chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had Pediarix injected into his left upper arm and that evening his arm started to swell. The following day his injected arm was twice the size of his other arm from swelling and the redness extended over his shoulder into his upper back all the way down to his elbow. He complained of pain and itching. We saw the doctor and was given Zyrtec (antihistamine) and Advil. Neither medicines seemed to help swelling but helped control his fever. Patient had a low grade fever 100 F. for most of the time his arm was swollen. Saturday 03.03.2012 patient complained of stomach pain and vomited twice, no other signs of illness. His arm started to decrease in swelling the day after he had vomited. Arm swelling has now, as of 03.13.2012, considerably decreased.
Patient came back the day after vaccination with a swolen uvula-had difficulty swallowing.  Took BENADRLY OTC which helped.
Fever 100.8, severe body aches, severe fatigue, rapid heart rate, high glucose level, low blood pressure, nausea. This lasted for 12 hours yesterday. Today is severe fatigue and body aches.
Patient received vaccination w/o issue. Was then ready to leave pharmacy and mother reports the pt mentioned a ringing in her ears followed by fainting. The patient, according to a bystander, hit her head when she fell. She regainded senses shortly after and complainded of a sore head, but no difficulty breathing. The patient was sit up in a chair and EMS was called at pharmacist's offer. EMS arrived and noted no abnormalitites with BP,HR, or blood sugars. Family member (aunt) reports the next day the patient is at home and with  a headache but no other problems.
Information has been received from a physician concerning a 19 year old male with no drug allergies and a history of familial risk factor (at birth, mother had positive hepatitis B surface antigen) who on 26-JUN-1990 was vaccinated with MUMPSVAX. The physician reported that the patient recently (dates not specified) tested negative for mumps titer. No problems were reported. Additional information has been requested.
An attorney alleged that a male child received 9 doses of vaccines containing thimerosal from 10/96 to 10/98. It is alleged that, as a result of the cumulative toxicity of the thimerosal contained in those vaccines, the child suffered and "in the future will continue, to suffer, from the toxic neurological effects of mercury poisoning."
Pt with shoulder pain due to incorrectly placed vaccine. Vaccine needle mark still visible at time of visit, and was injected into the subacromial space of R shoulder rather than the deltoid muscle. Pt had immediate R shoulder pain that has persisted.
This patient developed a rash 24 hours after the vaccination of Hep B #1. The rash appears to be erythema multiforme. No other complaints. She was treated with Atarax.
pt devel temp 102 on 16FEB98 followed by rash on trunk & limbs was seen by MD who felt this was side effect from vax;
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 17-SEP-2014 the patient was vaccinated with a dose of GARDASIL (lot#, dose, route were unknown, indication reported as routine). Concomitant medications were not provided. The physician reported that the patient fainted "immediately" after receiving a dose of GARDASIL. The physician reported that the patient was monitored in the office for an unspecified amount of time after fainting and then was sent home after feeling better. No treatment was given for the adverse event. No lab diagnostics studies were performed. Outcome of the event was reported as recovered on 17-SEP-2014. Additional information has been requested.
Redness is itchy; Redness is itchy , red and painful; Redness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness near injection site), VACCINATION SITE PRURITUS (Redness is itchy) and VACCINATION SITE PAIN (Redness is itchy , red and painful) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Consumer was exposed to Covid) in December 2020. Concurrent medical conditions included Drug allergy (Consumer is allergic to Lamisil.).   On 03-May-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) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness near injection site) and VACCINATION SITE PAIN (Redness is itchy , red and painful). On 05-May-2021, the patient experienced VACCINATION SITE PRURITUS (Redness is itchy). At the time of the report, VACCINATION SITE ERYTHEMA (Redness near injection site), VACCINATION SITE PRURITUS (Redness is itchy) and VACCINATION SITE PAIN (Redness is itchy , red and painful) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.
neuropathy in right leg; weakness in right leg; spot on his right leg / herpetic lesion the size is 3cm x 2 cm.; mosquito like bite; spot on his right leg; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknown date).   In December 2019, the patient received the 2nd dose of Shingrix (intramuscular). In December 2019, less than a month after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), lower extremities weakness of, herpetiform lesion, mosquito bite and rash. On an unknown date, the outcome of the peripheral neuropathy, lower extremities weakness of, herpetiform lesion, mosquito bite and rash were unknown.   It was unknown if the reporter considered the peripheral neuropathy, lower extremities weakness of, herpetiform lesion, mosquito bite and rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself. In December 2019, the patient received a dose of Shingrix on the left deltoid. In December 2019, the patient was beginning neuropathy and weakness in his right leg . The patient saw a neurologist in February 2020.  The patient had a spot on his right leg that initially looked like a mosquito bite but got worse. At the time of reporting, it was a herpetic lesion the size was 3cm by 2 cm. The reporter consented to follow up.
HEADACHE; COULD NOT SEE CLEARLY; FELT THERE WAS SOMETHING IN HIS EYE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, and wears readers. The patient experienced drug allergy when treated with methotrexate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-JUL-2021, the subject experienced could not see clearly. On 20-JUL-2021, the subject experienced felt there was something in his eye. On 21-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-JUL-2021, and had not recovered from could not see clearly, and felt there was something in his eye. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Pt reports that on 5/1/21 she had marked swelling of her right ankle only. Weight wise it seemed to be 4 pounds of water weight. Swelling has persisted until today's date. Pt physician thinks it may be a side effect of amlodipine but patient insists I report.
immed onset of pain @ inj site 10NOV94 cont (unresolved) for next 6days when pt was seen by PMD who treated for arthralgia in rt arm (shoulder/elbow) w/steroid, DepoModral shot & oral antiinflamm;
She got her vaccine, she didn't have any feelings of anything at that time.  When she came home and began her normal routines of eating dinner and getting ready for the evening hours, and later on became ill, she had fever, chills, headache, dizziness.  She had flu-like feeling, no energy, could not eat anything, weakness and not able to do anything.  Stayed in bed for the entire day and the same for the next 2 days.  She took an Advil for the headache and her arm was swollen where she had the shot.   She called the pharmacy to let them know about her reaction, and they did not say anything other than that it was just a reaction that people can get.    She has had Pfizer vaccines in the past and had no reactions to them.  She still does not have the energy that she had before, and has not been able to get out and walking like she was prior to the vaccine.
Burn ache; Joint pain; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Burn ache), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 028L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension and Seasonal allergy. Concomitant products included MONTELUKAST SODIUM, LOSARTAN and NEBIVOLOL for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Burn ache), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Burn ache), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 17-Nov-2021, the patient received third dose of Pfizer (3rd Dose) and LOT was FH8027.   On 08-Oct-2022, received fourth dose of Pfizer and LOT was GH9703.  On 29- Apr-2023, Patient had pfizer (5th Dose) and LOT was 6L2042. It was reported that Patient (Nurse) got sick from Saturday night all day yesterday, she was almost back to normal today. When paraphrased the concerned consumer stated, I am working but felt better. She was just not 100% yet. When paraphrased that consumer had fever and chills. Consumer stated, yes, burn ache and joint pain.  Patient further stated she got these reaction every time, every time she had COVID Vaccine she gotten sick.  Anatomical Location was left deltoid.  Patient took one tylenol on saturday night.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2023: Follow-up received contains no new information.
After receiving the shot, I started getting a headache within a few a hours so I ate and took 2 Tylenol (500 mg each); At 9:30p that night it escalated to a migraine (I took 1 Maxalt). My blood also went up to 137/82 (it normally runs 120/80 or lower).  I took another 5 mg of Lisinopril and laid on my left side to try to get it down. I fell asleep in that position with an ice pack on head. The next morning my blood pressure was back to normal.  By Friday, the injection site was swollen, the size of a quail egg underneath the skin, hard to the touch, and beginning to turn red..  Today I am one week out and the swelling has gone down on the outside, the "egg" is softening," but the redness continues (that wasn't there until 2 day AFTER the injection) . Also, the redness has grown to the size of a half dollar.  I called my PCP's nurse and she said it might take a couple weeks for it to go away.   I'm concerned because it to itch a couple days ago and I also don't think the redness should be getting bigger at the injection site.
felt like I had the flu for a day; This case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included shingles vaccine with an associated reaction of no adverse event (had single shot version with no problems).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza like illness. On an unknown date, the outcome of the influenza like illness was recovered/resolved.   It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group at vaccination was not reported but was captured as an adult as per vaccine indication. The patient felt like the flu for a day after vaccination. The patient already had Shingles in past and never want again. For tolerence with 2nd dose refer case US2021AMR048218.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR048218:same patient same reporter 2nd dose
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history and concomitant medications reported. On an unknown date, the patients were vaccinated with improperly stored oral, ROTATEQ orally (dose, lot# and expiration date were not reported). There were no adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
12 year old previously healthy female who presents with 4 days of fever, vomiting headache, confusion, and fatigue in context of imagining, lab, and exam findings concerning for meningitis vs. autoimmune encephalitis. Workup is still pending at the time of this report.
I had a heart attack prior to vaccination but I was fine. On the third day started having an irregular/rapid heartbeat I also noticed armpit lymph nodes and they were swollen for a while. On day 4 I had to go to ER I had strong chest pain I was given nitroglycerin which seemed to help. I also noticed I had anxiety issues. I thought it would be linked with ovulation-no test were done in urgent care. My breasts were tender and painful and that lasted more than 2 weeks from the beginning of ovulation to menstruation. After 4 months (09/2021) things went back to normal. I did miss one mensuration (11/2021).
upper arm red swollen hot itchy, resident states has felt terrible since receiving the vaccine will not get the 2nd dose, has had chills, body aches, headache, backache, was in bed for days states she would rather die than have the second vaccine still not feeling "right" to this day
I was 35 weeks pregnant at the time I received the vaccine. Estimated due date is 10/12/18. Estimated birth weight is >10 pounds if delivered at 40 weeks. Two days after receiving the vaccine, I developed a red, bumpy, itchy rash that went down the sides of my back. The rash was symmetrical. It was also on my upper arms. The following day, it was also on my lower arms and lower back and was no longer symmetrical. There were also a few bumps on my abdomen and legs. The bumps resemble insect bites. They go away after a few days and leave marks on my body, and new ones replace them. It's now a month later and new bumps are still appearing. The long term outcome is unknown since the bumps are still appearing.
2-3 patients return to the office 7-10 days after administration of VARIVAX due to a local reaction. The doctor ended up diagnosing each of those patients with cellulitis; This spontaneous report was received from a registered nurse, referring to 2 or 3 child patients between the ages of 1 to 5-years-old and unknown gender. Information regarding the patients' pertinent medical history, concomitant therapies, and previous drug reactions or allergies were unknown by the reporter.   On an unknown dates since February 2020 (reported as "over the past 6 months"), the patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (dose, vaccination scheme frequency, anatomical site of vaccination, lot number and expiration date were unknown by the reporter) as prevention of varicella.  Since February 2020 (reported as "within the past 6 months"), the reporter stated that the patients returned to the office 7 to 10 days after administration of varicella virus vaccine live (oka/merck) (VARIVAX) due to a local reaction. Subsequently, the doctor ended up diagnosing each of those patients with cellulitis and treated them with cephalexin (KEFLEX). The patients did not have any disability or incapacity due to the events, no overdose occurred, no laboratory tests were performed neither were hospitalized.  At the time of reporting, it was reported that every patients had recovered from cellulitis on an unknown dates in 2020. The causal relationship between the above-mentioned event and the varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.  Upon internal review, the event cellulitis was considered to be medically significant.  This was one of two reports received from the same reporter.  As of 06-AUG-2020, a telephone attempt trying to obtain additional information has been unsuccessful.; Sender's Comments:  US-009507513-2008USA003129:
administration date: dose 2: 21Jan2021, dose1: 14Jan2021; Lateral left breast simple cyst and simple cyst cluster, benign; This is a spontaneous report received from a contactable consumer (patient). A 44-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EK9231), via an unspecified route of administration in left arm on 21Jan2021 at 10:30 as second dose, single (age at vaccination was 44 years) for COVID-19 immunization. Medical history included nickel topical allergy. Concomitant medication included valacyclovir [VALACICLOVIR], received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EK 9231) via an unspecified route of administration in left deltoid on 14Jan2021 as first dose, single for COVID-19 immunization and experienced lateral left breast simple cyst and simple cyst cluster, benign. Patient received second dose on 21Jan2021 and first dose on 14Jan2021. On 02Feb2021, the patient experienced lateral left breast simple cyst and simple cyst cluster, benign. The patient underwent lab tests and procedures which included mammogram on 19Jan2021 and showed impression: lateral left breast asymmetries-CC view only. Assessment: BI-RADS assessment category 0- incomplete: need additional imaging evaluation; recommendation: left diagnostic mammogram. Targeted ultrasound if needed. The patient had another mammogram on 02Feb2021 and showed impression: Lateral left breast simple cyst and simple cyst cluster, benign-accounting for the mammographic appearance. BI-RADS assessment category 2 benign. The event resulted doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event lateral left breast simple cyst and simple cyst cluster, benign was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Birth weight (g): 4054/Large for gestational age; Foetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 02-Jul-2019, concerning a male neonate patient.  The patient's mother was a 29-year-old female of height 64 inches, body weight 142 lbs and body mass index (BMI): 24.4. The patient's mother did not have previous pregnancies. On an unknown date, the patient's mother family history of major congenital malformation was collected, and the patient's mother had no maternal or paternal history with major congenital malformations. The patient's mother concomitant medications included Prenatal vitamin (minerals NOS and vitamins NOS) for pregnancy.  The patient's mother last menstrual period (LMP) date was 11-Sep-2018. The type of pregnancy was singleton. The patient's mother did not consume tobacco, alcohol or illicit-drugs during pregnancy.  On 17-Oct-2018, the patient's mother underwent Hgb (haemoglobin) electrophoresis, spinal muscular atrophy screening, fibrosis mutation analysis and no major congenital malformations were noted.   On 29-Oct-2018, at gestational age of approximately 6 weeks, the patient was exposed to Flucelvax QIVc(influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252664, route of administration: transplacental, dose, anatomical location and expiry date: not reported) (explicitly coded as fetal exposure during pregnancy) for an unknown indication.   On the same day, after vaccination, the patient's mother was noted to have acne and was treated with Clindagel (clindamycin phosphate, rn, topically, from 29-Oct-2018 to 08-Dec-2018) for acne.   On 30-Oct-2018, the patient's mother had undergone ultrasound scanning and no major congenital malformations were noted.   On 25-Jun-2019, at gestational age of 41 weeks, live normal male patient was delivered via vaginal delivery and no pregnancy complications were noted. The birth weight of the foetus was 4054 grams (explicitly coded as large for gestational age), head circumference was 36.2 cm and length was 54.6 cm. Appearance, pulse, grimace, activity and respiration (APGAR) score at one minute was 8, at five minutes was 9 and no data was reported for APGAR score at ten minutes. No major congenital malformation was identified at birth.  The patient's mother estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were reported as 18-Jun-2019.  This case is linked to a case 201904082 (mother case).; Reporter's Comments: A male neonate patient was diagnosed with large for gestational age (LGA) at birth, after maternal receipt of Flucelvax QIVc vaccine at approximately 6 weeks of gestation (considered as foetal exposure during pregnancy). The known aetiologies of LGA includes genetic, increased maternal weight gain during pregnancy and maternal gestational diabetes. Considering the lack of biological evidence associated with suspect vaccine, the causality of event LGA assessed as not related. The event foetal exposure during pregnancy assessed as not related considering the intended use of vaccine. The company assessed the case as serious (medically significant).