chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Patient had first Covid Moderna vaccine on 3/21/21 and 2nd dose on 4/18/21, 28 days apart. He contacted the clinic on 5/28/21 to report he developed a rash after his 1st vaccine. He had his second shot even though he still had the rash. The rash has not gone away and is all over where there is contact from shirt collar waist band and underarms mostly. After he scratches it burns. He was self-treating with topical Benadryl ointment and PO Benadryl with some relief, but the Benadryl was making him tired. He saw his provider for an urgent visit on 6/3. Providers note states: rash/pruritus- exmatous looking-very dry skin- Medrol dose pk and then use absorbate to rehydrate and increase fluids hydrocortisone cr 1% provided for cream use. It's not clear if this is directly related to COVID shots but I entered it as an allergy as he feels the rash broke out 3 days after the 1st vaccine dose.
Began w/severe pain & swelling @ inject site, w/ 4cm swelling, 2cm erythemous ctr & 2.5 cm papule; very warm, non-fluctulant & very tender; Seen by MD & given meds;
Fatigue; Chills; Low grade temperature; Rash developed on ankles and the tops of feet; It began as a mottled pigment change right after the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 27Apr2021 at 14:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure and  COVID-19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), fluticasone propionate, salmeterol xinafoate (ADVAIR), salbutamol (VENTOLIN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) from unknown date for unknown indication. The patient previously took penicillin, sulfur, Benadryl. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 27Apr2021 at 15:00, the patient experienced normal symptoms of fatigue, chills, low grade temperature, began as a mottled pigment changed right after the vaccination into a rash developed on ankles and the tops of feet. The patient did not receive any treatment for the reported events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, chills, low grade temperature, mottled pigment and rash was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
I had a routine mammogram and they felt something so I got an ultrasound, then biopsy, then I was diagnosed on 01/14/2021 with breast cancer. I had a bilateral mastectomy. I had reconstruction on 07/06/2021. I was at the hospital for 1 night after bilateral mastectomy and 2 nights after the reconstruction.
SORE THROAT; COUGH; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JAN-2022, the patient experienced sore throat, and cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, and cough. This report was non-serious.
Next morning after vaccination (01/09/2021), I woke up to a slight "buzz" in both ears. They sound can be described as similar to the background noise produced by insects at night. Buzz intensity is low but persistent.
crazy for about a week; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL DISORDER (crazy for about a week) in a 66-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENTAL DISORDER (crazy for about a week). At the time of the report, MENTAL DISORDER (crazy for about a week) outcome was unknown.            Concomitant information use was not reported.  Treatment information was not provided.
Patient was given one dose of Proquad and one dose of IPV at time of visit. After entering vaccines into database and printing record to give to parent, this RN realized report read "invalid" for Varicella. Mother of the patient was notified immediately while still present at clinical site by this RN, and mistake was explained. After waiting 15 minute period, this RN explaining that the patient  would need to have the dose repeated on or after 10/17/22. Patient was overserved prior to leaving clinic and reported, as well as appeared to be in no apparent distress prior to departure. This RN immediately notified Nursing Director who notified vaccine coordinator.
Boostrix given to a 4-year-old; Boostrix administered in the left thigh; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3JS9E, expiry date 18-MAR-2024) for prophylaxis.   On 04-APR-2023, the patient received Boostrix (intramuscular, left thigh) .5 ml. On 04-APR-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix given to a 4-year-old) and vaccine administered at inappropriate site (Verbatim: Boostrix administered in the left thigh). The outcome of the inappropriate age at vaccine administration and vaccine administered at inappropriate site were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-APR-2023 The physician reported that the patient received a dose of Boostrix vaccine.  Nothing further to report.  The healthcare professional was transferred to medical information for next steps. The reporter consented to follow up. The 4 year old patient received a dose of Boostrix into left thigh, which led to Inappropriate age at vaccine administration and vaccine administered at inappropriate site.
Soreness at the injection; Muscle pain/achiness; Joint pain; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection), MYALGIA (Muscle pain/achiness), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection), MYALGIA (Muscle pain/achiness), ARTHRALGIA (Joint pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection), MYALGIA (Muscle pain/achiness), ARTHRALGIA (Joint pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-Apr-2021 contains no new information as email for the reporter was added
40 y/o female in good health presents with 2 week history of increasing pruritic rash on torso, back/chest/groin/neck. On physical exam, patient is well-appearing. Distributed over her chest, ab, back, flanks, groin, and neck are 0.2 to 3 cm pink discrete papules and plaques, some with collarette scale, consistent with pityriasis rosea. Pt was advised to discontinue anti-fungal cream (clotrimazole 1% cream) and started mometasone 0.1% cream to affected areas bid with partial relief. Patient advised of prolonged course (usually 2 weeks increasing, 2 weeks stable rash, and 2 weeks resolution).
Patient is experiencing severe stomach pain and diarrhea following first shingles vaccine - had to go into walk in clinic
ANAPHYLACTIC REACTION; Episode of syncope; Headache; Altered mental status; Nausea; Vomiting; This is a literature report for the following literature source(s): privacy  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaphylaxis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "MDD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant, life threatening), outcome "unknown", described as "ANAPHYLACTIC REACTION"; SYNCOPE (medically significant), outcome "unknown", described as "Episode of syncope"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MENTAL STATUS CHANGES (non-serious), outcome "unknown", described as "Altered mental status"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; VOMITING (non-serious), outcome "unknown", described as "Vomiting".  No Follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the close temporal association the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
TINGLING & NUMBNESS STARTED ABOUT 3 WEEKS AFTER SECOND INJECTION. IT IS FELT IN LEGS AND ARMS MOSTLY, BUT SOMETIMES BACK AND FACE AS WELL.  THIS CONTINUES TO THIS DAY, AUGUST 23RD 2021.  DURING SUBSEQUENT MONTHS, OTHER SYMPTOMS DEVELOPED SUCH AS BURNING SENSATIONS, NERVE PAIN AND MUSCLE TWITCHING.
note from 11/23/21 had pfizer covid vaccines 2/24/21, 3/19/21, and 10/5/2021, i do not have lot number for the 10/5/2021 dose  A/P: Pt is a 70 y.o. male with PMH of HTN, gerd, BPH who is transferred from a HCF with massive PE s/p ROSC and tPA. Placed on eliquis and developed right anterior chest and arm hematoma and need IVC filter placement. Now w/ e/o HIT, suspect classic HIT, w/in 5-10 days of heparin exposure, plt count nadir at 130 (>50% decline from 283) w/ h/o thrombosis and HIT Ab >2 OD (2.765) 4Ts of at least 5 or intermed, and w/ elev OD c/w and diagnostic for HIT. Suspect covid vaccine booster on 5 October 2021 could have been a risk factor for his initial presentation with PE and DVT however as the HIT is greater than 30 days post Covid vaccine and not present at initial presentation, this is not consistent with VITT at this point in time.   1. Massive PE s/p ROSC; acute LLE DVT and HIT -HCF CTA of chest which revealed acute bilateral PE with large clot burden and evidence of pulmonary hypertension and right heart strain -Echo from 11/15/2021 revealed EF of 70%, moderate diastolic dysfunction, right ventricular systolic pressure of 34.6 mmhg -Became pulseless while going to the restroom, was given tPA, intubated, required levophed  -Received heparin and then eliquis @ HCF- last dose 11/14/21 2/2 bleeding -11/16/21 BLE U/S: 1. Acute-appearing, occlusive and nonocclusive thrombus in the left low femoral vein, as well as occlusive thrombus in the left popliteal vein. No right lower extremity DVT. -AC back on, apix 2.5 bid, ok to go to 5 mg bid -rec avoiding further covid shots due to poss contribution to clot -avoid heparin, it is an allergy now, w/ dx of HIT -plt already improving, currently on DOAC   2. Acute blood loss anemia -2/2 right anterior chest and arm hematoma while on Eliquis  -Patient had right upper extremity arterial Doppler which did not reveal significant stenosis.  He also had right upper extremity venous Doppler which revealed large hematoma involving the anterior chest and extending down the medial aspect of the right arm. -Hgb stable/improved -back on AC, ok to go to full dose   3. AKI -Cr 0.9 @ HCF admit, currently 0.82 -Renal ultrasound at HCF revealed renal cortical atrophy bilaterally.  Enlarged prostate with palpable trabeculation.  Questionable nonobstructing left renal stone.   Recommendations: -resume eliquis 5 mg po bid  -avoid heparin products -f/u w/ Dr at HCF next wk
COVID BREAKTHROUGH: over the last 5 days.  Because of the abdominal pain, the patient has felt that he cannot tolerate oral intake, and he has been avoiding food and his regular, maintenance medication.  Past medical history reports history of Cushing's disease, systemic lupus erythematosus, and major depression.  He has not been taking his maintenance therapy for at least 5 days according to his statement. The abdomen initially developed in the epigastric area, described as colicky pain, "coming and going", and because got better, at the last evening ER visit he decided to leave against medical advise from ER visit and go home. BOOSTER DOSE 11/30/2021.
Patient developed red rash on 8/21/19 and went to urgent care on 8/28/19 and  diagnosed  with  shingles.  Patient is still under treatment.
Delivered babies on 4/20/2021 two health twins.   Adverse Health Event - Pityriasis Rosea   Start: 6/1/2021 Itchy red rash on hips and chest spread all over body  Stated on antihistamine to treat symptoms on 6/28  Still have rash as of 8/27 symptoms on going
Pt claims that his arms was swollen and painful... pain never went away even after several weeks. Pt claims shot was given correctly (since he is also a pharmacist) and I verifed with vaccinator and it was done correctly in the correct location.
pt recv vax & pt felt faint & exp nausea;the reporter noted 3 pt & WAES95081085 through 95081087 were assigned;no further details were provided;
REDNESS, ITCHINESS, INFLAMED AT INJECTION SITE AND SPREAD OUTWARDS ON ARM. MD ADVISED ON AND OFF COLD COMPRESSES.
Swelling & pain at injection site x 2 weeks. Tingling when moving arm.
This patient was requesting for a shingles vaccine.  He was inadvertently administered a pfizer shot.  He had previously completed his Moderna covid series in early April.  He had no immediate problems. I will be following up with the patient .
Patient had a sore arm immediately following injection. Patient was unable to sleep on left side overnight, and felt pain deep inside shoulder (under shoulder blade). Patient treated with OTC NSAIDs and heating pad, had pain rated 7/10 max and 3/10 min. Visited orthopedic clinic approx. 5 days post-vaccination and was diagnosed with Subacromial bursitis of left shoulder, following x-ray and physical examination. Provider administered triamcinolone steroid injection directly into affected bursa and has referred to PT.
Soreness & swelling of arm. Unable to lift anything. Joint aches in back and arms. Fatigue. Denies fever/chills/nausea.
Headache Fatigue  Body Aches Chills Hot Rash on R. side Large, Red bump feeling Hot @ injection site and 4 inches below injection site symptoms Lasting 3 days Tylenol taken & Benedryl For Rash
indurated, mildly erythematous area over rt deltoid, area tender, sl dec in shoulder secondary to pain;
On day 7 (after no issues for the entire week) I developed a swollen, red area around the injection site.  Area is 2.5 by 4 inches. It is noticeably warm to the touch.
2 hours after receiving the vaccine is experiencing itchy neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (2 hours after receiving the vaccine is experiencing itchy neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PRURITUS (2 hours after receiving the vaccine is experiencing itchy neck). At the time of the report, PRURITUS (2 hours after receiving the vaccine is experiencing itchy neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatments were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 contains non-significant information. The primary reporter mailing address was updated.
Pt experienced swelling in both ankles and itchy eyes three hours after vaccine. Took a benadryl and symptoms subsided overnight.
received only the adjuvant portion; received only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2022) for prophylaxis.   On 17th October 2022, the patient received the 1st dose of Shingrix. On 17th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment:  The office manager stated that the four patients received only the adjuvant portion of Shingrix.  The reporter did not have the demographics of the patients at the time of the call but would have if follow up were made.  These were the first dose for all four patients.  The reporter consented to follow up. This case is 1 out of 4 cases reported by the same reporter. Additional Supportive Information: The patients received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022AMR169909:same reporter US-GSK-US2022AMR169911:same reporter US-GSK-US2022168220:same reporter
Within 2 hours left arm began to swell with excrutiating pain. Within 6 hours client was bedridden with fever, chills and vomiting that progresed to irregular heart rate and feeling light-headed by the next day. The left arm was then grossly edematous prompting client to go to the ER where she was diagnosed with Allergic Reaction.
t104.5 R w/vomiting; eval p/6 hrs no obvious signs of infect;
MA administered vaccine.  About 5 mins after administration, patient complained of itching so I was asked to evaluate the patient.  No band-aid was applied to the site.  The itching was just at the administration site.  The area was swollen and bruising was noted.  Patient denied any changes in shortness of breath (has COPD), denied throat tightness, itching only at injection site.  Ice pack was applied and provider notified.  Patient was observed for an additional 15 mins (30 mins total).  At that time patient continued to deny symptoms other than itching at injection site.  Swelling did go down slightly with application of ice pack.
patient received improperly stored vaccine on 4/16/2019; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 16-APR-2019, the patient was vaccinated with an improperly dose of an measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R030799 and expiration date 22-APR-2020 (dose number, frequency and route were not provided) for prophylaxis (product storage error). The administered dose of the vaccine was stored with a temperature of 9.9 degrees Fahrenheit for 57 minutes and a previous temperature excursion of  28.9 degrees Fahrenheit for 5 hours and 30 minutes. There was a digital data logger involved.
Moderna COVID-19 Vaccine EUA Redness, swelling, itching at site of vaccination; approximately 2 inch radius from injection site
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions reported. On 25-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L016284, expiration date: 07-AUG-2016), which was improperly stored for 12 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported wheezing symptoms which didn't start until 24 hours after administration of ZOSTAVAX. RPH recommended consulting with doctor ASAP. Patient said wheezing symptoms might also be due to gardening done today, but she wasn't sure.
Itchy lips , swollen throat, itchy feet ,  hives on face , itchy body all over , Fatigue,
Fever 102.2, chills, headache, joint pain, fatigue, arm pain at injection site. Symptoms lasted a day and a half.
Notalgia Paresthetica; This case was reported by a consumer via call center representative and described the occurrence of notalgia paresthetica in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number ap545, expiry date 25th January 2023) for prophylaxis.   On 2nd August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th August 2021, 8 days after receiving Shingrix, the patient experienced notalgia paresthetica. On an unknown date, the outcome of the notalgia paresthetica was unknown.   It was unknown if the reporter considered the notalgia paresthetica to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and developed nostalgia paresthetica. The patient was referred to health care professional. The reporter consented to follow up.
Any contact with my left arm vaccination site arm was very painful.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Any contact with my left arm vaccination site arm was very painful.) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Any contact with my left arm vaccination site arm was very painful.). At the time of the report, VACCINATION SITE PAIN (Any contact with my left arm vaccination site arm was very painful.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-385869 (Patient Link).
Patient received Pfizer COVID19 Bivalent booster on 10/19.  He called the pharmacy the following day (10/20) reporting that the vaccine "leaked" out of his arm and he does not believe any of the dose absorbed.  Patient requested that we report this concern.