chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax; in may1996, devel a "breakthrough case" of chicken pox; it was noted that pt had bronchitis and was being tx w/ albuterol sulfate;
Patient began have crying spells the day after immunization. He would start crying for no apparent reason and nothing would console him. This continued till 08/29/2013. On 08/30/2013 he presented with a fever of 102.5.
Administered BEXSERO, HAVRIX, and FLUZONE in LD. Administered MENACTRA in RD and pt head slumped and briefly passed out. VS at 1555 94/59 HR 144 and water given. VIS at 1603 117/71 HR 78 water given, still pale and diaphoretic. VIS at 1611 122/81 HR 79 color WNL, left w/parents.
Hives, vomiting, tachycardia, chest pain, dizzy, swollen injection site,
Fever started 7 days after PROQUAD was given. Rash started 9 days after with severe irritability afebrile on day 9.
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/21/2023 DM 2 W HYPERLIPIDEMIA
Pt recv vax on 3/22/99; 1/2 hr post vax pt exp 4 hr of unconsolable crying, then crying x 2 hr, short sleeping periods
Patient reported over the phone that they experienced a rash appearing on their left leg, then right leg, then up their back.  Patient urged to visit healthcare. No follow-up obtained at this time.
Patient was hospitalized due to breakthrough infection. Patient received the Moderna vaccine (2nd dose completed on 03/31/2021) and a Pfizer vaccine booster (11/09/2021). Patient was hospitalized from 02/19/2021 - 02/21/2021. Below is copied from discharge summary:   Hospital Course:  85 yo F with COVID bronchitis/pneumonia with N/V/D   #COVID pna/ acute resp failure   - CXR w bl opacities  -dc rocephin -s/p solumedrol, will complete w dexamethasone for 10 days  -weaned off o2 this am -walking test done and passed, remained above 95% -crp elevated now downtrending  -supportive tx    #COPD - cont advair 250, budesonide BID, oxygen therapy to titrate >90% -+COVID  -as above      #CHF - ef 55-60% 12/18 with RV pacemaker, LAE -dc ivf    #HTN -better controlled -cont home meds   #CAD s/p CABG and pacemaker, h/o SMA stenosis -cont aspirin/plavix -cont lipitor -cont coreg   #glaucoma - cont eye drops   #hypokalemia -  Potassium 100 total (s/p 40) Likely d/t N/V/D resolved   Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP and MD within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
Cranky since Monday evening after shots given 102 temp Tuesday evening- resolved after 24 hours. Not sleeping well.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX lot # N010494 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced product use issue and no adverse event. The outcome of product use issue and no adverse event is unknown. The reporter considered product use issue and no adverse event to be not related to ZOSTAVAX.
Fever, headache, weakness, extreme fatigue, dizziness, heart racing, chest pain Sunday 9/26 following vaccine. Lasted till Tuesday 9/29. Only symptoms that lasted is headaches and chest pain.
Pt came back into office. Per mother child had been crying since received vaccine. On examination swelling of the upper R thigh warm to touch red and measuring 6X6cm (red raised spot) Benadryl and Tylenol given did to follow up in office.
15 hours after 2nd vaccine: Fever, chills, dizziness, lethargy, weakness, muscle ache, headache. After  20 hours above plus nausea. Most concerning, severe headache felt thru the base of neck, back & top of head, and forehead. 48 hours later still feeling these the severe headache and dizziness.
Dx of chickenpox on 12/27/02 after receiving Varicella vaccine on 1/6/98.
first dose of shingrix on 12/3/2019 / refused the second dose / now wants to receive it; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th March 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The patient refused the second dose, and now wanted to receive it. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter asked if they could restart the series, or could they just give patient the second dose, despite the time element. No further information provided. The reporter consented to follow-up.
Started with headache , fatigue  and muscular aches.later fever of 100.4   3rd day.. fever, low blood oxygen (90) increased heart rate, rigors Called 911  Taken to ER. Lab results revealed mild urinary tract infection Kidney stones ruled out.  Intravenous Levaquin. Fever subsided. Returned home after 6 hours. Next day still having difficulty urinating Dr increased dose of Levaquin. Improvement by 5th day
Nurse Mgr at Health Dept. discovered that the above mentioned Pfizer vaccine was not properly removed from the regular freezer (-25 Celsius to -15 Celsius) on 10/13/2021. The Pfizer vaccine was moved from ultra cold freezer to regular freezer on 09/28/2021 and should have been removed from the regular freezer the end of the day on 10/13/21 and placed in the refrigerator for 31 days. The vaccine was not removed on this day from the freezer. The vaccine is still in the freezer today 10/25/21. It was investigated and found that the vaccine was use in clinic Monday10/18 through 10/23. NP called Pfizer med and spoke to an attendant, walked her through the scenario and she made me aware that vaccine could not be used past day 17 after being in the regular freezer, voice that vaccine stability could not be determined and that vaccine should not have been used past the 3 day grace or day 17 and should have been moved to the refrigerator on day 14 after removed from regular freezer. Patient was notified of the incident.
Information has been received from a physician concerning a 4-month-old patient who on 27-JUL-2007 was vaccinated PO with a first dose of Rotateq (Lot # 657514/0667U). The patient is not experiencing any known symptoms. No further information is available. There was no product quality complaint. Additional information has been requested.
Red, swollen, painful redness over a large area of arm. It started out as about a nickel-sized round redness around the injection site. Grew to a 3? x 3? Red patch by the next day. Approximately 4? x 4? red patch now, 24 hours later.
Bell's Palsy; This case has been considered invalid as non-serious event was not reportable in clinical study.   This is a report from an interventional study.  A 51-year-old female non-pregnant subject received blinded therapy (BNT162; PLACEBO) first dose on 24Aug2020 at 13:15 and second dose on 15Sep2020, via an unspecified route of administration on left arm at single dose for COVID-19 immunization. Medical history included allergy to some foods.  No other vaccine in four weeks and no other medications in two weeks. The subject experienced bell's palsy on 03Dec2020 which considered as non-serious by investigator. Clinical course was as follows: on 03Dec2020, the subject had a diagnosis of bell's palsy post 2nd vaccine. The subject had no COVID prior vaccination. A nasal swab post vaccination on 30Nov2020 was negative.  After visit 3 (13Oct2020), the subject reported the Bell's Palsy. She went to her doctor, but mot hospitalized. The investigator did not think this was an SAE and was not considered life threatening. The action taken in response to the event for blinded therapy was not applicable. Event treatment included an unspecified medication. The outcome of the event was not recovered.  The investigator assessment with blinded therapy, concomitant drugs and clinical trial procedure not reported.  Follow-up (21Dec2020): New information received from site included: updated report type, patient ID, event seriousness (non-serious).
Per patient and spouse: 2nd dose of Moderna received on 04/01/2021. (This facility does not have record of administration). Patient seen in ED 4/11 after 5 days of  bilateral lower extremity weakness, gait problems and numbness.  Patient admitted and evaluated. Neurology consulted and on 04/13/2021  diagnosed with likely acute inflammatory demyelinating polyradiculoneuropathic form of Guillain-Barre syndrome.
This spontaneous report as received from a nurse refers to 2 patients of unknown age. No concomitants were reported. On 23-MAY-2014, patients were vaccinated with PEDVAXHIB (dose, frequency, route of administration and indication were not provided) lot J016188, expiration date 02-OCT-2016 that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have anyone by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013338, 1405USA013916, 1405USA013915, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link.
chills; Fever; weakness; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 16Feb2021 (at the age of 36 years old) at dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 26Jan2021 at dose 1, single for covid-19 immunisation. Patient had no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19. Post The patient had not been tested for COVID-19. No other vaccine in four weeks and it was unknown any other medications in two weeks. On 17Feb2021, the patient experienced chills, fever and weakness. No treatment received for the events. The clinical outcome of the all events were recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Chills night after vaccine administered. Red rash, swelling from injection site up back of arm, worsened over several days. Blisters developed at site of injection.
Onset of arthritis in right wrist Onset of arthritis in right  ring finger (is stiff especially in mornings  and won't bend to my hand to make a fist
Patient was injected with two Moderna Boosters ( .25 cc) dose (Lot #: 035C21A Exp date 12/30/2021) with one in each arm. Patient was informed he rceived two Moderna Boosters and were to be observed for 30 minutes. Patient was observed for 30 minutes after administration in observation area and left without any issues
Chills, headache, fever, sweats, restless legs, lethargy, decreased muscle coordination, difficulty with fine motor skills including signing name, shaky hands, restless legs and muscle cramps
This spontaneous report was received from a medical assistant concerning a 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L016429 and expiration date 09-AUG-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Throwing up; This is a spontaneous report from a contactable consumer (patient's parent). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EL9266) (at the age of 47 years) as dose number unknown, single for COVID-19 immunisation. The patient medical history was none. There were unspecified concomitant medications. The patient started throwing up on 27Feb2021 with outcome of not recovered. Treatment included Tylenol.   No follow-up attempts are needed. No further information is expected.
Fever up to 102 for 3 days with a rash consistent with erythema multiforme for 5 days.  Eventually treated with 3 days of prednisolone with resolution.  Fever treated with tylenol and ibuprofen
TIGHTNESS IN CHEST (BRIEFLY RIGHT AFTER INJECTION),  FATIGUE, SEVERE JOINT PAIN STARTING NEXT MORNING FOR 12-16 HOURS DEVELOPED FEVER BLISTER-WITHIN 12 HOURS OF INJECTION
Vomiting 2 times within 2 hours.  No other signs or symptoms and seems to be well afterward.
Running nose; Feverish / temperature 101.6 degree fahrenheit; Achy; chills; slight headache; lethargy; Sweats; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 18-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargy), HYPERHIDROSIS (Sweats), RHINORRHOEA (Running nose), PYREXIA (Feverish / temperature 101.6 degree fahrenheit) and MYALGIA (Achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-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) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced LETHARGY (lethargy). 18-May-2021, the patient experienced HYPERHIDROSIS (Sweats), MYALGIA (Achy), CHILLS (chills) and HEADACHE (slight headache). On 21-May-2021, the patient experienced RHINORRHOEA (Running nose) and PYREXIA (Feverish / temperature 101.6 degree fahrenheit). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargy), HYPERHIDROSIS (Sweats), RHINORRHOEA (Running nose), PYREXIA (Feverish / temperature 101.6 degree fahrenheit), MYALGIA (Achy), CHILLS (chills) and HEADACHE (slight headache) outcome was unknown.            No concomitant medication information was provided. Action taken with mRNA-1273 is considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: FU added on 21-MAY-2021, No new information was provided in FU source document.
can not walk at all; Swelling; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced cannot walk at all and swelling. The outcome of the events were unknown.  No Follow-up attempts are needed. No further information is expected
Pt tested positive in the ER 4 days prior to admission.  She was admitted due to dehydration and pneumonia consistent with COVID-19.
12/08/21 ID physician's note: " Acute diarrhea, 11 days PTA, recent abx use with keflex, improved, now with only 1 soft bm so far today, and 3 total yesterday. CT a/p: no evidence of obstruction, negative for acute process C.diff pending 2. Multifocal pneumonia due to COVID-19 virus;  Vaccinated with Moderna x2 in February per patient report.  Family exposure possibly 12/2, Covid + on 12/7, Onset unclear. Afebrile,  saturating at 95% on RA .   S/p casirivimab-imdevimab on 12/7 CT: Peripheral airspace opacities in the visualized lung bases covid labs not ordered 3. AKI, mild, improving 4. Recent fracture of LUE, in sling 5. PMH: Type 2 DM, DVT, HTN"
red warm inch circumference around vaccination injection site. Also states she had a low grade fever for 24 hours. Stated she took Benadryl one time and is feeling much better today. red area with less circumference today as well
Pt was in office for 1 yr well check. MMR and MMRV were both administered at this visit. Nurse recognized error while logging vaccines into EMR. Mom notified the following day and informed of possible reactions to watch for. Understanding was voiced. No adverse reactions reported thus far.
Information has been received through the Merck pregnancy registry from an 18 year old female patient with no known allergies and a medical history of blood clots, who on 18-FEB-2008 was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (Lot # 659441/1446U). There was no concomitant medication. On 18-FEB-2008 when the patient received the vaccination. "her heart was beating really fast, and she couldn't sleep because of sharp pain in stomach." On 25-MAR-2008 the patient stated that a pregnancy test given "today," showed that she was 8.5 weeks pregnant. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
With the 1st she got arm pain for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (With the 1st she got arm pain for 4 days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (With the 1st she got arm pain for 4 days). On 18-Feb-2021, PAIN IN EXTREMITY (With the 1st she got arm pain for 4 days) had resolved.            The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was not applicable.  Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-049547 (Patient Link).
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 21 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
2nd Vaccine, April 29, Thursday ~5 pm had 2nd COVID vaccine, Lot# 045B21A; April 30, Friday, Feeling very achy and sore muscles, feeling achy more quickly than 1st vaccine. Spent day in bed. April 31, Saturday, Feeling terrible, just as bad as worse part of COVID 19, achy and sore with fever. Spent day in bed. May 1, Sunday, still achy and sore, but feeling better. No fever, up and around some. May 2, Monday, returned to work. Tired but OK, feeling a little "Spacey"
Initial report received from the patients parent on July 05 2005. A 15 year old female patient with a medical history of gastrointestinal reflux and allergies to Augmentin and Septra developed a fever of 99.2 degrees F, swollen eyes and swollen glands in her neck hours after she had received an intramuscular injection in the right arm of Menactra, lot number U1657AA and an intramuscular injection in the left arm of Boostrix, lot number AC52B003AA. She was examined by a physician and blood work was drawn, including a mono test. At the time of this report, the patient had not recovered from these events.
Information has been received from a physician concerning a 12 month old female with no known allergies and sinusitis who on 29-JUN-2006 was vaccinated SC in the left thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot # 651813/0770R). Concomitant therapy included amoxicillin. Concomitant vaccination included a fourth dose of Prevnar (lot # B08655A) IM in the right thigh. On 08-JUL-2006 the patient developed a rash all over body, a measles-like rash with flat lesions which were bright red and hot to the touch but "not".  Additional information indicated that on 08-JUL-2006 the patient woke up with a rash that spread to his entire body. The rash was consistent with a measles vaccine rash. On 12-JUL-2006, "two days off the amoxicillin", the patient's cough worsened. The patient was started on Augmentin and her rash initially worsened becoming red, hot, raised and pruritic, the improved. On 20-JUL-2006 the patient recovered. Additional information is not expected.
On 3/28/05 noted redness and warmth at injection site which has increased to that seen at time of examination 3/29/05.
patient received first dose of Pfizer vaccine almost immediately patient felt flush, anxiety, jittery, nausea.  Patient moved to a facility for additional monitoring. VS  1026 HR 78, BP, 145, 99% 1035 HR 72, 150/97 1046 HR 72 150/89 1056 HR 62, 146/88 1106 HR 60, 143/102 Patient manager notified that patient would be transported to ED as symptoms did not resolve and would be going home. Device returned to unit.  Patient accompanied to ED for additional treatment /monitoring.
Got lightheaded intialky. Through out the day I slept b hurt then I woke up short of breath and itchy with a slight rash on my chest. I had but if itchiness in my arms but no sign of rash and she watched me an additional 15 minutes to the original 10. Pharmacist gave me shot in left arm.