chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was an unfortunate 68-year-old female with history of gradual clinical decline over the past year or so.  Complaints included weight loss, weakness, and shortness of breath.  She was diagnosed with a small pulmonary embolism in August.  She was placed on anticoagulation for this.  She had an extensive outpatient workup, which really did not reveal any evidence for malignancy.  She was then transferred on September 15th.  She was placed on the weaning protocol.  She developed acute lower GI bleeding, had to be transferred back  on September 17th.  Eliquis was held.  She was given Kcentra.  She was transfused.  Colonic source was suspected.  She was not felt to be a good surgical candidate.  Arterial embolization was considered.  Bleeding then stopped.  She was ultimately transferred back to Hospital on September 21st.  Extensive efforts at ventilator weaning were undertaken.  These were unsuccessful.  After discussion, it was decided to withdrawal vent support and supply comfort care.  She passed away with her family present and was pronounced dead at 11:29 a.m. on Friday, December 2, 2022.
Chest pain along with elevated troponin levels and Sinus tachycardia on EKG. Normal echocardiogram.  No MRI or CT scan performed. Treated with ibuprofen.
mom was pregnant w/child;infant was born w/lung which only works 2 percent;reporter stated that it grew enough to take the place of the other lung;one did not grow;MOC states pt kidney not the pt lung, was compromised;
Everything around my neck hurts and is getting more inflamed every day. It appears as if there were air all around it, this accompanied by a headache, chest pain, and upper chest.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022; No adverse event; vaccine 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 (vaccine administered after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) 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 (vaccine administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022).    No concomitant medications were reported.   The patient received half dose. The vial did not undergo any temperature excursions.  No treatment details were reported.
Elevated temperature of 101.7, weakness, and lethargy on 01/15/2021 Treated with 400 mg Ibuprofen Q6 hours, temperature down to 100.1 Temperature spiked to 101.3 on morning of 01/16/2021 Treated with 500mg Tylenol  All symptoms resolved completely 01/17/2021
pt recv vax 8JUL96 & c/o nausea 8-10hr p/vax;1st sx c/o fatigue from 8JUL to present;dec fatigue as of 12JUL;no fever or local rxn;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-JAN-2017, the patient was vaccinated with a first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date) in the series and then received a second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date) 5 months later on 09-JUN-2017. Additional information has been requested.
masseter muscle (gum muscle) hurts and is a little redness; hurt the muscular part of the left cheek; A spontaneous report  was received from a consumer concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hurt the muscular part of the left cheek, masseter muscle (gum muscle) hurts and is a little redness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 16 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event(s) hurt the muscular part of the left cheek . On 17 Feb 2021, the patient experienced the event(s) masseter muscle (gum muscle) hurts and is a little redness.  Treatment details includedthe muscular part of the left cheek, she put ice on it. Now the masseter muscle (gum muscle), hurts and is a little redness., Administration site: left arm, Facility: pharmacy, Consent to follow-up with safety: yes, No doctor aware for follow-up,  no.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hurt the muscular part of the left cheek was unknown.The outcome of event(s), masseter muscle (gum muscle) hurts and is a little redness was unknown..
period two weeks early; This is spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is the third of 3 reports, reporting for one of the colleagues. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Registered nurse calling regarding the COVID 19 vaccine. She was wondering if people were reporting if they got their periods early? She got her period two weeks early and mentioned she also has two colleagues who had that as well on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021002844 same reporter/drug/AE, different patient;US-PFIZER INC-2021004222 same reporter/drug/AE, different patient
as of Mon July 22, 2019 small rash at puncture site diminishing sudden sleepiness not as often digestive issues, nausea random aching in bones continues at same frequency
Admission Date: 7/5/2022 Discharge Date: Jul 7, 2022  1. COVID-19  2. Hypoxia  3. AKI (acute kidney injury) (HCC)  HOSPITAL COURSE 63-year-old gentleman presented with weakness and dehydration.  Had been experiencing several days of fatigue and poor appetite.  Diarrhea one week ago.  No fevers.  Continued his Lasix and Hyzaar while he was ill.  Patient had had a COVID test that was positive on 07/05.  In the ER, creatinine elevated to 1.96 (baseline 1.0-1.2).  D-dimer was normal.  CRP elevated at 15.0.  He was admitted for IV fluids.  Steroids and remdesivir not necessary.  He never required more oxygen than his baseline 2 L. The following day the patient felt much better.  He felt like he was much stronger and back to his baseline (baseline is the use of a wheelchair).  He was eating and drinking well.  He would like to go home.  Creatinine is improved but not back to baseline.  It is 1.42 today.  I have every reason to believe this will continue to improve back to his baseline.  I have told him not to take his Hyzaar or Lasix for the next three days.  He can resume them on Monday 7/11.  I have also sent on order for a BMP to be drawn on 07/11 with results to his cardiologist.
Post vax, the pt developed malaise. The pt recovered. This is 1 of 2 pts from this facility who experienced this event following receipt of vax.
administration of an expired vaccine; second dose administered >36 days after the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered >36 days after the first dose) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 012H21B and 012H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered >36 days after the first dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of an expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered >36 days after the first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: positive (Positive) POSITIVE. On 04-Jan-2022, SARS-CoV-2 test: positive (Positive) POSITIVE.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient received Second dose which was expired. The Patient had not experienced any symptoms after receiving the expired dose.  The patient was tested and also diagnosed with COVID on 18-Jan-2021 and 04-Jan-2022.   The patient not had known allergies. The patient also not had any history relating to mentioned events and both acute and Chronic illnesses at the time of vaccination. The patient not received any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  No concomitant medications was reported. No treatment drug details was reported.
FAINTED 25 MINUTES AFTER LEAVING DSHS OFFICE. SEEN IN EMERGENCY ROOM AFTER SHE FELL AND HIT HEAD ON FLOOR IN RESTAURANT.
c/o heart racing/SOB Narrative:  Pt was send by EMS to local Ed for evaluation/
Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in cheeks, throat tightness and lethargy
The next morning my arm was red in a small quarter size spot and felt itchy. Now my arm is red, swollen, warm to the touch and is about the size of a dollar bill. It is firm to the touch in parts of it and now it loss like it is starting to turn a little purple at the bottom.
took the bandaid off / red; took the bandaid off / swollen; took the bandaid off / hot; Hurt when touched; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were recovered/resolved and the outcome of the injection site tenderness was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The next day after receiving Shingrix, the patient took the band aid off and it was red and swollen and amp, hot the exact length and width of the band aid. The patient stated that, it lasted a little over a week spreading out and lighter than the original area. The patient reported that, it hurt when touched but it did not inconvenience him/her in any way. The patient was concerned about his/her next injection due in May and asking if he/she should still receive the 2nd injection.  The patent went back to showed it to pharmacist after about a week and a couple of days after receiving Shingrix.
Pt in for 2nd dose of COVID vaccine, negative reaction to first vaccine. Pt states he felt very dizzy after the injection. Staff (not including myself) witnessed pt have vasovagal fainting response (for about 3 seconds) and he fell straight down to ground from standing position. Paramedic(s) state they heard the pt hit the ground, and responded to the nurse stn quickly. This writer was passing out water to another pt when noticed the activity happening and was beckoned to come to the nurse's stn. Pt alert at this time, has c/o HA, no N&V, states does feel some dizziness, v/s 144/92, O2= 98%, R=16, responds to commands but keeps asking ?What happened? ? hand strength is stable, pupils are equal and reactive to light, no bleeding of head,ears, nose,etc, noted. Ice pack applied to pt?s forehead, does have profuse sweating. No significant medical hx, no allergies. 1205pm: 133/84, p=87, O2= 98% R 16, aware of name/ place/location, but continues to ask ?what happened?, no LOC noted. Advised team to call 911, pt needs to go for further exam of head injury, though he remains stable and alert. GF of pt unable to drive pt because she doesn't know how to drive stick shift. 1210pm: 135/86, p 94, R 16, 02 sat 98%, pt remains alert, sweating has stopped,denies dizziness at this time, does continue to say that ?back of head hurts? 1220pm paramedics have arrived, BP 128/68, p 85, R 16, 02 sat 98%. Assessment done by paramedics. Pt to go to hospital via ambulance, 1225pm pt left via gurney to ER. GF waiting for a ride for someone to come drive the car for her to meet pt at ER. Pt left alert, slowly starting to remember that he fell after injection he states.
Pt developed headache and photophobia 5-6 days post vaccination. Was hospitalized. LP and CT scan done-no encephalitis-discharged post 2 days.
Redness @ site, swelled & then arm swelled signigicant to fingers; lasted aprpox 1 1/2 days; arm was splotched w/red all over;
An expired Covid-19 pfizer vaccine was administered to the patient on 4/29/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Left messages on 5-9,5-10, and 5-11 for patient to return our calls.
Achy/Sore muscles all over my body including feet, ankles, hands.  Lethargy and  extreme chills for 4 hrs . Involuntary shaking for about 45 min at about 2:30-3:30 am.  Headache.
Patient had nausea for more than 3 days. Patient had soreness, redness and Swelling where the shot was given for more than 3 days.
Arm pain for 2 days  on a 7 of 10 pain scale. Swollen lymph nodes under the arm where vaccine was administer
The reactions after the vaccine that I had were nausea, fatigue, head spins. I couldn't keep anything down. It lasted until 04/04/21. I did not go see a doctor.
about 24 to 36 hours after vaccination, after a low grade fever and some chills, I developed a large lump under my left armpit.  This large swelling remained for about a week,  and once it diminished, there is still palpable inflamation of lymphnodes and tissues under arm.  Additionally, about 1 week after vaccine, significant Tinnitus and a feeling of pressure in the left ear started, and is still continuing
Pt received moderna bivalent and flublok vaccine. She reported having tightness in chest, unable to take a deep breath and a feeling of anxiety. Gave patient 1 shot of epipen in thigh, after 5-10 min she still was having chest tightness, gave 50 mg (1ml) of benadryl IM in arm. Within in 1 minute patient was feeling better and could breath normally. Recommended going to hospital, pt refused.
I woke up with thigh pain. 48 hours later I had a sore throat, fatigue, and difficulty swallowing. I tested positive for COVID-19 at home. I call a clinic and they prescribed me Paxlovid. I think it helped with my symptoms. I had to go to the ER 2 days later because the sore throat got so bad. They gave me a steroid, inhaler, Decadron, and throat lounges. My throat was slowing getting better, but I still get fatigue easily.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 26.12  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
After inject pt felt dizzy and lost consciousness for a couple moments before becoming alert.  Pt sat and began to feel better after about 5-10 minutes.
Patient woke up and felt lightheaded, dizzy, questionable loss of conscious, tachycardia, hypertensive, confused. Patient was found with her head on her steering wheel asleep while at a stop light. She was brought to the ER and then admitted to ICU.
3 days after my first dose of Pfizer I started getting really bad cramps right where my ovaries are. First it started on my right side and after a few minutes the cramps started on my left side. It lasted about 30 minutes. During that time I started also getting tight chest pain and with every breath I took there was more tightness and a sharp feeling. Chest pain lasted about 15 minutes. I continued to get cramps right on both sides where my ovaries are located every few days from the first initial day. As I am writing these side effects of right now it has been a month since my first dose.
This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (Inflammation in the upper arm), DIZZINESS (dizziness), BALANCE DISORDER (loss of equilibrium and fall in two instances), HYPOAESTHESIA (Sleeping foot) and ARTHRITIS (Inflammation in the elbow) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation in the upper arm), DIZZINESS (dizziness), BALANCE DISORDER (loss of equilibrium and fall in two instances), HYPOAESTHESIA (Sleeping foot), ARTHRITIS (Inflammation in the elbow), PAIN IN EXTREMITY (pain in the left hand  is increasing), ARTHRALGIA (left shoulder blade hurts) and MYALGIA (body aches). At the time of the report, INFLAMMATION (Inflammation in the upper arm), DIZZINESS (dizziness), BALANCE DISORDER (loss of equilibrium and fall in two instances), HYPOAESTHESIA (Sleeping foot), ARTHRITIS (Inflammation in the elbow), PAIN IN EXTREMITY (pain in the left hand  is increasing), ARTHRALGIA (left shoulder blade hurts) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. On an unknown date, the patient underwent some laboratory tests like blood test, urine test and x-rays and revealed to be normal, except that they had a little blood in urine. HCP prescribed treatment medication. This case was linked to MOD-2021-309675 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: significant follow up appended. Translation document updated the events. Which includes Inflammation, Dizziness, balance disorder, hypoaesthesia, arthritis, pain in extremity, arthralgia, myalgia.
Noted red, warm sore area on Lt. deltoid (upper arm). Swollen, tender.
Guillain Barre synd. the pt recvd flu vax 93-94 formula on 5Nov93, subseqently pt developed GBS and was hospitalized for tx in Jan94. This ia a serious labelled event.
the pt fainted for a couple of seconds after receiving the shot.   I gave the shot and was disposing of the items and caught the pt slumping over out of the corner of my eye.  the pt slumped over and out of the chair.  the pt had fainted for maybe a few second and was awake right away.  I questioned the pt as to his surrounding and he was alert.   the mother and I watched over the pt for about 15 to 20 minutes after the incident.  the mother was not surprised and told me after this happened that it tends to run in the family. mother she was not concerned and was told that if anything else happened to seek medical help
Shot was not given in the deltoid. Injection was given in wrong location. Caused are to be red, swollen and warm to touch. Greater care to ensure proper location used for giving an IM.