheumatica, vertigo presented to the ER with near syncopal episodes.  Still feeling very weak for the past 3 to 4 days she was going to the bathroom she felt dizzy and was about to pass out.  In the ED she was tested positive for COVID-19, CT angiogram of the chest was negative for PE given her elevated D-dimer, her orthostatic vitals were positive, she was hydrated her blood pressure medications were adjusted.  She was told to follow-up with her PCP in the outpatient setting for further blood pressure medication adjustment if required.  Also a Zio patch was placed on her to rule out any arrhythmia while in the hospital telemetry and EKGs were unremarkable.  She was discharged home in a stable condition.  Patient does not require any oxygen for her COVID-19.
Increased PVC's, resting heart rate 95 - 124.  Severe rash over back and chest.  Very painful, swollen lymph node in underarm of the injection site shoulder.  Heart issue required ER trip in the  evening of 4/17.   No intervention required. Worsening rash required urgent care visit in the evening of 5/18.  Steroid and antihistamine prescribed.
pt recvd vax 29NOV95 11AM & 10PM vomited p/given APAP;30NOV95 1AM t106 (ear); phoned hosp for advice;gave cool bath & APAP;130AM temp 103.9(ear);5AM temp 104.0 (ear)-vomited p/given APAP;30NOV95 temp stayed around 100 (ear);
Arm pain following injection. One day after the injection, I experienced a headache and used otc ibuprofen to treat it. Then a firm red bump appeared at the injection site about 2 days after receiving the vaccine. The bump is roughly 1" by .5" and hurts when touched.
37 Y.O. W/M HAD DIZZINESS AND WEAKNESS IN THE LOWER EXTREMITIES. PATIENT HAS A HISTORY OF SYNCOPE AFTER RECEIVING INJECTIONS. 911/AMR WAS CALLED. VITALS WERE TAKEN BP: 140/70; HR: 59; SPO2: 98% RA; COAX4; CHEST SOUNDS: CLEAR BI-LATERAL. UPON AMBULANCE ARRIVAL, PATIENT WAS CHECKED BY AMR PERSONELL. PATIENT REFUSED FURTHER TREATMENT.  PATIENT SIGNED A PATIENT TREATMENT & TRANSPORT REFUSAL FORM.  PATIENT WAS ADVISED TO CALL 911 SHOULD THE REACTION RETURN. PATIENT LEFT ON HIS OWN ACCORD.
Patient called after receiving flu shot and complained of the following symptoms: difficulty remembering things, difficulty communicating, unable to concentrate.
Patient returned to pharmacy on 1/6/10 and reported that starting the next day he had a constant severe pressure headache on both sides that lasted until present time and continues. He did not treat it fearing interaction with his medications. He also said since receiving H1N1 shot, he has moments of confusion where he forgets exactly what he was doing and becomes light headed.
Passed out; arm hurt; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in arm right on 24Jul2021 (Batch/Lot number was not reported) at age of 86-year-old as single dose for covid-19 immunisation. Medical history included eye problem (The only thing she has wrong is with her eyes.   She has to see her eye doctor real often, not very often, just once in a while), ongoing dyspnoea, ongoing insomnia, ongoing hypersensitivity. No family medical history relevant to AE. Concomitant medications included ongoing lisinopril taking for a long time; ongoing vitamin e; ongoing ascorbic acid (VITAMIN C); ongoing calcium; ongoing cetirizine hydrochloride (EQUATE ALLERGY RELIEF) taken for hypersensitivity; ongoing biotin; ongoing vitamin d3; ongoing melatonin taken for sleep disorder; ongoing fexofenadine hydrochloride (ALLEGRA); fluticasone propionate taken for eye disorder; ongoing umeclidinium bromide, vilanterol trifenatate (ANORO) taken for dyspnoea.  The patient previously took 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 3 weeks prior to the second dose in Jul2021 given late in the afternoon in the left arm at age of 86 years as single dose for covid-19 immunisation. No Additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No AEs following prior vaccinations. The patient experienced arm hurt on 24Jul2021, passed out on 25Jul2021.  The patient was calling regarding the Pfizer shot, she got 2 shots. She got the second Pfizer in the early afternoon, stated that it one they give for Covid. This was the problem, the first one she got, didn't bother her at all. The second one made her arm hurt but, she took a pill that was given to her. That was on Saturday. on Sunday, she went to church and she felt all right but then, she passed out and when she came to, her pastor and and his son and wife were all around her.  There were a lot of people around her.  Everybody was around her holding her up. Clarified that it was Sunday 25Jul2021 that she passed out at church. It was about noon. Everyone was holding her up and praying for her. She had no idea how long she was out. It truly wasn't very long. The pain in the arm, she was still sort of feeling but not all of it.  Treatment: She took one pill that was provided to her from the pharmacy. Did not know what it was. She now had no pain the arm, what so ever. The events did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included body height: about 5 foot 2 or 3, weight: 122 or 124 lbs (something like that).  Therapeutic measures were taken as a result of arm hurt. The outcome of event passed out was recovered on 25Jul2021. The outcome of event arm hurt was recovered in Jul2021.  Information on the lot/batch number has been requested.
Vertigo went away (resolved); This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo went away (resolved)) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Dizziness. Concurrent medical conditions included Vertigo.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo went away (resolved)). At the time of the report, VERTIGO (Vertigo went away (resolved)) had resolved.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
INJECTION SIGHT 3 1/2  INCHES  WIDE  X   3 INCHES  HEIGHT.....INDURATION.    FEVER 102 , FOR 2 DAYS..NAUSEA 3 DAYS.  TODAY FEBRUARY 1ST 2021 INJECTION SIGHT STILL RED, INDURATED AREA IS STILL THE SAME SIZE BUT REDNESS IS FADING.
9/7/2022 Asymptomatic until testing. A PCR COVID-19 test through a local hospital. Doctor prescribed treating symptomatically and to rest. After the recommended period of isolation, cleared by doctor to return to normal.
pt had an earlier hospitalization from 9/14/21 - 9/15/21 with a diagnosis of COVID; was dc'd to home and instructed to receive antibody infusions the following day; pt unable to receive infusions due to low O2 sats; sent to the hospital; readmitted with developing COVID pneumonia; pt with SOB, tachypnea; admitted; O2 supplementation; pt had a pneumothorax and had a right thoracostomy tube placed; pt's condition worsened; given decadron and baricitinib; intubated; renal failure with 1 dialysis; pt's condition deteriorated more and he expired in the hospital
Had symptoms of fatigue, chills, malaise, redness/bruising at injection site, and site had swelling compared to baseball size. Symptoms of fatigue, chills, malaise lasted 24 hours but baseball size swelling lasted until 1/25/21 and on 1/27/21 it was quarter size in swelling.
This case was reported by a physician and described the occurrence of severe pain in shoulder joint in a female subject of unspecified age who was vaccinated with ENGERIX B (Glaxosmithkline). On 31 March 2009 the subject received unspecified dose of ENGERIX B (unknown, unknown arm). On 1 April 2009, one day after vaccination with ENGERIX B, the subject experienced severe pain in shoulder joint. Physician reported that the subject was given ENGERIX B too high in the deltoid and he believed some part of the vaccine may have caused the severe shoulder joint pain the subject experienced. At the time of reporting the event was unresolved.
Patient entered false information as her birthdate on form.  Therefore, showing she was 18 to receive the vaccine. No known adverse reactions noted.
The patient is a 14YO female and received a Moderna first dose covid vaccine on 2/12/2022. No adverse event was reported.
Rapid heart rate, sweaty, after 10 minutes after injection. Once that stopped pt felt disoriented for up to 5 hours after. Pt states no sob, no redness, no rash at injection site. Only c/o arm pain after.
Sore arm/injection site began roughly 4 hours after receiving vaccine. No treatment used. Pain continue into second day.
SORE INJECTION SITE FOR A COUPLE OF DAYS; This spontaneous report received from a consumer (wife) via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient had not contracted Covid19. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection and route of administration was not reported and batch number: unknown, expiry: unknown) dose was not reported, dose number in series 1, 01 total was administered on an unspecified date in JUN-2021 for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, he had mild sniffle between the two shots (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection and route of administration was not reported and batch number: unknown, expiry: unknown) dose was not reported, dose number in series 2, 01 total was administered on an unspecified date in JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medication included influenza vaccine for prophylactic vaccination. It was reported that he obtained flu shots each year. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient had sore injection site for a couple of days (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore injection site for a couple of days. This report was non-serious. This case, involving the same patient is linked to 20220341258. This case, from the same reporter is linked to 20220336438.
Increasing redness, heat, swelling approx 8cm in circumfrence at injection site R deltoid from Tdap given 5/15/07.
Information has been received from a nurse practitioner concerning a 28 year old female who on 10 Apr 2006 at 9:30 am was vaccinated SC with a 0.5 mL first dose of Varivax (lot# 647538/0784R). There was no illness at the time of vaccination. ON 10 Apr 2006, within 24 hours after vaccination, the patient developed injection site soreness, erythema about inch in diameter, 3 inch induration, "local heat" and pruritis. The patient was reported as recovering. There was no product quality complaint involved. Additional information is not expected.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # reported as M031944, expiration date 27-DEC-2017, dose and route not reported). The doses of vaccine were exposed to 3 defrost cycles, each cycle was reaching 6 degree Fahrenheit for 5 minutes. Data logger was involved. There were no prior excursions. No adverse effects were reported. Additional information has been requested.