chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose).    Concomitant drugs were not reported. It was reported that administrations occurred over the course of approximately 1 month. Patient had no reported symptoms, no additional doses or treatments.   This case was linked to US-MODERNATX, INC.-MOD-2022-682544, US-MODERNATX, INC.-MOD-2022-682546, US-MODERNATX, INC.-MOD-2022-682547, US-MODERNATX, INC.-MOD-2022-682548 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682544:same reporter US-MODERNATX, INC.-MOD-2022-682546:same reporter US-MODERNATX, INC.-MOD-2022-682547:same reporter US-MODERNATX, INC.-MOD-2022-682548:same reporter
No additional AE; adult patient received pediatric dose (0.5mg) of VAQTA; This spontaneous report was received from a medical assistant referring to 29-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 27-OCT-2023, the patient was vaccinated with second and pediatric dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (0.5 mg, 1 dosage form, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (Adult use of a child product). No adverse effects reported (No adverse event). No additional adverse event (AE) or product quality complaint (PQC).
Within 12 hours after flu vaccine given my daughter started to vomit and complain of a severe headache.  She is still having these symptoms 18 hours later.  She has a huge welt and redness where the shot was given on her arm also.
I woke up about 6 o?clock in the morning the day after my shot) until I went to bed at 10 PM that evening and I had a continuous fever
I experienced adverse symptoms beginning 12/7/21 with coughing, acid reflux, which has triggered what could potentially be gird, it re-triggered my migraines with debilitating severity. I have been clumsy and forgetful which has been uncharacteristic prior to vaccination. I'm also experiencing depression. I collapsed with no warning and sustained a concussion on one occasion. I was diagnosed with asthma, and am undergoing further testing and am being referred to specialists for further diagnoses.
After vaccination on 10/08/2009 my left arm has hurt me going on 7 weeks now. I have felt sick tired and run down with mild symptoms of flu. I have had periods of chills off and on now for 7 weeks. On two separate dates 11/7/2009 & 11/24/2009 I have had episodes of warm flushing and my entire body turns red. All my skin becomes red and itchy. I feel a severe sensation of burning all over my body and head. My left arm at point of vaccination has had a "lump" swollen area in my arm muscle. I have a constant arm ache and sorness since 10/08/2009. I am irritable and itchy. I have used ZYRTEC as prescribed on 11/7/2009. I have had to use a Z-PAK antibotic and cough medicine for coughing. My PCP today Tuesday 11/24/2009 prescribed PREDNISONE for inflammation.
Rednesas, swelling, warm to touch. diagnosis: Cellulitis right thigh. Treatment-keflex 250/5
Itchy chest, back, arms (driving nuts); Skin was sensitive to cloth, sheets; driving him nuts; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy skin in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included INFLUENZA VACCINE (on an unknown date patient received flu shot) and COVID-19 VACCINE (on an unknown date patient received covid 19 shots (primary series)).   On 29-OCT-2022, the patient received the 1st dose of Shingrix (intramuscular, right arm) 50 µg. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced itchy skin (Verbatim: Itchy chest, back, arms (driving nuts)), sensitive skin (Verbatim: Skin was sensitive to cloth, sheets) and feeling abnormal (Verbatim: driving him nuts).  The patient was treated with sunscreens nos (Oil Of Olay). The outcome of the itchy skin and sensitive skin were not recovered/not resolved and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the itchy skin, sensitive skin and feeling abnormal to be related to Shingrix.     It was unknown if the company considered the itchy skin, sensitive skin and feeling abnormal to be related to Shingrix.   Linked case(s) involving the same patient:  US2023034604   Additional Information: GSK Receipt date: 03-MAR-2023 The patient received first Shingrix shot and since then his chest, back, and arms itched all the time. There was no redness, no breakout. But his skin was then sensitive to cloth and sheets.  One thing he had tried which helped him a bit was when he showered, he used  body wash which was recommended for itchy dry skin because it contained no alcohol.  This event was not resolved and he said that those events were driving him nuts. The reporter was the patient and he did not have email.  The reported was consented to follow up. For tolerance of second dose, refer case US2023034604.; Sender's Comments:  US-GSK-US2023034604:Same reporter
Child received DTaP #2, IPV #2, Comvax #2, and Prevnar #2 one day prior to sudden death. Cause of death not yet established. Autopsy Report received on 11/22/2004 states pt experienced apnea, asystole, cyanosis, and hypothermia. ER Record & Death SUmmary recceived on 12/01/2004 states pt experienced acute cardiopulmonary arrest. 4/29/05 Autopsy report received reveals COD as SIDS.
Breast swollen like a water balloon; Whole side from shoulder to feet is swollen; Armpit hurting; Swollen area tender; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Breast swollen like a water balloon), SWELLING (Whole side from shoulder to feet is swollen), AXILLARY PAIN (Armpit hurting) and TENDERNESS (Swollen area tender) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced BREAST SWELLING (Breast swollen like a water balloon), SWELLING (Whole side from shoulder to feet is swollen), AXILLARY PAIN (Armpit hurting) and TENDERNESS (Swollen area tender). At the time of the report, BREAST SWELLING (Breast swollen like a water balloon), SWELLING (Whole side from shoulder to feet is swollen), AXILLARY PAIN (Armpit hurting) and TENDERNESS (Swollen area tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment medication was provided.
Headache, Myalgia, fatigue, excessive sweating Employee reported moderate headaches 0-1021 until 02/11/21, moderate muscle pain 0-1021 until 02/11/21, moderate fatigue 02/10/21 and mild-to-moderate fatigue 02/11/2021. In addition, reported excessive swelling causing moderate discomfort over 48 hour period. Resulted in unable to work 02/11/21.
The patient presented at the pharmacy on 10/02/2018 and her upper left arm above the elbow was red and warm to the touch, patient stated it was itching, she also stated it looked better today then it did yesterday. I advised he patient to take diphenhydramine by mouth and called and informed her MD office.
About 3-5 minutes after receiving vaccine, patient complained of dizziness, nausea, and sweating.  Temperature dropped from 95.8 to 92.6.  Administered Epipen 0.3mg into the right thigh then called 911. Paramedics arrived about 7 -10 minutes later and transferred patient to check vital signs. Unknown yet whether patient decided to go to the emergency room or not yet.  Will follow up
This spontaneous report as received from a physician refers to a 14 year old female patient with asthma, contact dermatitis, pulmonary stenosis and pulmonary regurgitation. The patient's medical history included urticaria. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (injection, lot #, dose and route were not provided) in series for the reason of "age appropriate". And the patient developed a localized rash on an unspecified date. Patient was administered the second dose of GARDASIL (dose, lot #, expiration date and route not reported) series on 05-AUG-2014 and developed a localized rash from her elbow to wrist in the center of her right forearm on 06-AUG-2014. Patient sought medical attention to physician at the office on 06-AUG-2014. Treatment included HYDROCORTISONE and BENADRYL. Rash resolved within 1 to 2 days (on approximately 08-AUG-2014). The outcome of the "localized rash developed on an unspecified date" was not provided. Additional information has been requested.
vial used was from previous day and had been punctured 15-16 hours prior to administration. the vial was stored in the fridge
This is a spontaneous report from a contactable nurse via a company representative. This nurse reported for three patients, this is the second of three reports. A female patient of an unspecified age (in the age range right before 19) and ethnicity received TRUMENBA, via an unspecified route of administration on en unspecified date in 2017 at 0.5 ml, single for Neisseria meningitidis Type B immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a lot of soreness on an unspecified date with outcome of recovered.
Breakthrough COVID infection. Reported symptom onset 07/20/2022. Tested positive 07/24/2022
Within a couple minutes of having the injection, my blood pressure started to go up, my pulse rate went up, I felt like my entire body had been plugged into a socket, every cell felt activated, I felt light headed, nauseous, sudden urge to urinate.  I waited 25 minutes and felt a bit better.  Over the course of the next 2 weeks, I had severe episodes of blood pressure spikes and palpitations and high pulse and ended up in the hospital for 3 days just feeling horrifically sick.  I have had symptoms going on week 9 now.  Been diagnosed with pericarditis and thyroiditis.
Legs swelled up, had to call the paramedics. They took you to hospital emergency.
This spontaneous report was received from a licensed practical nurse refers to a 16 month old male patient. Medical history was not reported. The reporter informed that on 05-MAY-2014 the patient was vaccinated with PROQUAD lot number, strength, dosage and route were not reported, and on 09-JUN-2014 the patient received a dose of VARIVAX lot number, strength, dosage and route were not reported. Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
ADMINISTERED FLUZONE HIGH-DOSE 0.7 ML TO PATIENT UNDER THE AGE OF 65.
I had a rash starting on my right thigh, now it's on the left thigh. I was treating it on the presumption it was a fungus. I went to a Dermatologist in July and they are thinking it's an autoimmune response and I have elevated ANA.
Approx. 3-5 minutes after receiving vaccine became lightheaded with blurry vision, tongue became thick and numb.  About 10 minutes after vaccine pain in right arm and burning down my throat.  My hands and arms became numb and tingly and were heavy to move.  Symptoms got better with IV Benadryl and Solu-Medrol.  Approximate 4 hours after vaccine developed vomiting and diarrhea.
Mom called at about 6:00 pm of the day the child received his flu shot. Said his arm has a red area just below the injection site. Is going to draw a circle around the reddened area and have the child seen if worse in the morning. Follow-up call made by nurse the next evening. Mom reported that the redness had spread all the way down the arm. Took him to the doctor and was told it was an allergic reaction and gave him a steroid and Zertec.
NONE AT TIME OF INJECTION OR 15 MINUTES PATIENT WAS OBSERVED AFTER RECEIVING VACCINATION. UPON LOGGING INTO  VACCINE SYSTEM, IT WAS OBSERVED HE HAD GOTTEN A PFIZER VACCINE ON JUNE 9TH AT. PATIENT WAS CONTATCTED AND AT FIRST DENIED GETTING PFIZER VACCINE. THEN HE REMEMBERED, BUT SAID "IT WAS OK TO MIX BRANDS OF VACCINE." PLEASE NOTE THAT ON PATIENT CONSENT FORM, HE CHECKED 'NO' TO ALL QUESTIONS REGARDING ANY TYPE OF VACCINE IN THE PAST 2 WEEKS.
Swelling of arm, itchiness, fever, burning. Took Benadryl. Better by Monday. 9/12/22
COVID-19; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint 90000215590. This case is a duplicate of 20220202442. This case, from the same reporter is linked to 20220202505.
Narrative:  On 01/9/22 Patient presented to ER with chest pain. Pt had received a covid (Moderna) booster vaccine on 1/5/22 (location pt received vaccine is not reported & unknown- not at this facility). This was his #3 covid vaccine after 2 other full doses from unknown location (dated reported were 4/8/21 and 5/6/21. Pt was admitted and had cardiology workup. # NSTEMI/unstable angina, POA - woke up from sleep with chest pain - initial troponin 2.85 then 5.9, 6.0, 5.3, 10.1, 6.6, 3.8 - EKG NSR with no ST changes or T wave abnormalities - patient without risk factors or significant family history - trend trop and EKG q6 - given ASA 325mg in ED; start ACS protocol with heparin drip - atorvastatin 80mg and metoprolol 25mg q6 as BP allows - TIMI score 1 (low risk) Pt got cardiac cath on 1/10/22. Pt discharged home after with no medications. On 3/4/22 Primary Care Md noted possible SE from covid vaccine caused the chest pain and possible myocarditis. Pt's chart was flagged with ADE and reporting to VAERs (& CDC through VAERS).
No additional adverse event reported; PEDVAX HIB was possible given in the thigh/more medially than as recommended in the prescribing information; Caller unsure of which product was given more laterally and which one was given more medially; This spontaneous report was received from a physician concerning a 4-months-old patient of unknown gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 29-MAR-2021, the patient was vaccinated with the second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters intramuscular route, lot number T026067 expiration date 01-APR-2023 for prophylaxis. On the same date the patient was vaccinated pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) 0.5 milliliters intramuscular route, lot number DX8301 and expiration date 31-JAN-2023 also for prophylaxis.   The dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB was possibly given in the thigh, more medially than recommended by the prescribing information. The dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) was also given on the same thigh. It was not clear which product was administered more medially or laterally. No additional adverse event was reported.
Subsequent to receiving one dose of varicella virus vaccine live on 5/15/96, the pt experienced a rash with lesions on the front and back of the trunk 1-2 on the arms and 1-2 on the face on 4/20/99. The pt experienced less than 50 lesions total. The pt was seen by a physician. It was noted that there were other children at the pt's school with chickenpox.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with M-M-R II (lot # L020188, expiration date 03-JUN-2017, dose, dose # and route unknown) which was improperly stored. The vaccine was stored under 48 F for 1 hour and had been back in range. The vaccine was not out of range before. No adverse event reported. Thi sis one of several reports received from the same source. Additional information has been requested.
First dose / 2 years ago (2019) / can I still get the second dose / it has been almost 2 years. I got the first dose in October 2019; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: This case was reported by the patient himself or herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked if he/she had exceeded the maximum interval between doses or could he/she still get the 2nd dose and had it been effective. The patient stated he/she had already read almost everything on the internet, and as soon as possible, was too vague and asked could we you address a 2-year interval as there was very little information on specific intervals beyond 6 months. The patient asked about adverse event and do he/she had to start over, or would the 2nd dose still be effective 2 years after the 1st dose. The follow-up would not possible as no contact details were available.
Patient came to the pharmacy and stated that he had experienced severe and painful swelling of the legs the morning after receiving the vaccine.  He states that it was painful for him to walk for a few days.  He also let me know that as the last month has passed, the swelling has gone down, but he states that there is still some residual swelling in his legs that is not normal. He did not voice any treatments to me.  He did say that he had talked to his doctor and they had asked him to visit the pharmacy where he had received the vaccine.
diagnosed as COVID-19 positive 5 days after her first vaccination; severe headaches; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (diagnosed as COVID-19 positive 5 days after her first vaccination), HEADACHE (severe headaches) and FATIGUE (Fatigue) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (severe headaches) and FATIGUE (Fatigue). On 28-Mar-2021, the patient experienced COVID-19 (diagnosed as COVID-19 positive 5 days after her first vaccination). At the time of the report, COVID-19 (diagnosed as COVID-19 positive 5 days after her first vaccination), HEADACHE (severe headaches) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
No additional AE PQC reported; temperature excursion PROQUAD were administered to 5 patients; This spontaneous report has been received from a physician assistant concerning to a 4-years-old child patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (route of administration, dose number and dose were not provided) (lot#: T034613, expiration date: 10-APR-2022) (product storage error) as prophylaxis. The total temperature excursion was above -15 degree Celsius (-5 degree Celsius) for a total time frame of 15 minutes. There were no previous temperature excursions. No additional adverse events were reported.  This case is one of six cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA004895: US-009507513-2108USA004894: US-009507513-2108USA004893: US-009507513-2108USA004896: US-009507513-2108USA004892:
pt states arm sore by evening of shot;pt arm (pneumonia) but by next day felt warm to touch (24hr later) had temp but not sure how much masked by ASA;rt arm area swollen;extremely difficult to move arm;
Bi-lateral swelling of the hands which led to severe medial nerve damage and carpal tunnel release surgery on both hands. Loss of sensation and strength in both hands is the outcome.
Upon administration of IM FLUVIRIN to the left deltoid, swelling hard bump formed immediately after administration.
Patient recieved second dose of covid 19 Pfizer. He recieved 0.1ml vs 0.3mL dose. No adverse reaction noted  First dose on 8-4-21
On Oct 4 I woke up at 5:30 AM thinking I had a bloody nose, but it was just runny. I then took a COVID-19 at home test which was positive. I called my primary doctor, and she called back later that afternoon. The doctor prescribed PAXLOVID which I went and picked up same day. I continued isolation and took the medication. I felt crappy and had a headache but that was about it. This lasted for a total of 8 days, and I felt really crappy. Oxygen desaturation, now due to long COVID.
Continued headaches after vaccine. Chills and aches after vaccine for 24 hours.