chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Baby had acute onset of a erythematous masculopaular rash without vesiculation.  Rash is on torso, extremities, face and neck.  10 days after Vavicella & MMR.
High fever, (103°), headache, dizziness, pain in left side of body, shakiness, fever, chills,
[I'm reporting a "breakthrough" COVID-19 infection with this form after speaking with a CDC representative on the phone about my latest V-Safe submission. I'm also describing some post-acute symptoms I've experienced. To be clear, I do not associate any of these symptoms with my vaccination itself.]  On September 21, I received a positive test result for COVID-19. I was experiencing a fever, loss of smell, cough, and congestion, which prompted me to get tested. During my isolation period I treated symptoms with DayQuil and ibuprofen. On the 25th, most symptoms were resolved, but I experienced some slightly difficult breathing (not wheezing, but the feeling of "incomplete" breaths) and chest/intercostal muscle tightness. This was accompanied by notable feelings of anxiety/worry. I was examined by EMTs at my home, who noted normal blood oxygen levels and blood pressure. They advised my breathing seemed within norms, and not the "shortness of breath" that would indicate a severe problem (since I was able to speak without interruption). On the 27th I spoke with a provider at my PCP's office, who agreed that I was not at high risk, but prescribed an albuterol inhaler to be used as needed. This appeared to help, although the mental/emotional symptoms were still somewhat present.  Around October 30/31 I started to notice similar muscle tightness and "incomplete" breaths, provoking a significant anxiety response again. I did my best to self-manage with the albuterol, muscle stretching, and meditation. On November 1 I was seen by an urgent care center, with a follow-up chest x-ray on November 3. The x-ray was described to me as "normal, with some bronchitis" and I was advised to continue using the albuterol. I spoke with my PCP, on November 8, who recommended I switch from the albuterol to Flovent (fluticasone) since albuterol can increase heart rate and perceived anxiety. I've been on that course since November 13, and the symptoms seem to be well-managed so far.
PT PRESENTED TO PHARMACY SAYING THE VACCINE RECEIVED WAS GIVEN IN THE BONE BY PHARMACIST. SHE HAS HAD PAIN IN ARM AND HAS TO GO TO PHYSICAL THERAPY.
Received final shot in Moderna series 5/15/21. On 06/28/21 right testicle had swollen to the size of a tennis ball. 07/30/21 find out its testicular cancer. 08/06/21 right testicle is removed. Tumor markers go down to normal levels after that. 11/2/21 hCG levels rising to 28 H from 5H the previous month. Oncologist appointment with Dr. to follow up on results 11/10/21
The first two days after my initial  injection my right arm had a small red warm swollen bump which went away after about two days. For me this is typical with any vaccination however seven days after the injection the lump returned it was bigger warm and very itchy.
Narrative:  A 53yo B. male with PMH of GERD, Chronic Back Pain, Urticaria, HTN, ED, DMII, Hyperlipidemia, Tobacco use, Cerebral Infraction, Dysphagia,  Slurred Speech and Aphasia Received his Pfizer's Covid -19 vaccine first dose on  March 6, 2021at 08:45AM and second dose on March 26, 2021 at 09:00AM He was presented to the ED on March 11, 2021 with weakness and Hypotension and was reported Covid-19+vve
Took Vivotif doses in an inappropriate way; Spontaneous report received on 03MAR2020.   A non-healthcare professional reported that a 14-year-old male consumer "took Vivotif doses in an inappropriate way" (PT: Inappropriate schedule of product administration) while being on Vivotif for immunisation. The consumer did not take Vivotif doses according to the schedule. The doses were taken on 25FEB2020, 29FEB2020 and 02MAR2020 respectively. It was reported that he forgot to take his second dose on 27FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doses in an inappropriate way (Inappropriate schedule of product administration). This consumer took vivotif doses on day 1, 5 and 7 as he missed his second dose on day 3. Vivotif doses should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif doses in an inappropriate way (Inappropriate schedule of product administration). This consumer took vivotif doses on day 1, 5 and 7 as he missed his second dose on day 3. Vivotif doses should be taken every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
had local rxn to DTAP;arm is blotchy red 4x3cm area firm & tender to touch;father had child over weekend & mom didn't see arm until 14JUL98;MD observed arm on 15JUL97 & mod severe local rxn;
Received Tdap on Wed. 6/26/13, Thurs. started with generalized pain, fever, chills, HA went home early on Thurs. 6/27 and off from work on Friday 6/28. Also had a lot of pain at injection site but that was expected. By Sat. 6/29 pain and other symptoms resolved.
extremely tired, headache, aching joints, chills, fever, mild nausea, a large red area around the injection site -- the area is hard and somewhat itchy
Nausea, vomiting, flashes of white lights, chest pains, shaking, confusion
Information has been received from a 57 year old female patient who on unspecified dates was vaccinated too many times with "pneumococcal vaccine" (manufacturer unknown). It was reported that the patient experienced unspecified allergies to "pneumococcal vaccine". The patient's also experienced adverse events when vaccination with ZOSTAVAX (Merck) (WAES0909USA01309). This is one of the two reports for the same patient. No further information is available.
After 9 minutes my tongue start to swell and tingle .. within a hour my mouth and lips started tingling. My moth and lips felt as if they were swollen
He is sick; feels bad; This is a spontaneous report from a contactable consumer (patient himself). A male patient of unspecified age (reported as 'Age: 78; Units: Unknown') received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced stated "he is sick and will not be able to make it today." He asked how can he get in touch with them to cancel the appointment. He stated he did not report his symptoms because he feels bad so much of the time, he has so many days that he feels bad that it wouldn't give them much help because he doesn't think it is from the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. A causal association between BNT162B2 and the reported events cannot be completely excluded based on the information provided. Case will be re-assess once additional information becomes available.
Within 24 hours, redness, swelling at site. By 48 hours site was very red and swollen. Symptoms decreased so when seen in office at 72 hours, it was red, swollen (3" X 4"), non-tender. No other symptoms.
pt recv vax 21OCT98 & w/in 1hr exp inj site pain which radiated to the left side of neck & base of skull;
Eye irritation, eye redness, sore throat, persistent coughing, aches and pains of entire body. Worsened morning after vaccine was given.
02/15/07 telephone conversation, verbal report 2/14/07 noticed L deltoid area with redness, swelling, itching and puffiness approx size of an orange. States tried heat, did not improve. 2/15/07 site unchanged. RN observed 10-12 cm red, warm indurated site L deltoid area on 2/15/07.
12OCT96 & 13DEC96 & generalized sz reported by parents;post ictal period;both events reported on 13DEC96;both w/o fever;
Presented to ER with coughing and dyspnea, Abdominal swelling d/t ascites with chronic leg edema.  Initially admitted for COVID-19 PNA and AKI on CKD.  Started therapeutic dose Lovenox, and IV fluids.  Telemetry reported 3rd degree heart clock with a HR in 40's, repeat EKG showed Mobitz, type 1.  VQ scan inconclusive for PE, Echo showed preserved EF and no structural abnormalities.  Patient also found to have a UTI, started on meropenem.
pt presented to ED with worsening SOB; had been to ED earlier on 12/30/21 with same sx and was diagnoses positive for COVID, but he left AMA; significant weakness; O2 supplementation; admitted to hosp; ICU; given ABX, steroids; respiratory status worsened requiring intubation; renal and respiratory failure; DNR; O2 sats dropped and pt was transitioned to comfort measures; he was extubated and passed away
No treatment; experienced fever 100.1, aching, fatigue. All symptoms started 24 hr. after second vaccine shot. Lasted 24 hr. Some fatigue continued for a few days.
Pt had influenza quad given on 10/26/2018. Has had persistent hypopigmentation of the skin of the left deltoid. Was seen in the office for another medical issue on 2/12 and Mom showed us. I took a picture and sent to dermatology and they believe it is vasoconstriction of the area surrounding the injection. We have a picture in her chart of this area. It is not tender or bothersome but is disfiguring of the skin.
Missed second dose (Today it has been > 2 months after first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose (Today it has been > 2 months after first dose)) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (Today it has been > 2 months after first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose (Today it has been > 2 months after first dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No Treatment medications were provided. Expiry date of that vaccine was unknown. Patient states that she was too busy and forgot about dose.
W/in 24 hours of getting the ZOSTAVAX injection pt noticed a small red area which expanded to an area of 2" x 5" which stayed raised & red for approx 15 days. Was somewhat itchy but not enough to warrant using any treatment. Patients doctor wanted the event reported.
Hospitalized (10.16.21 - current, still admitted);  COVID-19 positive (10.16.21);  fully vaccinated  CHIEF COMPLAINT: Hypoxia;  HPI:  HISTORY OF PRESENT ILLNESS:  Patient is a 82 y.o. male who presents today with worsening shortness of breath since couple of day. He uses 2 liters of oxygen at baseline. For last couple of days his oxygen saturation is staying in 70's. He denies chest pain. He feels much better after oxygen. His appetite has been poor as well. No abdominal pain. No leg swelling. No dizziness or shortness of breath. He denies dizziness.  ASSESSMENT / PLAN: Acute on chronic hypoxic respiratory failure: Covid 19 pneumonia:      - Fully vaccinated      - decadron      - CT angio ordered      - remdesevir ordered      - not a candidate for MAB due to hypoxia      - does not appear fluid overloaded on exam Progress Note - Assessment and Plan from 10.26.21:  Acute on chronic (2L baseline) hypoxemic respiratory failure, secondary to  COVID-19 PNA - Fully vaccinated Moderna Feb and March 2021 - s/p Remdesivir 10/16-10/21 - Decadron (6 mg daily PO x 10 days, 10/17-10/26) - Pulmonary toiletting - Wean O2 as able, goal >92 - Off of HFNC today, on 6L - Consider pulm consult if unable to further wean.  - CXR 10/25 improved bilateral heterogenous pulm opacities, no acute cardiopulm abnormality - Lasix decreased to 20mg IV daily; will hold further diuresis now.
Within the hour of having left arm flu shot Monday Oct 23, 2017--had itching on skin within the hour--by the time she got home, had first eyelid burning and itching, then tongue and gums, inside the ears, and scalp had a burning itching sensation. Took a benadryl Monday evening and Tuesday morning. She woke up at 11 pm and behind the knees and the anal area were itchy. Took benadry every 6 hours, no appetite, no fever or rash. By Wednesday--no long itching, but tongue was sore and it still is. She stopped taking benadryl in the day, but took it at 10 pm, woke up at 2 am and felt fine. However today, in the morning, the tongue hurt again. No benadryl taken yet. Never affected the throat or swallowing. Pt has had flu shots yearly without a problem. Will need to fill out adverse reaction re: this shot.
Shortly after receiving the above vaccines, the patient developed a high fever (103.5 F) and started to cry that his arms hurt so much that he could not move them.  The next day he still had a fever and was refusing to move either arm, so his mother brought him back to my office on 1/20/2023.  There was no evidence of infection at the injection site at that time, and although the patient was unhappy, he was able to hold a coherent conversation and able to reach out with both arms to take a Band-Aid.  However, he was definitely in more distress than I find to be typical after receiving these vaccines.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 64-year-old female patient who received mRNA-1273  for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) Unknown. In 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of COVID-19 was not provided with IMBRUVICA(IBRUTINIB).  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.  Company comment: This is a spontaneous case reported by a consumer. A 64-year-old female patient, with concurrent medical condition of chronic lymphocytic leukemia, completed a two-dose primary series of mRNA-1273 vaccine and experienced non serious event of COVID-19 . Vaccination dates and onset date of the event were not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 64-year-old female patient, with concurrent medical condition of chronic lymphocytic leukemia, completed a two-dose primary series of mRNA-1273 vaccine and experienced non serious event of COVID-19 \. Vaccination dates and onset date of the event were not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
On 10/14/03 pt began having acute "double vision." The morning after receiving injection awakened with eye, slightly swollen and red which resolved post 12 hrs. Did not report double vision to parents until 10/22/03. At this time they made appt with opthamalogist who comfirmed dx of diplopia. Continue to have "double vision" and has follow up appt 12/10/03 with neuro opthamalogist. The medical record received on 2/3/04 states double vision.
Individual became symptomatic with headache, fatigue, nasal congestion, muscle body ache.  Tested positive for COVID 19 on 10/20/21.
Pt developed a bad rash and hives all over the body, one week post vax.  She took prednisone to clear it up but was advised by the physician to stop. She continues to experience hives and rash with itching and burning.
Swelling, redness, itching at shot site. Lasted for 6 days. Used cortisone cream. Occurred with 1st shot and 2nd shot.  Body aches, tiredness. Started  2/16 /21 at 10pm. Lasted through 2/17/21. No treatment. Gone by morning of 2/18/21. Occurred with 2nd shot only.
Patient is here regarding bruising from IZ from last week. Stated unsure if its from Pneumo or Tdap vaccine. Patient stated that vaccine bruising gets itchy, starts swelling, & affects daily routine because she is unable to move her arm around. Prescribed ibuprofen 600 mg tablet
Large patch of erythema surrounding needle mark 8 1/2cm x 7cm.
pt recv vax 13JUN95 & 1APR96 pt devel a fever followed by approx 15 lesions on skin;no further details were provided;
Lump at site of injection, feels hard and warm to touch but not hot. Slightly itchy at times. This also happened with my second dose of the vaccine and did not go away for 6-8 weeks last time.  Mild tenderness at site but not painful necessarily.
Allergic reaction. Given Pepcid and Benadryl. Pain and swelling in lymph nodes.
Fever of 102.4 F 1 day after shots nausea and vomiting 1 day after shot. CT feels alot better on 6/14 -2 days after shots with no fever then.
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 23-MAY-2017, the patients was vaccinated with improperly stored doses of dose of MMRII injection (recombinant human albumin) (lot # M039904, expiry date 26-SEP-218, dose, site and route of administration were not provided). Sterile diluent used for vaccines reconstitution was properly stored. The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 24 hours. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA012844.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the unspecified number of patients were vaccinated with ROTATEQ orally (dose, lot# and expiration date not reported). The patients received a dose of ROTATEQ that was stored improperly. There was no adverse effects reported. Additional information is not expected.
Local reaction to vaccine: redness and swelling. Treat with reassurance, cool compresses.
Patient reports shortly after receiving her first Pfizer COVID-19 vaccine on 2/23/21, she developed flushing of the face followed by erythema of the body, warmth and tingling. This was accompanied by numbness, a change in her vision and mental alertness. Patient reports similar symptoms occurred in the past when she experienced anaphylactic reactions, such as with bee stings.
1st dose Sept 23  2019 and 2nd dose Dec 13 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd September 2019).   On 13th December 2021, the patient received the 2nd dose of Shingrix. On 13th December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter reported that patient received a second dose of Shingrix outside recommended schedule, which led to lengthening of vaccination schedule. No know side effect was reported. No lot number and expiration date provided. The reporter consented to follow up.
Sat down after receiving vaccine. Started getting very tired very quickly. Got foggy. After a few minutes, lost consciousness for a brief period of time. Profuse sweating. Paramedics were called. 20 minutes later, he was awake and in the ambulance, vitals tested ok. They released from ambulance, he decided not to go to hospital.
Patient tested hepatitis B negative on 4/25/07. On July 5, 2007 the hepatitis B vaccine was administered. On July 6th, 2007 a hepatitis B lab was drawn and the patient tested positive.
No adverse event; Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.) outcome was unknown and NO ADVERSE EVENT (No adverse event) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.).    No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2023-698291, MODERNATX, INC.-MOD-2023-698271 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-698291:first patient case MODERNATX, INC.-MOD-2023-698271:1st patient
left facial nerve palsy-Bell's palsy shot on 4/1/21, symptoms 7 weeks later
Headache  Narrative:  Pt experienced headachex2 days, which started 30 minutes after covid vaccine. Home migraine therapy of topiramate, ibuprofen, and apap provided no relief, leading to presentation to ED where IV lactated ringers, prochlorperazine, diphenhydramine, ketorolac , magnesium, valproic acids, and hydromorphone were given.
Mom stated that swelling, hard knot at injection site, warm to touch, and red. Mom stated that swelling has moved up leg almost to hip area. Mom stated that she had given Tylenol with no improvement but has not tried any Motrin. Mom called to triage concerns to see if she needed to bring in for an appt. Office recommend warm compresses to the area and Motrin/Tylenol. Should resolve over the next few days. Continue to monitor and OV for worsening or new concerns.