chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10:38 patient experienced slight numbness of the right cheek. Obtained history, not very good at giving info about history.  10:40 took BP 132/92.  Denies hx of hypertension. denies having tightness of chest or difficulty breathing. 10:48 given benedryl 50mg.  10:58 reports feeling facial swelling improving, but complains of tunnel vision similar to when she has migraines. 10:59 assessed by NP at site location. Moved to Exam room for closer observation. NP informed patient if symptoms worsen she would be transport via EMS. 11:27 BP 135/85  pulse ox 98% pulse 76. Reports no further symptoms at this time and existing ones resolved. 11:31 patient allowed to leave with NP informing patient that if any symptoms return to be seen by a doctor. Talked with patient today at 11:30, to which she informed me that her arm was swollen and he face was slightly this morning. I asked her to see a doctor. She was going to call the Clinic and see NP that saw her Saturday during the clinic
Information has been received from a physician concerning a 5 year old female who on 10-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot #658024/0833U). Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot#655414/1470F). On 10-AUG-2007 the patient developed a red bump on her right arm after vaccination. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This patient also had adverse experiences after therapy with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (WAES0708USA03318).
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness) and FEELING ABNORMAL (brain fog) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (extreme dizziness) and FEELING ABNORMAL (brain fog). At the time of the report, DIZZINESS (extreme dizziness) and FEELING ABNORMAL (brain fog) outcome was unknown. No concomitant medications were reported. Treatment information included steroids. Action taken with mRNA-1273 in response to the event was not applicable.
5Aug2021 flew traveling and took rapid test and it was negative. 7 AUg2021 took a train and ate on the train. Midnight at 7aug, I had serious diarreaha and had a temperature of over 100. I did throw up. On the 8th aug201 I took a rapid test and it was negative. I as bringing down my suitcase and fell down and caused bruises on my arm. Called my doctor on 11Aug2021. Only had rotation problem on my arm. Fever left on by 8AUG2021.No fever on 11AUg2021 and no more diarehha .
Rash began in center of chest, below neckline; slowly spreading toward neck and rest of chest.  It presented as a red breakout ontop and under skin, with itching, pinching/pricking feeling.  Over the counter topical creams  were ineffective.  Dermatologist prescribed Triamcinolone Acetonide Cream 0.1%, which calmed the itching/pinching/pricking, but hasn't resolved the rash.
Awoke 7-17-03 crying c/o couldn't move legs, fever (101-102) right leg kept getting "bigger" for the next 3 days. Ran fever 3-4 days and did not feel well.  Right leg injection site swollen and painful.
Information was received on 19NOV2014 via a telephone call from a registered nurse. The nurse reported that an unspecified number of patients were administered improperly stored doses of PROQUAD (Merck) and VARIVAX (Merck). No adverse events were reported. No further information was provided. Additional information is expected.
no adverse effect; Patient was administered a dose of MMR II that was frozen in a syringe overnight and then thawed under hot water; Wrong technique in product usage; This spontaneous report was received from a Medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported.  On 19-NOV-2019 (also reported as last night), the medical assistant reconstituted a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, lot # S005248 and expiry date 20-FEB-2021 (strength, dose, anatomical location not reported), with sterile diluent (lot # S000977 and expiry date 14-SEP-2021), which was drawn up into the syringe to be administered to the unspecified patient, however, the patient changed the mind. The medical assistant reported that the syringe containing the reconstituted measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was placed in the freezer over night (product storage error). On 20-NOV-2019 (also reported as today), the syringe was thawed under hot water and administered to the patient (wrong technique in product usage process). No adverse symptoms were reported. No product quality complaint was involved in this report.
Site: Itching at Injection Site-Mild, Additional Details: Patient did not recieve vaccine. Patient fainted while holding wife's hand during her vaccine administration. He gained consciousness fairly quickly and recalled date, time, and location. No epinephrine or benadryl given. Was given two bottled waters and a 15 minute monitoring window before sending home. Vaccines were placed on hold. Patient did mention that this has happened in the past during a blood draw. Counseled to alert future healthcare provider to avoid looking at a needle.
This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a registered nurse concerning a 21 year old female with no relevant medical history reported who in August 2007, was vaccinated intramuscularly with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) with no reaction. On 17-OCT-2007, the patient was vaccinated subcutaneously with a 0.5 mL second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient developed a black and blue mark at the injection site on the same day of vaccination. The area turned red and swollen within 24 hours. The total area was larger than a 50 cents coin. The patient sought medical attention from the nurse. At the time of reporting, the patient had not recovered. Additional information has been requested. Follow-up information was received from the registered nurse. The patient reported that on 17-OCT-2007 the GARDASIL injection was given at the primary care physician's office in the right tricep arm area. On 18-OCT-2007, the hematoma appeared with a red hot area on the edge of the hematoma by the evening. The area was less hard by the morning. The patient also reported a red rash on the chest area which occurred in the morning which resolved. The patient also had local cellulitis from immunization. The patient was given KEFLEX and to do cold compress. The patient had no illness at the time of vaccination. On an unspecified date the patient recovered. Additional information is not expected.
pt devel rash which started on chest & spread to extremties; had sl fever (not measured) & runny nose;
Initial and follow up information has been received from an office manager for the physician and a physician concerning an 86 year old male with no known adverse drug reactions, no know allergies and no pertinent medical history reported. On 7/19/05, in th Am the pt was vaccinated in the left arm with the first 0.5ml dose of Pneumococcal 23v polysaccharide vaccine lot 650327/0792P. There were no concomitant medications reported. That same day, following vaccination in the AM, the pt developed pain and redness at the inj site, pain and was warm to touch at inject site and was reported to hurt to move his arm up and down (previously reported had difficulty moving his arm). The patient sought unspecified medical attention. On 7/21/05 the patient had recovered from the events. The physician reported a concern regarding the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is available.
Interchange of vaccine products; Horrible case of bulbous pemphigoid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 10:00 as dose 4 (booster), single (Lot number: Gh97036) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Peritoneal dialysis" (unspecified if ongoing). The patient has no known drug allergies. The patient had not been diagnosed with COVID-19 prior vaccination. Concomitant medication(s) included: INFLUENZA taken for immunisation, on 04Oct2022 as dose 1, single; ATORVASTATIN; AMLODIPINE; LISINOPRIL; HYDRALAZINE. Vaccination history included: moderna (DOSE 1, Administration time: 11:00 AM, Lot number: 026D21A, Vaccine location: Right arm), administration date: 21Oct2021, when the patient was 73-year-old, for COVID-19 immunization; moderna (DOSE 2, Administration time: 10:00 AM, Vaccine location: Right arm), administration date: 03Nov2021, when the patient was 73-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), Administration time: 11:00 AM, Lot number: 059M21A, Vaccine location: Right arm), administration date: 04May2022, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, life threatening) with onset 19Oct2022 at 10:00, outcome "recovering"; PEMPHIGOID (hospitalization, medically significant, life threatening) with onset 28Oct2022, outcome "recovering", described as "Horrible case of bulbous pemphigoid". The patient was hospitalized for pemphigoid (hospitalization duration: 2 day(s)). The event "horrible case of bulbous pemphigoid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2022) Negative. Therapeutic measures were taken as a result of pemphigoid which included steroids bi iv.
The patient had a swelling at the site of injection that started hours after getting the shot. Patient states it hurt when she tried to use that arm. The swelling and pain subsided the next day without any treatment.
-non-raised,  non-itchy, red rash on and around site of injection (asymmetrical). warm to touch. blanching. no pain. nsometimes soreness.  no other notable skin changes on arm. onset 1/7/2021, 8 days after injection. noticed around 18:30. has not significantly spread at time of submitting vaers (22:20). - no treatment at this time. monitoring. -arm soreness, onset day 1 after injection until day 4 after injection. no treatment. transient, resolved day 4
This spontaneous report as received from a Registered Nurse refers to a 5 year old patient of unknown gender. On 21-MAY-2014, the vaccine M-M-R II was exposed to 50.5 F for 1 hour. On 16-JUN-2014, the patient was vaccinated with M-M-R II 0.5 ml subcutaneous, dose 2, (lot # H017430; expiration date: 20-SEP-2014) that was exposed to 50.5 F for 1 hour. No adverse effects reported. At the time of the report the action taken was no reported. This is one of two reports from the same source. Additional information has been requested.
Soreness in left deltoid 12 hrs after vaccination; redness, warmth, swelling, soreness from injection site down into left upper arm and lack of energy and tiredness 24 hrs after vaccination and for past 3 days.
Complains of a numbness feeling in her right arm, extending from her elbow down to her right index finger on 7 Nov 05.
2mins post vaccination pt had a syncopal even associated w/ dizziness, nausea, and ringing in the ear. Vitals: supine @15:05 108/57, 78, 14, 100%, 97.4F -- > @15:15 sitting 108/64, 80, 12, 100% -- > standing @15:21 114/81, 90, 12, 100% -- > 15:23 Standing 107/66 Recommended pt f/u w/ PCP regarding symptoms.  Pt stable and released from the vaccination site.
At 5:00am the following morning I awoke you high fever of 101 and in severe pain throughout my body. I was heavily fatigued and had a difficult time walking. I made it to the toilet and vomited. I remained nauseous and heaved for about half an hour. My fever fluctuated for the next 24 hours before it broke and I am much better today, 2 days after getting my second vaccination.
This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who developed cellulitis. The patient received a dose on an unspecified date. On an unknown date, the patient developed cellulitis. The outcome was not specified. No additional information was available at the time of this report.
Chills Headache  Swollen sinuses  Body aches Fever Nausea  Severe fatigue
This is a non serious case from a nurse in the USA of involving cough. The reporter causality is not reported to FluMist. The case qualifies for accelerated reporting. This patient is a 40 year old female who received a dose of FluMist on 11/10/04. On the first evening after receiving FluMist, she reports developing a severe sore throat that kept her up all night. On 11/11/04, she reports developed a cough. On 11/12/04, she says she is feeling better but continued with cough, weakness, and fatigue and states she feels tired and completely wiped out. We have no medical history on this patient and no concomitant medications were reported. The patient reported feeling completely recovered as of 11/19/04. The patient also states that her daughter has some of the same symptoms and we are awaiting clarification as to whether the child received FluMist or if this would qualify as a case of accidental exposure.
Pfizer 2 dose series is indicated to be spaced out at 21 days per MFG instructions. Patient verbally reported receiving Pfizer dose #1 on 04/22/2022. Second dose of Pfizer was administered on 05/11/2022. However when patient presented vaccine card to be updated with second dose date, date recorded on vaccine card for dose #1 was 4/28/2022.  This was a spacing of 13 days, patient was placed in observation for 15mins per company protocol, and no sign and symptoms of adverse reaction was noted. Patient was advised of administration error, and to RTC for follow up dose of Pfizer  in 3 weeks (06/01/2022) per CDC administration error recommendation updated as of 02/22/2022. Patient verbalized instructions, reminder card given.
Only Slight pressure Headache for 2 days, a time intervals only 3 times. Slight pain in the muscle of the left arm for 3 days
Moderna COVID-19 Vaccine EUA was received mid afternoon on Day 0. I woke the next day around 8AM (as personally typical) with significant dizziness. After an additional hour of rest and following a few anti-vertigo maneuver attempts, I was able to rise. More than three weeks later, I still experience moderate dizziness when waking and often if tilting my head back more than 45 degrees in the normal course of the day. No medical treatment has bee prescribed.
Parent reported temp of 101.1 on evening of vaccines with swelling, redness, size of fifty cent piece next AM.  Fever that night 103.5 with site red, firm and painful to touch.  No red streak or purulence.  No other symptoms except occasional cough.  (Site of varicella injection)  Child seen in ER on 11/21 with fever of 102 degrees.  Given cephalexin 250 mg tid and warm soaks advised.  PMD wanted to lance site--mom declined.  11/24--temp 99 degrees and swelling decreased.  Redness decreased.  No further treatment.  1/8/09--no fever, redness or edema after 11/24/09.
I had no AE to the vaccine, but on 12/17 while caroling, my ears got real cold, but it was not cold outside as if I was getting an ear ache so I left from caroling. Later that night I developed a severe headache, my body was achy all over and I got a really wet cough and begin getting chills. I felt as if I had a fever, but one never developed and was hot and cold throughout the remainder of the night into the next day. By Sat I just laid around and on Sun 12/19 I still was feeling bad and the coughing, sneezing and stuffy feeling in my head continued so 12/20 I scheduled a COVID test which was negative. I self-quarantined because I still didn't feel well and didn't want to pass symptoms. The coughing had so bad I have a sore spot in my stomach where it feels like I've pulled a muscle to date, I am still feeling down, but the symptoms are getting better, and the cough has gotten much better as well. I self-medicated with cough drops and Alka-Seltzer plus cold and Acetaminophen.
2 minutes after vaccination patient felt "warm, dizzy, lightheaded, nausea "and c/o tingling in hands and feet. Provided cooling measures and food and drink. Resolved within 15 minutes.
The caller said no additional adverse events were reported.; A HBP was transferred onto the line by a Merck account representative to report a temperature excursion. The caller stated doses of improperly stored VARIVAX were administered to patients.; This spontaneous report was received from a office manager and refers to a unspecified age and gender patient.  No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 17-AUG-2023, the patient was vaccinated with an improper storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W039294, who had been verified to be a valid number and expiration date was reported as 11-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was administered with a 17.4 degree Fahrenheit with a time frame of 1 hours 0 minutes and 0 seconds. There was no information about previous temperature excursion (product storage error). No additional adverse events were reported.
mom describes rt leg w/ 1/8-1/4 hardened are reddened, hot to touch; screaming; local reaction began w/in 1/2 hrs p/vax; took pt to MD mom told is calcified blood clot;
Pt's mother states that the child was okay all week then on 02/09/2002 about 9:30am, she noticed hives in diaper area and belly then she could acutally see the "flushing" of skin moving up body to jaw line and back of hair line on shoulders and knees but no on her back. She took her to ER was given Pedia prednisone and benadryl with effect. On Sunday, hives all gone but flushing, red white splotches on arms, legs and face with itching remained. Eyes puffy on 02/11/2002. Never had temp or any breathing difficulty. Mom states the child had "flu" bug before vaccination.
Child received MMR on 10/20/03. Developed diffuse rash on 10/31/03 which resolved. Subsequently developed immune thrombocytopenic purpura, diagnosed on 2/21/04. Required oral steroids, immune globulin and bone marrow biopsy/aspiration.
Fever, sweating, chills, malaise, soreness, muscle and joint pain, nausea, tenderness at injection site.
Cold sore on left lip; Low grade temperature; Chills; Fatigue; Headache; Dizziness/ Light headedness/ Woozy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade temperature), DIZZINESS (Dizziness/ Light headedness/ Woozy), HEADACHE (Headache), ORAL HERPES (Cold sore on left lip) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (Dizziness/ Light headedness/ Woozy) and HEADACHE (Headache). On 07-Mar-2021, the patient experienced PYREXIA (Low grade temperature), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Mar-2021, the patient experienced ORAL HERPES (Cold sore on left lip). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Low grade temperature), DIZZINESS (Dizziness/ Light headedness/ Woozy), HEADACHE (Headache), ORAL HERPES (Cold sore on left lip), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by the reporter.
Very heavy period with clotting. I was on day 3 of my period at the time of vaccination. Immediately upon receiving the vaccine I had uterine cramps and heavy bleeding with large clots continued throughout the day and into the next day. Had some dark bleeding/discharge about 4 days after my period ended for 2 days. This also happened during my first dose of Moderna, although my first dose was on the first day of my period so I didn?t quite register it since bleeding is normally heavy at the beginning of my period.  First period was also substantially heavier with clots and had some dark bleeding/discharge 4 days after my period ended
This spontaneous report was received from a nurse and refers to a female patient of an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, after receiving GARDASIL, the patient experienced an unknown reaction. The patient's mother (hematologist researcher) documented this case in magazine journal, however, a copy of this article was unavailable at the time of this report. The outcome of adverse event was not reported. The relatedness between adverse event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported. Additional information is not expected because the reporter did not give permission to be contacted.
Information was received from a healthcare worker who reported that on 20-AUG-2012 an 83 year old female with a previous history of vaccination with PNEUMOVAX 23 (2006), was vaccinated with a dose of PNEUMOVAX 23 (Lot# H009826, expiration 11-FEB-2014). On 21-AUG-2012, the patient called the office reporting that the arm that the PNEUMOVAX 23 was administered developed an injection site reaction where the arm had become red, swollen, and warm to the touch from the shoulder to the wrist. Treatment given was specified as ADVIL and cold compresses. The patient was reported as recovered on an unspecified date. This is one of two reports of similar adverse events (1209USA02926). Additional information is not expected.
Significant Bilateral Hip, knee, shoulder, elbow and ankle pain.  Neck Discomfort.  Lower Back Discomfort
Pt presented to ED after receiving second COVID vaccine. Pt states within 5 minutes of second dose, she began feeling lightheaded, shakey, diaphoretic and generally not well. Personnel noticed pt leaning over the back of her chair and brought her juice, gatorade, donuts, and candy. Denies ever losing conscousness, chest pain, SOB. Pt was taken to the ED where glucose was 176. Pt states by the time she arrived to the ED her symptoms had resolved. On presentation pt had negative troponin, however EKG showed mild T wave changes. Pt admitted to internal medicine for ACS rule-out. No acute overnight events. Troponins remained negative, no EKG changes. Discharged next day.