chrisvoncsefalvay/vaers-outcomes huggingface dataset:
c/o eye swelling and watering, generalized itching without gross evidence of rash, complaints of throat closing sensation; approximately 32 hours after she Received COVID booster yesterday (dose 3).  Treatment: Naphcon topical, Benadryl 50 MG x 1 IM, EPINEPHRINE 0.3 MG x 1 IM with good effect within 10 minutes of arrival. Symptoms significantly improved, then returned. Transported to hospital/ED via ambulance.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 05-AUG-2015, the patients were vaccinated with unspecified number of improperly stored doses of VAQTA (lot # K012457; expiration date 04-JUN-2017) (dose, strength and route of administration were not reported). It was reported that the doses were exposed to temperatures outside of the recommended range. There was no concomitant medication reported and no adverse effects were reported. Additional information has been requested. This is one of four reports received from the same reporter.
Tingling in arms and feet; Sleepiness; Muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 (at the age of 49-year-old) as a single dose, 0.3 mL for COVID-19 immunisation. Medical history included mitral valve prolapse and calcium deposits. The patient had not received other medications within two weeks of vaccination. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within four weeks prior to the vaccination. On 26Mar2021, the patient experienced tingling in arms and feet, muscle soreness and sleepiness. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tingling in arms and feet, muscle soreness and sleepiness was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected
Admitted for syncopal episode on 5/14/21, found to have lung lesion with necrotizing granulomatous inflammation, deceased 5/20/21
Mouth sore,  left cheek. Seemed to be nerve related. A line of inflammation covered by white stuff that ran from the back of my cheek to my lip. Lasted about 3 days.
Patient post-vaccination (Pfizer/0.3ml/1st dose administered @10:23a) appeared to be seizing in his chair during observation @ 10:26a.  I rushed to him, requesting aid from his colleagues to help lay him on the ground and elevate his feet. He was unresponsive and disoriented, with shallow breathing and weak pulse, so I activated EMS @ 10:26a.  He appeared to seize again so I instructed two men to help roll him onto his side, at which time, an RN managing the vaccines, took over monitoring while I talked to 911.  EMS was on scene @ 10:29a. RN reports he'd had a vagal response, most likely due to witnessed severe anxiety during IM injection (name /right deltoid @ 10:23a). RN gave him Gatorade and he quickly became AOx3.  When EMS arrived, he was able to stand up, with assist, and be placed on the gurney.  EMS monitored him for ~ 20min onsite, at which time he became hypotensive, resulting in transport to the nearest ER with O2 and IV management.  Per HR representative for a business patient was discharged @ ~2p the same day, with diagnosis of severe dehydration and hypokalemia, his reaction most likely a vagal event.  Unknown if medications were given outpatient.
Reported pain at site of injection, warm to touch, and redness. Redness measured 6cm x 4 cm.
Father reported today (12-10-12) that his son had fever of 104 degrees on Thursday night (12-6-12). Fever resolved without treatment and temperature was normal on 12-8-12.
swelling, erythema, pain @ inj site;DPH, cold packs;
Had low grade fever 0n 3/11/2021 along with slight headache and slight body aches. Sore arm at injection site. Still felt tired on 3/12/2021 but fever gone.
Patient received Moderna bivalent vaccine that had undergone a temperature excursion.; Product storage error; Patient received Moderna bivalent vaccine that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine that had undergone a temperature excursion.).    No information about patient's previous COVID-19 vaccination doses was available.   Patient received Moderna bivalent vaccine that had undergone a temperature excursion.   The Pharmacist administered the bivalent vaccine before knowing if the vaccine was viable after the temperature excursion. No other adverse reactions were reported. No other information was known about the previous vaccine doses as the patient had not received them at the callers Pharmacy. Pharmacist provided permission for safety to contact her via e-mail.  No concomitant medication reported. No treatment medication reported.
Vertigo; This case was reported by a other health professional via call center representative and described the occurrence of vertigo in a female patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown.   The reporter considered the vertigo to be possibly related to Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was getting the accelerated dosing schedule for Twinrix, patient thought they had a reaction of vertigo to hep B portion of the vaccine. The patient reported the vertigo started after receiving the second dose of Twinrix on the accelerated schedule. The reporter did not have the patient information, vaccine information, nor could they consent to follow up.
Pt has morbid obesity and is on chronic home  oxygen.  She was admitted for COVID pneumonia and NSTEMI.
On day 9 after the vaccine, I experienced puffiness just below the injection site and just above the muscle into which the injection was made.  It was visible with external swelling, the kin was red in places, and it was itchy.  The muscle itself, which had been sore the first couple of days after the vaccine but then normal for the next few days actually hurt as I lifted it on day 9.  Symptoms were similar on day 10. Today as I file this report, day 11 after the vaccine, swelling and itchiness have diminished, but that area of the muscles in a little hard/stiff to touch.
sick; flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Nov2022, outcome "unknown", described as "flu-like symptoms"; ILLNESS (non-serious) with onset Nov2022, outcome "unknown", described as "sick".  Additional information: The patient received one of the most recent bivalent booster on tuesday 15Nov and it made the patient very sick for days with flu-like symptoms. The patient attempted to report this to the (name withheld) at (address withheld) where he/she received the booster and they said that they have no means of reporting side effects. This was unacceptable. Patient said that If there were no means of reporting and recording side effects then you are essentially running blind and using them as guinea pigs.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
started with runny nose. within an hour I developed a low grade fever 99 to 100 degrees, fever blister on lip, body aches, headache and fatigue. increased in severity over 48 hours then started to abate. Treated by self at home with day quilt severe cold and flu.  treated symptoms.
Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 040B21A and 031M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.            No treatment medications were reported.  Patient stated that he is taking other unspecified medication.   This case was linked to MOD-2021-369453, MOD-2021-369437 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow-up received and contains no new information.
ON the 11th 11/01; pt was brushing teeth in the AM, started to feel dizzy, saw blue spots.  Fell with head hitting bathmat (this part not witnessed).  Mom rushed in found her on the floor having seizure, incontinent and bit tongue.  Mom believes it lasted about 20 seconds.  MD spoke with mom, discussed possibility of EEG and how to handle seizures.
Patient reported vomiting x20 min after receiving vaccine, also reports "funny" taste in mouth; no other s/s reported.
approx 1 day p/vax in lt deltoid pt devel redness, pain & swelling;inc pain/swelling until muscle spasm in lt arm;pt states has been to a neurologist w/a dx of multiplex neuropathy;
Pt reported "dizziness" the evening she received vaccine. Then on and off, 11/30/09 increase in s/s, vomiting. Seen at MD office and ER. Dx Labyrinthitis UTI.
First 24 Hours Arm and Back Pain. Head Ache. Fatigue   72 hours Lumps in arm pits, sore to touch.
On 09/24/2022, the vision in my right eye suddenly went white. I went to the local emergency room where they ran a CT scan and an Angiogram. They said they couldn't find anything. My vision returned slowly after around 90 minutes. I followed up with my doctor the following week and he had me do a Holter monitor and an Echocardiogram. Both of those tests came back normal. I then saw a neurologist who referred me to a cardiologist. The cardiologist did another Echocardiogram and two weeks with a Holter monitor. Neither of those showed anything abnormal. He had me get an implanted Cardiac loop recorder and we are still waiting for the results of that. He advised that I see him again in six months.
This spontaneous report as received from a nurse practitioner refers to an unknown number of patients (genders and ages not provided).  Information regarding medical history, concurrent conditions or concomitant therapies was not provided. On an unknown date the patients were vaccinated with RECOMBIVAX HB intramuscular injection for prophylaxis (dose, dates, route, application site and lot # were not reported). The reported stated that when the RECOMBIVAX HB vaccine first came out there were so many non-resposonders they realized the vaccine was not effective enough  (vaccination failure ) so anyone who received that original vaccine series needed to be re-vaccinated with the whole series again a year later. The patients' outcome was unknown. The relatedness between the events and RECOMBIVAX HB was unknown. Additional information is not expected as the reporter did not provide consent for follow up.
We have had 2 errors one involving giving influenza versus Tdap and the other was giving Tdap when influenza was ordered. Reportedly the two packages look alike. Is this happening elsewhere?
Swollen face with red rash on face and neck. Red rash on left thigh where 2 shots were given. Started throwing up 06/03/2017 at 10 AM, and could not keep food or liquid down until 5:30 PM. Took him to ER at 12:15 PM on 06/03/2017, where he was given 5 ML of Benadryl for swelling and 2 MG zofran for vomiting.
Called out to vehicle by Covid staff that a patient had passed out.  Upon approaching vehicle, patient is in passenger side of his mothers van, with mother in driver seat, and is awake.  Patient is very pale and is sipping on Powerade.  Mother reports that patient passed out for about 10 seconds about 3 minutes after receiving Covid vaccine.  She also reports that patient does this every time he gets any type of injection.  Blood pressure at this time 118/60.  Patient is becoming less pale and reports he is starting to feel better.  Patient reports that he hasn't had anything to eat or drink all day.  Patient and mother deny the need to call the ambulance for evaluation.  Patient continues to be less pale and feeling better.  Encouraged patient and mother to always and eat and drink before receiving an injection and to wait at least 15 minutes and to make sure he is feeling completely back to normal before leaving.  Patient and mother report good understanding.
Pt became dizzy and had trouble focusing (vision) a few minutes after receiving SQ injection. Pt was also lightheaded. I had him sit down and I was going to give him Epi-pen when he stated he was feeling better. Symptoms resolved after 10 minutes.
Symptoms- tingling and numbness on the left side of face radiating down to left arm and hand. Intense headache. Fatigue
Initially, just had a very sore arm, chills, and fatigue for a couple of days. Around March 10, I started having weird heart palpitations that I could feel at the base of my throat. Increased in frequency and would cause me to be short of breath and tired. Saw my primary care doctor on 3/26. She referred me to a Cardiologist. ECG and wore a heart monitor for 7 days. Diagnosed with premature ventricular contractions (PVCs). Because of my age and menopausal symptoms, both my PCP and Cardiologist determined these were likely caused by hormones. Advised to start taking fish oil daily and also magnesium oxide to see if it helps. Told the symptoms may come and go.  It did not occur to me that these irregular heartbeats might be a side effect of the Moderna vaccine until I saw a CDC and news reports of heart inflammation being tied to mRNA covid vaccines. Symptoms listed included palpitations and shortness of breath. Today is 8/4/2021 and I am still having PVCs.
2 days later had bad stiffness on back of neck and then it went down both sides of torso.  Called doctor but said not related to vax.  Pain on back subsided after a week; however it made hernia worse to the point that required surgery on 3/4/09.  Weeks after surgery fell backwards and fractured right hand in landing.
I received the pneumonia vaccination at about 2:35 p.m. on 13 Nov 07 at the Health Department.  I was asked to wait 10 minutes in the lobby after receiving the shot.  I started to feel a little light headed and nauseaous but did not think it was that serious.  There was no pain when the vaccine was administered.  By 14 Nov 07 at 8 a.m. the site where the injection was given was extremely sore and felt very hot.  The injection site was about the size of a quarter.  By the evening of 14 Nov 07 I could barely move my left arm and there was tingling going down into my fingers on my left hand.  I took 800 mg. of ibuprofen that evening.  Had a difficult time sleeping because my arm was so painful.  I also started itching from head to toe.  On the morning of 15 Nov 07 I contacted my doctor's office because my arm hurt so badly.  I was also suffering with a headache, eye pain and my knees were hurting.  The nurse at my doctor's office said I was having a localized reaction and did not need to be seen by the doctor.  By the late afternoon of 15 Nov 07 I was absolutely exhausted, was running a fever, had a headache and body aches.  I had a difficult time sleeping on the night of 15 Nov 07 because of the body aches, itching and severe pain in my arm.  The fever broke during the early hours of 16 Nov 07.  I contacted my doctor's office again because the injection site had more than tripled in size from the size of a quarter.  It was very red, very itchy and had an extremely hard and painful lump under the skin.  I saw my doctor on 16 Nov 07 and he examined the injection site.  The affected area had spread to 6 cm.  It did not appear to be infected so I was instructed to continue watching the area to make sure it did not grow larger.  In addition to taking 800 mg. of ibuprofen every 6 hours, I was also taking 25 mg. of benadryl every 4 hours to help control the itching.  The affected area grew larger than 6 cm. by 17 Nov 07 but I was not having any more fever or body aches.  It has stopped getting larger however, I continue to have an extremely hard and painful lump under the skin where the injection was given.  I will follow up with my doctor on 21 Nov 07 because I was advised I could get cellulitis.
no energy; Woke up at 2 am with shivering; aching all over; Burning up; Couldn't move/Barely made it to the bathroom/sat in one position; Could not go back to sleep; Couldn't eat or drink/ Didn't want anything to drink or eat; Couldn't easily walk; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning up), MOBILITY DECREASED (Couldn't move/Barely made it to the bathroom/sat in one position), INSOMNIA (Could not go back to sleep), DECREASED APPETITE (Couldn't eat or drink/ Didn't want anything to drink or eat) and GAIT DISTURBANCE (Couldn't easily walk) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Heart disorder, Constipation and Hypercholesteraemia. Concomitant products included AMLODIPINE for Blood pressure high, MAGNESIUM CITRATE for Constipation, ACETYLSALICYLIC ACID (ASPIRIN 81) for Heart disorder, PITAVASTATIN CALCIUM (PIVASTA) for Hypercholesteraemia, EZETIMIBE for Hypercholesterolaemia.   On 21-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced BURNING SENSATION (Burning up), MOBILITY DECREASED (Couldn't move/Barely made it to the bathroom/sat in one position), INSOMNIA (Could not go back to sleep), DECREASED APPETITE (Couldn't eat or drink/ Didn't want anything to drink or eat), GAIT DISTURBANCE (Couldn't easily walk), CHILLS (Woke up at 2 am with shivering) and MYALGIA (aching all over). On 20-Feb-2021, the patient experienced ASTHENIA (no energy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg. On 21-Feb-2021, BURNING SENSATION (Burning up), MOBILITY DECREASED (Couldn't move/Barely made it to the bathroom/sat in one position), INSOMNIA (Could not go back to sleep), DECREASED APPETITE (Couldn't eat or drink/ Didn't want anything to drink or eat), GAIT DISTURBANCE (Couldn't easily walk), ASTHENIA (no energy), CHILLS (Woke up at 2 am with shivering) and MYALGIA (aching all over) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received contains significant information- Patient's race, ethnicity, concomitant, treatment medications and dosage regimen.
BURNING  ( AROUND EYEBALLS,NECK AND BODY); HOT FLASHES; SLEEPINESS; CHILLS; SUPER FATIGUE; HEADACHE; WEIRD TASTE IN MOUTH; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 279 pounds, and height was 67 inches. The patient's past medical history included asthma younger, and concurrent conditions included non smoker. The patient experienced drug allergy when treated with methylprednisolone sodium succinate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced weird taste in mouth. On 24-MAY-2021, the subject experienced headache. On 25-MAY-2021, the subject experienced sleepiness. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced super fatigue. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced burning ( around eyeballs, neck and body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, weird taste in mouth, super fatigue, hot flashes, chills, sleepiness, and burning ( around eyeballs,neck and body). This report was non-serious.