chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received PROQUAD vaccine that had undergone temperature excursion; No additional AE reported; This spontaneous report was received from a registered nurse referring to a male patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number T015598, expiration date 02-NOV-2021 (dose and route of administration not reported) for prophylaxis. No adverse event was reported.  The vaccine underwent a temperature excursion of 13.8 degrees Farhrenheit for 1 hour and 48 minutes. No previous temperature excursions detected.  This is one of 5 cases notified by the same reporter.; Sender's Comments:  US-009507513-2110USA001589: US-009507513-2110USA001521: US-009507513-2110USA001664:
Within 2 hours of receiving the vaccine patient described diffuse itching and broke out in hives on her face, neck, and arms.  She continued to have diffuse itching, and rash and was evaluated in the clinic today, August 26 where she had ongoing outbreaks of pruritic lesions on arms, legs, neck, hair line and waistline despite using Benadryl every 4 hours I put her on a prednisone taper starting August 26 and she will use some topical triamcinolone
Chills; Fever; cool; Night sweats; Soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EK9231), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Blood pressure, ongoing Cholesterol.  Concomitant medication included nifedipine (ADALAT) for Blood pressure and ongoing, atorvastatin (ATORVASTATIN) had been on this medication 6-7 year and ongoing for Cholesterol. Historical Vaccine included flu and had Soreness in her arm. The patient experienced soreness in arm on 20Jan2021; chills, cool, fever, night sweats on 21Jan2021. She woke up drenched. She imagined the fever was breaking. She woke up, and did not have a fever, and was fine other than that; She just couldn't warm up. She was cool, and the chill wouldn't go away with clothes or blankets or the fire place. The event outcome of soreness in arm was recovering, outcome of other events was recovered on 21Jan2021.
pt recvd vax;subsequently devel thrombocytopenia & vaginal bleeding which required er tx;recvd platelet transfus,blood transfus.high dose steroids;lab tests revealed neg platelet antibody & bone marrow aspiration,biopsy exams neg;
I noticed about 01:00PM that my arm was starting to itch. At first, I just kept scratching it. Then the muscles began to feel tight. Thats when I looked at it, and around the site of the injection, that?s where it began to swell and become red. The next morning, the whole upper arm was swollen and red and sore. Over progression of 2-3 days, I swelled from the top of my shoulder all the way past my wrist. It was swollen enough that I could barely move the arm and there was sharp pain in the elbow. Felt like it was on the underside of my elbow. That lasted for 3 weeks in total. I went to the doctor?s 2 weeks later because I saw online it has happened to other people. But after 2 weeks, I still had it. I still had swelling, sharp pain and redness at the injection site for over 2 weeks. That?s when I went to the doctors for them to have a look at it. They prescribed meloxicam and another medication. My first dose of meloxicam gave me an instant migraine and stopped using it. Stopped using all the medications in general and used Benadryl around the site which I had been using for 2 weeks prior and waited it out for another 2 weeks. It took 4 weeks for the pain in my elbow to stop. I do have some lingering occasional tinges of pain. Like I?ll grab something, and it?ll spike then go back to being normal again. Both times for the vaccine gave me a migraine, but they were very short. Both 6 hours after my shot. They weren?t really bad so I dismissed that.
Patient received the vaccine on 4/1/21 but on 4/8/21 started to feel itchy and saw a rash around the injection site looking like bumps (no puss), extremely red. No c/o fever, body aches, chills, chest pain ,sob.  Advised patient to take a Benadryl to help with the allergic reaction, also she can apply benadryl cream or hydrocortisone cream to help with the itchiness. Also informed her she can take Tylenol if she feels body aches/fever.  4/12-Patient feeling better today. Redness and pruritic rash resolved yesterday. On 4/8/21 patient took Benadryl at bedtime. No signs and symptoms at this time.
patient reported to nurse  within 5 minutes of being vaccinated that she had 'soreness and pressure' in her throat. She denied difficulty breathing with no other symptoms and Clinical Leader was notified. She was taken to the triage area for further monitoring and evaluation with CL. She maintained verbal ability during the observation period, and at no time reported difficulty breathing. No urticaria was observed; no itching or gi symptoms reported by patient during interaction. Patient was asked to lie down with her feet up which she declined, and was seated in a chair during triage. Vitals remained stable during her observation and she was encouraged to take liquids and given some water. She denied eating lunch as well, and appeared possibly anxious due to her symptoms. Clinical Leader asked her to remove her mask for optimal breathing, which appeared to lessen  anxiety in addtion to the supportive care provided. Clinic Medical Director was informed and in agreement with observation. She was observed for over an hour, at which time her symptoms continued to improve and vitals remained stable. Breanne reported feeling better and that her throat felt better with the water. She was advised to speak with her allergist (she denied any medications other than prn epi pen which she did not have with her in clinic) regarding her symptoms today as well and to bring someone with her for the next dose for support, for which she agreed.
anxiety due to previous shot 10 years ago  140/70 92 16 Alert and oriented x4
INJURED WITH THE VACCINE; This spontaneous report received from a consumer concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported 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 injured with the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injured with the vaccine was not reported. This report was non-serious. This case is a duplicate of 20230227379. This case, from the same reporter is linked to 20220429250.
She got her vaccine, Pharmacist gave her the shot, it hurt and it stung.  She is allergic to bees and wasps and felt similar to that.  The arm was then swollen, hard.  She put ice on it last night, went to bed, did not think about taking Tylenol.  She woke up and the area is now twice the size being swollen, hot to touch, very hard.  She is also having a slight headache.  She called the pharmacy and they told her to report it.  She can  move her arm, but when she does raise it she can feel pulling in that area.  She did take  Extra Strength Tylenol, and she is left handed as well.    She did have her COVID booster 1st one on 9/20/22 and her flu vaccine on 9/30/22 and no reactions to either one.
accidently administered an expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 34l52, expiry date 06-JUL-2023) for prophylaxis.   On 14-JUL-2023, the patient received Shingrix. On 14-JUL-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: accidently administered an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 14-July-2023 The reporter stated that the patient was accidently administered an expired dose of Shingrix on the day of reporting which led to expired vaccine used. The reporter consented to follow up.; Sender's Comments: GSK receipt date: 14-July-2023 The reporter stated that the patient was accidently administered an expired dose of Shingrix on the day of reporting which led to expired vaccine used. The reporter consented to follow up.
Passed out; Felt weird, Felt run over by a truck; Was ice cold; Was bucking in bed; Did not know who I was nor what was going on; Shivering; Teeth chattering; Blood pressure dropped; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), FEELING ABNORMAL (Felt weird, Felt run over by a truck), FEELING COLD (Was ice cold), JERKINESS (Was bucking in bed), CONFUSIONAL STATE (Did not know who I was nor what was going on), CHILLS (Shivering; Teeth chattering) and BLOOD PRESSURE DECREASED (Blood pressure dropped) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), FEELING ABNORMAL (Felt weird, Felt run over by a truck) (seriousness criterion medically significant), FEELING COLD (Was ice cold) (seriousness criterion medically significant), JERKINESS (Was bucking in bed) (seriousness criterion medically significant), CONFUSIONAL STATE (Did not know who I was nor what was going on) (seriousness criterion medically significant), CHILLS (Shivering; Teeth chattering) (seriousness criterion medically significant) and BLOOD PRESSURE DECREASED (Blood pressure dropped) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), FEELING ABNORMAL (Felt weird, Felt run over by a truck), FEELING COLD (Was ice cold), JERKINESS (Was bucking in bed), CONFUSIONAL STATE (Did not know who I was nor what was going on), CHILLS (Shivering; Teeth chattering) and BLOOD PRESSURE DECREASED (Blood pressure dropped) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: Blood pressure dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was reported. Company comment: This spontaneous case concerns an 80-year-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) events of LOSS OF CONSCIOUSNESS, BLOOD PRESSURE DECREASED, FEELING ABNORMAL, FEELING COLD, JERKINESS, CONFUSIONAL STATE AND CHILLS, on the same month of the first dose of mRNA-1273 vaccine. The vaccination date and the exact onset of the events were not reported; hence, latency to the dose of mRNA-1273 vaccine could not be properly assessed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
patient got vaccine on 2/3/21.  On 2/12/21 he developed fevers and chills and he then developed a scalp rash, he does have a history of scalp dermatitis.
Found out he had COVID; Runny nose; Stuffy and runny nose; Sneezing; Stuffy and runny nose; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Found out he had COVID), RHINORRHOEA (Runny nose), NASAL CONGESTION (Stuffy and runny nose), SNEEZING (Sneezing) and RHINORRHOEA (Stuffy and runny nose) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 102L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced COVID-19 (Found out he had COVID), RHINORRHOEA (Runny nose), NASAL CONGESTION (Stuffy and runny nose), SNEEZING (Sneezing), RHINORRHOEA (Stuffy and runny nose) and FATIGUE (Fatigue). At the time of the report, COVID-19 (Found out he had COVID) outcome was unknown and RHINORRHOEA (Runny nose), NASAL CONGESTION (Stuffy and runny nose), SNEEZING (Sneezing), RHINORRHOEA (Stuffy and runny nose) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Date of the test is not provided. and negative (Negative) Date of the test is not provided..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   The patient took emergenC for treatment of the events.
The pt developed a fever of 103 deg F, 12-20 hrs after immunization . Fever lasted for 3 days.
During immunization visit as the Varicella vaccine was being injected the child moved and vaccine was injected too shallow. At the time child appeared to be OK and we planned to repeat vaccine at a later date. One week later the parent called and informed us that a week after she had taken the child to a provider after the site become swollen. The provider said to the parent that the site may have had an infection and treated the child with antibiotics. The parent said the swelling was now going down.
On 01/09/2018, pt reported to ED at around 7:49pm with complaints of shortness of breath. EKG was performed resulted in "Normal Sinus Rhythm." Experienced 1 attack of SOB when being prepped for EKG. After evaluation pt. was discharged from ED at 8:23pm.
administered 0.25 ml instead of 0.5 ml to uncompromised adult/ wrong dose for Bivalent Vaccine booster dose (underdose); No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adult/ wrong dose for Bivalent Vaccine booster dose (underdose)) 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.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adult/ wrong dose for Bivalent Vaccine booster dose (underdose)) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adult/ wrong dose for Bivalent Vaccine booster dose (underdose)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adult/ wrong dose for Bivalent Vaccine booster dose (underdose)).    Concomitant medications were not reported.  Reported that patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster. It was reported when first administering Bivalent boosters. So, they assumed the same dose as the second booster, and they were administering 0.25 ml instead of 0.5 ml to uncompromised adult. It was reported that no adverse event was reported. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:MOD-2022-646512: Master case
Pain in arm when raised. Dad states his daughter had H1N1 shot several months ago has been complaining on and off about discomfort in her arm, states "no visible redness or bump" but when she tries to raise her arm up it hurts.
Pain at injection site, swollen arm after receiving the booster shot. Arm is still hot to  touch, welts in the forearm area. Used ice pack and Benadryl, did not work.
Develped headache & low grade fever within 24   hours after receiving #2 Hep. B. This occured in the afternoon for 3 days before it resolved. On day 5 after vaccination developed about 20 small welts scattered through out the body from the neck down.  The welts resolved within 24 hours. The welts were followed with a lacy type rash that was also scatterd through out the body from the next down. This was pretty much resolved within 24 hours. Client states that family members had developed the same type of rash several days prior to her onset of rash and they had not received any vaccinations.
19 year old received Engerix 1mL; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B) (batch number AX2D5, expiry date 7th December 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2023, the patient received Engerix B 1 ml and Engerix B Pre-Filled Syringe Device. On 22nd February 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-FEB-2023 Reporter's Comments: The reporter consented to follow up via email. Additional Supportive Information: The 19 year old patient received a 1 ml dose of Engerix-B, which led to overdose.
LEAKING NEEDLE ON SYRINGE DURING VACCINATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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 not reported, and batch number: 043A21A expiry: not reported) dose was not reported, administered on 02-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced leaking needle on syringe during vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leaking needle on syringe during vaccination was not reported. This report was non-serious.
Redness around the injection site, slightly warm to the touch. Noticed day 2 after the shot was taken but could have become red earlier, I just didn't notice it until then. Area is still red 3 days after shot.
I was woke up out of my sleep at 2:00 a.m. with terrible pain in back and chest around the heart.  It felt like I was having a heart attack.
Severe joint pain, fever, fatigue, nausea.  In bed for two days. Felt affects for 3 days further. Five days total.  Astonished by severity of reaction. My wife had same level of reaction (filed under separate report)
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 29-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided          No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
she has a box of ROTATEQ in which the foil pouches containing ROTATEQ are unsealed; No other AE; three doses have been given out of that box; This spontaneous report was received from a registered nurse referring to a 4-months-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 15-FEB-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliter (ml) orally, lot # 1742077 verified to be valid with an expiration date reported and established as 12-SEP-2022 (strength and vaccination scheme frequency were not provided) for prophylaxis. It was reported that the box of used rotavirus vaccine, live, oral, pentavalent (ROTATEQ) contained unsealed foil pouches and that three doses had been administered out of that box (Poor quality product administered, Product packaging issue). It was noticed on 11-MAY-2022 and the reporter could not be sure whether the foil pouches containing the administered dose were also unsealed. The patient did not have any adverse effects or symptoms following administration of the vaccine (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA003440: US-009507513-2205USA003333:
Patient contracted COVID after being fully vaccinated; no booster. shortness of breath, fatigue, fever, chills, hypoxia, dyspnea
started with myalgia in the hands, spread to arms and chest- feet and legs. Cardio-myalgia bad enough to warrant trip to ER to check for MI. Fatigue and lethargy noted as pain progressed.
Right arm swollen, red, hot to touch and itches. Treated with cephalexin, prednisone and elevate to shoulder level and ice packs.
Dizziness, Headache, Myalgia, Fever, Diarrhea, severe arm soreness Narrative: Muscle aches, really bad headache, diarrhea (resolving now), severe arm soreness, dizziness. Not taking anything OTC at the moment. Temp is 100F.
Patient was given 0.5ml instead of 0.25ml for booster 3rd dosage, patient called on 1/19/2022 and  stated she was weak, sick for a couple of days but fine and manageable, no other problems since 2 days after vaccinations. Letter was sent to patient with dosage given.