chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Night Sweats (During the night); Stomach Cramps; Zero Energy; headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night Sweats (During the night)), ABDOMINAL PAIN UPPER (Stomach Cramps), ASTHENIA (Zero Energy) and HEADACHE (headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced NIGHT SWEATS (Night Sweats (During the night)), ABDOMINAL PAIN UPPER (Stomach Cramps), ASTHENIA (Zero Energy) and HEADACHE (headache). At the time of the report, NIGHT SWEATS (Night Sweats (During the night)), ABDOMINAL PAIN UPPER (Stomach Cramps), ASTHENIA (Zero Energy) and HEADACHE (headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Pt. reports 15 minutes post vaccination experience double vision and tightness of the chest, causing it to be difficult to breath. This nurse was notified and vitals were 120/96, HR 110, O2 98. This nurse waited 5 minutes and took vitals again. They were - 120/88, HR 89, O2 99. After 15 additional minutes of patient resting on the cot, vitals were 118/20, HR81, and O2 99. Pt then began to be vomitous, experiencing increased chest tightness, and difficulty breathing. This nurse asked the pt if they would like to have EMS called and they obliged. Upon EMS arriving, pt vitals were stable and all tests done in the field came back WNL. Pt still wanted to be transferred to the nearest facility to be evaluated further. Pt. did state hx of elevated Red cell and was to follow up with PCP next week.
This report describes purpura on the legs of an adult male vaccinee of unspecified age who received Havrix vax. Medical history, concurrent conditions, and concurrent medications were not specified. On 3/2/02, the vaccinee received an injection of Havrix; the # of previous injections of Havrix were not provided. On 3/15/02, he experienced purpura on his legs. An unspecified time post-vax, he also experienced rash, fatigue, and abdominal pain. He was seen by an MD. Treatment and outcome of the events were not specified.
soreness at the injection site; muscle aches; chills & shivering; mild fever=99.7; low blood sugar; headache
2 YO CLIENT RECEIVED A TDAP AS DOSE #4 INSTEAD OF AGE-APPROPRIATE DTAP.
on Friday my Hands started to get extremely itchy. mostly in the morning.  The itchiness would go away after taking allegra.  the next several days my hands got more itchy, and I had red blotches on my upper chest in the left shoulder area.  This would also come and go.  Severe acid reflux started around this same time as well.  by monday I was taking 40 MG protonix, twice a day... I did this for a week with minimal changes, made a call to my gasteroenterologist to make an appointment, also call my allergist and made an appointment.  Recommneded to take Zyrtec otc but 2x daily for 1 month.   after about 1 week itchness is better and acid reflux is also better.
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of improperly stored ROTATEQ (lot #, expiration dates and doses were not reported) route defaulted to oral. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
mom states pt became irritable p/vax;would quiet down when held, ate normally via bottle & napped about 1/2-1hr @ a time when held;mom states when trying to lay pt down pt cried & has been irritable since this AM;mom noted lt leg red @ inj
After vaccine my toes got extremely sore and it was bad by midnight and felt like I wanted to lose my ten toes, on the scale of 1 - 10 the pain level was a 6 or 7. When I woke up I had a little pain in my right foot and it went away.
Initial report was received from a health care professional on 17 May 2011 which involve the administration of the wrong vaccine. A patient (age and gender not reported) had received an intradermal injection of DECAVAC (lot number, site and date of administration not reported) and an unspecified amount of time later reported the injection site became red, swollen, blistered and possibly necrotic. The reporter was unsure if 0.5 ml or 0.1ml was administered. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Itchy in her head; chills; Fatigue; Cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (Cold), PRURITUS (Itchy in her head), CHILLS (chills) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Psoriasis. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, OMEPRAZOLE and CLONAZEPAM for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold), CHILLS (chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRURITUS (Itchy in her head). At the time of the report, NASOPHARYNGITIS (Cold), PRURITUS (Itchy in her head), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was include acetaminophen and her doctor prescribed Benadryl for the itch (she has not used it yet).   Reporter did not allow further contact
This non-serious consumer report (initial receipt 09-May-2014) concerns a 51 year old male patient. In 2013, the patient received a influenza virus vaccine (manufacturer and batch number not reported). In fall 2013, two weeks after the vaccination, the patient got sick with fever and headaches. Outcome was reported as recovered in fall 2013. Reporter comments: The consumer reported the case to be related to the flu shot.
A day after administering the vaccine, the patient came back to the office with left arm swelling and pain on site of immunization. Doctor recommended Benadryl, Ibuprofen and cold compresses.  We call the patient a few days after reaction and the symptoms had disappeared.
pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered; received dose of Moderna vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and POOR QUALITY PRODUCT ADMINISTERED (pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion). On 09-Aug-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered). On 09-Aug-2021, POOR QUALITY PRODUCT ADMINISTERED (pharmacist reported that 4 doses of an affected vial of the Moderna COVID-19 vaccine were administered) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) had resolved.        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 Concomitant medications were provided.  No treatment medications were provided.
adjuvant without active component; adjuvant only administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number AT772, expiry date 5th October 2023) for prophylaxis.   On 31st May 2022, the patient received Shingrix. On 31st May 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The registered pharmacist called and reported that they provided Shingrix vaccine to a nursing home to be administered to a resident.  The reporter stated an registered nurse relayed to her that the resident was administered the vaccine adjuvant without active component.  The reporter consented to follow-up. Additional supportive information: The patient received adjuvant without active component of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
pt recv vax 19SEP95 & 19MAR96 pt devel a rash w/pox under the arms which spread to the torso & head;pt devel over 50 pox which had crusted over @ the time of report;
Sudden onset bilateral lower extremity paresthesias and loss of sensation began night of 9 Jan 11 on soles of feet. By 10 AM 1-13-11 encompassed sacrum/suprapubic area. No loss of sphincter control. Minimal pain - ambulatory. No intercurrent illnesses. Loss of pin prick-brush sensation to soles, dorsal surface feet - lower legs.
This case was reported by a nurse via sales rep and described the occurrence of pain localized in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain localized. On an unknown date, the outcome of the pain localized was recovered/resolved. It was unknown if the reporter considered the pain localized to be related to SHINGRIX. Additional details were reported as follows: The field reporter contacted GlaxoSmithKline adverse event line. The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient experienced local pain lasted for 5 to 7 days. The reporter did not provide any additional information as this report was already submitted the occurrences directly. The reporter did not agree to be followed up by GSK. This was one of four cases reported by the same reporter.
11/28 - local redness, swelling @ injection site left deltoid, 11/29 -Swelling  from injection site to sternum, Palpable sub-clavicular node. Tylenol PO taken, 12/03 swelling gone, Area tender
HEADACHE; BODY ACHE; LOW GRADE FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included heart transplant, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have drug abuse or illicit drug usage. The patient was previously treated with tacrolimus for heart transplant, and mycophenolate sodium for heart transplant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced headache, body ache and low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, body ache, and low grade fever on 11-MAR-2021. This report was non-serious.
Patient had area at warmth & redness 6.5 in x 4.5 in on Left thigh where MMR & PENTACEL given. On right thigh had 1.5 in x 2.5 in area of redness & warmth where Hep A & Varicella were given. MOTRIN & BENADRYL used as treatment.
4/18/21 - Patient reports waking @ 7 am with fever, chills, severe fatigue. and mental confusion. These symptoms progressively worsened over the course of the day until 9 pm when patient reports developing severe right sided facial pain 10/10 radiating from behind right ear, throughTMJ to nose and up into right eye. Pain was accompanied with dystonia presenting as involuntary muscle spasms of the right eye and jaw muscles and progressed to palsy of the right eye. Patient reports fever and malaise subsided 4/19/21 but dystonia and palsy continued along with severe facial pain. Patient reports ibuprofen reduced pain level to 8/10, but pain level prevented patient from sleeping. Patient reports pain, dystonia and intermittent palsy were still present when she reported to our clinic on 5/1/21. After a course of 3 acupuncture treatments, patient reports all pain, dystonia and palsy have subsided.
his arm was a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2), for covid-19 Immunization; Bnt162b2 (Dose:1), for covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "his arm was a little sore".  Follow-up attempts are completed. No further information is expected.
My daughter became rigid at first and then proceeded to convulse in my arms for at least 45 seconds at which time she projectile vomited.  She became listless and very lethargic and developed a fever.
blockage in intestine; condition aggrevated; This case was reported by a consumer via call center representative and described the occurrence of intestinal obstruction in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included colostomy (experienced 5 months before the date of reporting). Concurrent medical conditions included intestinal obstruction and scar.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced intestinal obstruction (serious criteria hospitalization and GSK medically significant) and condition aggravated (serious criteria hospitalization). On an unknown date, the outcome of the intestinal obstruction was recovered/resolved and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the intestinal obstruction and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. The patient could not remember which arm she received either dose of Shingrix. It was reported that, sometimes in between dose 1 and dose 2 of Shingrix, the patient was hospitalized for 4 days due to a blockage in her intestine. It was reported that, the patient gets these blockages from time to time in her intestine due to scar tissue that was there prior to receiving Shingrix.  The reporter did not consent to follow-up. This was 1 of the 2 cases reported by same reporter.
patient developed swelling, erythema and pain at site of injection within 24 hrs. She then developed pain shooting to 2nd and 3rd digit with soreness upon moving her arm.
I thought it was a really bad cold. I had runny  nose, sinus headache, dizziness, and chest congestion and coughing. I started to feel it on the 29th - Thursday and I went to Urgent Care - on the following Tuesday thinking I needed an antibiotic. They wanted to test me for COVID - positive. It continued to get worse after that - to the point where I couldn't sleep, I was waking up every morning with sheets being totally drenched from cold sweat. I would go downstairs and I had chills and I would lie under a blanket downstairs; if I got up I was dizzy; no appetite and had sinus headaches. It was about two weeks of this and I went back to Urgent Care - Dr. is who I saw. I am still having   have chest congestion and some coughing fits; Dr gave me an asthma inhaler - and an antibiotic; I'm still having the runny nose, too. I am still just knocked out exhausted. I am able to function but I can't do a lot without getting really tired and needing to come home sooner than I would normally have to.
Pt reports persistent proximal left arm pain with movement at site of injection (ab-duction, internal rotation, flexion, extension >90 degrees)
Bulging fontanelle within 14 hours of dose, infantile spasms, hospitalization for 4 days, subdural hygromas discovered. Baby quit hitting developmental milestones, developed hypertone with right sided weakness, underwent surgery at 7 months for a ventricular peritoneal shunt to relieve pressure from fluid. Currently still behind in gross motor skills, multiple therapies weekly to help with muscle tone and coordination, possible cp diagnosis in future.
Client rec'd Tdap, HPV4, MCV4, approx. 3 min after while sitting in waiting area she fainted, fell to side hitting head on floor. Placed feet up, laid on back, clammy, cool cloths to neck and forehead. 5 min sat client up, still seemed lightheaded. Brought in to nurse area sat in chair to watch, talking to staff, and fainted again, this time having jerking movements for few seconds, laid on floor. BP 102/68 P 62, clammy. No breathing difficulty noted, just pale skin color. 911 called and client left with paramedics at 10:03, to be checked at hospital.
This spontaneous report was received from a physician and refers to a 16 year old male patient. The patient did not have any concurrent conditions, pertinent medical history or drug reactions or allergies. On an unspecified date in August 2016, the patient was vaccinated with GARDASIL 9 intramuscularly (dose and frequency were not reported. The patient did not take any concomitant medications. On an unspecified date in 2016, 3 to 5 days after vaccination, the patient experienced dizzy spells. The reporter stated that sometimes the dizzy spells occurred daily and sometimes they occurred every other day. The patient did not seek medical attention, no treatment was given for the event and no laboratory diagnostic studies were performed. At the reporting time, the patient recovered from the event on an unspecified date in 2016 (reported as "3 or 4 weeks.") The reporter did not provided a causality assessment between the event and the GARDASIL 9. Additional information has been requested.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer. A female patient (Cousin's wife) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient pregnant information was unknown. The patient was tested positive for covid in Jul2021. Reporter stated my cousin and his wife also got diagnosed a couple days earlier than I did. I just wanted to make sure this got reported because I know you were still trying to figure all this out. Especially when I found out my cousin and his wife had both doses and tested positive. Reporter asked, "is there any more information about this". The patient underwent lab tests and procedures which included COVID-19 as positive on Jul2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
lt thigh red swollen extends to knee reported by phone approx 430PM;advised to be seen in ER:ER MD confirmed local skin rxn;f/u call following day reported improved;
4/25/2021 Loss of visual acuity in right eye, went to Urgent Care for testing treatment. No improvement MRI scheduled for 8/11 and referral to Rheumatology. 7/16/2021 Woke up early, felt unusually groggy, by 10:00AM I had the chills, 6:38PM temp 100 6:51PM exhausted, chills pulseox (O2) 98 Heart Rate (HR) 86 was asleep by 7:45PM. 7/17/2021 1:38AM woke up with chills temp 99.4 took Benadryl, and a Tylenol. 7:15AM temp 97.5. 10:45AM stomach cramps, achey lower back, rt. side sinuses stuffed up and fatigue 1:15PM woke up from nap, no appetite, took 1/2 hyoscamine drank gatorade. 4:00PM temp 99.4. 5:33PM temp 100 7:08PM 1/4 promethazine for stomach upset, sneezing, congested and headache 7:15PM temp 100.1 8:35PM temp 100.4 9:31PM temp 99.7 took Tylenol. 7/18/2021 7:21AM temp 99.7 O2 98 HR 76 9:00AM 5mL Children's Claritin 8:55AM temp 100.4 11:45AM temp 99.1 6:00PM temp 100.4 O2 97 HR 91, overwhelming fatigue 8:15PM temp 99.9 O2 97 HR 83 took Tylenol. 7/19/2021 6:50AM temp 99.1 O2 97 HR 87 9:00AM went to Urgent Care for symptoms, positive COVID test 11:30AM Tylenol and 5ml children's Claritin O2 98 HR 89 3:00PM temp 99.2 O2 97 HR 85 4:20PM temp 98.6 O2 98 HR 74 6:30PM nasal congestion returned 7:30PM temp 99.1 O2 99 HR 91 Tylenol, drank warm tea and gatorade 8:06PM woke up w/ low back ache and stomach cramping 9:53PM temp 98.0 O2 98 HR 71 10:00PM Sense of Smell disappeared, like a light switch, just vanished. 7/20/2021 1:00AM woke up with stomach cramps temp 98.1 O2 98 HR 71, headache 7:50AM temp 98.5 O2 97 HR 77 8:30AM took Claritin & Tylenol 9:30AM temp 97.7 O2 98 HR 68 headache, super thirsty all morning 11:30AM temp 97.6 O2 98 HR 77 12:45PM O2 98 HR 64 clinic PT/INR 2.9 4:45PM. I happened to have a heart rate monitor from Zio on during this entire time and can obtain that data for your records as well. This session is about to time about in 5 minutes and I don't want to lose what I've typed, have details through today.
At about 6pm, started feeling run down and not good; had a fever of 100; Could only sleep off and on; chills; This is a spontaneous report from a contactable consumer. A 48-Year-Old female non-pregnant patient (consumer) received second dose BNT162B2 (Solution for injection, EN5318, COVID19, Brand: Pfizer) via an unspecified route of administration in right arm on 18Feb2021 at 10:00 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (COVID19, Brand: Pfizer, Lot number: EN5318) on right arm on 28Jan2021 at 10:00 AM for COVID19 immunization. On 18Feb2021, at about 6pm, started feeling run down and not good. Took 2 Advil Liquid Gels. Woke up at about 2am and took temperature and had a fever of 100. Could only sleep off and on, had chills and fever persisted until about 7am. No covid prior vaccination and no covid tested post vaccination. Outcome of events was recovering.
On 12/29, employee began feeling a hard, cellulitisy spot on her right arm at the injection site. No pain, just a mild itch.
I have a skin rash all over my left arm and shoulder, my right shoulder and wrist, my chest and the front and back of my neck. Its a extremely itchy rash. The rash looks like small bumps under the skin . I took a 25mg Benadryl and it seems to be helping.