chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No observed or reported adverse event. This is an administration error related to interval timing of a second booster dose. The second booster dose administered prior to the minimum interval after first booster dose. The first booster dose was given on 5/20/2022. A follow up phone call was made on same day at approximately 04:52 PM to patients assisted residential care home where RN spoke to patients Nurse Practitioner on their patients health status. Nurse Practitioner communicated that patient presented with no adverse ill effects after receiving Covid vaccination. Nurse practitioner stated patient is currently eating dinner in the dining room and is without incident or complaints.   Prior to administration the patient stated she was advised by their Nurse Practitioner to recieve their next Covid vaccine booster dose. Patient communicated to RN that she contracted Covid one week after reciving her first booster dose on 5/20/2022 The patient completed their primary covid vaccination series on 03/03/2021   During the time RN administered the Covid booster, he did not register the time between booster doses until it came time for charting. The Covid Immunization record was printed and provided before administration but RN was fixated at this time at providing the patient with their booster shot at the advisement of their NP.   In the future, RN is to follow through on the recommended dose interval schedule per the CDC guidelines regardless of personal provider advisements. These guidelines are to be kept and reviewed by all staff administering all Covid vaccinations.   The Nurse practitioner was also advised during the patient follow up call on timing of all second booster vaccine administration times for future patients, as four months after their first booster dose and three months after their first booster if immunocomprised.
Patient reported pain at injection site which extended to whole arm. Developed chills, temperature up to 102.4 on the day after the injection. Symptom resolved by day #2 except for slight arm soreness.
I was extra tired when I woke up this morning and by 4PM felt extremely tired and really out of it. I may have a slight fever.
Breakthrough COVID 19  not requiring hospitalization. This patient did have ER visit and received IV fluids to address dehydration.
Injection abt 11 am, felt tired 2 hours after injection and had pain on side.Felt warm and chilled later in evening abt 8:00  , in Morning Temp went up to 102.2.  2 am took Ibuprofen. Later  then 100.1. Temp  had headache and body aches, took another Ibuprophen.  Still had headache and body ache.
7-10 days injeciton site tender painful and redness  not resolving size about the size of iphone xr picture available
The wrong formulation was given. The patient was given 0.5ml of the Moderna for 6mos - 5 yrs formula as opposed to the Moderna 6yr - 11yr formula. This was realized after patient had left the clinic. Patient did not have any adverse effects during the observations time. A call was placed to CDC but they did not have an answer as to what to do next and will call clinic back with a response; the CDC report number is: CDC-2654547-V4Q0T9.
Patient developed acute symptoms of rheumatoid arthritis about 2 weeks after H1N1 inoculation wrist, thumb, other joints.
I went to the Dr. with the shingles. They gave me a shot, they told me it was for the shingles. I have never ending pain. They are as bad as they were when I found out I had shingles. I later went to a different Dr. he told me they were not to give this shot unless I did not have the shingles. So every day I have pain. I have suffered with this pain till I tired of it. I have been to Dr. after Dr. no one has helped. I still have the pain. I need to no how I can get rid of this? Giving a shot that is working against me? So please tell me what I can do. Sincerely, pt.  DX: post-herpetic neuralgia per PCP 1/26/2010 Follow-up: Nothing has changed. My pain is as bad as it was 3 years ago. Nothing has helped.
Moderna Covid-19 Vaccine EUA 10 days after receiving the 1st vaccine, I developed a rash below the injection site which was about 4-5 in. in diameter.  It was warm to touch and itchy.  Also felt small lump under the skin.  I had no fever and no other symptoms.
ROTOVIRUS VACCINE GIVEN ON 7/29/2008.  IMMEDIATE REACTION TO ORAL VACCINE WAS GAGGING AND COUGHING.  WITHIN HOURS WE WERE ABLE TO HEAR LOUD STOMACH GRUMBLES.  PATIENT CRIED THE ENTIRE REST OF THE DAY.  WE ADMINISTERED INFANTS TYLENOL AS DIRECTED.  THE NEXT DAY 7/30/2008, SHE BEGAN TO HAVE DIARREHIA AND HAD A FEVER OF 100.4.  BY THURSDAY EVENING 7/31/2008 HER FEVER WAS BACK TO NORMAL AT 97.4.  SINCE THE ADMINISTRATION OF THIS ROTOVIRUS VACCINE PATIENT HAS HAD DIARREHIA AND WHAT APPEARS TO BE STOMACH DISCOMFORT.  WE ARE ABLE TO HEAR HER STOMACH CHURNING- WHICH WAS NOT PRESENT PRIOR TO 7/29/08.  AS OF TODAY'S DATE SHE CONTINUES TO HAVE DIARREHIA AND HAS NOT RETURNED TO HER PREVACCINE STOOL PATTERN OR TYPE.  I CONTACTED THE DOCTORS OFFICE SEVERAL TIMES SINCE RECEIVING THE VACCINE.  THE FIRST TIME THEY STATED A POSSIBLE SIDE EFFECT WAS DIARREHIA AND THAT IT COULD LAST 7-10 DAYS.  THEY SUGGESTED I SIMPLY SWITCH FORMULAS- CHANGE FROM NESTLE GOOD START TO SIMILAC.  CHANGING TO SIMILAC MADE THE DIARREHIA WORSE.  I CALLED AGAIN AND THEY RECOMMENDED ANOTHER FORMULA SWITCH.  ON 8/25/08 I CALLED TO REQUEST AN ALLERGY TEST FOR MY DAUGHTER TO DETERMINE WHAT IS GOING ON SINCE WE WERE WELL BEYOND THE 7-10 DAY WINDOW OF POSSIBLE SIDE EFFECTS.  THE LAB WAS UNABLE TO GET A VEIN ANYWHERE SO THIS TEST WAS NOT ABLE TO BE COMPLETED.  AFTER INSISTING IN THE DOCTORS OFFICE THAT PATIENT IS HAVING A REACTION TO THE ROTOVIRUS VACCINE I WAS ABLE TO SEE A DOCTOR ON 8/25/08.  AT WHICH TIME SHE STATED THAT IT MAY IN FACT BE ROTOVIRUS AND IF SO THERE IS NO TREATMENT.  SHE ORDERED A STOOL ANALYSIS WHICH IS STILL PENDING AT THIS TIME.
Information has been received from a healthcare worker referring to 5 patients of unknown age and gender. Information about current condition or medical history was not reported. On an unspecified date the 5 patients received improperly stored (Oka/Merck) VARIVAX (lot#, dose, route not reported). No adverse effects were reported. Additional information has been requested.
Low-grade fever, nausea, fatigue, joint paint/muscle weakness, pain and swelling at injection site. I have taken ibuprofen to manage symptoms but it does not help much.
no adverse event; Medical assistant reported a temperature excursion which was administered to the patient; This spontaneous report was received from a medical assistant concerning, a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.     On 03-APR-2021 the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 1 dosage form (lot number T024831 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 18-NOV-2022), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion above 9 degree Celsius (°C) (9.3C) during a time frame of 0 hours 46 minutes and 0 seconds, as recorded by data logger. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T024831; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001382: US-009507513-2104USA001375: US-009507513-2104USA001383: US-009507513-2104USA001385: US-009507513-2104USA001386:
The date symptoms began is March 7th and approximately 3 hours after the shot was given (approximately 3pm). Patient reports fever of 101.8,  severe chills, some difficulty breathing and intense pain and redness at the site of injection as well as up and down her arm. Most symptoms subsided on the 9th of March around noon. The redness at the site of injection and down my arm lasted until the next day, March 10.
Small fever blister on bottom lip; This is a spontaneous report from a contactable pharmacist (patient). A 38-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 25Jan2021 12:00 as single dose for COVID-19 immunization in an nursing home. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EL0142) on 04Jan2021 in the left arm for COVID-19 immunization. The patient previously took naproxen and experienced drug allergy. No other vaccine administered in four weeks. Patient has not been tested for COVID-19 post vaccination. The patient experienced small fever blister on bottom lip on 27Jan2021 06:00 with outcome of recovered. No treatment was received.
about 2 hrs p/receiing vax pt devel shrill high, ptiched screaming, unable to sooth for 5 1/2-6 hrs; phoned MD who inc APAP to every 3 hrs;
Swelling and redness of a roughly 6 inch diameter around injection site in right arm.
Arm was swelling and turned red the next morning. She waited a couple of days and then went to the dr, who diagnosed her with cellulitis. She stated she remembered touching the immunization site after taking the trash to the compactor and without washing her hands.
Unexplained leg pain, started on right inner thigh, became extremely tight and sore, pain increased over the course of a week, went down below knee, currently eased up on inner thigh and now in lower leg, shin pains and still some thigh pains.  May have applied ice initially, briefly.  Feels crampy.  Applied ice pack around knee on 4/11 and area inflamed quickly, intensely.  Subsided after a few days without ice on thigh, which was when pain travelled downwards.   Wasn't sure if an existing knee injury was the cause, but also not sure if this was muscular or perhaps surface/skin oriented in nature. Felt bumps at one point, but not clear what was happening.
Severe headache, body aches, fatigue, congestion starting approx. 12 hours after vaccination. Symptoms subsided within 48 hours.
2 1/2" diameter reddened warm area on arm p/Td x 3-4 days;
receiving accidentally a 3 dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number ZG744, expiry date 28th August 2023) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose of Shingrix on 20th December 2021). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 15th June 2022, the patient received the 3rd dose of Shingrix. On 15th June 2022, unknown after receiving Shingrix , the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The reporter stated that the patient receiving accidentally a 3rd dose of Shingrix. The reporter gave consent to follow up. Additional Supportive Information: The patient received 3rd dose which lead to Extra dose administered.
right leg from the knee down to the foot wasextremely swollen; This non-serious case was reported by a consumer and described the occurrence of swelling of legs in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3Y7P4) and (batch number 555Z2) for prophylaxis.   On 02-NOV-2023, the patient received Arexvy .5 ml. In NOV-2023, an unknown time after receiving Arexvy, the patient experienced swelling of legs (Verbatim: right leg from the knee down to the foot wasextremely swollen). The outcome of the swelling of legs was not resolved.   It was unknown if the reporter considered the swelling of legs to be related to Arexvy.     It was unknown if the company considered the swelling of legs to be related to Arexvy.   Additional Information: GSK Receipt date: 13-NOV-2023 The reporter was a patient. The patient reported that the morning after the vaccine was given her right leg from the knee down to the foot was extremely swollen. Patient reported that this condition had existed for more than 10 days. Patient asked question that was this an adverse side effect. Patient reported that she had no injury, sprain por insect bite to account for the massive swelling. Patient's physician had ruled out DVT. The reporter requested to consent the follow up.
For Dose 1, I had the "COVID Arm" after 7 days of receiving the FIRST dose.  My initial rash was HUGE (10cm), super red, swollen, itchy, and hot to touch. For Dose #2, the rash was much smaller. It is still painful (e.g. to lift my arm and to touch), but not as itchy or red. I got the rash the day after Dose #2. The symptoms were much better & reduced. I did not have any other symptoms outside of feeling very tired and I had a headache.
Birthdate on signed consent was reported, but verification in Database shows a birthdate that makes the child 4 years old and underaged to receive vaccine.
SUBJECTIVE: Patient had a flu shot today and she vomited shortly after. She  vomited before dinner tonight. Her vitals are stable. I discussed this with  the nurse. Her dementia is to such a degree that this cannot be trauma related from just having a shot. So, I do think this may well be an allergic  reaction. Despite her age, did give her 25mg of Benadryl and watch her  closely overnight
IDIOPATHIC THROMBOCYTOPENIC PURPURA; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced idiopathic thrombocytopenic purpura (ITP) immediately after the J and J vaccine. Nothing was working and reporter believes their hematologist was not quite up to par regarding treatment. Patient had not yet done splenectomy. Reporter was asking for advice before a splenectomy and wanted to know about success rate for the splenectomy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of idiopathic thrombocytopenic purpura was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221224980-idiopathic thrombocytopenic purpura . The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Injection site pain/painful to touch beginning a few hours after injection. Took ALEVE for pain without relief. No swelling/redness/oozing.
Rash in the form of ~7 small red itchy bumps across the body (stomach area, scalp hairline and crotch)
Initial misuse report received from a healthcare professional on 09-Sep-2013. The 4-year-old patient had received two ADACEL, multiple doses. No adverse event was reported. List of documents held by sender: none.
Fever up to 101.3 drank water, used Tylenol for fever and aches and stayed in bed
sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medication include Augmentin(Amoxicillin/Clavulanate) prescribed by her doctor. She is still having the infection. She has not yet started taking the prescribed drug.
12/13/00 pt was given DTaP given at Health Dept.  12/15/00 seen at HD with caregiver, no fever. Reports child able to play, walk normal act at this age. Left thigh redness and warm to touch, measures 3x2 inch.
Very severe swelling at injection site. The whole top of my arm swelled out about 4 inches from my skin. A very distinct circular redness in the area. I have a little swelling from the injection every year, but this was very out of the ordinary. The are is still very swollen and painful today, but I have begun applying ice packs and taking Benadryl and the swelling is beginning to come down slowly. I just thought you might want to know.
2x1 red rectangular lesion under the injection site; Painful; "felt tired after but it was nothing"; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE ("felt tired after but it was nothing"), VACCINATION SITE ERYTHEMA (2x1 red rectangular lesion under the injection site) and VACCINATION SITE PAIN (Painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced FATIGUE ("felt tired after but it was nothing"). On 19-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (2x1 red rectangular lesion under the injection site) and VACCINATION SITE PAIN (Painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE ("felt tired after but it was nothing"), VACCINATION SITE ERYTHEMA (2x1 red rectangular lesion under the injection site) and VACCINATION SITE PAIN (Painful) outcome was unknown.            No concomitant medication information was provided
No additional AE's or PQC's noted; Caller reported a temperature excursion/ which was administered to multiple patients; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 19-MAR-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dosage form orally, lot # 1688825 and expiration date 24-NOV-2021, administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 47.7 degree fahrenheit (°F) for 8 minutes, 54 °F for 28 minutes and 47.8 °F for 12 minutes. Previous temperature excursions were reported with the following details: 61.9 °F for 9 hours and 21 minutes and 56.3 °F for 4 hours and 27 minutes.  The call was made due to a digital data logger. No adverse symptoms were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA003252: US-009507513-2104USA003253: US-009507513-2104USA003255:
I had soreness in my arm for over a week, and restless sleep for 3 days each time I had this vaccination.  But a day after the 2nd dose I had itchy breakouts in various places on my body: lower back, finger, wrist, arm, chin, leg.  Most were single spots, but my lower back had a cluster of 3 large welts. They looked like large pimples or bites, and took over 2 weeks to totally disappear. In retrospect, I also had a few breakouts after the first dose, but at the time thought they were from gardening.
As soon vaccine was done being administered patient stated he was not feeling well. I helped patient to lying position when he passed out. Patient came back to fairly quickly. I got a cool wash cloth and a juice for patient which helped him feel better. Patient was feeling back to himself when he left appointment about 20 minutes after vaccine was administered.
Headache after getting the vaccine; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache after getting the vaccine) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after getting the vaccine). At the time of the report, HEADACHE (Headache after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.