chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with induced hives [ spontaneous urticaria] 1/28/22. Started on 1/20/22. Symptoms  include hives, swollen eyes, swelling ears, welts, nasuea, headaches, fatigue, whole body itching.  Still currently experiencing  symptoms they come and go. Was ordered to take zyrtec in the morning and benadryl  in the evening. Without antihistamines Symptoms  are consistent.
27OCT96 1700 arrived via ambulance;catatonic, twitching eyebrows & arms x 10min, fell asleep w.eyes open;vomited x1;unresponsive;911 called;pt sl lethargic but arousable;exp rt facial twitch, rt gaze & rt arm jerking;
hospitalized after the first dose for over a month; Patient received three doses of Moderna Covid 19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (hospitalized after the first dose for over a month) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A, 045A21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by the reporter.  Concomitant products included FLUTICASONE, TRAZODONE, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), LITHIUM CARBONATE, NORTRIPTYLINE, BENZONATATE, HALOPERIDOL and CLONAZEPAM for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HOSPITALISATION (hospitalized after the first dose for over a month) (seriousness criterion hospitalization). On 13-May-2021, the patient experienced OVERDOSE (Patient received three doses of Moderna Covid 19 vaccine). On 13-May-2021, OVERDOSE (Patient received three doses of Moderna Covid 19 vaccine) had resolved. At the time of the report, HOSPITALISATION (hospitalized after the first dose for over a month) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable.  Company comment: This report refers to a case of Overdose for mRNA-1273 (Lot #: 031M20A, 045A21A and 027C21A)  with the event of "Hospitalisation'. Very limited information regarding Hospitalisation has been provided at this time.  Further information is not expected   This case was linked to MOD-2021-141444 (Patient Link).; Sender's Comments: This report refers to a case of Overdose for mRNA-1273 (Lot #: 031M20A, 045A21A and 027C21A)  with the event of "Hospitalisation'. Very limited information regarding Hospitalisation has been provided at this time.  Further information is not expected
Thursday, 02/11 typical vaccine side effects,  fever, noticed redness, hardness, itching at injection site  Friday, 02/12 - fever,  redness, hardness, itching - went to primary care. Diagnosed with cellulitis - treated with Ceflex
I had advised two pharmacy techs that I normally had a robust reaction to vaccine shots so I should probably just get the standard flu shot as I have had most every year as an adult with no reactions.  They persuaded me to get the high dose shot and that all I would have "is a sore arm".  Not so much!!  Within 5 hours of getting the shot, I had full-blown flu symptoms:  high fever (102 to 103 degrees), shaking (with teeth chattering), nausea, muscle aches, high fatigue, headache, and sweats.  This continued for 18 hours.  I took three doses of extra strength Tylenol which helped with the fever, but I was forced to stay in bed the rest of the day of the shot (Friday) and most of the next day (Saturday).  By Saturday night I felt fine, but it made for a miserable start to my weekend. Pharmacy and other administrators of this shot should pay attention when a patient has reservations about the high dosage shots!  I will never take one of them again!!  (I was at home all week so was not exposed to some mysterious 18 hour flu).
Swelling of left axillary lymph nodes beginning Friday (10/22) night.  Symptoms persisted until Sunday (10/24) morning.
Death 4/8/2021 1) Acute respiratory failure secondary to COVID 19 pneumonia
Red, raised, itchy rash on abd, neck and chest; lesser so on back; not on extremities.  Took Benadryl twice for sleep disturbance due to itching.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), FATIGUE (fatigue) and HEADACHE (headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN (pain), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN (pain), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication also included an unspecified blood pressure medication.  Treatment information was not provided.
12 days after vaccine,  i felt swollen both of my breast,  pain  and tender and itchy on the side and on the breast and having back pain.
This may not be related but on 11-5-21 I received the COVID 19 Pfizer booster shot. About 2 hours later I noticed blurred vision and floaters in my right eye. I have have retinal issues but was just cleared with stable eyes on 10/26/21, I called my Retina specialist and was told I have a vitreous hemorrhage in my right eye. Like I said this m ay not be related to the booster, bur just seems odd it happened after getting the injection, I just wanted to make someone aware.  Thank you.
3 days after 2nd dose: Hives on neck and chest; Dose 1: 21May2021; Dose 2: 6Jun2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jun2021 at 15:00 as dose 2, single (Lot number: EW0172) at the age of 19 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Exercise induced anaphylaxis" (unspecified if ongoing); "Known allergies: fruits" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EW0712; Anatomical location: Right Arm; Vaccine Administration Time: 15:00), administration date: 21May2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Jun2021 at 15:00, outcome "unknown", described as "Dose 1: 21May2021; Dose 2: 6Jun2021"; URTICARIA (non-serious) with onset 09Jun2021 at 15:00, outcome "unknown", described as "3 days after 2nd dose: Hives on neck and chest".  Additional Information: Patient did not take other vaccine in four weeks and also did not take other medications in two weeks. Patient did not have COVID prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201067878 same patient, different dose/events;
Hospitalised; A spontaneous report  was received from a consumer, concerning a male patient of unspecified age, of unknown age, who received Moderna's COVID-19 vaccine and was hospitalized.   The patient's medical history included allergic to iodine. Concomitant product use was not provided by the reporter.    On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknow) via unknown route for prophylaxis of COVID-19 infection.    On an unspecified date, after vaccination, the patient was hospitalized. Treatment information was not provided.    Action taken with mRNA-1273 in response to event were not provided.  The outcome of the event hospitalized was unknown at the time of this report..; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.
Subject  observed 30 min. post vaccine with no adverse reaction. Mother states pt called her and c/o itching, fine rash at 4 pm.  Mother states that at 6 pm was taken to Emergency Room due to c/o chest tightness,   SOB. ER physician administered EPI pen. Pt improved and was sent home. Physician reported "may have been due to vaccine, not sure".     Mother reported this per telephone to school the next am (5-26-21), and was called back by RN for report. Mother will not give second dose vaccine. Contacted 5-27-21 and had no other ill effects.
12 hours after the injection, horrible fatigue, could not stay awake.  Chills, sweats, body aches (terrible), headache.  Hands were swollen, pain at injection site.  Slept for 20 hours.  The first injection did not cause a severe reaction. I was tired but able to function.
This is a spontaneous report from contactable physician via sales representative. A 4-month-old patient (gender unknown) received PREVNAR 13 0.5 ml single dose, intramuscular, ROTATEQ and PENTACEL on unknown date. On unknown date the patient experienced on and off bright red hands and feet. Follow-up (26-APR-2013): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. On 12-FEB-2015, the patient was vaccinated with an expired dose of RECOMBIVAX HB (0.5 ml, intramuscular, expiration date 01-FEB-2015, lot# was not specified). Dose was supported. It was unspecified which dose number this was in the vaccination series. No adverse experience was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
AFTER 5 MINUTES OF RECIEVING THE VACCINE THE PATIENT LOST CONSCIOUS FOR COUPLE OF SECOND HIS COLOR WAS PALE AND AFTER i CALLED HIM HE OPENED HIS EYES , BUT WAS NOT RESPOSIVE FOR A SECOND THEN HE START RESPONDING . i GOT HIM WATER AND ASKED IF i COULD CALL 911BUT HIS DAUGHTER AND SISTER SAID NO . HE ALSO DID NOT WANT TOO. THEY SAID THAT HE HAS A FEAR OF THE NEEDLE . HE DID SAY THAT HIS BREATHING WAS SHALLOW SO i ASKED AGAIN TO CALL 911 FOR FURTHER CHECK UP AND HE REFUSED. HIS BLOOD PRESSURE WAS 111/62 THEN AFTER 10  MINUTES IT WAS 110/72 AND THE THRID ONE WAS 117/80. HE SAID HE FELT BETTER  AND i KEPT HIM IN THE PHARMACY FOR ANOTHER 20 MINUTES AND THEN i WALKED HIM TO HIS CAR AND THEY TOLD ME THEY WILL CALL ME BACK
This case was reported by a physician and described the occurrence of severe joint pain in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced severe join pain. At the time of reporting the outcome of the event was unspecified.
On the day of vaccine administration, I had severe body aches and my bones were hurting. I was very lethargic and blood pressure was continuing to drop. I drank about 3 bottles of energy drink to bring the blood pressure back up.  I also had severe arm pain; the pain was so intense I could not lay on my left side for 3 nights.  Miscarriage 4 weeks after receiving second dose of Moderna Covid-19 Vaccine.  HcG beta and progesterone blood tests completed 48 hours apart to classify this as a miscarriage. Patient is having heavy vaginal bleeding and is feeling very lethargic.
Developed hives or red blotches on skin that seemed to come and go occurring a little over 24 hours after receiving immunizations.  Noted to have red blotches scattered on trunk and extremities, wheal and flare reactions scattered on her skin.  No temperature, resolved with Benadryl.  Dx: Urticaria.
pt recv vax 3JUN97 p/11 days pt broke out w/40-50 chicken pox lesions;pt was seen by RN;
This spontaneous report as received from a pharmacy technician refers to unspecified number of patients of unknown age and gender. It was reported that between 01-NOV-2015 and 03-DEC-2015, the patients received unspecified doses of ROTATEQ orally (lot number K017575, expiration date 01-JUN-2016, lot # K011952, expiration date 17-JUN-2016, L008059, expiration date 18-DEC-2016) that were improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Breakthrough case admission after three vaccines  Moderna 4/14/21 Lot# 031B21A;  Moderna 5/10/21 Lot# 043B21A;  Moderna 6/11/22 Lot# 058A22-A2
PT. SAID FELT TINGLING IN ARM, UPPER THIGH, AND FACE ALL ON RIGHT SIDE (same as side of injection).
Guillain-Barre Syndrome; right leg paralysis, IVIG (4 doses); subsequent 45 day hospital stay.
low grade fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th February 2020, 3 hrs after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: Patient stated he experienced low grade fever 3 hours after getting the dose of Shingrix vaccine. The reporter did not consent to follow up. No further details were provided.
4/26 received 2nd Pfizer dose.  4/28 did nonstrenuous exercise.  4/28-4/29 acute abdominal pain/soreness out of proportion to activitiy
Pain on gums; Body aches; High temperature (102F); Blistering on lips ("like a giant cold sore, but not a cold sore"); Brown coloration on mouth; Woke up in a puddle of sweat; Dryness on mouth; Soreness on mouth; Bad respiratory infection ("worse than before"); This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY TRACT INFECTION (Bad respiratory infection ("worse than before")) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ACETYLSALICYLIC ACID (ASPRIN), METOPROLOL, TRIMEBUTINE MALEATE (BUMETIN [TRIMEBUTINE MALEATE]), EZETIMIBE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), LOSARTAN, ATORVASTATIN CALCIUM (LIPITOR), MONTELUKAST SODIUM (MONTELUCAST), ALBUTEROL [SALBUTAMOL], AZELASTIN [AZELASTINE] and GLYCERYL TRINITRATE (NITROLINGUAL) for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced RESPIRATORY TRACT INFECTION (Bad respiratory infection ("worse than before")) (seriousness criterion medically significant). On 24-Mar-2021, the patient experienced PIGMENTATION DISORDER (Brown coloration on mouth), HYPERHIDROSIS (Woke up in a puddle of sweat), DRY MOUTH (Dryness on mouth) and ORAL PAIN (Soreness on mouth). On 27-Mar-2021, the patient experienced LIP BLISTER (Blistering on lips ("like a giant cold sore, but not a cold sore")). On an unknown date, the patient experienced GINGIVAL PAIN (Pain on gums), PAIN (Body aches) and PYREXIA (High temperature (102F)). At the time of the report, RESPIRATORY TRACT INFECTION (Bad respiratory infection ("worse than before")), HYPERHIDROSIS (Woke up in a puddle of sweat), DRY MOUTH (Dryness on mouth), ORAL PAIN (Soreness on mouth), LIP BLISTER (Blistering on lips ("like a giant cold sore, but not a cold sore")), GINGIVAL PAIN (Pain on gums), PAIN (Body aches) and PYREXIA (High temperature (102F)) had resolved and PIGMENTATION DISORDER (Brown coloration on mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: high (High) 102 F.         Patient reported that patient did not seek medical attention for any of the reported symptoms. Patient reported that "patient received some Tylenol, at the beginning after symptoms following second dose". No additional information reported.  Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported event and positive rechallenge, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported event and positive rechallenge, a causal relationship cannot be excluded.
Numbness and pain in both arms and into right hand and unable to write (patient is right hand dominate). Symptoms, pain, nerve damage, and inability to use bilateral upper extremities latest for three days!
Patient had a 12 inch diameter swelling of the arm, which was warm to the touch.  There was no redness present.  There was a golf size ball lump at the elbow.  He had a slight fever of 100 degrees.  His arm was sensitive to the touch.  I suggested cold compresses and to call his physician.  A visiting nurse was also going to visit today and look at it.  At  the time of this report, the swelling is decreasing.  However, the patient will be seeing his PCP tomorrow, Oct 11.
Sore arm; Chills; Headache; Body ache; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 18Apr2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included congenital heart disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included acetylsalicylic acid (ASPIRIN) and beta blocker; both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 28Mar2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced sore arm, chills, headache, body ache, fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, chills, headache, body ache, fatigue and nausea was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Local site reaction: erythema, hard welt, warm to touch, burning at injection site at time of injection. Erythema grew over next 48hrs to a max of 2inches, warm, hard to touch with persistent burning. Resolved 12/25/2020. Beginning at 4:00pm 12/22/2020 generalized body, muscle, and joint pain, increased generalized neuropathy pain and generalized sensitivity to touch. Symptoms resolving 12/26/2020 at 10:00am.
She mentioned that ever since she got the COVID vaccine she has been experiencing constant tremors lasting 2-3 minutes. She has been feeling exhausted more than usual and cannot explain why she feels this way. Her daughter has been coming over to check on her more than usual.
Patient received her first Pfizer COVID-19 vaccine and began feeling throat tightness, SOB, chest tightness and itching about 15 minutes after vaccine. Patient was going to be observed for 30 minute due to history of anaphylaxis. Patient was given 0.3 mg epinephrine in left thigh and 50 mg benadryl IM in right deltoid at 17:06. VS before medications 174/73 HR 73 and after medications was 187/64 HR 78. Nitro patch was removed by Dr. prior to medication administration.
One week after injection, site became swollen and redness occurred the next day.  Treated with ice pack and pain medication.
Covid-19 virus ( tested positive); Covid-19 virus ( tested positive); This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, expiration date: Not provided), via an unspecified route of administration as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 27Feb2021 patient received first dose of Covid 19 Vaccine, today the patient was scheduled for second dose of Covid 19 Vaccine, today the patient experienced Covid 19 virus. The patient laboratory data included SARS-CoV-2 test positive on 27Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Patient had redness and swelling and pain at the injection site. She has taken Ibuprofen to help with the pain and inflammation. I have suggested to also take BENADRYL allergy tablets at, one tablet every six hours.
After administration, patient went to check out eyes got "fuzzy" "I didn't feel well"
Immediately after MMR (0n 10/4/07 Vaccine given) was achy and tired. On 10/15/07 had rash on trunk, face and arms, fever to 101.5.
Patient had syncope/apneic episodes x 4-5 starting 3 min. after immunizations.
This spontaneous report was received from a 76 year old male patient reporting on himself, with no reaction/allergies reported who in 2003, ten years ago was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown), and had no reaction at all to that vaccine. On 03-JUN-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 in the arm (lot # and expiration date not reported) for prevention of pneumonia. The patient reported that he developed significant pain in the arm where he received an injection of PNEUMOVAX 23. It was unspecified whether the injection was subcutaneous or intramuscular. The pain was developed 3 to 4 hours after the vaccination (on 03-JUN-2013). He described the pain as being felt throughout his arm and as about a 7 on a scale of 1 to 10 with 10 being the most painful. The patient did not receive any treatment for the event. Laboratory tests were not performed. At the time of reporting the patient was recovering from the event of significant pain in the arm. This is one of several reports received from the same source. Additional information has been requested.
Patient says the day following her immunization the injection site was raised and red but there was no bruising. The area is better now.