chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old male patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. Concurrent medical conditions included multiple sclerosis. Concomitant products included SHINGRIX. On 18th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injected limb mobility decreased. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site pain, injection site erythema and injected limb mobility decreased were unknown.  It was unknown if the reporter considered the injection site pain, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The patient was vaccinated with the 2nd dose of SHINGRIX at the right arm. In 2018, the patient experienced redness and pain in right arm at injection site. The patient experienced limited range of motion of the arm. The physician saw the event and prescribed antibiotics which did not help. This case was linked with case US2018GSK151987, reported for the same patient (1st dose case).
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified improperly stored ROTATEQ (valid lot number K016261, expiration date 23-JUN-2016, and non-valid lot number L013241 with expiration date 28-JAN-2017). The vaccines were exposed to 9.7 degrees centigrade for a cumulative time frame of 4 hours and 41 minutes. There was no previous excursion. This report was for data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Urticaria moving around in arms, legs, genitals, scalp, face, lips, ears every 30 minutes Dec. 4th- currently  Dec. 7 th and 8th throat swelling and acid reflux occurred along with urticaria and digestive issues of bloating, gas, stomach aches and migraine (histamine intolerance symptoms) Took Benadryl 2x a day with  only mild results, started eating anti inflammatory and low histamine foods and migraine finally subsided on day 3 of the diet. Currently I still have urticaria although it isn?t as severe and I get mild headaches often, digestive troubles have lessened, although I have to eat low histamine foods only.
No adverse events. "Patient" was vaccinated with MMR which had an expiration date of 04-29-08. CDC was called. Recommendations of re-vaccination after 4 weeks time due to live virus was advised and to notify VAERS.
The diluent that was used for the ProQuad vaccine had reached an undesirably cold temperature as it had been inadvertently placed in a freezer cooler and may have frozen and then thawed.
Patient told us that she has a fist size red spot that is warm to touch located below the flu vaccine injection site.
I experienced soreness in my right arm at the injection site and a few days later it went away.
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
Muscle weakness in the legs when walking for more than Five minutes. Used to walk 2 miles a day. Not treated. Ongoing.
A few hours after the vaccination, I developed pain and swelling in my left arm around the shot location (deltoid ms). Then the pain spread to my whole posterior upper arm (triceps). 12 hours after the shot, I developed a headache, 102 fever and chills, and severe pain trying to move my arm. That all lasted several hours. The next day, I felt awful, had a headache, slept most of the day, still couldn't move my arm.  By the 2nd day, I felt pretty much back to normal except the pain persisted in my posterior arm (triceps). Today (the third day) the pain is isolated to the distal triceps, and tolerable.
This vaccine was a Booster shot after J&J single dose 04/27/2021. At apx 4:30pm same day I started having an extreme headache, flashes of light while I slept with uncontrolled shivering and shaking, more toes and knees would crap up and finger on both hands were stiff. I took 1000mg Tylenol  at about 3:30am. I had no fever at the time.These symptoms  lasted throughout the night into the next day but the headache was lessened and the light flashes stopped.  At about 1:30pm I went into a fever of 99.4F and was still shivering and sweeting profusely.  I took another 1000mg of Tylenol and by 6:30pm the fever subsided and the sweeting was almost gone. I was finally able to eat and by Sunday morning I was fine and went about my normal rpotine.
This spontaneous report as received form a 65 year old female consumer reporting on herself with back pain and there was no allergies or drug reaction reported. On 12-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, lot number and expiry date were not reported). It was the patient was on therapy with an unspecified pain medication for existing back pian which had not helped the headache. On the same date, 2 hours after vaccination, the patient developed redness (injection site erythema, soreness (injection site pain) and swelling at the injection site (injection site swelling) along with headache, facial pain and dizziness. The patient did not seek medical attention, there was no treatment received or laboratory diagnostics studies performed. The outcome of facial pain, headache, injection site swelling, injection site pain, injection site erythema and dizziness was reported as not recovered since there was no adverse event improvement. The relatedness between the events and ZOSTAVAX was not provided. Additional information is not expected because no reporter details were provided.
Involuntary muscle twitching noted in hands, feet and thighs 2 days after vaccine. (Had tick bites within the week preceding sx also).
ON SUNDAY JUST PRIOR TO NOVEMBER MY LEFT LEG AND FOOT SWELLED FROM THE KNEE TO THE FOOT.  VISITED PROVIDER 11/24/2021, GOT A  DOPPLER 11/26/2021, SAW PROVIDER AGAIN FOR DOPPLER RESULTS AND GET BLOOD THINNER PRESCRIBED ON 11/30/2021 AND BEGAN IMMEDIATELY TAKING BLOOD THINNER. ABOUT JUNE 2022 THE SWELLING WAS GONE BUT A TINGLING PERSISTS IN LEFT FOOT. I SEE A LICENSED MASSAGE THERAPIST EVERY 2 WEEKS TO MASSAGE THE LEFT SIDE WHICH SEEMS TO HELP WITH RELIEVING THE TINGLING AND IMPROVE BLOOD FLOW IN THE LEFT LEG. BEYOND 2 WEEKS MY LEFT LEG AND FOOT STIFFEN UP AND FEEL TINGLY IN THE FOOT AREA. I TAKE 81 MG BABY ASPERIN TO HELP WITH THINING THE BLOOD WHICH HELPS. IN JUNE 2023 PROVIDER PRESCRIBED A STRONGER ASPERIN TO SEE IF THIS WILL HELP WITH THE BLOOD FLOW IN THE LEFT FOOT AREA.
Acute onset of achy joints, nausea, vomiting, bilateral flank pain, h/a, & t103;
Symptoms appeared Mar 18, 17 hours after administration, in a progression:  1) headache-dizzy-nausea, 2) jittery-high b/p (160, normal for me is ~115)-faster pulse (76, normal for me is ~60), 3)sensation of flushing/rushing in head, neck, chest-brain fog-fainty, 4) wheezy @ base of throat & upper chest.  Progression built over ~ 1 hour and subsided over ~1 hour.  Symptoms started appearing again Mar 21 ~ 5:30p, but this time, I took an Allegra ~ 6:00p and went to Urgent Care.  By the time I was seen ~ 6:30p the reaction was subsiding before reaching phase 3.  All vitals were taken as well as an ECG and were normal except b/p was still high (167/80).  Diagnosis was allergic reaction and I was advised to take a 2 week
07/22/02 immunizations given: L arm DTaP, L arm MMR, R arm IPV. 07/24/02 visit to our office with redness and swelling to L arm. Visited urgent care at hospital later that evening. Advised to use Benadryl and Motrin q 4-6. Redness and sweling was 8cm x 13cm.
Patient received immunization and proceeded to waiting area for 15 minutes.  After a couple minutes, patient was very pale and appeared to be possibly passing out.  Patient was transferred to floor with feet elevated.  Blood pressure and pulse were taken and were within normal range.  Patient's lips appeared to be turning blue which was alarming.  EMS was activated.  Patient stayed conscious entire time and kept talking to me.  Patient stated that his lips didn't feel tingly or numb.  Right before EMS arrived, patient gained more color and was able to tell me he had a blue slushy drink before he came to pharmacy, which explained blue lips.  EMS checked him out and patient sat up in chair for 15 minutes after they left.  He was fine and left store on his own.
There were redness and heat at the site of injection and a knot developed under the site.  This remained through the weekend.  On Monday, the site is still quite pink, warm and swollen. Encouraged to use warm moist packs over the site.
This spontaneous report was received from a office manager (healthcare worker) via a company representative on 04-NOV-2014 and refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient were vaccinated with late doses of GARDASIL (dose, lot #, expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Started with mild pain in left thumb joint, then went to severe pain in left big toe joint. Very severe pain in toe joint to the point I couldn't stand to walk on it or wear shoes for about 24 hours, but did, so that I could go to work. But not pumps!!!
arm was red; hot to touch; itchy; soreness in arm; twitching in leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), MUSCLE TWITCHING (twitching in leg), ERYTHEMA (arm was red), VACCINATION SITE WARMTH (hot to touch) and PRURITUS (itchy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm) and MUSCLE TWITCHING (twitching in leg). On 06-Apr-2021, the patient experienced ERYTHEMA (arm was red), VACCINATION SITE WARMTH (hot to touch) and PRURITUS (itchy). On 31-Mar-2021, PAIN IN EXTREMITY (soreness in arm) and MUSCLE TWITCHING (twitching in leg) had resolved. At the time of the report, ERYTHEMA (arm was red), VACCINATION SITE WARMTH (hot to touch) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications  were not reported  Treatment was not specified
Feeling pain on the left side of my chest; uncomfortable chest pain after I take my regular medication; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6198), via an unspecified route of administration on 21Feb2021 (at the age of 70-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported.  The patient's concomitant medication included an unspecified medication. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EL9262), on 31Jan2021 for COVID-19 immunisation. The patient was feeling pain on the left side of her chest; uncomfortable chest pain after she takes her regular medication on an unspecified date. Consumer stated, "I am calling because I take both doses, the first dose I didn't have any problem, the second dose however, after about two or three days I start feeling pain on the left side of my chest and during the day I guess, I didn't notice too much because I was doing other things but in the evening you know, I have uncomfortable chest pain after I take my regular medication (further not clarified hence, captured as Unspecified medication), last night it was bad and it is still bothering me right now." When probed for any other help, consumer stated, "No, I registered for, we safe right and then I received it the first time with you know I didn't have any problem and the second one I went in and I think it might re-registration because then I keep them receiving both of them every day. The both can retake every day I receive both of them, so I went in and I stop one but somehow, I stop all of them so it seems then I have not receive any then we safe checked. So, I just registered again before you call me. Is it hope you got some answer to me because I do have a concern and I don't feel very comfortable." Consumer further stated, "I am just wondering if that's you know one of the I know that's you know this is very unusual other reaction and side effect putting to you so I just wondering you know if this it is side effects from the vaccines I received." The outcome of the event was unknown.    No follow up attempts are possible. No further information is expected.
SkinRash, UrticariaPruritus, Injection site swollen, hot painful itchy Narrative:
Fever of 101.8F in early AM at 04:30 with vomiting (AM after shot). Had red "spot" on arm the size of a silver dollar and the 2nd day had a "dark ring" around it.
ITP, bruising, spots 1st, then bruising, then one blood stool within a 1 1/2 wk period. Treatment: Prednisolone and Zantac. Information from 60 day follow-up report states: Platelet count has lingered around 13-16 thousand for the last 2 wks. We have had one IVIG treatment due to this when his platelets dropped to 4,000. 1/31/06 Review of 5-page d/c summary and 7-page medical record. Both confirm diagnosis as ITP.
No additional AE reported.; the MA administered the wrong immunization; administerd to a 5-month-old baby on 10/25/2021; This spontaneous report was received from a medical assistant and refers to a 5-month-old female patient. There was no information about the patient's concurrent conditions, allergies, drug reactions or medical history provided.  On 25-OCT-2021, the patient was inadvertently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in dose 0.5 (units not reported) (lot # T025367 verified as valid with expiration date: 18-NOV-2022) via intramuscular route in the right vastus lateralis for prophylaxis, instead of pneumococcal vaccine (manufacturer unknown). Concomitant vaccines administered also on 25-OCT-2021 included: hepatitis b vaccine rhbsag (yeast)(ENGERIX B) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid(PENTACEL). On 25-OCT-2021, the wrong vaccine was administered to patient of inappropriate age. The immunizations were ordered correctly by examing provider. The medical assistant administered the wrong immunization. The patient was monitored for reactions. No reaction occurred. The outcome of the events was unknown.
I went to my PCP, for my yearly routine check-up on 12/28/2021, when it was discovered my blood pressure was extremely high. The doctor informed me that my blood pressure was over 200 over more than 100, which was news to me. When he discovered this, he immediately wanted to take an EKG, which he did. He also asked me if I had previously felt any discomfort or had any unusual symptoms, which I had not; I had felt perfectly fine. He then sent me to Hospital to undergo a urinalysis and bloodwork, the results of which were then sent to my PCP. The doctor determined that the results of the EKG, urinalysis, and bloodwork were all normal, and he could find no discernible reason why my BP was so high. He then prescribed me 2 medications: Losartan/HCTZ 50-12 and amlodipine. On the night of 12/28/2022 at about 10 PM, I took my own BP, which read at 205/108 with an 89 pulse. Since that time, my BP has remained relatively high, but not dangerously so. During my most recent check, which was this morning, it was 157/96.
First 2-3 days, flu symptoms. End of Day 3 I began to have very rapid heart rate approximately 20-30 bpm higher than normal. Immediately became dizzy upon attempting to stand. Nearly fainted more than once. Lasted 4 days before it finally normalized some. Used telehealth, was told not a symptom of vaccine at the time, just rest.  Recent flare in chest pain resulted in hospital visit, chest pain, trouble breathing. More tests are being done to include an echocardiagram which was not done at hospital to determine cause. Heart attack ruled out by hospital.
Within 10 minutes skin began to burn on chest, spreading to face. Over the next 5 minutes burning and then itchy spread to arms, back, abdomen and later to legs.  Around the 20 minute mark the was a sudden chill then uncontrollably shaking . Itching and burning was intolerable covering whole body head to toe. No visible raised hives. Chest became heavy and tight accompanied by a metallic taste, pain in jaw and hips and sever headache  around 45-50 min . Solumedrol, Benadryl and famotidine given in ED. Discharge home. 04/09/21- burning itching skin continues, extreme fatigue, tremor,  metallic taste in back of mouth.
Experienced some nausea about 3 hours after receiving vaccine. Around 12:30 the next day after receiving vaccine, starting having pretty bad pain down my spine and lower legs and experienced  fatigue. Woke up around 4:00 and had a red itchy rash under both arm pits and down the back of my right arm (vaccine received in left arm). Rash continued into the 3rd day and spread to my inter-thigh area more on my right leg then my left leg. This is the 4th day and there is still redness under my arms but is not itchy like it was before and the rash on my thigh area has cleared but there are itchy patches on my lower right leg this morning.
synthetic flu from the flu shot; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (grandparent of the patient).  This case involves a male patient of an unknown age who had synthetic flu from the flu shot (influenza), while he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date (unknown latency), after starting the suspect vaccine therapy, the patient had synthetic flu from the flu shot (influenza).  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
This spontaneous report as received from a physician refers to less than 10 patients of unknown gender and age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M009766, expiration date 13-FEB-2018 and lot # M024683 expiration date 18-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine underwent the temperature excursion of 23 degrees Fahrenheit for 40 hours which was detected by a data logger. There were no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
As soon as vaccine was given, on right arm, site was hurting, had chills at night, uncontrollable cold. 10/12/06, arm was swollen, red all the way around, itched a lot, was really heavy, couldn't move it. 10/15, felt better.
positive for Covid; positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. He would be 70 on Monday. The patient's relevant medical history included: "tongue swell" (unspecified if ongoing); "have trouble breathing" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid 19 vaccine (DOSE 1, SINGLE), administration date: Feb2021, for Covid-19 immunisation; Pfizer covid 19 vaccine (DOSE 2, SINGLE), administration date: 2021, for Covid-19 immunisation; Pfizer covid 19 vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 2021, for Covid-19 immunisation; Pfizer covid 19 vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 2022, for Covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Nov2023, outcome "not recovered" and all described as "positive for Covid". The event "positive for covid" required physician office visit. Clinical course: In Feb2021 the patient got their first shot and got 2 boosters in 2021, for a total of 3 doses in 2021. They got another dose in 2022. They just received a another booster on 24Oct2023. All Pfizer Covid-19 vaccines. The patient had some underlying conditions and had been isolating from anything outside. After they got the 5th booster on 30Oct2023 they went to concert went out without a mask on 30Oct2023. By Thursday 02Nov2023 the patient had a sore throat and was not feeling good. He had a sore throat, headache, and fatigue. The patient came up positive for covid. Friday (03Nov2023) the patient called their physician and he put in for Paxlovid. The patient did not take the Paxlovid because he read the instructions and reported that he had a reaction from a different medication previously a few years ago that made his tongue swell and have trouble breathing. Some of the side effects showed swollen mouth and breathing issues and he already had a sore throat. He did another test the next day and he was positive still. He couldn't go anywhere since he was still testing positive. He could start Paxlovid because he was beyond 5 days of the positive test.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pt. stated injection site was tenderness with redness and warmth. Dr. placed pt on antihistamine. Pt. stated returned to Dr. on 1/24/11 with difficulty swallowing. Dr. told pt. to cont. antihistamine.
Moderna on 2/12 and 3/12. Positive on 8/27 hospital stay ended with death
Was diagnosed with COVID 8/24 and received an antibody infusion that day. Went home and felt nauseous after the infusion. Fall at home and Patient admitted to Hospital for a fall.