chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a pharmacist, describes the occurrence of product dose omission issue (patient never received the second dose/not received the 2nd dose >2 months away from the first dose) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 7, 2021, patient experienced product dose omission issue (patient never received the second dose/not received the 2nd dose >2 months away from the first dose). At the time of the report, product dose omission issue (patient never received the second dose/not received the 2nd dose >2 months away from the first dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
This spontaneous report was received from a nurse prescriber regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M022077 and expiration date of 10-MAR-2019) (dose and route not reported). The administered dose experienced a temperature excursion of 9.6 degrees for 19 minutes and -9.8 degrees for 33 hours. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
Pt was admitted to the hospital with Covid post vaccination. Patient had Covid Pneumonia and the patient expired on 02/10/22 due to Covid complications.
Fever, extreme body pain (entire body), nausea, diarrhea migraine, fatigue. April 17, progressed throughout day, starting @ 2am with diarrhea and vomiting, Sunday April 18 was unable to move eat nor drink the entire day, Monday April 19th  still unable to eat nor drink without throwing up, headache still present slight fatigue, body aches easing up.
Patient received one dose of Pfizer vaccine following previous completion of moderna vaccine series at off campus vaccination clinic location. The error was noted during documentation into patient's electronic medial record following return to medical campus. Patient was contacted and reported that he had lost his vaccination card and made personal decision to falsify vaccination status on screening form in order to receive additional doses and get a new vaccination card. Patient was reeducated following error. Plan made to have list of personnel pending immunization available at location and recipients will be cross checked against list to verify vaccination status prior to administration. There was no identified harm to patient following administration at this time.
Patient presented for vaccinations. Flowsheet (EMR) reviewed and records reviewed. Patient due for DTaP (5), Polio (4), MMR (2), Varicella (2) and Hep A (1). Imms due reviewed with second clinical staff, pre vaccination draw, and after they were drawn from vials. After administration of these vaccines, it was noted that the patient had a two records. I reviewed the duplicate which noted that he was UTD on all vaccines, except for Hep A (due for second dose to complete the series). I spoke with the Guardian regarding this while still in office. She was advised of the error and counseled. Patient doing well in office after 25 minutes post immunization.
Day 9 after the shot I woke up covered in hives and welts. For the past three days my skin has been on fire with welts all over my body that are very itchy. I have tried benedryl and allergy medication and nothing is working to minimize the swelling and the itching. This was for my booster. When I received my first dose of moderna in January I did have Covid Arm but it was a minor raised ring around the injection site. It too also appeared 9 days after my injection.
This case was reported by a lawyer and described the occurrence of death nos in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received 2nd dose of TWINRIX (details unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced death nos. The subject died due to unknown cause. It was unknown whether an autopsy was performed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2022 as dose 4 (booster), single (Lot number: 33036BD) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery calcification" (unspecified if ongoing); "Known allergies: Carba Mix and Thioram Mix (2 rubber chemicals)" (unspecified if ongoing), notes: Known allergies: Carba Mix and Thioram Mix (2 rubber chemicals); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: sulfa; "OSA" (unspecified if ongoing), notes: OSA. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: It was reported that rebound. Patient began Paxlovid on the second day of COVID symptom onset. COVID symptoms improved rapidly. But COVID symptoms returned 2 days after completing the five-day course of Paxlovid treatment. Patient had fatigue and still have cough, nasal congestion, copious mucus, burning of nasal mucosa.  Information on the lot/batch number has been requested.
broke out in a rash on her left arm; felt her throat closed / doctor told her those were lymph nodes / pain over both sides of neck; didn't receive the second one / scared to get the second dose; arm was very red and there was a print/ mark on it to show where she had the shot.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (broke out in a rash on her left arm), LYMPHADENOPATHY (felt her throat closed / doctor told her those were lymph nodes / pain over both sides of neck), VACCINATION SITE ERYTHEMA (arm was very red and there was a print/ mark on it to show where she had the shot.) and PRODUCT DOSE OMISSION ISSUE (didn't receive the second one / scared to get the second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was very red and there was a print/ mark on it to show where she had the shot.). On an unknown date, the patient experienced RASH (broke out in a rash on her left arm), LYMPHADENOPATHY (felt her throat closed / doctor told her those were lymph nodes / pain over both sides of neck) and PRODUCT DOSE OMISSION ISSUE (didn't receive the second one / scared to get the second dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency; TRIAMCINOLONE at a dose of cream 0.1% applied topically twice daily; AZITHROMYCIN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Neck pain, at an unspecified dose and frequency. At the time of the report, RASH (broke out in a rash on her left arm) and PRODUCT DOSE OMISSION ISSUE (didn't receive the second one / scared to get the second dose) had resolved and LYMPHADENOPATHY (felt her throat closed / doctor told her those were lymph nodes / pain over both sides of neck) and VACCINATION SITE ERYTHEMA (arm was very red and there was a print/ mark on it to show where she had the shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medications include spray for throat.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow up appended. Added reporter details and events (product dose omission issue, rash and lymphadenopathy). On 05-Aug-2021: Non-Significant follow-up appended. Reporter's address added.
Patient hospitalized with COVID-19, s/s started on 10/2/2021. Pt was diagnossed with acute respiratory failure, bacterial pneumonia, fungal pneumonia,  pt transfered to higher level of care on 10/16/2021
Sudden hearing loss in left ear. Went to ENT one week later after it didn't get better, diagnosed with sudden sensorineural hearing loss.
On January 13th, I received my COVID-19 booster (MODERNA brand) as required by my college to attend school. At the time, I had no adverse events. However, on February 1st, 2022, my menstrual cycle had flipped and my period started. I am on a non-hormonal copper IUD (Paragard) for 6 plus years and have always had a very regular period and have and am in a monogamous marriage with no children. The event was noticeable and disturbing. Since the event, my body has been trying to shift back to my normal cycle, but still not there yet.
3 inch by 4 inch hard, red, warm knot at injection site. Itching, burning and pain through out arm
I started to experience back pain and light spasms two  to three hours after the second vaccine shot. When I woke up the next day I was unable to move. I have had intense back spasms which make it hard to; walk, pick up items, and walk up/down stairs. I have been bed ridden since I received  the shot getting up to eat and do light stretching.
Soreness, redness, swelling spreading down arm to elbow joint, worsening each day.
7 Hours after administration of vaccination left upper extremity. Patient developed a "heavy feeling around vaccination site, and a "crawling" sensation getting up left neck to head. She did not report sx until one week later.
I have had a mild burning sensation on my tongue not long after receiving the 1st dose of my Moderna Vaccine. The symptoms are rather annoying and have not subsided or worsened even after receiving the 2nd dose of my Moderna Vaccine.   Researching my issue it would look to be best described as "idiopathic glossopyrosis"
never received her second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 07 July 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter stated that a patient received her first dose of Shingrix and never received her second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
p/1215AM 19NOV had fever, chills, t103.5 & poss higher;saw MD 20NOV 3PM dx w/pneumonia was put on crftin & floxin;
6hr p/vax pt c/o eye pain, could not open eyes, leg pain, strong stomach pain & nausea, fever of 105;MD dx severe local rxn & advised mom not to have child recv hep B unless in high risk situation;APAP used to relieve sx that lasted 2 wk mo
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # N025428 exp date 19-JUN-2020) (dose and route not provided). Data digital logger was reported. The vaccine was exposed to a temperature of 47 °F to 77 °F for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1806USA006387: US-009507513-1806USA006474: US-009507513-1806USA006475: US-009507513-1806USA006477: US-009507513-1806USA006478: US-009507513-1806USA006479.
This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 17-APR-2018, the patient was vaccinated with an expired dose of VAQTA strength: 50/1.0 U/ml, lot number N005605, expiration date 17-APR-2018 (dose and route were not reported) for prophylaxis. No symptoms were reported.
27 y/o male, received 1st dose of Pfizer Vaccine (Lot # ER2613) on left deltoid @ 1136. Vaccinator RN explained risks/benefits of vaccine and received verbal consent to administer vaccine. Past medical history includes heart valve malfunction (valve does not close all the way). No hx of allergic reactions. At 1157, patient at EMT station complaining of tightness in chest that started "just a 1 min ago." EMTs responded. Patient moved to zero gravity chair and water was offered. Patient alert and oriented x3. Vital signs taken Q 5min. Patient reported that he last ate at 1115 (30 minutes ago). At 1159: BP 130/90, P 69, R 14; patient reports diagnosis of heart valve malfunction. EMS services offered, patient declined. At 1204: BP 126/80, P 66, R 14; patient reports that his tightness in chest has now resolved. At 1210: BP 124/78 P 71 R 12; patient states his "chest feels better." At 1212, patient requested to leave facility. EMTs recommended that patient should continue to be observed for a full 30 minutes until 1227. Patient declined and left facility against medical advice. Patient was adviced to speak to his health care provider. Patient stated his wife and children are waiting in the car. Patient left building with no assistance and with a steady gait at 1215.
18 IN. BY 8 IN. RED SWOLLEN AREA AROUND INJECTION SITE. HOT TO TOUCH. PATIENT STATES THAT IT DOES NOT HURT BUT ITCHES.
Feeling down a little bit emotionally; Soreness in the left arm, where he received the injection; Persistent fatigue that becomes overwhelming at times, feeling tired, periods of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration on 18May2021 (at the age of 69-years-old) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, patient experienced soreness in the left arm, where he received the injection, having persistent fatigue that became overwhelming at times, felt tired, felt down a little bit emotionally, periods of exhaustion out of the blue which were periodic, not all the time and the events had gone for probably 5 to 6 days. The events were assessed as non-serious. Patient reported that he will receive the second dose on 03Jun2021 or 06Jun2021, (earlier than the recommended 3-week period) and he asked if he should wait for side effects to resolve before receiving the second dose. He also provided his prescribing physician's information. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
1st dose: Syncope 2nd dose: rash (Chest and injection site, lip edema)
Soreness of arm; Feeling fatigue; A spontaneous report was received from a consumer concerning a 63 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue and soreness of arm. The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 23-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042L20A) intramuscularly in an unknown anatomical location for prophylaxis of COVID-19 infection.  On 23-JAN-2021, The patient experienced fatigue. On 24-JAN-2021, the patient experienced soreness in arm. No Lab Details provided Treatment mentioned states she took Benadryl 12.5mg, Sudafed 30mg and Ibuprofen 200mg;  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event was unknown.
Pain at injection site - w/i 2 hours and lasting 5 days Fatigue - w/i 4 hours and lasting 4 days headache - w/i 4 hours and lasting 3 days nausea - w/i 4 hours and lasting 3 days dizziness - w/i 4 hours and lasting 4 days joint pain - w/i 5 hours and lasting 2 days swelling of lymph nodes in throat leading to not being able to swallow saliva leading to panic - w/i 8 hours and lasting about 40 minutes then gradually reducing in size over the next couple of days
approx 1/3 of the pts treated w/Engerix-B failed to respond or had borderline titer levels produced p/3rd dose; 60 to 70 pt have been treated to date;
pt recv vax; very pale, limp & sound sleep; to er where MD felt rxn to vax; occurred about 4 hr p/ vax;
She developed a fever to 101 on Friday August 5th. Fever returned on 8/6/2022, last fever was on the evening of 8/6/2022. Resolved with motrin and tylenol. Two episodes of emesis one am on 8/6 and another in the middle of the night on 8/7/22. Went to pediatric urgent care 8/6/22. Afebrile, no abnormal findings, flu and covid negative. Doctor believed it be a virus and that it would resolve with rest, fluids, tylenol.
11/9 patient called and stated: 11/6 pain shooting thru arm, 11/7 low grade fever 99.3, 11/8 tired. Rash developed from about 2 to 3 inches from top of shoulder to almost to elbow and trying to go around to underside of arm. Bright red. Also hurt under her arm like in her lymph node areas. Wanted to know which shot was on the bottom. That's where the reaction occurred. The FLUZONE was given in the bottom of the injection site. She then remember what I have listed in the previous boxes.
yfvax administered 01/12/09, 01/13/09 morning red and swollen by evening small blister that increased in size to 1 inch diameter, blister broke am 1/14/09 no fever, no headache, no problems with any other anaphylatic type reaction.  Requested that if fever develops or problems with breathing or hives to see/call Dr or call 911.  Also to put antibiotic oint. and cover until weeping stops and call if any changes.
Tinnitus (high pitched ringing in my ears) started a couple days after the injection and hasn?t stopped yet.
In January I badly sprained my wrist while moving things around in my home. I was moving from one state to another. I went to see my doctor who looked at my wrist and indicated that it seemed to be a sprain. She recommended that I rest and not do anything for a couple of days. She also prescribed physical therapy where my symptoms improved drastically. We are now working on rebuilding strength. I wish to submit this report as I am not sure if the vaccine could have had an effect on my tendons.
This spontaneous report was received from a medical assistant refers to a adult patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 23-APR-2018, the patient was vaccinated with pediatric dose of both vaccines VAQTA (dose, units and frequency not reported) (lot number N019924 and expiration date: 02-SEP-2019) intramuscularly and RECOMBIVAX HB (dose, units and frequency not reported) (lot number M037248 and expiration date: 21-FEB-2019) intramuscularly (drug administered to patient of inappropriate age). No adverse effects have been reported to the patient. No product quality complaint was involved.
After receiving MMR, within 4 days, lost all speech, was in his own world, no eye contact, no interaction, loss appetite, went into zombie-like state, fussy and had diarrhea. Dx'd with autism and PDD.
with in 1 hour pt  c/o  queasiness, weak, fever, and  chills.  Lack of appetite and at one point passed out and vomited.  Pt now feels well again.
Hives on the arm 24 hours after first vaccine. Treated with Allegra 180 mg.
Body started acting weird; Arm started hurting; could not move without crying; Crying; excruciating pain of whole body; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Body started acting weird), PAIN IN EXTREMITY (Arm started hurting), DISCOMFORT (could not move without crying), CRYING (Crying) and MYALGIA (excruciating pain of whole body) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Body started acting weird), PAIN IN EXTREMITY (Arm started hurting), DISCOMFORT (could not move without crying), CRYING (Crying), MYALGIA (excruciating pain of whole body) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Body started acting weird), PAIN IN EXTREMITY (Arm started hurting), DISCOMFORT (could not move without crying), CRYING (Crying), MYALGIA (excruciating pain of whole body) and PYREXIA (Fever) had resolved.            Concomitant medications were not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Mini stroke after Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "Thyroid condition" (ongoing); "High blood pressure" (ongoing); "Overweight" (unspecified if ongoing). The patient's family history included: "Stroke" (unspecified if ongoing), notes: Grandmother had stroke, that was years ago. The patient took concomitant medications. Vaccination history included: Moderna vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna vaccine (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 2023, outcome "unknown", described as "Mini stroke after Covid vaccine". The event "mini stroke after Covid vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. Clinical course: Patient had to hospital but clarified it was just to emergency room, was not admitted to hospital.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300371824 same patient, different drug/event;
Approximately 2.5 hrs after vaccination, child in car in parking lot, mother noted ashen face and not responsive although child was breathing-appeared to have "fainted". Mother called 911-afebrile.