chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4th dose administered 3 weeks after 3rd; 4th dose administered 3 weeks after 3rd as 4th dose Dtap series and early IPV; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included PEDIARIX.   On an unknown date, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered 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: 13-SEP-2022 Reporter's Comment: The reporter reported that the patient received 4th dose of Pediarix vaccine after 3 weeks of received 3rd dose of Pediarix vaccine. The reporter stated that as a 4th dose of Dtap series it should be Infanrix vaccine and the patient received an extra dose of Hepatitis B and it was early. Additional supportive information: The patient received extra dose of Pediarix in error, which led to extra dose administered. The reporter reported that, patient administered Pediarix instead of Infanrix , which led to wrong vaccine administered. The reporter did consent to follow up.
Peri-orbital edema, tiredness. Went to ED, administered BENADRYL/steroids. Pt. fully recovered.
I was fine after I got the shot.  No pain or anything.  The next day I was light headed, had a temperature of 102, and felt total body ache.  This feeling was persistent and constant for all of the day after the shot and in the morning two days after the shot.  The symptoms then subsided and I was fine for the remainder of the day and have been fine since.
Swelling and pain in underarm where 2 sentinel lymph nodes were removed 1/17/20 and radiation late June-2020-August 2020 following chemo and Keytruda for triple negative breast cancer T1c, N0. Pain and swelling extended down left arm into forearm requiring compression sleeve. Lasted a few weeks necessitating getting a referral for PT from my Radiologist. It abated prior to may PT appointment. It was quite painful causing anxiety over possible recurrence.
sore arm at the injection site; ached all over (body ache); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm at the injection site) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A.) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm at the injection site). At the time of the report, INJECTION SITE PAIN (sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Information has been received from a corpsman concerning a 9-year-old female with no pertinent medical history or allergies who on 14-SEP-2007 was vaccinated subcutaneous with her second dose of varicella virus vaccine live (Oka/Merck) (Lot # 656576/0446U). There was no concomitant medication. On 14-SEP-2007 the patient passed out for 6-10 seconds after vaccination. The patient sought unspecified medical follow-up. Subsequently, on 14-SEP-2007 the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Patient mistakenly requested a Shingrix vaccine. Turns out it was dose #3. She reports having no adverse reaction, just a sore muscle like the first 2 doses.
Period was set to start day after I received the vaccine. It did start as usual but few days after I?m noticing I?m bleeding extra heavy. I asked the pharmacist and he said it could be an adverse effect. I?m bleeding thru super tampons and within 20 mins of changing a tampon. There?s no pain or intense cramping. There?s also no other weird side effects going on.  Maybe just bad timing, I didn?t think about getting the vaccine the same time my period was supposed to start. It was a last minute decision to get it.
pt recvd vax;w/in 3 hrs, fever,high pitched crying for 4 hrs;15mar95 MD recommended give only HIB/OPV; mom to return to ped DT on 29mar;
Patient immediately became dizzy and almost fainted. Store contact EMT. EMT arrived and documented event. Patient did not take ambulance. Currently under observation at grandparents home.
fingers hurt and tingled; hands swelled; nerve pain; arms felt heavy; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (fingers hurt and tingled), PERIPHERAL SWELLING (hands swelled), NEURALGIA (nerve pain), LIMB DISCOMFORT (arms felt heavy) and FATIGUE (fatigued) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CETIRIZINE HYDROCHLORIDE (ZYRTEK), POTASSIUM, LEVOTHYROXINE SODIUM (SYNTHROID), PREGABALIN (LYRICA), OMALIZUMAB (XOLAIR), DOXYCYCLINE and MELOXICAM for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (fingers hurt and tingled), PERIPHERAL SWELLING (hands swelled), NEURALGIA (nerve pain), LIMB DISCOMFORT (arms felt heavy) and FATIGUE (fatigued). At the time of the report, PARAESTHESIA (fingers hurt and tingled), PERIPHERAL SWELLING (hands swelled), NEURALGIA (nerve pain), LIMB DISCOMFORT (arms felt heavy) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CETIRIZINE HYDROCHLORIDE (ZYRTEK), POTASSIUM, Cingular, LEVOTHYROXINE SODIUM (SYNTHROID), PREGABALIN (LYRICA), birth control, OMALIZUMAB (XOLAIR), DOXYCYCLINE and MELOXICAM for an unknown indication. Treatment Medications were not provided by the reporter.
Severe fatigue, body aches, chest tightness, shortness of breath, difficulty breathing
dermo office body rash after I would eat, i would get it more. In certain places it would mark even more and get crusty around my eyes.  Everything was more intense on my left side of my body.
Fever started after WCC visit, Tmax 103.0 On 11/8, fever did not resolve and mother noted change in behavior and less active so they went to UC Treatments tried: Gave a fever reducer (80 mg Acetaminophen chew tablets) Warm-cool bath, cool wash cloths with temp decrease from 103-102
The day after my shot the left side of my body ached all day then on Nov 1 I woke up and had a bump in the palm of my left hand about the size of a dine. My middle finger felt like it was jammed. When I try to touch my palm by bending my middle finger I can?t. When I grip something for more than a few minutes, when I open my hand the pain level is frequently 9 or 10.
Covid19 breakthrough.  1st vaccine received on 03/12/2021.  73 y/o with PMHx of HTN, CVA, CKD, and gout presents to ED with c/o nasal congestion, cough, fatigue and fever.  Pt tested Covid + in office and was advised to the ED for increased SOB and labored breathing.  Pt febrile, placed on O2 2L NC, pt states feels better.  Treated with steroids.  Remdesivir held due to kidney fx.
Information has been received from a registered nurse concerning a 7 year old Caucasian male patient who on 1/13/99 was vaccinated (at previous doctor's office) with a dose of varicella virus vaccine live. No concomitant therapies noted on previous records. Approximately 7 months later, he developed full blown varicella described as extensive chicken pox. On 3/14/03, the patient developed chicken pox described as, a rash over a good bit of the body, breaking out in crops with red bases and vesicles. No tests were completed. It was noted that this was not a reaction to the vaccine but rather that the patient had developed chicken pox twice since vaccination and that chicken pox was going around school. It was unknown if medical attention was sought. The physician also reported on another patient. Additional information has been requested.
Began having symptoms on 12/22/2023 with runny nose. I tested with at home test on 12/22, 12/23, & 12/25. Woke up the morning of 12/26 and all symptoms had increased severely. Went to walk-in clinic, tested positive, and was prescribed PAXLOVID. After 3 doses of PAXLOVID I took a PCR test at the hospital I worked at and it was negative. Symptoms worsened and I developed an ear infection. Went to ER 3 times for ear issues and still experiencing eustachian tube disfunction. Depleted folic acid during this time also. Still experiencing chronic fatigue and hearing loss in right ear.
3/4 towards afternoon mom was changing diaper and child's fists and jaw clenched, seemed to be holding breath. Had lips turn blue. Denies tonic-clonic movements, emesis or incontinence. Lasted about 2 min, then child started to breath normally, but body was limp and he was "out of it." Post ictal state lasted prob about 1.5-2hrs. Was taken by EMS to ER.
Local reaction with swelling, erythema, induration, tenderness, increased, local temperature. Symptoms getting worst since started.
SEVERE NEEDLE/JABS ALL OVER BODY/NOT ON FACE; PRESSURE IN CHEST LIKE CALCULUS BOOKS  SITTING ON CHEST; NECK PAIN; LIGHT-HEADEDNESS; DIFFICULTY SLEEPING; STOMACH IS QUEASY; OVERALL MALAISE; SEVERE MUSCLE PAINS/COMING FROM INSIDE OF MUSCLES; NUMBNESS IN RIGHT FOOT/TWO LEFT TOES; This spontaneous report received from a patient concerned a 56 year old female. 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 not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-SEP-2021, the patient experienced severe needle/jabs all over body/not on face. On 21-SEP-2021, the patient experienced pressure in chest like calculus books sitting on chest. On 21-SEP-2021, the patient experienced neck pain. On 21-SEP-2021, the patient experienced light-headedness. On 21-SEP-2021, the patient experienced difficulty sleeping. On 21-SEP-2021, the patient experienced overall malaise. On 21-SEP-2021, the patient experienced stomach is queasy. On 21-SEP-2021, the patient experienced severe muscle pains/coming from inside of muscles. On 21-SEP-2021, the patient experienced numbness in right foot/two left toes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure in chest like calculus books sitting on chest on 23-SEP-2021, had not recovered from severe muscle pains/coming from inside of muscles, severe needle/jabs all over body/not on face, numbness in right foot/two left toes, overall malaise, neck pain, stomach is queasy, and light-headedness, and the outcome of difficulty sleeping was not reported. This report was non-serious.
Pt rec'd 1st dose of VARIVAX then at the site of injection developed 3 blisters that were very itchy followed by a red tender 3 x 4 cm patch that is tender but not warm to the touch.
On 4/20/2023, we were notified by upper management that Pfizer's monovalent vaccine was no longer authorized for use, AND that the authorization had actually ended the day PRIOR to the patient's vaccination being given. The patient experienced NO NEGATIVE ADVERSE EVENTS from the administration of this vaccine.
Caller got the vaccinations and he went to the doctor today and told him that he has Covid; Caller got the vaccinations and he went to the doctor today and told him that he has Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller got the vaccinations and he went to the doctor today and told him that he has Covid". The events "caller got the vaccinations and he went to the doctor today and told him that he has covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Clinical course: Patient was asked if this is the same as the vaccinations shot but only in a pill form. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, crying, decreased appetite and loose stools. That night fever became worse but then dissipated by morning. During the day of 01/20/2014 had a low-grade fever, continued decreased appetite and loose stools. The night of 01/20/2014 and early in the morning of 01/21/2014 fever reached 103.1 and vomiting occurred. Treated with Tylenol, cold shower, and cold compress.  Fever subsided then around 9:00 AM of 01/21/2014 noticed rash- small red dots all over back some on legs, and arms and then spreading to face and chest throughout the day. Visited doctor and was told there were some spots in the mouth as well. I was advised to continue Tylenol treatment and wait to see if fever continues or gets worse.
"I woke up itching the next morning. By the end of the day, my feet, legs, and arms were itching. The itching ended the 16th-17th. I saw a doctor on the 14th and 17th and had a shot and antibiotics and a pain reliever. My skin peeled on my legs, feet, and hands. I also took Ciprofloxacin for a UTI on the 10th and 11th.
My reaction to a vaccine was a migraine and a lot of sinus congestion. It makes it hard to breathe and I have to go to my doctor to get a prescription to clear up the sinuses I get when I take these vaccines. However with the 3rd dose, it would not go away and it triggered a sinus infection. This has been a reoccurring problem since March 4th, when I took my 2nd dose, and the sinus infections began in June.
left swollen arm; hard left arm; pain in arm at injection site; body aches; just didn't feel great; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), FEELING ABNORMAL (just didn't feel great), PERIPHERAL SWELLING (left swollen arm), MUSCLE RIGIDITY (hard left arm) and VACCINATION SITE PAIN (pain in arm at injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (body aches) and FEELING ABNORMAL (just didn't feel great). On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm at injection site). On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (left swollen arm) and MUSCLE RIGIDITY (hard left arm). On 18-Mar-2021, PAIN (body aches) and FEELING ABNORMAL (just didn't feel great) had resolved. At the time of the report, PERIPHERAL SWELLING (left swollen arm), MUSCLE RIGIDITY (hard left arm) and VACCINATION SITE PAIN (pain in arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Anxiety induced reaction to vaccine, felt heart rate / beat higher than normal, white in face, nausea, vomitting in bathroom, dizzy, requested 911, left with paramedics
Pt urinated 5-7 min after receiving GARDASIL. On his way out of bathroom became unconscious, hit head on wall, fell to ground. Brought into exam room, vitals taken, O2 administered, regained consciousness. Given water to drink and ice pack for head.
Uncontrolled shaking, extreme leg aches, headache, decreased PO intake, temp 100.1
3/25/21. awoke dizzy, unable to walk properly, phantasmic visions, headache, eventually bowel urgency (not exactly diarrhea) violent vomiting (and stress incontinence, very unusual for me), return of rapid strange mental images and rapid eye movements, and five hours completely lost, possibly sleeping, again the headache and neck ache (which might've been positional?) 3/26/21. just able to drive for a COVID test (because I work, I thought I should rule it out), eventually able to tolerate liquids, but other wise in bed all day 3/27/21. in bed all day til 4 pm, still light headed, but able to tolerate food (rice, avocado, tea) after 32-36 hours, went out to practice motion and fighting gravity/blood pressure (because going to work Sunday) 3/28/21. a bit weak still, eating simply, lightly, little - went to work (church organist, Palm Sunday), back in bed saving energy for week-day job (librarian) and planning to be better very soon
pt devel t104.4 R @ home p/vax & exp mild sz & loss of consciousness-pt drowsy;dx febrile sz react to DTP shot; adv mom to sit pt in tepid bath & sponge skin exp pulse points; adv to monitor temp & go to ER if elevated or convuls;
After second dose, I felt okay until the next day at 3:00 pm I started feeling flu-like symptoms; extremely fatigued. I was thirsty. I had a little bit of high blood pressure and high heart rate but medicine kept that in check and it's better now. Arm super sore  in the muscle where they injected and up to my armpit.  I have a follow up appt on the 12th and my doctor will re-exam me. I still havedifficult  time going to sleep and with waking up early. I am still on the new med from the first dose.
p/vax pt devel a fever of 102 & inj site rxn characterized by swelling & large bolus blisters which spread down the arm;pt hosp & treated w/ATB;pt discharged p/4 days & recovered;
Information has been received from a pediatrician's office. It was reported that four children who received a dose of Tripedia vaccine (U0583AA). All four of the pts experienced local reactions of redness and swelling. No additional info was provided. A telephone call was made to the reporter on 9/12/02, to obtain additional info on pts. Reporter stated that she does not have any specific info to identify each pt at this time. She agreed to inform manufacture when the info becomes available. See cases U2002-00697, U2002-00803, and U2002-00804, same reporter.
The evening of the vaccine, Pt developed headache and puffiness of his eyes, as well as a decrease in vision.  The following morning, his eyes were still very puffy. He was seen by his ophthalmologist 1-2 days later, who diagnosed him with corneal inflammation and keratitis. Steroid eye drops were prescribed to be instilled in both eyes qid.  He went back for a follow-up on 1/28/2021 at 9:00 am.  His eyes were worse, and he was prescribed a stronger steroid drop.  HIs ophthalmologist advised him NOT to get the 2nd dose of the COVID vaccine, which was scheduled for that same day.
Night 1-severe chills Days 2-3-4 -flu like symptoms-diarrhea Chronic diarrhea has continued to this day
About a week after injection I developed itching at the injection site along with redness and slight swelling.  Symptoms lessened over the next two days with no treatment.
Rash/irritated skin one week after injection. Warm to touch, skin feels tight. Slight itch.
Patient received Fluad vaccine on 10/17/20, she noted no pain at initial injection.  Later that evening began experiencing shooting pain radiating down her arm from the shoulder.  Stated that the condition has continued from the date of vaccination until now with no improvement.  She stated that she hsa taken advil without much benefit.
Bled down her leg; Hematoma on lower leg; Creepy; Rash on legs, hands, wrists, fingers; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers). At the time of the report, HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers) 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.   This case was linked to MOD-2021-059458 (Patient Link).; Sender's Comments: This case concerns a 62-year-old female with a serious unexpected event of hemorrhage, and nonserious unexpected hematoma, feeling abnormal and expected rash. Event onset with unknown latency after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
22APR95 2-3 hr p/vax pt ran low grade fever w/APAP q 4 hr; t103 24APR95 fever went to 105; called MD gave Motrin; went to ER given APAP & Motrin again; saw MD 25APR95; pt cries out @ noc x last 2 noc;
pain all over my body; muscles and joints pain scale a nine; muscles and joints pain scale a nine; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0181) via an unspecified route of administration in left arm on 13Jun2021 at 10:00 AM (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included depression, migraine headaches, drug hypersensitivity. Concomitant medications included Vitamin C and Vitamin D. The patient did not have covid prior vaccination. Covid was not tested post vaccination. Other vaccine in four weeks was reported as none. On 23Jun2021 at 12:00 AM, the patient experienced pain all over body, muscles and joints pain scale a nine and even on 21Jul2021 she was still in pain so saw a doctor but they did not know what to do to help her and she had never experienced this before. On 23Jun2021, the patient underwent pain assessment at a scale of nine. The events resulted in visit to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken for any of the events. The patient received bnt162b2 (Batch/Lot Number: Fa6780) via an unspecified route of administration in left arm on 10Jul2021 as dose 2, single for COVID-19 immunization and one week later experienced panic attacks and painful hot flashes, depression and pain all over. It was reported that on Jul2021, the patient was still experiencing all of these symptoms, they were all increasing. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.