chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy; little raised bump on her arm at the injection site, 15 days after the first dose; yellowish color, like a healing black and blue bruise; around the bump there is a 2-inch light pink rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), MASS (little raised bump on her arm at the injection site, 15 days after the first dose), CONTUSION (yellowish color, like a healing black and blue bruise) and RASH (around the bump there is a 2-inch light pink rash) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (itchy), MASS (little raised bump on her arm at the injection site, 15 days after the first dose), CONTUSION (yellowish color, like a healing black and blue bruise) and RASH (around the bump there is a 2-inch light pink rash). At the time of the report, PRURITUS (itchy), MASS (little raised bump on her arm at the injection site, 15 days after the first dose), CONTUSION (yellowish color, like a healing black and blue bruise) and RASH (around the bump there is a 2-inch light pink rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Flushing Elevated BP @1254   BP152/95, P93, R20, T98.3, Spo2 99%RA Nausea
flush; fast heartbeat (120bpm); rash; nausea; dizzy, lightheaded; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient (pregnant: no) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration at arm left on 19Dec2020 11:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included celecoxib (CELEXA), ethinylestradiol and etonogestrel (NUVARING) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefalexin(KEFLEX) and cefdinir(OMNICEF) and experienced allergies. The patient experienced flush, fast heartbeat (120bpm), rash, nausea, dizzy, lightheaded, feeling unwell on 19Dec2020 12:00 PM, the events resulted in emergency room/department or urgent care. Treatment of Benadryl received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Dec2020.  Information on the lot/Batch number has been requested.
Vaccine breakthrough infection; COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) and COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) and COVID-19 (COVID-19) to be related.    Results shown that vaccine breakthrough infections are overrepresented by antibody-resistant SARS-CoV-2 variants, and that symptomatic breakthrough infections may be as efficient in spreading COVID-19 as unvaccinated infections, regardless of the infecting lineage.  Concomitant, treatment medication information were not reported.  This is a literature-non-study case  concerning  a  patient of unknown age and gender with no reported medical history, who experienced the unexpected serious events of Vaccine breakthrough infection and Covid-19 as an added event. The events occurred on an unknown date after the unspecified dose of mRNA-1273 COVID 19 Vaccine. It was noted that Differences in viral loads were non-significant.  Vaccine breakthrough infections are overrepresented by antibody-resistant SARS-CoV-2 variants. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-491379, MOD-2022-491472, MOD-2022-491473, MOD-2022-491474, MOD-2022-491475, MOD-2022-491476, MOD-2022-491477, MOD-2022-491478, MOD-2022-491479, MOD-2022-491480, MOD-2022-491481 (Patient Link).; Sender's Comments: This is a literature-non-study case  concerning  a  patient of unknown age and gender with no reported medical history, who experienced the unexpected serious events of Vaccine breakthrough infection and Covid-19 as an added event. The events occurred on an unknown date after the unspecified dose of mRNA-1273 COVID 19 Vaccine. It was noted that Differences in viral loads were non-significant.  Vaccine breakthrough infections are overrepresented by antibody-resistant SARS-CoV-2 variants. The events outcome were unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
dose of boostrix to a patient on 8/9/2022, last dose of tdap was on OCT 2021.; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   Previously administered products included Tdap vaccine (Last dose of Tdap vaccine received on October 2021).   On 9th August 2022, the patient received the 2nd dose of Boostrix. On 9th August 2022, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.      Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comment: The reporter was a healthcare professional. The reporter stated that on the day of reporting healthcare professional administered Boostrix vaccine to the patient. The reporter wanted any data. The reporter consented to follow up. Additional supportive information: The patient received Boostrix vaccine early than recommended time frame, which led to shortening of vaccinations schedule.
Feeling sick for the last 5 weeks with elevated body temp/heat , pressure especially on the left side of the head with lack of appetite and constant ringing in the left ear , symptoms on some days are milder but always coming back ...
Child vomitted on pillow in the middle of night, early morning started complaining of stomach ache.  Next day, child still complained of stomach ache then complained of back ache.  Took child to the doctor on Monday, 10/19, doctor diagnosed stomach pain due to constipation prescribed enema and laxative.  Treatment administered but child still complaining of stomach pain, back pain and as of 10/20, knee pain on left knee.
Patient presented to ED on 4/1/21 and was subsequently hospitalized; within 6 weeks of receiving COVID vaccination.
did not receive the second dose because of COVID precautions; This case was reported by a pharmacist and described the occurrence of social problem in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on 28th December 2019.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follow: The case was reported by a pharmacist. The patient did not receive the second dose due to COVID precaution which led to social problem. The pharmacist did not provide lot number and expiration date of first dose of Shingrix. No further information was provided. The reporter consented to follow up.
The Flublok indicated for ages 18 and older was given to a 15 year old. the child is experiencing severe abdominal pains, arm pain and fever
104 fever first 3 days  day 4/5 swollen arm now joint pain , elbows ,, wrists ,, fingers ,, ankles and toes
Information has been received from a registered nurse (R.N.) concerning a 40 year old female with hypothyroidism, hypercholesterolaemia and drug reactions/allergies to codeine and COMPAZINE. On 18-NOV-2008 the lab test results revealed varicella titer was 0.82 and rubeola titer was negative. On 22-MAY-2009 the patient was vaccinated SC with a 0.5 ml dose of VARIVAX (Merck) (lot # 658967/1521U) in the right arm. Concomitant suspect therapy included a dose of MMR II (rHA) (lot # 663106/1507X) given in the left arm on the same day. Other concomitant therapy included oral contraceptive, ALIGN, thyroid medication, pravastatin Na, LEXAPRO, vitamin B complex and ESTER-C. Prior to receiving the vaccines she complained of a low grade of fever, allergies and a sore throat. The nurse reported that the patient developed lesions in her throat after vaccination. On 26-May-2009, "four days after receiving the vaccines", the patient experienced a fever of 100F-101F, sore throat, difficulty swallowing and achiness. She was examined in the office by her physician who reported she had pharyngeal lesions. Unspecified medical attention was sought. At the time of this report, the patient's symptoms persisted. Follow-up information received from another registered nurse (R.N.) reported the 40 year old female with hypothyroidism, hypercholesterolaemia and seasonal/environmental allergies and sore throat at time of vaccination. On 22-MAY-2009 the patient was vaccinated SC with the first 0.5 ml dose of VARIVAX (Merck) (lot # 658967/1521U) in the right arm. Concomitant suspect therapy included the first dose of MMR II (rHA) (lot # 663106/1507X) given in the left arm on the same day. On 24-MAY-2009 the patient complained with a sore throat. On 26-MAY-2009 she had a fever of 100.6 F and sore throat. She was evaluated by her physician. On approximately 29-MAY-2009 she developed lesions in her throat and mouth. She also had a small amount of lesions around the injection site. It was reported that on 01-JUN-2009 the patient recovered from these events. Additional information is not expected.
Received shot and as soon as I was given the shot, my throat started closing. They shot me with an epipen twice and told me to take my inhaler. I also took Benadryl. They also gave me 50mg steroid for a week. I am also on oxygen; Loss of memory.
Migraine headache; A spontaneous report was received from a consumer concerning a 29-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced migraine headache.  The patient's medical history included migraine since she was a teenager. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) for prophylaxis of COVID-19 infection.  On 28 Jan 20213-4 hours after the shot, the patient experienced headaches. It was worse the second day despite taking paracetamol and ibuprofen. She was eventually sent home from work because she couldn't function. The patient sought for medical intervention from her neurologist. Doctor prescribed her a migraine headache medicine but her prescription medication was not helping her headaches.  Treatment details included paracetamol and ibuprofen initially and then later her doctor prescribed her a migraine headache medicine.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event migraine headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of migraine, a causal relationship cannot be excluded.  However, patient's medical history of migraine is considered a significant confounder.
Received DTaP on Monday 5/13/02. Little red mark, size of quarter that night. Tuesday morning same, Tuesday night-parent noticed leg swollen from knee up. Looks the same today. Giving child Benadryl's (children) liquid and Benadryl cream 05/20/02-leg normal size, everything-ok.
No adverse reaction noted on patient.  The facility "over vaccinated" the toddler due to incorrectly chart-prepping  and review of ALL medical records prior to patient coming into the office and receiving vaccines. This had been over-looked by the MA working up this toddler and the Provider that day. Family never voiced any concerns at the time the vaccines were reviewed by the Provider and agency.
Night sweats, chills, muscle pain in legs, aching, headache, feeling rundown, throat was sore as well
No additional AE reported; Caller is a HCP calling to report a TE for PNEUMOVAX 23. During the evaluation the customer reported that the PNEUMOVAX 23 was administered to the patient after the excursion occured. Additional AE filed in  02190216, 02190130, 02190106, 02190106, 02; This spontaneous report has been received from a nurse referring a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies.  On 03-MAR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number U021995, expiration date on 13-JAN-2023 for prophylaxis (strength, formulation, dose, frequency, and route of administration were not reported) that underwent a temperature excursion of 0.3 Celsius grades in 24 hours (product storage error). No additional adverse events were reported.  The outcome of the event was not reported. ; Sender's Comments:  US-009507513-2206USA006770: US-009507513-2206USA006587: US-009507513-2206USA007098: US-009507513-2206USA007068:
arm has been a little sore around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm has been a little sore around the site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm has been a little sore around the site). At the time of the report, VACCINATION SITE PAIN (arm has been a little sore around the site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of the event was not reported.
Immediate soreness, ~5x6 cm area of erythema, induration, exquisite tenderness to palpation.
Hearing Loss (within 2 weeks) Stroke (within 3 months) Seizures (within 3 months) Arterial Dissection (within 3 months)
Spasm and jerking of right extremity followed by eye movements to the right. Sustained for few seconds then tonic/clonic convulsions of entire body.
This spontaneous report as received from the registered nurse refers to an unspecified number of patients of unknown gender and age. Information about the patients medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of COMVAX (dose, dose number, lot/batch# and expiration dates were not reported) after being improperly stored. Information about concomitant medications were not provided. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information is not expected as no consent for contact was given.
I had a reaction to the first dose, which including mild fever, severe fatigue, itching, swelling and pain at injection site, that last approx 5 days. Withing 3 weeks of my second dise, I broke out in a severe rash that was so painful, I had difficulty sleeping. When I told the dermatologist the date of my 2bd dose, he suspected the possibility of lupus, based on family history and symptoms. My internist agreed, a biopsy and other labs were done, and Systemic Lupus Erythematosus was confirmed. I have been ill since the onset of the rash. I have started medication, and I'm told I will need immunosuppressive drugs.
Lot # 053E21A was administered outside the 30-day Use by Date. A case was opened with Moderna ID.  "The vaccine administered maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration."
Left arm goes numb at times.  More often in left thumb and index finger.  It feels like when your arm falls asleep and then starts to wake up.  Tingling feeling but NO pain or discomfort.
little on my back then scratch marks; little rash on lower back; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (little on my back then scratch marks) and RASH (little rash on lower back) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced SCRATCH (little on my back then scratch marks) and RASH (little rash on lower back). At the time of the report, SCRATCH (little on my back then scratch marks) and RASH (little rash on lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (0.65 ml, once, lot# K018176, expired date 10-JAN-2016; lot# L003218, expired date 30-MAR-2016) subcutaneously. No concomitant medication was reported. No adverse events were reported after improperly stored ZOSTAVAX was administered. Additional information has been requested.
Tinnitus worsened dramatically within 24 hours after getting boosted. I have had middle ear myoclonus (objective tinnitus - clicking left ear) intermittently since Fall 2019. Mostly at night during hours of sleep, only a minor annoyance.  The morning after I got boosted, the tinnitus remained during the day, and MUCH MORE FORCEFULLY AND ALMOST CONTINUALLY.  I scheduled an appointment with an otologist April 25. He recommended I have an MRI - brain & external ear canal, done May 3, normal. I have followed up with the otologist who prescribed medication (Nortriptyline) which has not reduced the tinnitus. In fact it has continued to worsen.
3 -4 hrs after vaccine - pain down arm and up neck, headache, chills and then feverish, restless night am. headache and hoarseness, dizzy with position change - did not take any meds or temp.
Info has been received from a health professional concerning a 6 year old black male with asthma, who on 7/12/00 was vaccinated, SC, in the left arm with a 0.5 mL first dose of varicella virus vaccine live (lot 632276/1454J). Concomitant vaccination included a 3rd dose of Hep-B virus vaccine rHBsAg (yeast) (lot 635516/0426K) given, IM, in the right thigh and a 3rd dose of (IPOL) (lot R0444) given, SC, in the right thigh. Concomitant therapy included fluticasone propionate (Flovent). On 11/1/05, the pt developed fine bumps which were dx'd as chickenpox. It was reported that the rash involved 25 lesions. Unspecified medical attention on was sought. Subsequently, the pt recovered. There was no product quality complaint involved. No further info is available.
After 36 hours, I began breaking out in hives starting near the back of my left underarm and back of right underarm. Over the course of a few days, hives spread to chest, back, BUE, BLE and abdomen. Severe itching continued for three weeks.
p/vax pt exp a balancing problem, tinnitus & 50% hearing loss;
Fatigue with second COVID vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of Covid-19 vaccine (unspecified trade name or manufacture) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The patient experienced fatigue with second COVID vaccine on an unspecified date with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Immediately and for the first 15 or 20 minutes the site of the injection burned, like a bee sting the whole 15 or 20 minutes.  Then as that passed, my throat began to itch and inside my ears became itchy, then after about 5 minutes or so my tongue started to tingle on the front end and felt thicker at the back. After a total of 20 minutes or so after this started I was home and took a Benadryl, which helped, however after a few hours my face started itching, no rash just an itch and it is still itching after 5 days. It seems to be getting better every day.  It was definitely a similar type of reaction I get from raw pitted fruits.
Information has been received from a consumer concerning "thousands of children" some as young 9 years old or 10 years old, who on unspecified dates were vaccinated with a dose of GARDASIL (lot #, dose and route not reported). The consumer reported that on an unspecified date thousands of children were sending reports to her website about the following side effects, vomiting, weight loss, inability to eat anything with gluten, sugar, preservatives or carbohydrates, numbness in their feet, in bed for months and toxic level of aluminum. At the time of this report the patients had not recovered. This is one of several reports received from the same source. Vomiting, weight loss, could not eat anything with gluten, sugar, preservatives or carbohydrates, numbness in their feet, in bed for months and toxic level of aluminum were considered to be disabling and immediately life-threatening. Attempts to validate the identity of the patients are not possible. Additional information is not expected.