chrisvoncsefalvay/vaers-outcomes huggingface dataset:
08/04/2021: Reported to ER via EMS for nausea, weakness, shortness of breath x 1 week prior to admission. Patient positive for fever, decreased breath sounds, tachypnea, with pneumonia secondary to COVID infection. 08/05/2021-08/08/2021: Continued above symptoms with little improvement. Stable on oxygen.  08/09/2021: Blood pressure elevated to 182/77 overnight and lowered with clonidine. Patient discharged on oxygen.
Loss of appetite; Forceful Vomitting; Diarrhea; Nausea; very tired; fever; headache/headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), SELF-INDUCED VOMITING (Forceful Vomitting), DIARRHOEA (Diarrhea), PYREXIA (fever) and HEADACHE (headache/headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache/headache). On 06-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), SELF-INDUCED VOMITING (Forceful Vomitting), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and FATIGUE (very tired). On 03-Feb-2021, PYREXIA (fever) had resolved. On 06-Feb-2021, SELF-INDUCED VOMITING (Forceful Vomitting) and DIARRHOEA (Diarrhea) had resolved. On 07-Feb-2021, DECREASED APPETITE (Loss of appetite), HEADACHE (headache/headache) and NAUSEA (Nausea) had resolved. At the time of the report, FATIGUE (very tired) had not resolved.            No concomitant and treatment drugs were reported. The action taken with the drug was Not applicable.
This spontaneous report was received from a nurse regarding to a 5 years old male patient. The patient's had no concomitant medications and no pertinent medical history. The patient had no known history of allergic reaction to vaccination but the he presented allergy to egg. On 10-SEP-2018, the patient was vaccinated with VAQTA, intramuscular way, in the right deltoid, lot # R013858 with expiration date 12-JUN-2019 (dose and frequency were not provided) as normal vaccines given for well child exam. On the same date, 40 minutes after, it was reported that the patient disseminated hives on his arms, legs and trunk (urticaria). The patient's mother had the patient in a cool tub and gave him 12.5mg of BENADRYL. It was also reported that the patient had no oral airway involvement. No laboratories and studies were performed to the patient. No product quality complaint was involved. At the reporting time, it was unknown if the patient recovered from the hives on his arms, legs and trunk (urticaria). The causal assessment between the aforementioned event with VAQTA was not provided.
Patient has a history of advanced melanoma with brain metastasis. He developed seizure disorder as well and had some mild seizures at home over the prior month. He received the vaccine at 4pm and was monitored in the office for 15 minutes. He then went home with his daughter whom he lives with. He ate dinner with her and read until 8pm when he went to his room. She found him in his room at 9pm unresponsive with seizures. Hospice was alerted and recommend oral valium. He continued to be unresponsive and expired the following day at 7:30 pm.
Erythema nodosum on legs and one spot on one arm. No other causes identified.
double pneumonia; Also suffered an outbreak of herpes zoster and cellulitis of her face resulting in facial swelling, severe pain, ear problems and medical treatment; Also suffered an outbreak of herpes zoster and cellulitis of her face resulting in facial swelling, severe pain, ear problems and medical treatment; ear problems; swelling of her lower extremities; edema; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 03-JUN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (the dosage regimen information was not reported). In December 2016 (also reported as "shortly thereafter"), the patient was diagnosed with double pneumonia, which was caused by the zoster vaccine live (ZOSTAVAX) vaccine, resulting in her hospitalization (unknown dates). As a result of zoster vaccine live (ZOSTAVAX), the patient also suffered an outbreak of herpes zoster and cellulitis of her face resulting in facial swelling, severe pain, ear problems and medical treatment. Since zoster vaccine live (ZOSTAVAX) vaccination, the patient suffered swelling of her lower extremities and edema that continued at the time of the report. As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. The outcome of the events was considered as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX). The adverse events were considered to be disabling as the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and inability to work.  Upon internal review, pneumonia and cellulitis were considered to be medically significant.
Pt. called MD on 10/29/09 @ 4pm with c/o generalized itching. Denies SOB or other symptoms. Instructed to take BENADRYL and call MD if any other symptoms occurs.
noticed facial rash 18JAN97 which spread to torso & then extremities;20JAN97 seen by MD;exanthem-gen rash, facial area torso-extremities;viral rash;tx DPH for rash;felt feverish;rash described as flat red, then few that had some fluid;
No adverse effects reported; a patient received their first dose of GARDASIL 9 at 14 years of age. The patient came back to the office and received a second dose of GARDASIL 9 at 16 years old.; This spontaneous report was received from a registered nurse referring to a 16-year-old female patient. Her pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.   On an unspecified date in 2019  and in 2021 (reported as "at 14 and 16 years of age respectively"), the patient was vaccinated with the first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), administered as prophylaxis (dose regimen, route of administration, lot number and expiration date were not reported) (Inappropriate schedule of product administration)..
PFIZER COVID VAC 0.3ML - Chest pain, left arm went numb, unexplainable nervousness, distraught, fatigued, disorientated and panic attack(s) with heart palpitations that resulted in an ER visit.
headache, chills, weakness, nausea the day after - progressed to severe abdominal pain, vomiting bile, bloody diarrhea on day 2.
Patient received MMR #2 on 5-26-11 at 1:00pm. Mom states patient started sneezing repeatedly at 1:45pm, after leaving the office. Mom states EMS activated, EPIPEN administered & BENADRYL given at 2:00pm due to s/s of anaphyl. widespread hives, SOB, cough, (R) ear, lip edema.
I received the vaccine on 12/29 at about 2:15pm. I had a sore left arm after shot which awoke me at 2am. I also work up due to fever (temp 100.1 ), chills, and myalgia. I had a lot of trouble sleeping that night and got very little rest as unable to get comfortable. The next day I still had fever, chills, myalgia, nausea, joint pain, low back pain, fatigue and headache (felt similar to prior bad flu symptoms). I was sent home from work early as symptoms continued throughout the day with a little relief from a 500mg of acetaminophen. The following day 12/31 symptoms were gone except for the left sore arm which was improving and now completely done on 1/3.
Pt was seen in office at 10:30AM for a diabetic follow up and given flu shot. Her Levemir was also increased. She then left office and ate breakfast (bacon, egg and cheese). She noted some nausea and vomited once at 3pm. She also reported shaking chills at that time as well. Felt better after vomiting.
Left chest pain; Difficulty breathing; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 22Jan2021 (15:30 )at single dose for Covid-19 immunization. There was no medical history. Concomitant medications included Flu shot (reported as other vaccine in 4 weeks) 1 dose on 08Jan2021.The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. On 24Jan2021 (12:00 PM), the patient experienced left chest pain and difficulty breathing. There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.  Information about lot/batch no has been requested.
patient with hx of thrombocytopenia received vaccine and presented to hospital with thrombocytopenia with platelet count of 6
Rash to arms hands feet itching that started 1.5-2 days after receiving the flu vaccine.
head felt like it would explode; sinuses were stuffy; 103 degree F temperature; tired; whole body hurt; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head felt like it would explode), NASAL CONGESTION (sinuses were stuffy), PYREXIA (103 degree F temperature), FATIGUE (tired) and MYALGIA (whole body hurt) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced HEAD DISCOMFORT (head felt like it would explode), NASAL CONGESTION (sinuses were stuffy), PYREXIA (103 degree F temperature), FATIGUE (tired) and MYALGIA (whole body hurt). At the time of the report, HEAD DISCOMFORT (head felt like it would explode), NASAL CONGESTION (sinuses were stuffy), PYREXIA (103 degree F temperature), FATIGUE (tired) and MYALGIA (whole body hurt) outcome was unknown.            No Concomitant medication was reported. No treatment medication was reported.
On August 25th, patient began to have pain and weakness in his left arm. I gave him some Motrin but later on that same evening he could not walk to the bathroom without help. The next day, Aug. 26th, he was able to walk on his own until about 4pm and then had the paralysis again. Each day he would be able to walk for the first part of the day but by around 2pm he would be too weak and we would have to carry him. He complained of should pain, ankle pain, knee pain, elbow pain, etc. The pain and weakness would move around from one joint to the other and from one side to the other. We saw Dr. on 8/28/08 and had an x-ray of his ankle done. Results were unremarkable. On 8/30/08 we took him to Urgent Care and additional x-rays were done. Once again, unremarkable. On 9/1/08, we took him to Dr. who diagnosed him with a virus that attacks his joints. He said it would go away within two weeks and it did. He slowly regained his strength and was back to mostly normal activity by 9/3/08. I now suspect Guillain Barre Syndrome brought on by the vaccinations.
Reports she received 2nd dose of Moderna Covid-19 vaccine Lot #012L20A on 1/26/21 at 7:58 AM. Reports around 10 PM that evening, she developed chills (without fever), headache, body aches, nausea, sneezing, runny nose. Self managed with Ibuprofen 600mg. On 1/27/21, contacted Covid line and was directed to get tested and quarantine at home. Test result was negative. 1/28/21, developed a fever 100.8F and large swollen, painful left axillary lymph node. Contacted the Covid line a second time and was advised to continue quarantine and get retested since fever emerged. Second swab was negative. Reports symptoms self resolved except swollen lymph node. Plans to self monitor. D/c from Center.
Joint pain in the arm vaccine was given. Patient has taken ibuprofen 400mg with little to no relief. This has occurred starting 1 week after vaccine, and has not resolved (now longer than 1 month after vaccine).
4-5 days after vaccination, patient reports 5 day episode of indigestion, headache, nausea, sweating, shaking, body aches. Denies rash.
Within minutes of receiving the 2nd dose, I experienced a burning sensation in my right eye.  Within a couple days a twitch around the eye developed.  This eye twitch continued and I saw an optometrist and was prescribed eye drops.  Followed the course of eye drops as prescribed.  The twitch has mostly gone away, but still persists.
Information has been received from a health professional concerning an adult patient who, in the last month, in approximately October 2005, was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P). In approximately October 2005, in the last 30 days, the patient experienced cellulitis at the injection site and was treated in the hospital with IV antibiotics, recovered and was released. It was noted that the patient recovered within 3-7 days post vaccination. It was also noted that this was a revaccination and the patient had at least one and possibly as many as 6 prior vaccinations before this dose. No product quality complaint was involved. Cellulitis at injection site was considered to be an other important medical event (OMIC), immediately life-threatening, and disabling by the reporter. Additional information has been requested.
Nausea, headache, body aches, fever - site warm, red, hard and painful. Also stiffness neck.
Feelings of weakness/Felt weak; Cold symptoms/Symptoms similar to cold; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feelings of weakness/Felt weak) and NASOPHARYNGITIS (Cold symptoms/Symptoms similar to cold) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced ASTHENIA (Feelings of weakness/Felt weak) and NASOPHARYNGITIS (Cold symptoms/Symptoms similar to cold). At the time of the report, ASTHENIA (Feelings of weakness/Felt weak) was resolving and NASOPHARYNGITIS (Cold symptoms/Symptoms similar to cold) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of asthenia and nasopharyngitis with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt had a positive COVID test on 10/11/21 at local clinic; 10/20/21 pt to ED with fevers, aches, coughing, fatigue, increasing SOB; COVID pneumonia; Hypoxic Respiratory Failure; given ABX, dexamethasone, O2 supplementation; transferred to CCU; worsening respiratory status; intubated; condition worsened; poor prognosis; DNR; pt passed away in the hospital
Information has been received from a registered nurse concerning a male child who on 28-APR-2010 was vaccinated with a dose of ROTATEQ. On 01-MAY-2010 the patient's mother called the office stating that her child had very mucousy stools. It was reported that the patient's mother was breast feeding and there had been some dietary changes to dairy free. On 01-MAY-2010 the patient was placed on a soy formula but mucousy stools continued. At the time of the report, the patient was on "ALIMENTUM" formula and had not recovered. Additional information has been requested.
Information has been received from a health professional concerning an 8 year old male who on 12-MAR-1999 was vaccinated with a first 0.5 ml dose in the right arm of Varivax (Lot# 627337/1057H). There was no concomitant medication. On 11-AUG-2006 the patient experienced rash on his back with less than 50 lesions. The patient had no fever and recovered completely by 14-AUG-2006. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
Bruising on injection site, black and blue, left arm immobile due to severe swelling, pain in the injection site, sniffles .
pt recv vax & 10min later stood to put on coat & saw white & fell backwards;pt pale w/resp;eyes deviated to rt w/chin then eyes rolling back;unresponsive;eyes midline & blank stare;
Patient reports eating supper 10/5/05 and "feeling funny" stood up-passed out/vomited up to. Went to ER vitals within normal limits. Saw PCP 10-6-05 has large area on right upper arm from elbow to shoulder. Red hot-edematous-PCP instr. pt to take Benadryl and prescribed antibiotic.
FLU LIKE SYMPTOMS FOR 3 DAYS FEVER OF 100.5 BY MOUTH, PALPITATIONS, STOMACH PAINS, NOT ABLE TO EAT, STILL VERY WEAK AFTER 4 DAYS COULD NOT GO OUT AS I FELT VERY SICK.
HSV C4 distribution on Left starting 4 days after receiving Zostavax vaccine.
This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (missed the second dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product dose omission issue (missed the second dose). At the time of the report, product dose omission issue (missed the second dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medication and treatment information not reported.
Large local reaction: up to 7 cm induration with erythema, ecchymosis, pain and tenderness. 3.5 cm induration and erythema when examined 7 days after vaccination, incidental to medical followup of other problems.
Rash at site of injection 2 in x 4 1/2" M.D. called in Rx of Cephalexin 500mg 3/21/2014.
Patient was mistakenly giving her second dose of the Moderna COVID vaccine on day 19 instead of day 28. Patient has been contacted and states that she is feeling "worn down" but no more so than after her first dose. Will continue to monitor for any other symptoms.
Patient received Pneum 23 vaccine earlier today. Returned to office with adverse site reaction- erythema, warmth, swelling. No SOB/difficulty breathing. Afebrile. Site inspected, consistent w localized reaction. Advised to take 1-2 tabs of BENADRYL 25mg every 6 hours as needed, TYLENOL 500mg 1-2 tabs PRN for pain control, ice area, as well as topical hydrocortisone 1% cream. If reaction worsens, there is any trouble breathing or increased swelling-- go to ER or urgent care. Patient in agreement w plan and satisfied w care provided.
Chief Complaint Patient presents with o Rash  HPI  16 yo female with PMH significant for Addison's Ds under the care of endocrinology, takes fludrocortisone and hydrocortisone.  Noted hypothyroid.  Denies other significant health issues.  She presented to Urgent Care with new onset anular rash that began on flexor forearms and anterior thighs.  Progressed to hands and feet including palms and soles.  Few lesions noted on bilateral legs and lower abdomen.  Mom notes new peri-oral lesions including external lip involvement. No recent fever, chills, viral prodrome.  No known viral illness.  Travel ~ 1 month ago.  No noted insect or tick bite.  No n/v or diarrhea.  No blood in stool.  No hematuria.  No history of STD or STD exposure.  No reported pharyngitis.   No recent change in medication aside from stress doses hydrocortisone recommended and begun today by endocrinologist.  No antibiotics, no anticonvulsants
pt recv vax 10SEP97 & devel small hard lump up in 1wk-lump remained-late MAY-early June-noticed lump was red & tender;saw MD surgically removed on 6JUL98;
Continuous and uncontrollable body shaking Low grade fever Fatigue Dry mouth Nausea
(1) Swelling at injection site (2) warm to touch (3) mother gave patient BENADRYL (4) hives
TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
A report has been received from a Health Professional, mother of the patient concerning a 5 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT started on 29-Dec-2015. It was reported that FLUMIST was administered to patient in first week of Oct and then again on 29-Dec-2015. MD's office reported not having documentation of first administration of FLUMIST in Oct. This information was considered as FLUMIST administered twice. FLUMIST QUADRIVALENT was continued. The outcome of the event of FLUMIST administered twice is unknown. The report was considered to be non-serious.
No additional AE reported; HCP reported VARIVAX was administered after a temperature excursion to a patient.; This spontaneous report has been received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 02-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot number: W011625, expiration date 06-APR-2024; strength, dose, and route of administration were not reported) was administered to the patient once after a temperature excursion of -8.1 Celsius degree for 1 hour and 58 minutes (product storage error). There was no previous temperature excursion. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA002433: US-009507513-2208USA002443: US-009507513-2208USA002739: US-009507513-2208USA003187:
Information has been received from a consumer concerning his wife, who on 28-SEP-2007 was vaccinated with ZOSTAVAX.  That evening (28-SEP-2007), she developed itching.  Medical treatment sought by the patient was not specified.  By the next day (29-SEP-2007), the itching had resolved.  A product quality complaint was not reported.  This is one of two cases from the same source.  Additional information has been requested.
Employee received Hep B vaccine (1st shot) in 05/31/07, 0830am complain of sore throat since 430pm 05/31/07. Seem to get worse overnight. No temp increased, no redness or inflammation at injection site. Doctor notified 0830 06/01/07.