chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067.
Moderna COVID- 19 Vaccine EUA: the next morning after receiving vaccination patient woke and spouse reported patient had problems with balance, word finding, weakness, and potentially hit head and hip when fell getting out of bed.  Patient experienced fever and body aches overnight. On arrival to the emergency department patient's vital signs were blood pressure 165/75 mmHg, pulse 107 beats per minute, repiratory rate 20 breaths per minute, temperature 38.3 degrees Celsius, and oxygen saturation 92%. Physical exam documented a well-appearing patient with mild difficulty with word finding. Cardiovascular, pulmonary, and abdominal exams were unremarkable. Neurological exam reports cranial nerves intact, strength and sensation to light touch normal in all extremities. Patient declined medications for fever and body aches. Patient observed and repeat vital signs within normal ranges except blood pressure 137/78 mmHg. Symptoms improved and patient was discharged with prescription for anti-epileptic medication and scheduled for follow-up visit with neurology clinic.
Information has been received from a physician concerning a 4 year old male with no medical history or allergies who on 06-SEP-2002 was vaccinated in the thigh with 0.5 mL IM (previously reported as SC) first dose of varicella virus vaccine live (lot# 643121/0548M). There was no concomitant medication. There was no illness at the time of vaccination. At 2 PM on 21-JUL-2005 the patient came to the office with a mild case of varicella (also described as breakthrough) with about 40 scattered lesions. There was no fever and did not receive any treatment. Unspecified medical attention was sought. At the time of the report the patient had recovered. There was no adverse event following prior vaccination. There was no product quality complaint involved. Additional information has been requested.
a few minutes after injection patient began to feel flush in the face, soon followed by hives neck, chest, abd.  complained at that time of tight breathing,  epipen delivered and patient further observed by ems
Patient vaccinated x2 (Moderna: 3/18/21, 4/15/21) Patient tested COVID+ prior to receiving Chemo and admitted to hospital on 5/31/22
Ache in joints and muscles; agitation; mood: anxiety; balance; vertigo; dizzy; blood pressure varies; blisters in right hand and right foot; high cholesterol; coordination problems; concentration trouble; anxious; depression; skin pain; papules filled with clear fluid and when papules broke, fluid burned skin and was extremely painful; tachycardia; thinking abnormally; tiredness; vision problems, possible glaucoma; walking difficulty; insomnia (unable to sleep flat without medication); stomach problems; night sweats.
PATIENT CALLED TO INFORM PHARMACY OF VACCINE ADMINISTRATION GIVEN TOO HIGH ON THE SHOULDER, SHE REPORTED EXTREME SORENESS AND STATED THAT HER PRIMARY MD REFERRED HER TO ORTHOPEDICS. SHE REPORTED IMPROVEMENT WITH HEAT, ICE, AND ACETAMINOPHEN. PATIENT HAS A FOLLOW-UP APPOINTMENT IN TWO WEEKS
Patient received two vaccinations with out difficulty. Patient and step father were checking out at front desk, then there was a big bang. Front office staff call for the nurse. When nurse arrived, patient was sitting on the floor with back against wall. Step father was asking pt if he was ok. Step father assisted pt into a standing position. Nurse escorted pt back into a room, had pt lay down on table, and placed a cool paper towel on pt head. Step father and MA came into room and asked pt if he hit his head when he fell. Patient stated he did not hit his head. Patient was offered a popsicle or a cookie and pt refused. Patient stated in room with step father for approx. 10-15 mins. Step father came out and stated pt felt fine. Patient and step father left office with no further concerns present.
I started having a hard time working out, it was real intense, it started in my groin, hips and lost strength in my hands. It was hard for me to get out of bed. They diagnosed me Polymyalgia Rheumatica on June Put me on a low dose prednisone and counts came down. I also was diagnosed with pulmonary embolism, I have had those before.
Reactivation of Thyroid Eye Disease symptoms: Irritated, bloodshot, eyes, tearing, swelling of eyes. This started approximately 2 weeks following second dose of vaccine. Has continued to this date (02/06/22). Eyes had been in  inactive phase for approximately 4 years prior to this.
Error by vaccine administration nurse, 0.2 mL given by nurse on 3/2/21 at Clinic. Client called at 3:58 pm. Client understood situation and will be returning on 3/3/21 at 6:30 pm
Left shoulder faded erythema and edema. Vaccines administered on 8/26/13. Patient seen in office for exanthem on 8/29/13. No treatment.
Period started early mid cycle after both shots; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 06Feb2021 at 13:30 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9209) via an unspecified route of administration in the right arm on 27Feb2021 as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to sulfa, dairy and gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included medication for birth control (unspecified) and fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for unknown indication from an unknown date and unknown if ongoing. On 09Feb2021 at 07:00, the patient experienced period started early mid cycle after both shots. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event period started early mid cycle after both shots was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
first dose administered on 20-JUN-2008 (when the pt was 56 days old); This spontaneous report has been received from a lawyer and physician, via a memo and medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2303USA000365), concerning a 8-week-old (exact 56-days-old) female patient (pt). The pt's historical vaccine included hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as HBV) administered on 26-APR-2008. The pt's concomitant medications included diphtheria, tetanus, acellular pertussis, hepatitis b, polio (dTAP-HBV-POL) administered on 20-JUN-2008. No information regarding pt's medical history or concurrent conditions was reported.  On 20-JUN-2008, when the pt was 56 days old, she was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #, expiry date, route of administration and anatomical location were not provided) for prophylaxis, which was considered an inappropriate age at vaccine administration.  The pt's vaccines also included hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as HBV) administered on 31-OCT-2008; diphtheria, tetanus, acellular pertussis, hepatitis b, polio (dTAP-HBV-POL) administered on 29-AUG-2008; 30-JAN-2009 and 06-AUG-2009; diphtheria, tetanus, pertussis (DTaP) vaccine administered on 29-APR-2009; measles, mumps, rubella (MMR) vaccine administered on 29-APR-2009 and 09-AUG-2012; hepatitis A vaccine (HAV) administered on 29-APR-2009 and 06-NOV-2009; pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) administered on 30-APR-2010; influenza (INF) vaccine administered on 17-OCT-2011, 22-SEP-2012, 21-DEC-2013 and 15-NOV-2014; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) administered on 09-AUG-2012; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT) administered on 11-OCT-2015; influenza vaccine inact sag 3v (FLUVIRIN) administered on 11-NOV-2016; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered on 25-JUL-2017 and 25-JAN-2018; meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) administered on 28-NOV-2017 and influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT) administered on 27-OCT-2017 and 26-OCT-2018.  This is one of the three reports concerning the same patient..; Sender's Comments:  US-009507513-2303USA000365: US-009507513-2307USA001583:
On morning of Sept 30, 2006 patient had extreme soreness, redness, swelling and a feeling of warmth in area of left shoulder where shot was given. Patient had hardly any strength in left hand or arm & was unable to move left arm much at all patient felt sick & had chill which lessen in time patient has some movement in arm but not normal capacity now.
about 24 hours after getting it my shoulder swelled up. I have like a large Hematoma on the outside of it so a large swelling on the outside of my shoulder; about 24 hours after getting it my shoulder swelled up. I have like a large Hematoma on the outside of it so a large swelling on the outside of my shoulder; I can''t put any weight on my arm or lift without having shooting pains; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: FH8030) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "booster"; JOINT SWELLING (non-serious), HAEMATOMA (non-serious), outcome "unknown" and all described as "about 24 hours after getting it my shoulder swelled up. I have like a large Hematoma on the outside of it so a large swelling on the outside of my shoulder"; PAIN (non-serious), outcome "unknown", described as "I can''t put any weight on my arm or lift without having shooting pains". Therapeutic measures were taken as a result of joint swelling, haematoma, pain.  Additional information: Yesterday around 4 o'clock so about 24 hour after my booster shot (10Dec2021). Anatomical site of administration: Left shoulder. The number looks like 4335, that's the only number on here and on the back there is a number that says FH8030, I am not sure which one the Lot number would be. I have FH8030. No lab test (within 2 weeks). Patient was still experiencing the problem. Treatment: Taking Ibuprofen, putting ice on it as well.  No follow-up attempts are possible. No further information is expected.
Within 30 - 60 min after vaccine, temp 102.  Nurse called mom to come get child.  Fever 102 all night.  To Dr. next day.  Complained of tongue itching.  Dr. said throat infection - not allergic reaction to vaccine.  Still fever Fri am (101.3) but on antibiotic - feeling better.
Rash and swelling on inside forearm and fingers. Taking Benadryl at bedtime.
Patient received Johnson and Johnson vaccine on Saturday May 1st. I administered the vaccine. Today, 5/5 she came to the pharmacy to show me the  circle rash that had developed around injection site. It was also swollen and felt like a bruise. I counseled patient on "covid arm" and that it was likely her immune system activating. I explained this can be a common reaction after getting the COVID vaccine. Patient had no other symptoms. I went over things to look out for in relation to blood clots and any warning signs and when to reach out to her doctor. I suggested she fill out Vsafe and I told her I would report to VAERS.
pt recv vax 23SEP96 & p/vax pt exp a sl fever;7OCT96 pt devel 4-5 typical vesicles on forearm & hands & a few on lower back;presented to MD;
miscarriage/spontaneous abortion; This is a spontaneous report from a contactable nurse. A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),  intramuscular, administered in Arm Right on 17Feb2021 15:30 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing herpes simplex 2 and sulfa allergy. Patient previously received the first dose of bnt162b2 for covid-19 immunisation. Concomitant medication included acyclovir) taken for an unspecified indication, start and stop date were not reported. The mother was 7 Weeks pregnant at the onset of the event. The patient experienced miscarriage/spontaneous abortion on 25Feb2021 16:45.   The patient was supposedly due to deliver on 18Oct2021. The with outcome of event was recovered with sequelae.  No follow-up attempts are possible, information about batch/lot number has already been obtained.
This spontaneous report was received from a registered nurse and refers to a 11 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-AUG-2016. On 04-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD, lot # M019233 with expiration date of 17-OCT-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 7 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA013888:
Small red area on right arm with increased warmth 2 days after injection. Pt given 5 day treatment of antibiotics in case it was infection.
pt devel fever 100.6, vomiting on 30JAN93, then following morning pt eye rolled back, shallow breathing 5 mins;
More than 42 days for administration of second dose; Dermatologic reaction/Papulopustular rash; This spontaneous case was reported by a physician and describes the occurrence of RASH PUSTULAR (Dermatologic reaction/Papulopustular rash) and PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concomitant products included USTEKINUMAB (STELARA) for Psoriatic arthritis.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced RASH PUSTULAR (Dermatologic reaction/Papulopustular rash). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose). At the time of the report, RASH PUSTULAR (Dermatologic reaction/Papulopustular rash) had not resolved and PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants drugs were provided. Treatment drugs were oral and topical steroids.
headache fever sore on mouth swollen face eyes puffy stomach pain ear pain don't feel normal itchy
left lymph node tenderness noted in axilla the morning after the injection. That evening, I noticed marked swelling to the left axilla as the tenderness continued. Both resolved after 3 days. Injection was in left arm.
soreness, red, swollen, rash, itching, sneezing, coughing, runny nose, nauseated
Woke up with 102.4 fever morning after vaccines. Left arm is very swollen, very red and hot to touch.  Swelling and redness goes from top of shoulder to elbow.
Early AM hours awoke with c/o chest pain and diaphoresis-taken to Hosp. ER cardiac enzymes positive for acute coronary syndrome-cardiac catherization done 1-27-08 (normal findings) Discharged eve of 29 Jan to parent's care (Parents called to bedside due to condition) transferred to another hospital 01 Feb 08 for admission and further testing. Given meds p.o. (Plavix, Toprol XL, Pendil, Zocor, ASA)
24MAR95 mom stated pt had fever 104.7 about 6 hrs past 24OCT94; APAP & tub for sponging to control fever & kept it about 101; fever free p/2 days; had no szs or other signs of illness; did not see or consult MD;
From Day 1, swelling at shot site, fever/chills, nausea and vomiting Day 2, fever continued through Day 4.  Arm extremely sore, red, swollen from site down to elbow, very limited range of motion.   By Day 5, Fevers gone b it not much Arm improvement. Cefalexin  500mg/3x day started for possible cellulitis.  Day 6, improving range of motion, but very hard lump at point of injection, erythema and some pruritus underside of upper arm to below elbow. DEFINITE POUCHES OF EDEMA UNDERSIDE OF ARM NOW EXTENDING DOWN HALFWAY TO RIGHT WRIST.  INJECTION SITE STILL EXTREMELY PAINFUL.
6 hrs after vaccination arm began to feel sore and over next few hours, became swollen, red, warm and more tender.
Chills and fever that peaked at 103 degrees.  Total duration of chills/fever was approximately 10 hours.
PT 14 yo female, received Pfizer 1st dose LD.  Once vaccinated PT attempted to get up from sitting at vaccinator table and slid from chair onto the floor unassisted. PT unresponsive RN immediately repositioned Pt on back and rolled to back with legs elevated, 1738 PT pale and A/O, BP 90/60 HR 39 O2sat 97.  Parent reports child had not eaten prior to vaccine administration and had limited fluid intake. Pt alert, color returning to baseline, while talking given 11 oz of apple juice. Pt reports no nausea, HA, dizziness. Continue monitoring PT and reported improved status. Sitting BP 87/60 with heart rate 63, SPO2 99% at 1740.  Pt assisted to standing position by RN and Mom without vertigo or lightheadedness, escorted and walked to post observation. Pt sitting in post observation eating a snack that parent provided and sipping juice. 1826 Pt denies vertigo and is asymptomatic when standing and discharged to home accompanied by mother.  Recommended that with second dose to be well hydrated and ingest a recent meal.  Encouraged her to have second dose in a supine position to avert a vasovagal response.
Patient developed severe episodes of eye deviation to the right, tonic and clusters, lasted for several weeks.
Patient started complaining of chest pain and troubles breathing on 2/13/2022 to the medical staff. After further questioning, he stated that it had been going on for 1 week prior. Admitted  for inpatient hospitalization for bilateral pulmonary embolisms and started on an IV Heparin drip.
sore throat; This spontaneous case was reported by a health care professional and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0006B21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OROPHARYNGEAL PAIN (sore throat). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-123354 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-123354:Mother
Dizziness, fatigue, nausea, general malaise. Started severe day 1 where couldn?t move around. Got better over a couple days but symptoms remained. Still present intermittently 2 months later.
I did not have an adverse reaction to the vaccine. On 11/05/2022, I began not feeling well with a sore throat. I was sick with a respiratory illness for 10 days. I got a prescription for a steroid and an antibiotic.
FEVER AS HIGH AS 102.7, MUSCLE ACHES ALL OVER , HEADACHES FOR 24HOURS. TOOK TYLENOL THEN IBUPROFEN. FEELING BETTER SECOND DAY 48 HOURS STILL FEEL LOUSY