chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he was 18 years of age; HCP wanted to revaccinate the patient anyway because he was 18 years of age; no additional information; improperly stored PROQUAD was administered to a patient on 03/01/2021; This spontaneous report was received from a nurse who was reporting on 18-year-old male patient. There was no information about the patients concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided. Concomitant vaccines included unspecified hepatitis b virus vaccine, unspecified diphtheria toxoid, pertussis acellular vaccine from GlaxoSmithKline, unspecified poliovirus vaccine inactivated from Sanofi Pasteur and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from Merck/MSD.   On 01-MAR-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live  rHA (recombinant Human albumin) (PROQUAD) subcutaneously in the left arm (dose and strength were not provided; lot number T021644 was confirmed to be valid, expiration date 21-DEC-2021) for prophylaxis. The physician wanted to vaccinate patient even the product prescribing information states that the product was indicated for children through 12 years of age (Inappropriate age at vaccine administration, Intentional product misuse). Administered dose of vaccine was stored in temperature of 42.8 Fahrenheit for 96 hours. Data logger was involved. There were no previous excursions reported. No additional information was provided. The follow up with the patient was scheduled, and the vaccine was returned to the UFC program so it was not available for manufacturer. No additional information was provided.
Patient was given an extra HPV9 vaccine in error after miscommunication between staff (pt had already completed a 2-dose series). Parent was notified by phone after realization of error. The patient has not reported any adverse symptoms or effects to date since the vaccine was given
hot and cold sweats; loss of appetite; developed a fever; headache; nausea; throwing up mucus; thick snot in their nose; cough; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (thick snot in their nose), COUGH (cough), HYPERHIDROSIS (hot and cold sweats), DECREASED APPETITE (loss of appetite) and PYREXIA (developed a fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-Feb-2021, the patient experienced RHINORRHOEA (thick snot in their nose) and COUGH (cough). On 21-Mar-2021, the patient experienced HYPERHIDROSIS (hot and cold sweats), DECREASED APPETITE (loss of appetite), PYREXIA (developed a fever), HEADACHE (headache), NAUSEA (nausea) and VOMITING (throwing up mucus). At the time of the report, RHINORRHOEA (thick snot in their nose), COUGH (cough), HYPERHIDROSIS (hot and cold sweats), DECREASED APPETITE (loss of appetite), PYREXIA (developed a fever), HEADACHE (headache), NAUSEA (nausea) and VOMITING (throwing up mucus) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
L sided supraclavicular lymphadenopathy.  Lasted 3 weeks after the eschar fell off.
Pt reported periorbital swelling  for 12 hours that began within 24hs of vaccine administration on 04/03/21. The patient was evaluated by one of our providers and prescribed Benadryl for symptom relief on 04/06/21. On 04/ 08/21 pt reported that periorbita swelling has resolved but is now experiencing facial itchiness. Denies other swelling or difficulty breathing.
Nauseous an hour after, whole body went cold multiple times, felt faint, GI upset. Insomnia that night.
Client complained of intense itching of head within hour of vaccine injection lasting several hours - (??) began subsiding after shower at home.
Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and left collarbone and neck; edema left arm pit and left collarbone and neck; tingling down the back of neck to shoulder blade for 1 week; All left side, pain at injection site with warm to touch for three days; All left side, pain at injection site with warm to touch for three days; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via intramuscular in left arm on 08Jan2021 13:15 at second single dose for covid-19 immunization. Medical history included diabetes type 2, allergies. Concomitant medication included metformin, simvastatin, semaglutide (RYBELSUS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose BNT162B2 (LOT# EL1685) on 20Dec2020 01:15 PM, via intramuscular in left arm for Covid-19 immunization. The patient experienced headache and body aches for 24 hours, edema under left arm pit and left collarbone and neck with tingling down the back of neck to shoulder blade for 1 week. All left side, pain at injection site with warm to touch for three days. Adverse event start date/time: 09Jan2021 06:00 AM. Events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was recovering.
feeling lazy; Swelling at injection site; very tired; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (feeling lazy), VACCINATION SITE SWELLING (Swelling at injection site) and FATIGUE (very tired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LAZINESS (feeling lazy), VACCINATION SITE SWELLING (Swelling at injection site) and FATIGUE (very tired). On 16-Mar-2021, LAZINESS (feeling lazy), VACCINATION SITE SWELLING (Swelling at injection site) and FATIGUE (very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. No treatment of events was reported.   This case was linked to MOD21-054800, MOD21-054802, US-MODERNATX, INC.-MOD-2021-046313 (Linked Report).; Sender's Comments:  MOD21-054800: MOD21-054802: US-MODERNATX, INC.-MOD-2021-046313:cosslinked
heart pounding; fatigue; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart pounding), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event, Atrial fibrillation since 2016, High cholesterol since an unknown date, Acid reflux (esophageal) since an unknown date, Shoulder discomfort (Reported as Bad shoulder) since an unknown date and Cardiac ablation (Failed) in 2019. Concomitant products included RIVAROXABAN (XARELTO), ATORVASTATIN, DRONEDARONE HYDROCHLORIDE (MULTAQ), PANTOPRAZOLE and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). On 15-Mar-2021, the patient experienced PALPITATIONS (heart pounding). On 15-Mar-2021, FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) outcome was unknown. At the time of the report, PALPITATIONS (heart pounding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
POST VACCINE, C/O CHEST TIGHTNESS, SOB, NAUSEA, BLURRED VISION. BROUGHT BACK TO OBS VIA WC AND ASSISTED TO STRETCHER AND PLACED IN TRENDELENBERG. STATES SOME RELIEF AFTER A FEW MINUTES. ADMITS TO HAVING ANXIETY ISSUES. VSS OTHER THAN SATS DROPPING TO HIGH 80'S WHEN TALKING INCREASES. NO DISTRESS NOTED, DEEP BREATHING EXERCISES PERFORMED, RECOVERS IMMEDIATELY. LUNGS CLEAR IN ALL LUNG FIELDS, ADMITS TO DECREASED STAMINA AND INCREASED SOB WITH EXERTION FOR LAST FEW MONTHS AND IS SEEING NEW PCP IN A FEW WEEKS. INSTRUCTED TO SEEK FURTHER TREATMENT/EVAL SOONER IF WORSENS/PERSISTS. ALSO C/O EYES BURNING MILDLY. ALL S/S RESOLVED AFTER LAYING DOWN FOR 30 MINS. VSS WHEN STANDING/AT DEPARTURE. ESCORTED VIA WC TO EXIT AT , AND CRUTCHES RETURNED TO PATIENT TO AMBULATE TO VEHICLE. GAIT STEADY, NOT FURTHER ISSUES OR CONCERNS.  1330 INITIAL BP 148/88 HR 97 RR 18 SATS 100% RA 1335 BP 128/88 HR 104 RR 20 SATS 92% RA 1345 STANDING BP 134/71 HR 99 RR 20 SATS 96% RA
Severe headache same day lasting for 36 hrs.   Severe fatigue starting next day lasting 24 hrs.  Severe headache starting again on day 4 lasting through day 5.  Unable to focus, eat because of headache.  Sore arm for 24 hrs post vaccine.
She could not even lift her arm and had limited mobility- Redness at the site occurred and it grew to about 5 inch in diameter. She experienced a rapid heart rate, fever, and nausea. On 10/19/16 the rash grew to almost her elbow and was hot to the touch - she is currently on antibiotics and was diagnosed with cellulitis - fever is gone but rash is still there.
Noticed slight red rash around injection site 11/17/06 6:30 am complain slight nausea.
I haven't had my period for about 2 and a half years.  I started bleeding vaginal on the 24th of May, about 12 days after the first dose of the covid 19 vaccine.  On May, 25th I started having menstrual cramps, I felt nauseous, tired and general malaise.  the bleeding is very heavy.  today is the fifth day and I'm still bleeding.
VOMITING; FEELS HOT; FEVER; DIARRHEA; COULDNT SLEEP; CHILLS; MUSCLE ACHES; NAUSEA; This spontaneous report received from a consumer concerned a 61 year old female. 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 not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021  to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced could not sleep. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced muscle aches. On 31-MAR-2021, the subject experienced nausea. On APR-2021, Laboratory data included: Body temperature (NR: not provided) under 100. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced feels hot. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, and nausea, had not recovered from muscle aches, chills, feels hot, and fever, and the outcome of diarrhea and could not sleep was not reported. This report was non-serious.  Version created to amend previously reported information on 01-Apr-2021. Upon review the following information was amended: Event ranking updated and reporter type changed to consumer/ non health care professional from contact.
1249 at end of 15 minute monitoring RN (this writer)  approached pt to ask about symptoms, pt was seated in chair calmly stated "I feel a little dizzy" this writer asked pt to please stay a little longer and offered water, this writer took vital signs, pt verified wit writer they did not have a reaction with 1st dose, vitals WNL exception RR 24, pt warm, pink and dry, got a second RN to stay with pt and requested  site lead to come assist, 222 was dialed a CAT team was called to the clinic. as a second set of vitals were taken pt began to become pale and stated "hard to swallow"provider responded, directed Epi to be given from allergic reaction kit on site, dose verified and given by nurse recorded as approx. 1230. Other CAT team members arrived and the pt was put on O2 and transferred to a stretcher and taken to ED approx. 1249.
The patient listed above received her 2nd COVID vaccine and was given this dose from a vial that had been open for 23hours. Was contacted for guidance. Was asked to report and not to give another dose. This nurse recommend to the patient to receive their booster in 6 months.
Client called 11/12/03 and stated after receiving flu vaccine on 11/10/03 took two reg strength Tylenol and went home about 5:30pm, c/o having tingling-numb like feeling from upper lip to chest that lasted approx 45 min.
Breakthrough case admission after 2 vaccines Pfizer 3/18/21 Lot# ER2613;  Pfizer 4/8/21 Lot# EW0150
pt recv vax 9/4/97 & pt sought medical attention & lab tests revealed that titer was negative;the reporter noted that pt had a similar exp p/2nd vax;
Red swelling at site.  2.5 x 2.5 inches.  Rt.Deltoid
it was a pain in the butt; fever; arm just hurts.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Lot number: EW0170) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient asked how long my fever was going to last and I got the shot yesterday. It was only 99.5 and took Tylenol, she felt ok, except her arm just hurts and it was a pain in the butt. the patient wanted to know how long a fever last after your second shot. The patient underwent lab tests which included body temperature resulted as 99.5 Fahrenheit on an unspecified date. The clinical outcome of the events was unknown.  Information about batch/lot number has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 04-JAN-2016 the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage)(Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
I was pregnant at the time of the vaccine. About a week later I noticed my resting heart rate had increased by about 20 beats per minute. It started to come down then went up again after the second dose. It has now returned to normal. Around this time I also started showing signs of gestational diabetes. Previously I had passed the glucose tolerance test. When I redid the test after the vaccine, I failed. I am now monitoring my blood glucose 4X daily and managing the levels with diet and exercise. My heart rate has returned to normal.
Patient reports that the day after injection, she had site reactions, a little pain, controlled with ibuprofen. was not spreading at the time. today, 8/5/17, patient reported spreading of the injection site reaction down the arm. Patient also reported left lower eye pain. Upon examination, the injection site itself was not red but there was a rash above the patients left bicep. I will be following up with patient personally over the next two days. If it continues to spread or get any worse, i instructed patient to contact the doctor.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 at 13:00 as dose 1, single (Lot number: ew0162), in left arm, on 01May2021 at 13:00 as dose 2, single (Lot number: ew0179), in right arm and on 09Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  clinical course: Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 03Jul2022, Treatment stop date: 26Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician through a Merck pregnancy registry concerning a 27-year-old female with one previous live birth (one previous pregnancy) who on 08-FEB-2005 was vaccinated subcutaneously with a 0.5ml first dose of Varivax (lot# 649480/0763P). On 05-APR-2005 she took 2 norgestrol 0.75mg tablets PO, however, the patient was already pregnant. LMP= 24=MAR=2005 and EDD= 28=DEC-2005. Unspecified medical attention was sought. There was no reaction at the vaccination site, no symptoms of varicella or herpes zoster post vaccination. It was also noted that the patient took 6-7 Vicodin HP tablets, 10mg/660mg, during the fourth week of pregnancy (21-APR-2005 to 23-APR-2005). On 10-MAY-2005 an ultrasound was performed to confirm dating, results indicated that the estimated gestational age was 7.1 weeks. No product quality complaint was involved. Additional information has been received from an R.N. indicating that the woman, with tobacco abuse and marijuana use (22-APR-2005 for 2 days); gave birth to a normal male child (7lb. 11 oz.) on 05-DEC-2005 (38 weeks from LMP). There was no complication during pregnancy or labor/delivery. It was reported that the patient had slight anemia during pregnancy. Follow-up information received on 25-APR-2006 contained the following adverse experience: rash on her hand (treated with OTC hydrocortisone cream). Additional information is not expected.
After receiving her 2nd shot of Pfizer about 8 hours later her left ankle became weak and numb and her left toes became numb, tingling and in pain. It was painful to wear a shoe or even a sock. She had trouble even walking (putting weight on her ankle). This went on for almost 1 week. By May 6th her ankle was still weak and she still has numbness in her left big toe and the one next to it.  To this day, she is still in the same condition.
Itchy and painful the first night. Continued to worsen the next day, was seen in doctor's office the 14th and the ER on 01/15/2010.
High fever(103.3), chills, body aches, headache, nausea, general malaise and fatigue had onset 2100 hours 03/07/2021.  Fever reduced 03/09/2021 1000 am.  Remaining symptoms other than headache resolved 03/11/2021 0600.  Headache still present 03/16/2021.
Sore muscle at injection site; This is a spontaneous report from a non-contactable consumer (patient) through a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 13Feb2021 as dose 1, single, with route of administration unspecified, for COVID-19 immunization).  The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had sore muscle at the injection site. The outcome of the event was unknown. The patient had anticipated an epidural treatment with steroids will be ordered for him.  No follow-up attempts are possible. No further information is expected.
Right deltoid pain and redness, body aches, diarrhea, nausea. Augmentin 500 TID.
Information has been received from an unspecified nurse concerning a "14 or 15 years old" (unsure of actual age) female patient who was vaccinated with her second dose of GARDASIL and a dose of MENACTRA date in the office. No dates were specified as to when any doses were received. Following the injections, the patient experienced diarrhea and stomach pain. It was not specified if anything was given for the symptoms or which medication caused the symptoms. The adverse events were recorded in regard to the GARDASIL. The patient did not seek any medical attention. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.
Pt. noted to be pale & diaphoretic, A&Ox4, reports to feeling "lightheaded" after receiving vaccine, which is why he laid on the ground. Pt. reports that this is his "normal" when receiving injections. Patient monitored until he reported no further symptoms.
8 days later on 1/24, my arm at the injection site began itching, turned red, and warm.
Friday the day after the vaccine, I experienced chills when I woke up and had a fever. Went up to 101.8. had a lot of body aches, especially back aches and couldn?t walk very well. On Saturday, it dissipated, then I was doing well. We went out, then on Sunday at 3 in the morning, I was spitting out blood and the back pain returned, and I couldn?t even walk a little bit. Very slow getting around. ER Sunday morning. There they treated with me two shots of fentanyl and they gave me a nebulizer treatment for spitting up blood. My fever had returned that morning also. After the nebulizer treatment, I stopped coughing up blood for a while and the pain went away for a while. Sunday night into Monday morning, it returned again. The pain also returned but I have been taking more tramadol for that so the pain has reduced. So that?s not the big thing right now. I am still spitting up phlegm that has red blood in it. So I emailed my doctor regarding that. I did not react like this to the original vaccines, and I have been knocked out because I haven?t been able to do anything. The ER doctors told me that this was due to the booster vaccine. They checked my lungs and everything was clear, COVID test was negative. They said that it was a reaction to the booster. I still feel exhausted.
Body aches, temperature 99.5, weak, dizzy, chills, fatigue, upper chest congestion, nausea, upset stomach
This literature market report has been received from the authors of a published literature article, concerning two of 14 students presented with clinical mumps. The patients were university women had no known exposure to the infected male students (captured in MARRS # 1608USA014935 and 1608USA015163). The patients had received 2 doses of MMR (manufacturer unknown) (lot#, dose and route unspecified) vaccinations in childhood. On unknown date, the patients presented with a chief complaint of unilateral parotitis. Fever was the second most common symptom, followed by upper respiratory symptoms. At the time of the initial student health visit, the patients were found to have high mumps immunoglobulin G (IgG) levels of greater than 4 index (positive was >= 1.10) and negative immunoglobulin M (IgM) levels (< 1:20). Both patients had detectable buccal swab mumps virus ribonucleic acid (RNA) reverse transcription polymerase chain reaction (RT-PCR). The outcome of parotitis was unknown. The reporter considered the event to be related to MMR (manufacturer unknown). This is one of several reports received from the same source (linked with MARRS # 1608USA002099, 1608USA014935 and 1608USA015163). Additional information has been requested.