chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few minutes after receiving her vaccination and while I was about to administer the vaccination to her husband, the patient (while sitting in a chair next to her husband) stopped her conversation to say that her throat was itching/tingling. She said that she felt her throat might be closing up as well and immediately wanted benadryl. Patient was able to chew two tabs (50mg total) of benadryl and swallow. She continued to sit there for a moment and talk.  Then, she went silent and limp over the chair. We immediately got her to wake up and she still said that she felt that her tongue was swelling. I informed her that we would have to give Epinephrine and call EMT if she continues on this route. She did not want to be given Epinephrine at that time and was very hot. We fanned her to cool her down and continued to assess her. We finally came to the decision to call the EMTs for assistance. EMTs arrived and took blood pressure, which was high but did eventually go down. EMTs said it was more than likely high due to the anxiety. She did not want to go with the EMTs to the hospital and agreed to go home with her husband as she was sleepy at this point due to the benadryl. Patient returned three days letter in a better state describing her recovery as joint pain, not feeling too good, yet feeling better the day she came back in to the pharmacy that day.
broke out in varicella rash (5 lesions) 16 days p/vax
Patient, a certified MA, was administering the vaccine and noticed the solution had substantially leaked around the syringe onto the patient's arm. Attempted to contact PFizer Medical Information twice without success. I was disconnected both times after waiting a total of 1.5 hrs. Contacted Our district immunization coordinator. She responded via email that we should administer another dose since it was a substantial amount of vaccine that leaked around the syringe. The patient verbally agreed to this plan with, LPN, present. LPN, administered Pfizer COVID-19 vaccine 0.3 mL (lot EL9267) intramuscularly in the patient's right deltoid without difficulty at 4:03 P.M.
Sore arm, chills, headache, muscle ache - Two doses of 500mg Tylenol 12 hours apart relieved the symptoms. Fatigue (not able to complete the routine daily walk of 3 miles) the day after vaccination for one day.
20 mo male with hx of "slight fever" with prior immunizations had PCV 13 at 2:30 PM 7/22/10. Began with intermittent fever first 24 hrs then with increased temp to 104.2 degrees with emesis x 1 early AM (02:50 AM) 7/24/10. Given antipyretics. Taken to ER at 0247 7/25/10 with Temp to 101.7 degrees given Amox for "slightly red TM". Later developed hives - thought to be related to Amox.
Initially had body aches, chills, and more localized to lower body in general that resolved by next evening with light headache which resolved. Since then off and on feet and ankle aches and pain. Past two days with tingling of left greater than right wrist hand but patient did do yoga 2 days ago and has distribution of carpal tunnel syndrome on left wrist.
My son woke up with a bad rash on face and neck. I brought him to the Dr that morning (01/03/2012) and was told it was nothing to worry about. The rash continued to worsen spreading to stomach and back. Returned to Dr 01/05/12 and the rash spread to his legs. It was then thought to be measles resulting as a side effect of his MMR vaccination.
Child was prescribed Hep B vaccine #3 and Hib was inadvertently given. Child with no adverse reaction, no complications.
Pt was seen for 15 month EPSDT in office on 8/14/17. She was doing well per mom's report but continues to have issues with poor weight gain/underweight. She had no acute symptoms upon presentation to clinic and was doing well, meeting developmental milestones. She was given her 4th DTaP and 4th Hib vaccine. She has tolerated prior vaccines without adverse reactions. She has never had a seizure before. No family h/o seizures. Mom called the office at 12:45pm and spoke with CRNP stating she had 1 large vomitus of Pediasure formula after today's visit but was otherwise well. At 2:30 pt was sleeping and mom noted her to be having a tonic clonic seizure lasting 8 minutes and 45 seconds. 911 was called and she was transported to local ER. CT scan was normal. Electrolytes and chemistry was within normal limits. She was afebrile. She was discharged to home from ER following return to baseline status. She presented to clinic on 8/15/17 for follow-up with PCP. She was doing well at the time, at baseline, with constipation.
Swelling at injection site and wheals on both arms, hands and legs, neck intense itching, wheals go away after a few days, but new ones pop up every day, still on going (7/21/16) after two trips to doctor, one to family physician and one to dermatologist.
PATIENT RECEIVED VACCINE IN THE MORNING AND AT NIGHT HAD NUMBNESS IN ARM AND CHEST PAIN. PATIENT WENT TO SLEEP AND WOKE UP THE NEXT MORNING WITH CONTINUED CHEST PAIN AND THEN CALLED PHARMACY. WAS ADVISED TO GO STRAIGHT TO EMERGENCY ROOM
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 100-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 18-Mar-2021, PAIN IN EXTREMITY (arm soreness) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-2 test negative: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included -  blood pressure medication, diabetic medication. No treatment reported. Lab data short test and long test for COVID was negative
lost my abiity to taste things;  everything tastes bitter;  Face is flushed like a light sunburn;  has continued for a week
This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: A 10 month old patient received Kinrix instead of Pediarix which led to inappropriate age at vaccine administration and wrong vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Swelling of arm, shortness of breath, pain in shoulder, severe headache, nausea, hypertension. Was given Prednisone & Zyrtec. I left the hospital around 9:30 PM.
Moderna COVID 19 Vaccine   Around noon on the 8th day after receiving my first dose of the vaccine I developed a large hive at the injection site. It?s approximately 3 inches long and 1 1/2 inches wide. The hive is itchy,  bumpy, and raised and my arm is warm to the touch. I used a cold compress and took an antihistamine before bed but when I woke up the hive was still there.
Maculopapular rash on (L) thigh about 4" x 4" around injection site, itch, NT, no fever. Tx w/ BENADRYL, cetirizine.
patient started with a large area of ecchymosis to left arm about 5 days following booster shot
Information has been received from a health professional concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed erythematous bump at injection site.  The patient recovered on an unspecified date without any medical treatment.  A product quality complaint was not involved.  Additional information has been requested.  This is one of several reports received from the same source.
23MAR92 rt upper arm @ inject site had 3" x 3" red warm swollen area; 24MAR92 seen by MD mom instructed to apply DPH cream; in 2 days was greatly improved;
Moderna Vaccine vial was removed directly from Freezer and thawed by hand at room temperature for 15 minutes then drawn up in a syringe and administered to patient.
A 45 year old female experienced a severe pruritic rash on 2/19/01 after receiving RabAvert for pre-exposure vaccination on 1/31/01 and 2/7/01. On 2/19/01, after the 2nd RabAvert injection, the pt developed a severe rash on about 90% of her body surface; the rash was on her torso, arms, thighs, buttocks and feet. The rash was red, very itchy, burning, raised and bumpy in some places and smooth in other areas. There were spots the size of a quarter to the size of dinner plates. The pt had no trouble breathing. She was treated with oral Benadryl and Benadryl cream for 1 1/2 weeks, and soaked herself in Aveeno bath. The rash resolved on 3/7/01. Her physician had told her not to receive the 3rd injection because of the rash. The pt had no medical dx and no other medication. She had no known allergies and no changes in soap, lotion, cosmetics, jewelry or clothes.
INJECTION RELATED REACTION; WEARING OFF EFFECT; INJECTION SITE REDNESS; INJECTION SITE BURNING; ANAPHYLACTIC SHOCK; PAIN; This spontaneous report received from a patient concerned a 53 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient felt pain a few days before next injection was due. She was going on this way for years. She loved it, and did not want to stop because of this. She had injections burn but insurance, did not want to allow citrate free version. She gets a red spot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown expire: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Humira (adalimumab) (solution for injection, subcutaneous, batch number: 1136781 and expire: Unknown) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. Non-company suspect vaccine included: influenza vaccines (form of admin, route of admin, and batch number: Unknown expire: Unknown), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On unknown dates, the patient experienced reaction to flu injection, feels pain a few days before next injection was due and burning on injection/gets a red spot. On an unspecified date in 2021, the patient experienced pain. On an unspecified date in Mar-2021, the patient experienced anaphylactic shock from covid vaccine. On an unspecified date in 2021, the anaphylactic shock from covid vaccine and pain resolved. COVID-19 VACCINE was also considered suspect. Epinephrine was given and cleared up within a few minutes. She got a reaction to flu injections too. She did not take Humira for 56 days while getting the covid vaccine. Physician said to take a break as long as possible. She went as long as she could, but she was having a lot of pain. The patient was taken Flu injection as a co-suspect drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic shock on an unspecified date in 2021, had not recovered from pain, wearing off effect, and injection site burning, and the outcome of injection related reaction and injection site redness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210661838-covid-19 vaccine ad26.cov2.s -Anaphylactic shock, Pain, Wearing off effect, Injection related reaction. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).20210661838-covid-19 vaccine ad26.cov2.s -injection site burning ,injection site redness. This event(s) is labeled per other facility and is therefore considered potentially related.
pt. was fully vaccinated - dose 1 2/4/21 Lot 013M20A; dose 2 3/11/21 Lot 003A21A. Tested + for COVID 8/19/2021
patient received a Moderna booster dose from a vial that had been refrigerated more than 30 days; refrigerated more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a Moderna booster dose from a vial that had been refrigerated more than 30 days) and PRODUCT STORAGE ERROR (refrigerated more than 30 days) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a Moderna booster dose from a vial that had been refrigerated more than 30 days) and PRODUCT STORAGE ERROR (refrigerated more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a Moderna booster dose from a vial that had been refrigerated more than 30 days) and PRODUCT STORAGE ERROR (refrigerated more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Follow up received contains non significant information.
Excruciating Pain in left shoulder down to finger tips, across chest. Burning pain, pain level 10+.  Had to take Tylenol to minimize the pain level.  Anytime Tylenol wore off I felt level 10 pain. This lasted for 2 weeks+. Left arm had limited Movement afterwards. Could move front and back and side to side slightly but very uncomfortable. Could not raise arm up, this cause level 10 pain. The less I used the arm the less pain I felt so the arm was seldom used.  I tried to stretch out my shoulder and arm, but it activated the  pain , which went back to a level 10+.  Up until this point I was worried about the pain I was experiencing but I thought that this was possibly a common side affect, but to me it seemed way too severe, so I voiced my concerns to my husband, who also got the shot at the same time as me, given by the same nurse.  At this point I realized something was seriously wrong  and that and I noted that stretching made it worse. After the third week the pain was dormant but the arm mobility was limited. After I stretched to try and get more mobility, I realized that stretching has the adverse affect that I desired. It made it worse. Any time I go to use my arm , for example exercise, it makes the pain flare up.  Currently my pain is at a level 10. I went paddle boarding and although it was challenging, I did it anyway. The next day my arm pain flared up again to an 11+.  I can?t sleep and I can?t use my arm. I can?t relieve the pain with any position. It is terrifying.
Got dizzy after vaccine and was told to sit down for 15 min after 15 I still felt dizzy so I stayed seated for an extra 10 min, still felt  not ok  but enough to go. Went home and still felt dizzy and then I felt like I need to pee  but I was very cold ,  urinated 3 more times thinking it was because it was due to being cold but doctor explained it was due to me drinking lost of water.  Went to bathroom and bassed out and woke up about an hour later, but during the fall I injured the neck by heating your head on the sink, back and broke my nose, when I woke up  I was still very dizzy. Also felt a fast heart rate,  chest pain, very nauseas and started sweating a lot.
Information has been received from a physician and a practice manager via company representatives referring to a patient of unknown age and gender. On 17-FEB-2014, the patient was vaccinated with an improperly stored dose of VAQTA lot # J006521, expiration date 23-AUG-2015 (dose and route unspecified). This specified lot number vaccine was exposed to temperature excursions for two tines. The storage criteria and the type of excursion (R/F) were refrigerator (R). The lowest recorded temperature (Fahrenheit degree (F)) and total cumulative excursion time (hour) were as following: 34 F for 152 hours and 33 F for 336 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
I also had the flu vaccine, but I am not sure what type of vaccine, so I did not enter it above. On Sunday afternoon, I noticed hives all over my body and they have continued through today (9/20/22). I take one Allegra 24 hour and the hives subside but come back almost 24 hours on the dot. I have not, to my knowledge, been exposed to anything different in my environment - food, medicines, etc. When I received the prior covid-19 vaccines and booster (always Moderna), I would get a rash at the site of injection but it would disappear within a week of the injection.
Tingling in right arm to fingertips numbness on right cheek tingling in tongue; Tingling in right arm to fingertips numbness on right cheek tingling in tongue; Tingling in right arm to fingertips numbness on right cheek tingling in tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 16:00 (Batch/Lot number: unknown) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METRONIDAZOLE; LEVONORGESTREL AND ETHINYL ESTRADIOL; CEPHALEXINE. The following information was reported: PARAESTHESIA ORAL (non-serious), PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 26Aug2021, outcome "unknown" and all described as "Tingling in right arm to fingertips numbness on right cheek tingling in tongue". The event "tingling in right arm to fingertips numbness on right cheek tingling in tongue", "tingling in right arm to fingertips numbness on right cheek tingling in tongue" and "tingling in right arm to fingertips numbness on right cheek tingling in tongue" was evaluated at the physician office visit.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
allergic reaction; itchy, raised hives/rashes all over the body; itchy, raised hives/rashes all over the body; itchy, raised hives/rashes all over the body; This is a spontaneous report from contactable male consumer (patient) reported for himself. A 42 years old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199) via unspecified route of administration in left arm on 01Apr2021 10:45 AM at age of 42 years old at single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. Patient previous received the first dose of BNT162B2 (Pfizer/BioNTech COVID-19 vaccine, Lot number EL3248) on 09Mar2021 02:00 PM at age of 42 years old at single dose in left arm for COVID-19 immunisation. Patient developed itchy, raised hives/rashes all over the body, after 48 hrs (on April 3rd evening) of receiving the 2nd dose of the vaccine. Contacted the Teledoc and got prescription for diphenhydramine hydrochloride (BENADRYL). Patient stated he was the patient who experience the adverse event and he developed the allergic reaction on 3rd April 2021 (48 hrs after receiving 2nd dose). So his aware date was 3rd April 2021 (around 4 pm). The adverse event result in Doctor or other healthcare professional office/clinic visit. After taking 4 doses (36 hrs) all the hives/rashes disappeared. Outcome of events was recovered.   No follow up attempt needed. No further information is expected.
Pt wanted Pfizer bivalent booster, was unintentionally given regular Pfizer
Very sudden severe tremors of face and limbs. I hesitate to refer to it as chills, it was closer to a seizure (of which I have no history). It ended as suddenly as it began, approx 5-10 minutes later. I fell asleep for 12 hours. Today have severe malaise and mild confusion consistent with post-ictal response. Had difficulty organizing  routine task  (how to  make coffee) then slept 4 hrs afterwards from the effort (despite it being caffeinated).
Large swollen injection site, red, hot, itching, painful.  I received the booster on Monday. The previous does had similar reactions but this one was much worse.
Patient lost consciousness ten minutes after receiving shot with a reduced pulse and losing all color in face.  Patient denies any history of adverse reaction to previous injections or immunizations.
Left arm red and swollen at injection site. Pain on left side of neck, swollen painful lump on left side between clavicle and bottom of neck that lasted for at least 1 week, extreme shaking/ chills that lasted for 3 hours to the point it was difficult to walk, shaking started approximately 13 hours after the injection. Temp 101.8 when checked the following day, 24 hours after injection.
12MAY92 pt devel a temp & became very irritable; Mom gave APAP-fever did not come down; 13MAY92 pt taken to hosp t104 R mom states pt was given med @ hosp for fever; mom denied pt having any convuls;
Tightening of throat, rapid heartbeat, congestion, unsettled stomach. Treated w/BENADRYL. Felt fetter two days later.