chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient ID:   77 y.o.    Admit Date:  7/5/2022   Discharge Date: 7/8/22   Principal Dx/ Final Dx: Acute respiratory failure with hypoxia   Relevant Inpt Dx: Principal Problem:   Acute respiratory failure with hypoxia Active Problems:   NSCLC metastatic to peritoneum   AKI (acute kidney injury)   Diarrhea   Pericardial effusion   PAD (peripheral artery disease)   HTN (hypertension)       HPI:   Hospital Course:   This 77 year old man with metastatic lung cancer was admitted with symptoms of covid.  He has received paxlovid outpatient but was hypoxic and had diarrhea and aki.  He was admitted and did receive ivf.  He did get remdesivir and steroids.  He is improved and says heis breathing is at baseline.  Diarrhea has resolve.  AKI is improved with hydration.  He had CTA chest that showed chronic issues.  No PE.  He does have known pericardial effusion and had echo but no sign of tamponade.  He remains stable and will go home on steroids.  Follow up with pcp and oncology        Consults:   None       Disposition:  home   Discharge Condition:  fair
Tenderness below and on the side of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness below and on the side of the injection site) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INSULIN, AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ROSUVASTATIN, HYDRALAZINE and VITAMIN D NOS for an unknown indication.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tenderness below and on the side of the injection site). At the time of the report, TENDERNESS (Tenderness below and on the side of the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Immediately after vaccination, I developed severe polyhydramnios that led bi-weekly non-stress tests and ultrasounds,  breech presentation and eventual C section delivery at 37 weeks.   I also developed an allergy to eggs and dairy post vaccination.
Pain and swelling at injection site (right deltoid), pain in anterior axillary lymph nodes, headache
All the normal like having the flu for a day or two after second dose; Fever after second dose; Chills after second dose; Headache after second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (All the normal like having the flu for a day or two after second dose), PYREXIA (Fever after second dose), CHILLS (Chills after second dose) and HEADACHE (Headache after second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (All the normal like having the flu for a day or two after second dose), PYREXIA (Fever after second dose), CHILLS (Chills after second dose) and HEADACHE (Headache after second dose). At the time of the report, INFLUENZA (All the normal like having the flu for a day or two after second dose), PYREXIA (Fever after second dose), CHILLS (Chills after second dose) and HEADACHE (Headache after second dose) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-281108 (Patient Link).
Nausea and dizziness immediately, rash on forearm 24 hours after vaccine
pt was given first injection with air only.  was caught after and patient received vaccine in 2nd injection
01/15/2021 - Smelled Metallic oder from vagina all day when I went to bathroom 01/16/2021 - Started to spot bleed 01/23/2021- Started bleeding all the time 02/22/2021 - Made an appointment with OB/GYN for March 1, 2021 03/01/2021 - Stopped Bleeding 05/16/2021 - Started Bleeding 06/05/2021 - Stopped Bleeding 06/15/2021 - Started Bleeding 06/25/2021 - Stopped Bleeding 07/03/2021 - Started Bleeding 07/07/2021 - Stopped Bleeding 07/16/2021 - Started Bleeding 07/21/2021 - Stopped Bleeding 08/17/2021 - Started Bleeding after Dr  did Endometruim Biopsy 09/01/2021 - Stopped Bleeding 09/05/2021 - Started Bleeding 08/23/2021 - Dr told me that legally he can not say that my bleeding is from the Covid 19 Vaccination Shot, but it more than likely is the cause of it.  He said , he has heard of many other women has also experiences these issues.
No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medication was reported.     27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was reported.  This case contains information for the 21 of 27 adult patients described by the reporter.
menveo lyophilized part with reconstituted with the diluent of shingrix; menveo lyophilized part with reconstituted with the diluent of shingrix; menveo lyophilized part with reconstituted with the diluent of shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number AMVA751A, expiry date 30-NOV-2023) and (batch number NF442, expiry date 05-OCT-2023) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: menveo lyophilized part with reconstituted with the diluent of shingrix), wrong solution used in drug reconstitution (Verbatim: menveo lyophilized part with reconstituted with the diluent of shingrix) and inappropriate dose of vaccine administered (Verbatim: menveo lyophilized part with reconstituted with the diluent of shingrix). The outcome of the inappropriate preparation of medication, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 6-Jun-2023 The reporter consented to follow-up. The patient received a dose of a menveo lyophilized part with reconstituted with the diluent of shingrix, which led to inappropriate preparation of medication, wrong solution in drug reconstitution and inappropriate dose of vaccine administered.
X-ray 12/18/09. Chronic rotator cuff tendinopathy (left) above the greater tuberosity of the left humerus near the insertion of the rotator cuff. Pain started off slowly and increased over time and spread to up per shoulder and back of shoulder.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient became pale in color while sitting in the chair following the Pfizer Covid shot.  He said he felt nauseas and then laid on the floor.  He was sweating and complained of chest pain.  He then said his arms felt tingling.  911 was called immediately.  Wet rag was applied to his forehead and 2 pharmacists stayed with him until EMS arrived. The sypmtoms began midway thru the 15 minute waiting period.  He said he had not had any food today.
Fatigue and low grade fever started 5/21 about 24 hours. Arm sore as well. Felt tingly skin n chest and stomach for 3 days. That has quit now. 5/24. Continued having low grade temp between 99 and 101 still on 5/25. No real appetite but probably due to fever. Can smell and taste. Just curious as to how much longer temp will continue to come and go? Assume fatigue is tied to fever.
pt recv vax 27APR98 & pt was found to be pregnant;LMP was 27MAR98;Estimated delivery date is 21DEC98;pregnancy was confirmed by UA on 27APR98;pt began spotting vaginally 2 days p/confirmation of pregnancy;noted elective abortion desired;ect
4/22/08-Developed rash on thighs & c/o aches.  4/23/08-Rt. side of face & neck swollen, rash resolved.  4/25/08-Rt cheek & gland under rt ear swollen.  Referred to ENT, Dr and who diagnosed her with viral parotitis.
4/30 ER triage assessment: Patient ambulated into ER FT#3 Reports whole body aches since got COVID shot Wednesday Not appetite; denies N//V/D, fever or cough - sent to clinic 5/2 ER hpi 67 y.o. male who presents with UPPER ABDOMINAL CRAMPING AND CONSTIPATION.  PT STATES ABDOMINAL CRAMPING STARTED THIS MORNING AND CONSTIPATION STARTED 3 DAYS AGO.  PT HAS TAKEN MIRALAX WITH NO RELIEF. triage assess: To ER with c/o not feeling well since had Covid vaccine last week just feel yucky not much of appetite this AM started having abdomen pain right upper quadrant across to mid abdomen last BM three days ago Took Miralax last night no results yet pain worse with ambulance ride no facial grimaces noted with palpation active bowel sounds noted.Saline lock right hand site clear.
On 9/29/2020, pt reported that she has been experiencing mid-lower arm pain that she described as nerve pain since her immunization on 8/20/2020.
Dibilitating reaction in left arm, unable to use arm at all approx 2-3 hours after injection. Injection given high at shoulder joint. MRI revealed tears in tendon, edema and fluid. At this time mobility restored in arm with bursitis and pain.
Started  the day after my second shot with chills, headache, and a sore throat. Sore throat progressed to something similar to laryngitis- coughing, sore throat, no voice (10/12/21). Eventually moved to my eyes making them red and puffy (10/15/21)
5 x 3 cm erythemic area around shot site. Right arm No Rx except cold compress and PO Benadryl PM.
I woke up stiff and had a difficult time moving all day yesterday.  It felt like I had an adrenaline rush like the type you get from having a car accident.  I tried using Tylenol and it did not relieve the stiffness and pain.  Plus there was extreme fatigue.  Conditions are much better today.
No adverse effects reported; The patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistance concerning to a 5 year old patient. The patient medical history, concurrent conditions and concomitant medications were not reported.     On 15-JUL-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # R023513 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) expiration date reported and establish as 16-AUG-2020) (strength, dose, frequency and route of administration were not reported); it was reported that a sterile diluent properly stored was used to reconstituted the varicella virus vaccine live (oka/merck) (VARIVAX).        The administered dose of the vaccine experienced a temperature of -14° to -10° Celsius (C) for 46 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect was reported.; Sender's Comments:  US-009507513-1909USA006939: US-009507513-1909USA007177: US-009507513-1909USA007118:
Pt recvd vax & 3 days afterwards was dx w/viral meningitis like sx which lasted 1 1/2 wks;
Breakthrough case admission after 3 vaccines ] Pfizer 1/25/21 Lot# EL9265;  Pfizer 2/19/21 Lot# EN6200;  Pfizer 10/20/21 Lot# 301258A
PAIN, TENDERNESS AND SWELLING OF THE LYMPH NODE AT LEFT SIDE: ABOVE CLAVICLE BONE, LOWERSIDE OF LEFTSIDE  NECK AREA.
Local AE: Pain at injection site, bad enough to prevent normal movement (rate 6.5/10)  Systemic AE: moderate headache, moderate fatigue, chills I'm taking ibuprofen and it helps with all the side effects.
Hello, i took the Moderna 1/4 and am scheduled for 2nd shot 2/1. I just wanted to pass on some side effects and i did not go on the agency website which i should have to report them. I had a headache off and on the first week. the first day afterward i had a 100 degree fever as well. I never have sleep issues (falling asleep etc) i had insomnia and could not sleep and didnt sleep well for around a week. What i noticed most though is it really affected my stomach and i was awakened with acid reflux several times. the muscles of my stomach were sore like i had been coughing (but hadn't) and i had no desire for food, only fruit, light watery things. as soon as i eat anything i have stomach pain digesting. Since last weekend i sleep way too much, even if i set the alarm i turn it off and keep sleeping. I try to walk and get out.  when i wake up it seems my stomach has been really active, i have a horrible taste in my mouth and acid reflux liquid in my through.  Just letting you know; and I have the 2nd shot so fingers crossed i'll come through all of this. Take care as well. Thanks
Patient is a 71 year old male with a PMH significant for COPD, Hep C, HTN, and PE presents for worsening sob since last wed. He reports that he received his Covid vaccination last week but does not think that the two are causally related.  He denies fevers but reports chills.  No loss of taste or smell but decreased appetite.  No diarrhea.  He does have a history of COPD but no reported home oxygen use.  Slightly hypoxic in ED.
No additional AE information provided; HCP states that a pediatric patient received a dose of PROQUAD and a dose of VARIVAX on the same date: 01AUG2022; This spontaneous report was received from a physician referring to a pediatric patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 01-AUG-2022, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (strength and route for both vaccines were not provided) for prophylaxis (Overdose). Lot numbers and expiration dates were unknown by the physician at time of call. No additional adverse event (AE) information provided.
Fatigue- started 02/02/2021 morning - currently experiencing muscle ache (shoulders and arms)- started 02/02/2021 - ended 02/06/2021. Teeth hurt when tongue touched their teeth- started 02/05/2021 - ended 02/06/2021 Headache- started 02/05/2021 - ended 02/06/2021 Chills- started 02/05/2021 - currently experiencing Fever- started 02/05/2021 - currently experiencing
Immediately after 2nd phizer shot I had horrible smelling urine for two days. Third day after 2nd shot had signs of UTI took Bactrim 5 days symptoms came back 5 days later took three more days of Bactrim. After last Bactrim August 9, I had what felt like gas pain lower right abdomen. Same pain persisted and on August 15 I went to the ER at hospital where I underwent blood tests and a CT. It was determined I had a perforated appendix and surgery was immediately performed to remove it.
Patient called pharmacy on 09/09/2020 17:15pm.  Spoke with RPH.  Told him about adverse events.  Left store on 09/08/2020 at approximately 09:15am after receiving vaccine.  Soon afterwards, arm began to swell to size of orange around injection site, with red appearance.  Patient described throbbing pain at injection site, and bad, throbbing headache.  She also said that she became very lethargic.  Spent most of the afternoon with spouse at doctor's appointment.  Headache had subsided until she got back home.  At 21:00, she said that headache and arm were both throbbing worse than before.  She took some Tylenol Arthritis and used a heating pad.  CD instructed her to take Ibuprofen 400<CONTINUED ON PAGE 2>
pt recv vax; 5 days p/ DT adm, was indurated & erythematous;erythema was 5 1/2 by 3 3/4 cm; induration 2x2;
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reproted the 26 patients received doses of VARIVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Breakthrough case admission after 3 vaccines Pfizer 4/21/21 lot# EW0162;  Pfizer 5/12/21 lot# EW0172;  Pfizer 12/15/21 lot# 33038D
Patient received    6/8/2021 Given 0.5 mL Lt deltoid IM MOD 034C21A Moderna COVID-19 Vaccine (EUA)  History  5/4/2021 Given 0.5 mL L Deltoid IM MOD 002C21A Moderna COVID-19 Vaccine (EUA)  completed full vaccination for COVID with moderna and tested positive for COVID-19 on 7/13/21 with mild COVID symptoms. His other family members also tested positive for COVID
THE VACCINE WAS DILUTED WITH SALINE FROM A SINGLE-DOSE VIAL THAT HAD BEEN PREVIOUSLY PUNCTURED. TYPICAL PROTOCOL IS TO USE A SINGLE DOSE VIAL. CORRECT AMOUNT WAS GIVEN AND ASEPTIC TECHNIQUE WAS USED AS WELL AS A NEW NEEDLE WAS USED TO PUNCTURE THE VIAL.
patient born in 2019 was administrated with a partial dose of Havrix for adult; patient born in 2019 was administrated with a partial dose of Havrix for adult; This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 19-month-old male patient who received HAV (Havrix adult) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 28th April 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and inappropriate age at vaccine administration. On an unknown date, the outcome of the adult product administered to child and inappropriate age at vaccine administration 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 details was reported as follows: The patient received a dose of Havrix, administrated with a partial dose of Havrix for adult, which led to adult product administered to child and inappropriate dose of vaccine administered. No adverse event was reported . The reporter did not consent to follow-up. Note: The suspect was coded as Havrix adult conservatively as per source document narrative and regarding suspect confirmation clarification mail was marked by Hub not received any response.
Patient called 4 hours later to say she cannot move her arm. Immunization was given correctly.
A week after the vaccination, caller had a blood infection; experiencing urinary symptoms; still has to go to the bathroom every 5 minutes because i can not hold it even if she tried¨, this has never happened; Last week she has a nosebleed; i had never had none of this problems in my life¨; Constipation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (A week after the vaccination, caller had a blood infection), URINARY TRACT INFECTION (experiencing urinary symptoms), DYSURIA (still has to go to the bathroom every 5 minutes because i can not hold it even if she tried¨, this has never happened), EPISTAXIS (Last week she has a nosebleed) and FEELING ABNORMAL (i had never had none of this problems in my life¨) in a 60-year-old female patient 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.     Concomitant products included SALBUTAMOL (VENTOLINE [SALBUTAMOL]), TIOTROPIUM BROMIDE (SPIRIVA) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (A week after the vaccination, caller had a blood infection), URINARY TRACT INFECTION (experiencing urinary symptoms), DYSURIA (still has to go to the bathroom every 5 minutes because i can not hold it even if she tried¨, this has never happened), EPISTAXIS (Last week she has a nosebleed), FEELING ABNORMAL (i had never had none of this problems in my life¨) and CONSTIPATION (Constipation). The patient was treated with CIPROFLOXACIN at a dose of 500 mg, 5 days; CEPHALEXIN [CEFALEXIN] at a dose of 500 mg for 5 days and PERMETHRIN at an unspecified dose and frequency. At the time of the report, INFECTION (A week after the vaccination, caller had a blood infection), URINARY TRACT INFECTION (experiencing urinary symptoms), DYSURIA (still has to go to the bathroom every 5 minutes because i can not hold it even if she tried¨, this has never happened), EPISTAXIS (Last week she has a nosebleed), FEELING ABNORMAL (i had never had none of this problems in my life¨) and CONSTIPATION (Constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include blood pressure medication.   Treatment medication include Medication for constipation.   This case was linked to MOD-2021-073259, MOD-2021-073241.
Patient received vaccine at2:25 and was advised to stay in store for 15 minutes to monitor . After approximately 10 minutes he was leaning over reading materials and fainted. I went to patient who was stirring and he dazed but coherent. I assessed for serious anaphylactic rxn and EMT was called. They arrived in 5-10 minutes and did additional testing showing no serious concerns (blood sugar, BP, and EKG). He reported seasonal allergies that at times caused light headed feelings.   Patient decided he did not wish to go to ER and left with his companion. No further reports at this time