chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner concerning a 13 years old female patient. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient after was administered GARDASIL developed a fever. The patient was treated with antibiotics. The outcome of the event was reported as recovered/resolved. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
Myalgia, Fever, temp 100.2f, body aches, sore/swollen arm Narrative:
Initial unsolicited report received from a physician via other company (Pfizer) on 03 Jan 2017.. Manufacturer control number: 2016457413. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had allergy to tetanus toxoid. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Vaccine given 3:50 pm. Facial swollen and rash 30 minutes after injection.  Two Benadryl were taken at home.  Drove to urgent care for treatment, and they advised to go to ER.  Upon arrival to ER, started having chest pain and mouth/tongue were starting to swell (5:30).  Was admitted to ER around 5:45.  Full work up was done in ER.  Was given two albuterol nebulizer treatments, Pepcid, soul-medrol and nitroglycerin ointment.  Was admitted at hospital around 12:05 am to a telemetry unit to rule out cardiac etiology. Nuclear stress test read negative for inducible ischemia.  Overnight telemetry monitoring  revealed no tachyon bradycardia arrhythmias. Patient was discharged on 3/18/2021 and advised to contact Pfizer and CDC in regards to reaction
SORE ARM; HEADACHE; FATIGUE FOR 48 HOURS Narrative:
Patient states he woke up at 2 am burning in chest, stomach irritation,nausea.  Arm at vaccination site has a large welp approximately 3 inches in diameter with heat.  Patient states "temperature of 99.2".  He states he didn't take anything but was able to rest after about an hour.  At 9:00 am Friday morning, advised patient to take benadryl to help with the obvious arm reaction and apply ice to comfort the arm.  He did admit to arm swelling after the second vaccine but not like this.   Has received Moderna each time.  If gets any worse advised patient that he should seek medical attention via ER.
Date of first thaw was 5Jan2023 Dates of administration of vaccine was 20Feb2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date of first thaw was 5Jan2023 Dates of administration of vaccine was 20Feb2023) and NO ADVERSE EVENT (No adverse event) in a 12-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: MMR on 20-Feb-2023, PNEUMOCOCCAL VACCINE (P-13) on 20-Feb-2023 and HIB VACCINE on 23-Feb-2023. Past adverse reactions to the above products included No adverse event with HIB VACCINE, MMR and PNEUMOCOCCAL VACCINE.    On 20-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date of first thaw was 5Jan2023 Dates of administration of vaccine was 20Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date of first thaw was 5Jan2023 Dates of administration of vaccine was 20Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date of first thaw was 5Jan2023 Dates of administration of vaccine was 20Feb2023).    No concomitant medication were reported.  It was reported that date of first thaw was 5-Jan-2023, so it expired on 4-Feb-2023. The patient did not report any reactions. Vial size was unknown. The vial was initially stored in the refrigerator on 5-Jan-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712504 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712504:same reporter
Starting about in May I had some issues but I didn't think it was part of the possible side affects so I didn't say anything considering I had lung issues. I had a nagging cough and had to start oxygen and fainted, had two seizures and ischemia issue and hypoxia. Other than childbirth, i never had to go to the hospital before and I went 3 times in a six mo. period. I had many labs and medical test done, more than I can possibly remember for this report. Of which I could remember, Blood work, MRI, CAT, EEG, Urinalyses, CT scan, ect.
I have a sudden loss of hearing on my left ear.  It feels like it is full of water.  I am also experiencing mild dizziness and off balance while walking.
Information has been received from a registered nurse concerning a 6 year old male patient at an elementary school of kindergarten to fourth grade, who on 09/22/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Between 03/01/2004 and 04/05/2004, the patient developed breakthrough varicella.  The patient had less than fifty pox and was afebrile.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The reporter also mentioned other cases of breakthrough varicella at the same elementary school.  Additional information is not available.
This literature marketed report as received from the author of a public article. It was reported that current literature on the effectiveness of measles post-exposure prophylaxis (PEP) was limited and variable. The authors examined the effectiveness of measles, mumps, and rubella vaccine (MMR) and immune globulin (IG) PEP among children exposed to measles during an outbreak in 2013. Contacts were identified by the Department of Health and Mental Hygiene between 13-MAR-2013 and 30-JUN-2013. Immunity to measles and receipt of PEP was determined for contacts. PEP effectiveness [(1- relative risk of developing measles) x 100] was calculated for MMR, IG, and any PEP (MMR or IG) for nonimmune contacts aged less than19 years. Of the contacts included, 44 received MMR PEP and 77 received IG PEP. Effectiveness of MMR PEP was 83.4% (95% confidence interval [CI], 34.4%, 95.8%). No contact who received IG PEP developed measles; effectiveness of IG PEP was 100% (approximated 95% CI, 56.2%, 99.8%). Effectiveness of receiving any PEP (MMR or IG) was 92.9% (95% CI, 56.2%, 99.8%). The authors concluded that contacts who received PEP were less likely to develop disease. Their findings supported current recommendations for administration of PEP following exposure to measles. These results highlighted the importance of a rapid public health outbreak response to limit measles transmission following case identification. This case refers to an infant patient of unknown gender, aged 6 to less than 12 months. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. In approximately 2013, the patient was vaccinated with measles, mumps, and rubella virus vaccine (manufacturer unknown) (dose, route and lot # not reported) for measles PEP. After receiving MMR, on an unknown date, the patient met the clinical case definition and was confirmed to have wild-type measles infection through virus genotyping. Developing measles after MMR was considered as effectiveness issues by the author. The outcome of the events was unknown. Upon internal review, measles after MMR was considered to be medically significant. This is one of two reports received from the same article (related case ID: 1712USA004133).; Sender's Comments: US-009507513-1712USA004133:
Patient had a positive COVID test on 1/24/22 and 2/19/22. Patient expired on 2/20/2022.
pt recv vax & c/o itching @ site redness & painful;denies n/v or fever & chills;denies SOB;DPH given
My son walked out of the vaccine appointment clutching his leg and limping an by the time we arrived home he could not walk or put pressure on that leg. He did not walk for 6 days. By the 7th day he walked but his leg twitched when he was sitting for a while and then stood up or he was walking too long. This lasted another week. He also had a gigantic welt that lasted a few weeks and redness at the site. He complained of a lot of pain at the site for a month.
pt brought to ED on 8/12/21 after being diagnosed positive for COVID on 8/9/21; c/o increasing SOB, cough, weakness, O2 sats in 70s on RA; treated with O2 supplementation, remdesivir, decadron bariticinib, vitamin C, vitamin D, melatonin; pt's condition worsened requiring intubation; experienced sudden hypoxia with bradycardia (O2 sats 50%) despite maximum ventilation; comfort measures established; pt experienced bradycardia and ultimately asystole.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Swelling of fingers. Concurrent medical conditions included Arthritis (left shoulder and right foot).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-047839 (Patient Link).
pt recv vax & 1 days post vax exp nausea, t100 to 102.8;gen myalgia, h/a, chills, pus coming from inj site;
Had typical body aches during first 36 hours post 2nd shot (had no reaction to 1st dose).  In addition, at about 24 hours after getting 2nd dose, I developed hives. First patches on upper back and front of torso. Hives spread each day to a new location on lower back, upper legs and arms, butt and eventually in crevices at elbows and behind knees. Each patch dried up after 2-3 days. Whole episode lasted 9 days, then poof, gone. Since hives weren't terribly itchy (except after shower or if rubbed by clothes), I didn't take any antihistamine or put cream on them.
Itching, redness, warm and swelling at the injection site. Diameter of  area is 2.5 inches
Sore were they put the needle; Provider gave him a full dose of the Moderna vaccine instead of a half dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Provider gave him a full dose of the Moderna vaccine instead of a half dose) and VACCINATION SITE PAIN (Sore were they put the needle) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 037K20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Provider gave him a full dose of the Moderna vaccine instead of a half dose). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore were they put the needle). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Provider gave him a full dose of the Moderna vaccine instead of a half dose) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore were they put the needle) had resolved.            Patient takes several regular medications but, not not want to mention them. Treatment information was not reported. Patient is not immunocompromised
Fever 8 days after vaccine.  Rash starting 9 days after vaccine. Papular rash on torso, face and extremities. Fever to 100.5 degrees.
After trying so so hard not not catch covid, fell victim to an innocent close contact; After trying so so hard not not catch covid, fell victim to an innocent close contact; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), . The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "After trying so so hard not not catch covid, fell victim to an innocent close contact". The patient was home with an annoying "cold" and not in a hospital, and not dead.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200043443 same drug/reporter/event, different patient;
Sinus congestion, nausea, vomiting, diarrhea, muscle heaviness, low-grade temp.   Symptoms began early in the morning with nausea and sinus congestion. Injection site pain. Symptoms increased during the day. Persistent vomiting. Later in the day diarrhea. Vomiting abated by 7p, at which time I fell asleep. In bed 32 hrs, no food, sips of water. Next day continued ?queasy? stomach, diarrhea, but able to eat and drink.
No additional adverse event; the patient was vaccinated with an extra dose of VARIVAX; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-AUG-2023, the patient was vaccinated with an extra dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # X007372 and expiration date was reported as 12-MAR-2025 (dosage regimen, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event (no adverse event).
Vaccine shot at 8am.  muscle stiffness and trouble walking around 5:30 pm getting progressively worse throughout the evening. Very difficult to walk by 8 pm.  Exhausted and painful to move. Laid down. Tried to get up to use bathroom. Very painful and difficult. Walked a couple of steps and had heart palpitations and shortness of breath. Laid back down. Next day: muscle stiffness. Hard to move and painful when I tried, Migraine in morning. Rested in bed the entire day. Better the next day- but still stiff and exhausted. Muscle stiffness lasted about 3 days During the week after the shot I did not have a bowel movement (I usually have several a day) I had a migraine headache every day for a week after getting the shot. Everything gradually got better after 6 weeks. But since then, about every 3-4 weeks, I have had bouts of debilitating exhaustion that lasts 1-2 weeks, accompanied by memory loss/cognitive degradation that lasts 2-4 days. I have had 3 episodes so far. The last episode was accompanied by red itchy welts, abdominal, hip, and lower back stiffness.   3-4 weeks after the shot I experienced muscle weakness. Hard to lift and exercise.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.  It was reported that date of refrigeration  was 07-MAY-2021.
previous wounds that had not yet healed having extra bleeding; never get nosebleeds and had one unexpectedly; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 03Mar2021 09:00 (batch/lot number: EN9581) as single dose for covid-19 immunization in a workplace clinic. Medical history included ongoing wounds that had not yet healed. The patient's concomitant medications were not reported. The patient has no covid prior vaccination. The patient has no other medications in two weeks. The patient has no other vaccine in four weeks. On 04Mar2021, the patient noticed previous wounds that had not yet healed having extra bleeding. The patient informed that he also never got nosebleeds and had one unexpectedly 1 week after vaccine (Mar2021). The patient was not covid tested post vaccination. The patient had no treatment received due to the events. The outcome of the events was unknown.
patient received the pfizer covid monovalent vaccine in error and was supposed to get the pfizer covid bivalent vaccine
This patient describes having chills the same night of vaccination on 3/29/22 and reports having slight soreness in R. arm the same night. This patient reports pain was located just at the  site of injection and denies having redness, or feeling warmth or heat over injection site but reports having slight swelling and states pain continued and worsened on 4/2/22 and reports being unable to move or raise his R. arm due to the pain on 4/2/22.  This employee called his physician on 4/4/22 and states he was prescribed steroidal medication methylprednisolone QD for 6 days. This employee states since taking the medication his pain has resolved.
Was admitted to hospital from 8/27/21 - 8/30/21 due to COVID pneumonia and pulmonary embolism.  Another hospital admit 9/13/21 due to CVA and seizure.
Itching, rash, large hive ("baseball-sized") swelling on the injection arm.
He received a monovalent vaccine and he should have received a bivalent booster dose. No adverse reactions noted.
Redness about size of quarter 10 minutes after injection.  Resolved when call 8PM same day applied ice.
vials were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again).    No concomitant medication was reported.  Nurse reported that 100 bivalent boosters were given a day before reporting from vials that were put in the fridge and after that refrozen and thawed again.  No treatment information was provided.  This case contains information for the 85 of 100 adult male patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Patient was feeling nauseated, tired, shaking, having tingling in extremities, kept trying to close their eyes.  Gave some orange juice and crackers and was able to keep them awake.
Possible anaphylactic shock, acute kidney injury, shock liver, hypotension, rash, thrombocytopenia. Full body rash, abdominal pain, vomiting, diarrhea, RLE pain, fever, dizziness, body aches, headache. Sx onset 06/26/2021 after receiving COVID vaccine #2 the same day. Pt went to medical facility on 06/30/2021 and was sent to ED. Pt admitted to ICU 06/30 - 07/02. Transferred to general medical floor on 07/02/2021.
Small Bowel obstruction; ED visit, surgery and hospitalization. Patient died during hospitalization. These events were within 6 weeks of receiving COVID vaccine.
Swelling and redness at the site with a severe rash 2 weeks after the vaccination was given.
There was a malfunction with they syringe.  Upon injection the syringe detached and the content spilled on patient arm and clothes.  I cannot estimate the exact amount, but suspect more than 50 percent.    Patient said she believes she did not get any of the medication.  The patient did not have any adverse events.    I'm not sure if its needed to fill this form out for a device malfunction but I'm doing it in case it is required.