chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered the vaccine, during her 15 min observation she stated "my lips feel tingly".  Patient appeared pale, her feet were elevated, she reported that she had not eaten since the previous evening.  She was able to drink 11.5 oz of orange juice, blood pressure was 175/122, apical pulse was 68, blood glucose was 76.  Butterfly IV was started by assistant clinical manager who administered diphenhydramine 25 mg.  Clinical director was notified and orders received to continue to monitor the patient until systolic blood pressure had declined to 140-150 then she would be discharged if asymptomatic.  The patient rested and was monitored, blood pressure declined to 145/82 and she notified her primary care physician to follow up the same day.  She was summarily discharged and was seen by her physician later in the afternoon.
Chronic diarrhea. Every single day, 4-10 times per day. Not alleviated but fasting or changes in diet. Worsening.
pt presented today 9/19 with a swollen arm- swollen from shoulder down to half way down the lower part of arm.  A bit red and warm to the touch.
Nasal congestion, phlegm, and shortness of breath when laying down to sleep.
Nausea and anxiety immediately post #1 slowly getting slightly worse, strange behavior noted after 2nd - getting worse by the day and mid June admitted hospital for convulsive seizures/encephalitis
OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE AND GIVEN TO ADOLESCENT AGE 14; This spontaneous report received from a patient concerned a 14 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, hyperlipidemia, and adhd, and other pre-existing medical conditions included: the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: 24-OCT-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced off label use, and product administered to patient of inappropriate age and given to adolescent age 14. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product administered to patient of inappropriate age and given to adolescent age 14 was not reported. This report was non-serious.
Unconsolable cryhing for at least 3 hours within the first 48 hrs shots were given.
menactra administered 04/12/05 on 04/16/05 pt developed redness, swelling, itching at the injection site. 04/17/05 bruising and itching noted warm to touch no fever. 04/19/05 site reaction resolved.
Nausea, vomiting, chills,  lethargy, inflammation of injection site, complaints of headache. Nausea and vomiting were treated with zofran. Vomiting lasted from 1:30 am on 10/1/18 to 8pm on 10/1/18.
My arm was really sore; The person that gave me the first shot she pinched my arm you know to put the shot in and my muscle were really sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia; "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "High cholesterol" (ongoing), notes: Verbatim: High cholesterol. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "My arm was really sore"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "The person that gave me the first shot she pinched my arm you know to put the shot in and my muscle were really sore". Therapeutic measures were taken as a result of pain in extremity, vaccination site pain.  Additional Information: Patient stated, she just wanted to report some side effects that she having from the first one except for her arm was really sore for 2 or 3 days and she think its because the person that gave her the first shot she pinched her arm to put the shot in and her muscle were really sore. She has her regular medications that she takes, take medication for the blood pressure so that keeps it under control. Treatment: Consumer stated, she just used some Advil, its a pain relief. Consumer added, "No, is there anything she can do about she feels or not. Is it just going to pass or what.  No follow-up attempts are possible. No further information is expected.
On my second vaccine and about 10pm, I experienced a typical fever, chills. I took Advil for relief of pain. Then I had on onset of chills, tremors, body aches and headaches which I had not experienced before. I again took Tylenol and Advil to try to keep my temperature and symptoms down. I was bedridden for 48 hours. I also had insomnia through the night. I had a temperature of 101F. After 72 hours post, I began to feel better and was fine.
pt recvd vax; 16sep95, fever 105; to med ctr for evaluation;
Pin point rash appeared around ankles that itched and then spread to stomach. Patient went to Dr. who treated him for "dermatitis" and gave RX for Medrol Dosepak   ...Rash went away Rx was written on 9-9-09 and filled and picked up that date.
Swelling of nasal passage and throat. Then swelling of feet, ankles, calves, thighs, genitals, and shortness of breath.
Swelling, hot feeling, discomfort, chills at 2230. Swelling from elbow to injection site. Decreased swelling, no chills, decreased discomfort at site 12/11/03.
Hallucination, HYPERtension, Metallic taste and pale after 2 mins of receiving COVID vaccination. BP 166/76, HR 86, Repeat in 5 and 10 mins BP 130/76, 123/77 HR 82,  Employee awake, alert and oriented, recovered in 10 mins  Narrative:
Received Pfizer Covid 19 vaccine for age 5 and above; ; no adverse effects noted
she administered a pediatric dose of Engerix-B to an adult today; she administered a pediatric dose of Engerix-B to an adult today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 34-year-old female patient who received HBV (Engerix B pediatric) (batch number A9349, expiry date 19-APR-2024) for prophylaxis.   On 19-SEP-2023, the patient received the 3rd dose of Engerix B pediatric. On 19-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: she administered a pediatric dose of Engerix-B to an adult today) and adult use of a child product (Verbatim: she administered a pediatric dose of Engerix-B to an adult today).  The outcome of the underdose and adult use of a child product 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 Information: GSK Receipt Date: 19-SEP-2023 CMA states that she administered a pediatric dose of Engerix-B to an adult on the reporting day, which led to underdose and adult use of a child product. The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter.
The monovalent formulation was given to the patient instead of the bivalent for the 4th vaccination of their covid 19 series.
Dizzy and woozy, arm kept swelling up , painful , hot and got hard, extreme tiredness
Vomiting after every feeding for 2 days. Vomiting even without any liquids or feedings. Baby was hospitalize with an IV and the intussusception was found once she started vomiting bios and they did an internal exam. She had emergency surgery 30 hours after first symptoms.
Per employee, dyspnea (such as with pleuritis or chest wall irritation), fatigue  Narrative:
This spontaneous report as received from a nurse concerning a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reaction and concomitant medications were reported. The nurse reported that the patient was prescribed to receive VARIVAX but on 09-AUG-2016, the patient was inadvertently vaccinated with ZOSTAVAX (dosing details, lot#, expiry date were not reported). No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
At 2:30am on June 22nd, 2021, i woke up with a terrible headache.  I took some Advil and went back to sleep. At 5:30am I woke up and had body aches, chills,  nausea,  a 99.9 degree fever,  and my arm was terribly sore.  When i woke again at 7:30am i felt like had been hit by a truck.  Extremely tired and weak.  By mid afternoon i realized my chest was pounding and i had very frequent chest pain.  After a few days passed with no improvement,  i went to my Dr. to see if there was anything i could do because i was so dizzy and light headed that i was having trouble walking across the room without falling over or losing my breath. He ordered an EKG which was done at the Hospital. The results came back normal. By I'm still having trouble with catching my breath after doing very minor tasks.  I still have chest pain and palpitations.  Whereas I did not have these problems prior to receiving the second dose of the Moderna vaccine.
Although the vaccine did not give me genital herpes, I wonder if it caused my first outbreak to occur on March 28th, 2021. My husband  had herpes before we met 31 years ago and I just came down with my first outbreak one month after my second moderna vaccine.  At the same time, I came down with severe folliculitis.  Perhaps it weakened my immune system?
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K021581, expiration date 24-OCT-2016; lot# K026531, expiration date 15-APR-2017; dose and route were not reported; temperature: 52 F, time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
eye itching; eye tearing; eye swelling; This case was reported by a consumer via call center representative and described the occurrence of eye pruritus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 10th November 2020, several weeks after receiving Shingrix, the patient experienced eye pruritus, eyes tearing and eye swelling. On an unknown date, the outcome of the eye pruritus, eyes tearing and eye swelling were unknown.   It was unknown if the reporter considered the eye pruritus, eyes tearing and eye swelling to be related to Shingrix.  Additional details were provided as follows: The case was reported by the girlfriend of the patient. The age at vaccination was not reported. The patient received the Shingrix vaccine a couple of weeks before the time of reporting. The reporter reported 3 days ago the patient had eye swelling, eye tearing, and eye itching. The reporter did not consent to follow up. The patient's consent to follow up with health care professional was not received.
No adverse event; Patient received Bivalent Moderna COVID-19 vaccine as their first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as their first dose) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 28-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as their first 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Bivalent Moderna COVID-19 vaccine as their first dose).    Concomitant medications were not reported.  It was reported no reported symptoms. Treatment medications were not reported.
Date of vaccines given was 3/5/14, child given dose of Tylenol at 7:30pm, she awoke at 10:30pm shivering and fever of 105.4f.  Taken to ER and ER MD told grandmother that child had too many vaccines that overwhelmed the child's system and that is what caused the fever.  When released from the ER fever was 99.1.
Roughly 5-6 minutes following administration of the vaccine, pt had what was thought to be a seizure - but was later confirmed as a likely fainting spell.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was mentioned that the vial was initially refrigerated  on 18 Oct 2021, the vial did not undergo any temperature excursion and the patient did not experienced any adverse events.
No fever.  Mom stated it started with blotchy bumps on arm and rash on neck noted at bedtime.  Pinpoint rash on right side of back and stomach.  Rash area itchy.  She gave him benadryl last night.  He slept well.  This AM child has "football shaped" reddened area on upper arm of injection site that is about 3.5 in long.  She described knees and feet as sunburned red.  I advised seeing childs doctor.
Fatigue, feverish, sweaty, headache, ached all over, felt like I was out of my mind/head. Had regular flu shot with bivaliant booster. Have never had any adverse symptoms following boosters.
Night sweats and overall feeling tired.  Hot flashes.  Low grade fever.  Missed 60 hours of work in the 2 weeks following the vaccine due to not feeling right
This spontaneous report was received from a pharmacist and refers to a 67-year-old male patient with diabetes. No information regarding the patient's medical history was provided. On 26-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N020854 with expiration date on 31-JUL-2018, 0.65 ml, via intramuscular route in the left arm. The dose of the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) lot # N021894 with expiration date on 28-NOV-2019. Concomitant vaccinations included PREVNAR 13 and FLUARIX QUADRIVALENT. The patient had no illness at the time of the vaccination. He experienced no adverse events. The reporter stated that the patient was checked again on 27-SEP-2017, and he still did not develop any adverse reaction.
8 1/2 x 10cm lump RVE inner aspect of arm above elbow, slightly warm and slightly pink (pt reports slightly warm and red on 10/15/03). Area is not located at injection site.
Received vaccine before shift. Within 10-15 mins bilateral back of the tongue numbness and tingling. Walked to ER (my department) and  asked charge nurse for Zyrtec. Advised to stay and be monitored, opted not to be checked in to ER. BP 146/105, 126-120 BP, abnormally high. Experienced red lips, itchy hands and feet, 'frog in throat' feeling. Convinced to check into ER. Swollen uvula, tonsils, lips red/swollen, stridorous breathing. Checked  in to ER, given IV Benadryl, fluid, prednisone, and Pepcid. Hands and feet were mottled. Confirmed anaphylactic reaction. Became nauseous, given Zofran.  Given Epi in left shoulder. Stayed for 4 hours for continued monitoring. Symptoms started to subside. Also given inhaled albuterol. Discharged w/ Benadryl, Pepcid, prednisone 5 days course, and prescription for Epi.
Information has been received from a consumer concerning a 14 month old male pt with down's syndrome, who on 10/14/02 was vaccinated with a dose of MMR II. Concomitant vaccination included a dose of varicella virus vaccine live. On approximately 10/21/02 the pt developed constipation for over one week, was "crabby and crying," developed a rash, had a temperature of 102 and experienced fatigue, lethargy and malaise. These adverse events were described as "reactions from MMR II or varicella virus vaccine live." Unspecified medical attention was sought. The pt previously had adverse events post vaccination with hep B vaccine (WAES0211USA00367). Additional info has been requested.
Chills and Fever. Muscle Ache, Sore Throat, Chest congestion, Coughing. Temperture few days later reached 100.0 F. Symptoms continued over a week and still have all symptons. Treated with cough medicine from doctor and decongestant pills.
Itchiness from head to toe, tightening of throat muscles. From 10/19/07 at 5 PM up to 10/22/07 every day. Benadryl 100mg, once a day x 4 days.
my left leg has been cramping ever since i got it; injection site is sore; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (my left leg has been cramping ever since i got it) and VACCINATION SITE PAIN (injection site is sore) 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 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced MUSCLE SPASMS (my left leg has been cramping ever since i got it) and VACCINATION SITE PAIN (injection site is sore). At the time of the report, MUSCLE SPASMS (my left leg has been cramping ever since i got it) and VACCINATION SITE PAIN (injection site is sore) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
pt recvd 29NOV95 10MA & felt shakey & felt ill-returned to RN placed supine-feet elevated 02 nasal cannula-BP 1120Am 160/90-apical 140 skin warm/pale-dry, crying-mild tremors-crying to hard to answer questions;hyperventilating;
Sweating profusely; Woke him up from sleeping; Jolt or a tingle in his chest which lasted for 2-3 min; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Jolt or a tingle in his chest which lasted for 2-3 min), HYPERHIDROSIS (Sweating profusely) and SOMNOLENCE (Woke him up from sleeping) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A2) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (Jolt or a tingle in his chest which lasted for 2-3 min). On 27-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating profusely) and SOMNOLENCE (Woke him up from sleeping). On 25-Mar-2021, PARAESTHESIA (Jolt or a tingle in his chest which lasted for 2-3 min) had resolved. On 27-Mar-2021, HYPERHIDROSIS (Sweating profusely) and SOMNOLENCE (Woke him up from sleeping) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Heart rate: 77 (Inconclusive) 77 beats per min.     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 treatment information was provided.
This spontaneous report received from a registered nurse referred to a 27 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-MAR-2017, the patient was vaccinated with PROQUAD (dose, frequency not reported, lot:M022400, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Fertility problems. Haven't been able to get pregnant since trying October 2021. 1 miscarriage April 2022. DNC surgery 2 weeks later that followed with an emergency room visit due to extremely heavy bleeding/clotting. Abnormal menstrual cycles. I have 2 children who were easily conceived but have not been able to get pregnant since the vaccine.
pt recvd vax 1989 & 1 wk later devel sz; subsequently recovered; No further details were provided;
Case number PHEH2013US020546 is an initial spontaneous report received from a nurse on 30 Sep 2013, with the follow-up received on 28 Feb 2014. This report refes to a 22-years-old female patient. On 27 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) intramuscularly in the deltoid. It was reported that before vaccination, FLUVIRIN was kept in the shipping container at room temperature for 72 hours. No adverse event was reporting following this medication error. Follow-up received from nurse on 28 Feb 2014: Updated vaccination site.
"Patient received Janssen Vaccine. While in post vaccine observation area patient reported feeling like she was going to pass out. Patient escorted to EMS Observation Room. BP 116/68, HR 62, RR18, SpO298%. Patient rested and felt better. Patient refused transport to hospital for evaluation and left clinic ambulatory with no complaints." Site Supervisor Report