chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient had no reaction/adverse event after VARIVAX was given; vaccine exposure during pregnancy; This spontaneous prospective pregnancy report was received from a 23-year-old female patient who was reporting on herself. The patient's medical history included pre-term labor. The patient's concomitant medications included iron supplements. The patient was pregnant with gestation period of 33 weeks and 4 days. No information regarding the patient's drug reactions or allergies was provided.  On 19-AUG-2020, the patient was unintentionally vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # t008129, expiration date reported as ??-MAR-2022, but upon internal validation established as06-MAR-2022, 0.5 milliliter, subcutaneously (anatomic location was not reported). The wrong order was entered and the patient was supposed to receive a lab draw to check "varicella level", however she was vaccinated with  varicella virus vaccine live (oka/merck) (VARIVAX)  instead. The patient's last menstrual period was (LMP) was estimated as 28-DEC-2019 and estimated date of delivery w(EDD) was 03-OCT-2020. The pregnancy outcome was pending. There was no adverse event reported. No treatment was given. The patient had glucose tolerance teat and chlamydia/gonorrhea test performed, however no results were provided. The patient sought for medical attention.
ARM HURTS; LITTLE FEVER/FELT LIKE CAUGHT THE FLU; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 10-JUL-2021, the subject experienced little fever/felt like caught the flu. On an unspecified date, the subject experienced arm hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from little fever/felt like caught the flu, and had not recovered from arm hurts. This report was non-serious.
RN called pharmacy and indicated that patient had "hives, welts, itching and redness localized at site of injection".  RN gave benadryl 25mg po x1.
Patient feel a tingling sensation. Patient also complain of chest tightness, constant coughing, and itchiness. Gave patient 25mg unit dose liquid cup of Benadryl. Patient waited for 30 minutes after getting the vaccine. Thereafter, patient felt better and was release.
12 days after first dose vomited clotted blood; 12 days after first dose vomited clotted blood; chest tightness; extreme fatigue to the point of barely being able to walk continued for several weeks.; extreme fatigue to the point of barely being able to walk continued for several weeks.; bleeding; elevated HR; BP; elevated HR; BP; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6202) via an unspecified route of administration, administered on the left arm on 01Mar2021 as 1st dose, single for COVID-19 immunization. Medical history included Echo from Nov2020, exposure to A. flavus in 2014 with development of fungal ball in sphenoid cavity causing brain injury and all body damage, Autonomic disorder developed tachycardia. Concomitant medications were not reported. It was reported that 12 days after first dose on 13Mar2021, patient vomited clotted blood; hospitalized. The patient was hospitalized from 13Mar2021 to 15Mar2021. Cleared and discharged after a day unknown cause of bleeding on 16Mar2021. Elevated HR; BP; difficulty breathing, chest tightness and extreme fatigue to the point of barely being able to walk continued for several weeks. Events were considered serious, disability. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. No treatment was received. Covid test post vaccination: Nasal Swab on 22Mar2021 and 10Apr2021 Negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event vomited clotted blood was recovered on 15Mar2021 while not recovered for the other events.
Patient had the initial Pfizer COVID vaccine on December 18th.  She started to having arthralgias, myalgias, fever, fatigue and weakness starting on  December 20th.  The patient continuously had arthralgias, myalgias and weakness for the next few weeks.  Patient follow up with physical therapist once a week to work on muscle weakness.  The patient continuously had arthralgias and myalgias until January 10th.  Primary care provider on January 7th orders CBC, autoimmune and thyroid panel since patient was having ongoing myalgias and arthralgias.  Patient postpone 2nd dose because side effects from 1st vaccine were ongoing.  Patient got 2nd dose vaccine on January 12th at 4:30pm.  On January 13th at 11am the patient initially had nausea and arthralgias.  Patient took Zofran 4mg ODT about 11:15am.  30mins later the patient tongue swelled.  No lips swelling and no SOB.  Patient immediately took liquid Benadryl 50mg to 75mg PO.  Patient immediately drove to  ED.  Patient was observed until 2pm for progressive signs and symptoms of allergic reaction.  Patient was discharge and advised to take Benadryl 25mg to 50mg  every 4 to 6 hrs prn allergic reaction,  Patient took famotidine 20mg at 4pm along with 25mg of Benadryl PO.  Tongue swelling began to decrease.  Patient also had fever, myalgia and arthralgias at 4:30pm.  Took Tylenol 1,000mg and symptoms subsided  (fever, myalgia and arthralgias). 1st Vaccine lot#EH9899 on left arm. 2nd Vaccine Lot#EL01T2 on left arm.
The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 11-May-2022; Patient received expired dose after the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 11-May-2022) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Janssen (Primary 1 dose and 207A21A.) on 20-Aug-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 11-May-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 11-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient received booster 1 dose. It was reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. The vial was initially stored in the refrigerator on 11-Jan-2022. The dose administered more than 30 days after 11-Jan-2022 was not in accordance with a Regulatory Authority. The vial did not undergo any temperature excursions. The patient had not reported adverse reaction to the HCP knowledge. No treatment information was reported.
Dizzy/Fatigue/Achey/Nausea for 4-5 days. Sore arm at injection site for 3 days. Left toe swelled up and painful on day 2, but subsided within 24 hours.
Patient complaining of pain in rt arm 2 days after flu shot. Pain is intermittent. Worse with abduction. Treated with ice and NSAID.
My wife (69 years old) and I (80 years old) got our flu shots in Sept. 2014 in a pharmacy operation. Since that time we both have had several bouts of nausea, some vomiting, weakness, and sneezing on and off since Sept. HAS THERE BEEN ANY REACTION TO THIS YEARS SERUM SIMILAR TO THIS? We have never had problems with previous years flu shots.
nausea, body aches & pains, fever, fatigue,  dizziness. Spent 2 days flat in bed, severe headache. fever, body aches, nausea. Ate only dry toast & soup. By 3rd day fever left and  I felt ok at first but after breakfast I became very nauseated. On 4th day I felt fair, went to Easter service, but throat was dry and shortness of breath,  nausea, 1/2 day in bed, On 5th day, I called my primary care Dr. My tongue was white and throat very dry. I could hardly swallow. Still short of breath. He prescribed a mouthwash of Nystatin. It has helped some but I still am nauseated, short of breath and easily fatigued. Today, day 9, I am back in bed, dizzy and fatigued, nauseated and short of breath. I thought I'd be better by now.  First shot my arm bruised badly plus red and sore, but otherwise I felt okay.
Redness and swelling of right deltoid, with discomfort and bruising, worsening 2 days after immunization, then starting to improve. Residual redness 6cm diameter and 4-5 cm ecchymosis, with improved symptoms 3 days after immunization.
Headache 3 days, fever (99-101.3) 2 days, nausea 24 hours.  Headache and fever treated with acetaminophen 1000 mg PRN.   Soreness at injection site treated with lidocaine 5% patches PRN (ongoing)
ringing in ears started ~1 week after 2nd dose of Moderna Covid 19 vaccine
Patient was treated in the emergency room twice for severe pain/swelling and cellulitis at the injection site.
Lt arm sore and red, firm warm area 60 mm round noted on left deltoid.  Used ice.  Advised to follow-up with PMD.
PT stated she is afraid of needles and ALWAYS faints when blood is drawn from her or given a vaccine or shot. PT fainted within a couple of minutes of the pharmacist administering the vaccine. she was sitting in a chair with arms. her friend and myself lowered her unto the pharmacy floor. he was at her head and I was at her feet. I lifted her legs. pt regained consciousness within 3 minutes.  she sat up for another 15 minutes and then left with her friend.
Chills, headache, extremely sore arm. I couldn?t use it all all. Terrible bone pain in both legs, I could barely walk. Lethargy
Patient received flu vaccine 10/15 father noted that eve small amt redness; afebrile. Called on call 10/16 increased redness swelling at site, went to ER Dx with cellulitis on KEFLEX. 10/22 Spoke with parent area all improved.
(2nd dose) soreness at the injection site; (2nd dose) trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN ((2nd dose) soreness at the injection site) and INSOMNIA ((2nd dose) trouble sleeping) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (Sore arm after first shot of covid-19 vaccine that resolved in two days) on 02-Feb-2021.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN ((2nd dose) soreness at the injection site) and INSOMNIA ((2nd dose) trouble sleeping). At the time of the report, INJECTION SITE PAIN ((2nd dose) soreness at the injection site) and INSOMNIA ((2nd dose) trouble sleeping) outcome was unknown.            medication for diabetes was taken concomitantly by the patient  No treatment information was provided  Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable
SHIVERING; HEADACHE; EXHAUSTED; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included surgery to remove a fibroid tumor from her uterus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) once a total dose was not reported, administered on 27-MAR-2021 at 10:30 am on right arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced shivering. On 27-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shivering, and had not recovered from headache, and exhausted. This report was non-serious.
I noticed redness, warmth, swelling & itching Left upper arm. It became warm & progessed to about 9 inches in length & 4 1/2 inches wide & raised about an inch. over the next 24 hrs. It took 8 days to recede & go away. I treated it with an herbal ointment topically and took oregano oil orally
pt recvd vax 22APR94 & 24 hrs later exp periodic screaming, would not crawl, & was irritable; these sx resolved on 25APR94;
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:33 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  For batch  031A21A, vial was stored in cooler 1, on 20-Mar-2021, Excursion duration at 9 am: 34, at 10 am 30, at 11 am 41, at 12 am 45, at 1 pm 44, at 2 pm 44, at 3 pm 44, at 4 pm 44 and at 5 pm 43 taken using a Fisherbrand traceable temperature monitor in degree F.  On 20-Mar-2021, total doses given for the day were 184, condition of vaccine; prior to vaccination was not frozen, vaccine was moved to fridge on 09-MAR-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were moved to clinic. Vaccine BUD date was 08-Apr-2021 for batch number 031A21A.  Vials were only punctured right before administration. Vaccines were not frozen at time of administration Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic No treatment information was provided   This case was linked to MOD-2022-566976 (Patient Link).
positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 08Mar2021 as first dose, single for COVID-19 immunisation. Medical history included diabetes from an unknown date. The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced chills and feeling really bad. The patient tested positive for COVID-19 on an unspecified date in Mar2021. The patient underwent lab tests included SARS-CoV-2 test with a positive result on Mar2021. Outcome of the event was not recovered. The reporter would like to know if the patient, her husband, will have to start the COVID-19 vaccination series all over again once no longer in isolation from his current diagnosis of a COVID-19 infection. Also, the reporter would like to know whether she will have to take a COVID-19 test before receiving her second dose of the COVID-19 vaccine since she was in contact with her husband.
Technician administered 5-12 year pfizer to 2 year old @ 1500 on 16 August 2022
DTaP and IPV vaccinations left thigh about 11:00 9/9/02. About 36 hours later, noted redness, moderate swelling life thigh. Injection sites had ecchymosis. Next 24 hours, redness down and swelling up. Evaluated 13:00 9/11/02 by me. Question cellulitis, treated with Cephalexin.
Pt. received a FLUVIRIN vaccine on 10/13/08. On 10/15/08, approximately 12 PM, pt. stated she noticed red spots and lumps on her back, sides, and shoulders. Besides, feeling ..., the pt does not feel sick or have any difficulty with breathing. She took a CLARITIN to help with the rash and itchiness. I also advised her to apply hydrocortisone cream to the rash, if CLARITIN does not help with the itchiness.
Small red bump - slight itching - redness spreading. MD treating with KEFLEX 500mg QID x 10days and OTC BENADRYL.
Local reaction at injection site in left arm with erythema, swelling, and warmth to touch. Noted by parents 1 day after injection. Seen in ED 2 days after and again by PCP 4 days after- erythema still present 4 immunes given in total on 3/15. DTaP and Varivax given in left arm.
Patient broke out in hives on face on forehead above eye. Extreme itching . Advised call 911 or visit ER if symptoms worsen or if new symptoms arise.
Had fallen asleep on the couch and I went to get up and I fell. I stood up and tried to walk again and fell again. I was very dizzy. And when I woke up in the morning, I still was very dizzy and it felt like I was super, super drunk - bouncing off the walls when I try to move. I waited to see if it would clear up. It didn't.  My daughter took me to ER at 1:00 pm. Diagnosed as Vertigo . They gave me two medications - Meclizine and Promethazine - I'm still taking those. That has helped. Two days I was good, I was back to normal. But yesterday, it was back again (the dizziness) - it's like I'm drunk but not falling into the walls - just dizzy. It's still here today. (Dizziness). Upcoming appointments in July - one with  a Neuro doc and one with a new primary care doctor.
body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) had not resolved. Not Provided          No concomitant medications were reported. No treatment medication was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Fever; chills; extreme fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm, on 08Mar2021 at 02:00 PM (Lot Number: EN6204) (at the age of 43 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19. The patient has known allergies to codeine, beef, chicken, tomatoes, cucumbers, eggs, and hormones. The patient was not pregnant at the time of vaccination. Concomitant medications included olmesartan; cetirizine hydrochloride (ZYRTEC), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, and extreme fatigue on 08Mar2021 at 10:00 PM. The patient has not been tested for COVID-19 since the vaccination. The patient has not taken any treatment for the events. The outcome of events fever, chills, and extreme fatigue was recovering.  No follow-up attempts are possible. No further information is expected.
Initial case was received on 19 March 2010 from a physician. A 9 year old male patient received a right arm injection (route not reported) of Influenza A H1N1 2009 Monovalent Vaccine - Preservative (lot number UP022AA) and a left arm injection (route not reported) of FLUZONE No Preservative 2009-2010 (lot number T3252BA) on 22 December 2009. According to the physician, the patient developed right leg sequential dystonia soon after a right ankle sprain which occurred 7-10 days after vaccinations. The dystonia progressed rapidly; no etiology has been found and his brain MRI was normal. The physician was ordering a cervical spine MRI to look for transverse myelitis. The patient's dystonia is severe; he is undergoing physical therapy. The reporter was not sure if the patient had previous doses of the vaccines. No adverse events occurred following prior vaccination. The patient had no illness at the time of the vaccinations, no pre-existing medical conditions, no known allergies and no concomitant medications. The outcome status of the ankle sprain was not reported. As of this report the patient had not recovered from right leg sequential dystonia. Documents held by sender: None.
PT RECEIVED COVID 19 SHOT ON 4/13/21 AT SEPARATE LOCATION. PATIENT FELT WARMING SENSATION IN HER THROAT WITHIN 15 MINUTES OF VACCINATION BUT WAS DISCHARGED HOME; A SHORT TIME AFTER THAT SHE BEGAN TO HAVE TROUBLE BREATHING WHICH INCREASED THROUGHOUT THE NIGHT DESPITE USING HER INHLAER AND NEBS MULTIPLE TIMES. PT ARRIVED TO EDMORNING OF 4/14/21 WITH SHORTNESS OF BREATH AND WHEEZING. PT GIVEN IV STEROIDS IN ADDITION TO NEBULIZER TREATMENTS. AFTER SEVERAL NEBULIZER TREATMENTS, PT RESPIRATORY STATUS STABILIZED AND WAS ABLE TO BE DISCHARGED HOME.
After 2-3 minutes of receiving shot (H1N1), patient complained of light headedness and felt warm. No difficulty of breathing or palpitations. Called 911 and they checked her and 4-5 minutes later, patient said she is feeling much better and denied going to hospital.