chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We administered the first dose of the Pfizer COVID19 vaccine to a patient at approximately 3:34pm on 8/8/2021. The vial we used (Lot EW0198, EXP 9/2021) was first put in the fridge on 7/26/21 and good until 8/26/2021. We had taken the vial out of the fridge at 11:59am, and reconstituted it approximately 12:15pm (when the vial was at room temperature). This shot was the 4th used out of the vial today, and standard sanitation practices were followed throughout the day (alcohol swabs used at every entry into the vial). None of the previous patients experienced any side effects. The patient filled out an online survey, and when I reviewed the sheet with her, she mentioned she was nervous with needles. I offered to give the shot myself (rather than a technician), and she agreed. When I administered the shot, she asked "was that all?" because she had no pain. She was laughing at how she was nervous and felt fine. I advised her to sit for 15 minutes in the waiting area. She looked like her face was red when I checked, but she was talking with her mom and they didn't seem worried. Her Mom approached the window about 5 minutes after the shot, and said she wasn't feeling well. I went out, and she said her vision was weird and she was hot. I stated I was going toget an epi pen. I ran to the drawer where we keep the epi pen (while I was running, I instructed our technician  to call 911, which she did), and I pulled out a 2 pack of the generic epinephrine pens, and went back to the patient. At this point, she had lost consciousness and her mom was holding her up. The first epi pen I could not get the lid off, so I threw it aside and grabbed another. I was able to pull the pin, twist off the lid, and administer it. (LOT 037H20AA, EXP 05/2022 - NDC 00093-5986-27). The patient was alert and feeling fine within 5-10 seconds after giving the epi pen. I disposed of both pens in the sharps container. EMS came within 5-10 minutes, at which point I told them what happened and that I administered an EPI PEN (not a HIPAA violation as it was for treatment purposes). They stated that they would take her to the hospital because we used an epi pen.
uncontrollable crying >2 1/2hr;no fever, no dyspnea;directed to got to Er, where they were given APAP for fever if it arised, leg was splinted
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# L013429, expiration date: 21-JUL-2017 or lot# reported as L020015, expiration date: 16-AUG-2017 or lot# L025737, expiration date: 28-JUL-2017) (dose and route of administration were not reported). No adverse effect was reported. There was no product quality complaint. This is one of several reports from the same reporter. Additional information has been requested.
SHINGLES; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
cold symptoms; flu like symptoms; sore throat; episodes of nose bleeds (lasting 45 minutes); feels like throat is closing; can't breath; horrible arm pain; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold symptoms), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (sore throat), EPISTAXIS (episodes of nose bleeds (lasting 45 minutes)) and THROAT TIGHTNESS (feels like throat is closing) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced NASOPHARYNGITIS (cold symptoms), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (sore throat), EPISTAXIS (episodes of nose bleeds (lasting 45 minutes)), THROAT TIGHTNESS (feels like throat is closing), DYSPNOEA (can't breath), MYALGIA (horrible arm pain) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Apr-2021, MYALGIA (horrible arm pain) had resolved. At the time of the report, NASOPHARYNGITIS (cold symptoms), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (sore throat), EPISTAXIS (episodes of nose bleeds (lasting 45 minutes)), THROAT TIGHTNESS (feels like throat is closing), DYSPNOEA (can't breath) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment includes cough medication.
Her lips began to feel tingly and became swollen. She also reported a mild headache. Laid supine for about 30 minutes. After which she reports all symptoms resolved.
Patient fainted and fell to the floor several minutes after receiving the Hep B vaccine (#3) and sustained a head injury. The patient went into a seizure and cardiopulmonary arrest and CPR was not successful. Follow Up: frontal lobe contusion, cerebral hemorrhage, cerebral edema Autopsy report received which revealed COD as blunt head trauma, occipital scalp contusion, contre-coup contusions, 10-ml subarachnoid hemorrhage of right frontal region, cerebral edema and transtentorial herniation.
Arm very sore for first 24 hours; extreme fatigue.  Brain fog started on Sunday and continues (I received the vaccine on April 3rd at (9:25am).  Shortness of breath on day 2, with brain fog.  Day 3 - continued brain fog....although not as bad as Day 2 - but it is preventing me from normal activity.
Patient experienced redness above injection sites and raised area she considered like hives towards the neck and not at injection site of right arm where she got PREVNAR. Said there were red lines. Experienced within an hour of getting shot. Reported it around 4 in afternoon. Advised to contact Dr after making sure no difficulty breathing. Told her they would probably suggest BENADRYL and that is what MD told her. She took BENADRYL. Pharmacist called her at 8 PM and she was better but tired. Not itching as much.
Pain started 3 days after shot, swelling, neck pain, shoulder pain, then every day my range of motion was limited. Went to the doctor could see swelling told me to go to physical therapy. I started in December and I'm still going. Swelling has decreased but I still have pain and limited motion when I raise my arm to the side or lift anything.
Pt recvd vax 19OCT92 & 21OCT92 devel fever of 104 & an urticarial rash;
Nausea; diaphoretic; tingling legs (suffers from anxiety). Evaluated by EMS-Cleared.
Completed 15 min observation; as exiting felt flush, and hot wanted to sit; sat down and slumped over; Daughter called help; No Bp or O2 measurable; felt cool and clammy to touch; chest rises with breathing; eyes open and blinking but not responding to questions asked; performed sternal rub, did not react; Rapid response notified;Connected to monitor; aganol respiration noted,Transferred to stretcher. lips turned purple; bag mask placed and bagged respirations; approx 15 chest compressions performed, responded to compressions; Started to breath and color returned to face. Immediate transfer to ED.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. There were no medical history and concurrent condition reported. On 21-APR-2015 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # reported as K025759, Expiration Date 08-JUN-2016, dose and route not provided). There was no concomitant medication reported. No adverse effect reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Clinical course: It was reported that patient took Paxlovid as COVID-19 treatment from 07Apr2023 to 12Apr2023. Other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300161988 same patient, different drug, different event;
Mild flu like symptoms; Arm Soreness; Doses from temperature excursion were administered; Doses from temperature excursion were administered; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild flu like symptoms), PAIN IN EXTREMITY (Arm Soreness), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses from temperature excursion were administered) and POOR QUALITY PRODUCT ADMINISTERED (Doses from temperature excursion were administered) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     It was unknown that patient had ever been diagnosed with or tested positive for COVID-19. It was unknown that patient had any acute illness at the time of vaccination or a month before.  Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, GERD, Drug allergy (Quinine), Drug allergy (Sulfa), Drug allergy (codeine), Contrast media allergy and Drug allergy (Hydrocodone-APAP).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 09-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses from temperature excursion were administered). On 09-May-2022 at 9:30 AM, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses from temperature excursion were administered). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Mild flu like symptoms) and PAIN IN EXTREMITY (Arm Soreness). At the time of the report, INFLUENZA LIKE ILLNESS (Mild flu like symptoms), PAIN IN EXTREMITY (Arm Soreness), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses from temperature excursion were administered) and POOR QUALITY PRODUCT ADMINISTERED (Doses from temperature excursion were administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The reporter stated that the temperature excursion occurred on 09-May-2022 at 9:30 AM.   Storage condition at the time of the excursion was reported as refrigerated storage. Maximum 8.6 C and minimum 5.1C temperature were reached. Excursion duration was reported as 15 minutes.  Date vial(s) moved from freezer to refrigerator was unknown. Number of vials/doses impacted was unknown. Vials are now returned to and stored in refrigerator. Visual inspection noting any vaccine state change: No No previous excursion was reported.  It was reported that the patient only experienced mild flu like symptoms and arm soreness as expected.  Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2022: Follow up received. Case validity updated. Patient demographics, dose details, additional events and medical history were added.
After getting my vaccine I got a headache on both side of my head for seven days; This is a spontaneous report from a non-contactable physician, the patient. A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via an unknown route of administration on an unknown date as a single dose for COVID-19 vaccination.  The patient's medical history was unknown. The patient's concomitant medications were not reported. The  patient reported that "after getting my vaccine, I got a headache on both sides of my head for seven days." The event was reported as non-serious. Treatment for headache was unknown. The clinical outcome of headache was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
weak; sleeping; headaches; sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), ASTHENIA (weak), SOMNOLENCE (sleeping) and HEADACHE (headaches) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included TRIAMTERENE, ATORVASTATIN, NORTRIPTYLINE, METFORMIN, MELOXICAM, OMEPRAZOLE, GABAPENTIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and MULTIVITAMIN IRON for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced HYPERHIDROSIS (sweating) and HEADACHE (headaches). On 22-Apr-2021, the patient experienced ASTHENIA (weak) and SOMNOLENCE (sleeping). At the time of the report, HYPERHIDROSIS (sweating) and HEADACHE (headaches) outcome was unknown and ASTHENIA (weak) and SOMNOLENCE (sleeping) had not resolved.            Concomitant medications includes Stool softener daily along with above mentioned medications. No treatment drugs were reported. Consumer states he did not have any symptoms after his first dose that he received on 24-Mar-2021,Consumer calling in today, 23Apr2021, reporting symptoms her husband is having following his second dose. He received his second dose on 21Apr2021 in his right arm, lot number 030B21A, expiration unknown (01Jan1900), and that night began having sweating and headaches. Consumer states he had to call in to work yesterday and today because he is still having weakness and sleeping. States she is going to call his doctor today and he has not taken anything for symptoms, just his regular medication but has not taken that yet today.
awoke w/rt ear strange sensation on 5NOV92; had flu shot in AM; 6NOV had sore ear & dizziness which became progressively worse on 9NOV rt side of face paralysis w/vertigo, n/v; 21NOV went to ER for hydration; 26NOV hospitalized
Stomach cramping, diarrhea, nausea, vomiting, headache, and fatigue.
12/07/2023, After I had the vaccine, I had a terrible pain in my left arm for the next few days. With all the other Pfizer shots I did not have that reaction or any reaction.  On 01/26/2023, I left on a trip for several days with friend. After a few different flights. After a flight on 02/7/2023, a few days after the flight, I started notice symptoms. I started feeling like I was getting a cold, sore throat, and my nose was running, and I was somewhat fatigued. And then it got worse. 02/11/2023, I decided to do a COVID-19 Home test. The negative line was very strong and there was a very faint positive line. So, I retested on 02/13/2023, the positive line was much stronger. I began to self-isolate. I saw a doctor on a ship and he did another COVID-19 test and the result was positive on 02/13/2023.  The doctor said I should self-isolate, and he gave me some antihistamine pills. The next day, 02/14/2023 I went back to see him again because the sore throat got worse. It was difficult to swallow. And the doctor just gave me sore throat lozenges.  The doctor tested the functionality of my lungs, he said that my lungs were clear. 12/07/2023, After I had the vaccine, I had a terrible pain in my left arm the next few days. With all the other Pfizer shots I did not have that reaction or any reaction.  I seem to have more muscle aches when I get up in the morning or if I have been sitting for a while, when I get up.  I am not sure if it is an effect of the COVID-19 infection. I had a checkup, mid-March, with my doctor and he said that was common after a COVID-19 infection. I am still gradually gaining my strength back to take long walks.
Nausea; This is a spontaneous report from a contactable other hcp, the patient. This 23-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK9231), intramuscularly in the left arm on 07Jan2021 at 10:00 (at the age of 23-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). On 07Jan2021 at 10:15, the patient experienced nausea. No therapeutic measures were taken as a result of the events. The clinical outcome of the nausea was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient had 2 inch wide raised, hard, and inflamed area where vaccine was given. It started to turn purple. Patient was monitored for 30 minutes and told to take Benadryl when she went home. She did not want to take Benadryl in the store because she was worried she would get drowsy before she got home. Only issue was inflamed area.
extremely tired; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (extremely tired) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B1A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills). On 09-Apr-2021, the patient experienced FATIGUE (extremely tired). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (extremely tired) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history reported. No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Had MMR and TB test on 5/30/2003.  Started having sore throat on right side, head and neck pain at 2:00 PM, 6/4/2003.  By 10:00 PM 6/4/2003, had  joint pain in arms and legs, groin, neck and back pain, headache, low-grade fever (99.6 F).  Fever and headache subsided by 12:00 PM 06/05/2003.  Joint pain is still present, but much improved 06/06/2003.
I had been traveling including flying. Initially I only had sneezing so I decided to use a home COVID-19 test, it came positive. Once it came positive I called my doctor and although I was traveling I was able to get a prescription for PAXLOVID and start it that evening.
Fever of 101.9 started about 20 hours after vaccine given, lasted about 12 hours. Lethargy started 20 hours after vaccine and continued into about 48 hours after vaccine Injections site soreness started about 2 hours vaccine Swelling/warmth at injection site started about 48 hours after vaccine Swollen/painful lymph node in life axilla (arm of injection) started about 48 hours after vaccine
Her arm swelled up. She had headaches, chills, cough and extreme fatigue. It took 3 days for it to disappear.  She did a virtual visit with urgent care.  Stayed at home and rested for 3 days.
The day after receiving vaccination, the employee complained of stinging sensation at vaccination site, per an RN at our facility. Four days after vaccination employee was noted to have rash. RN inquired about rash, and employee stated she had woken up with red itchy rash. RN stated rash was on employee's neck and progressed to her face. Today employee describes symptoms as "red blotches all over her body" including chest, neck, and arms, which was itchy. Unknown what steps employee took to treat reaction other than leaving work for the day. Today, employee has no symptoms of reaction.
I had a very mild sore throat and that is why I took a COVID-19 test. I tested positive on that same day. I called my doctors office and they prescribed me Paxlovid. My symptoms lasted for 2 days.
Information has been received from the patient's wife concerning her husband of unknown age. The patient's pertinent medical history and concurred conditions were not reported. In approximately 2011, reported as 5 years ago, the patient was vaccinated with ZOSTAVAX 19400 PFU, administered per subcutaneous route (lot #, expiration date and dose were not provided). The patient's wife reported that in approximately 2011, 5 years ago, her husband got shingles after vaccination with ZOSTAVAX and it spread to his eye and it eventually led to a stroke. It was also reported that on unspecified date the patient was treated by an ophthalmologist. The outcome of shingles and stroke was unknown at the time of the report. No product quality complaint (PQC) was involved. Upon internal review, the stroke (cerebrovascular accident) was determined to be medically significant. Additional information has been requested.
105 degree fever x 16 hrs, diarrhea, fever up to 103 degrees for next 4 days, no URI symptoms.