chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm to find that my tongue and throat were swelling. I immediately took 1 25mg benadryl and went to the Emergency Room (ER). After many questions and examination of my mouth. I was given another benadryl, prednisone, and famotidine. I waited and was observed for approximately 2.5 hours in the ER. At that time it was obvious that the medication was effective and I was comfortable leaving the ER to return home. I had prescriptions for more prednisone and famotidine to take for 5 days. On Wednesday, I felt well enough to go to work at my school, though I did light duty. On Thursday, I was also at school and also attended a physical therapy session and exercise class. I talked at length with my PT about my experience and she could tell that I was feeling good (presumably from the prednisone) and cautioned me about not overdoing things during exercise. I felt like my tongue was beginning to swell and the PT mentioned that my words sounded a bit funny (she was the only one to comment on this). I then went to dinner at my daughters house and began to feel tired from the benadryl. Upon arriving home and getting ready for bed, my husband and I both noticed how flushed my chest and face had become during the day. My throat and tongue were still somewhat swollen and my throat was beginning to hurt. During the day on Thursday, I had registered with the local  Covid information website and had received an email stating that I should feel free to call the triage phone number if I needed. At approximately 9:45 pm I called and talked with a nurse who urged me to return to the ER because of the flushing and continued swelling. In the ER I was seen by a different doctor who was concerned not so much about the swelling, but about the white streaks in my throat and had me swabbed for strep throat. That test was negative. He said he had read my chart from Tuesday night and felt that the medication that had been prescribed was appropriate and that he didn't feel anything needed to be changed. He asked about how bad my throat felt and wrote a prescription for Magic Mouthwash and I asked for an EpiPen, which he also prescribed. We arrived home at approximately 12:00 am, but it was still difficult to lie down and sleep. I had already decided that I would not go to school on Friday and stay home and rest. I needed to pick up my prescriptions when the pharmacy opened and I ran a few other errands while I was out, but returned home and slept most of the afternoon. I have not been very energetic this evening, but decided that I wanted to get this form filled out. At approximately 10:00 PM on Friday evening, I hope that I am able to sleep better than I have the last several nights.
This spontaneous report as received from an other health professional refers to a 15 or 16 year old female patient. On 10-JAN-2013 (reported as 6 weeks ago) the patient was vaccinated with the first dose of GARDASIL. On 11-JAN-2013, reported as the next day, the patient experienced hives. The reporter implied that the patient would not return for the next dose. It was unknown if the patient sought medical attention. The health professional believed that the patient had recovered from hives. Additional information is not expected.
Pain and soreness at injection site every day for 5 days afterwards-moderate to extreme.  One week after shot, on my upper left arm: swelling and bumpiness, redness, extreme itching, warm/hot to the touch, achy. covering a large portion of my arm.    I called my family doctor and was told to use topical or injected antihistamines. I have been using topical Benadryl.   It has not cleared up yet.  Still red, swollen, bumpy and itchy and achy but itching is not as intense though still very bothersome.  Question 21 below, asks if permanent damage exists.  I certainly hope it is not permanent.
Immediately after receiving my first dose, my face started to twitch, I became nauseous, was flushed, got a headache and became clammy. They wanted to administer an Epi Pen, but I asked them to wait. I did not receive an Epi Pen, but I was observed for about 30 minutes. I ended up leaving the Clinic in a wheelchair. I did not go to the hospital. I spoke to my Neurologist, and she told me she didn't know if I should receive the second dose. She said she would like for me to have it, but would understand if I didn't. It was a fear for me because I have an auto immune disease and COVID was really going around.
GENERALISED ACHING; CHILLS; FEVER ON SATURDAY NIGHT; HEADACHE; FEELING WEAK; PAIN IN KNEES ALTERNATING; PAIN IN RIBS; PAIN IN BACK; PAIN IN LEGS GOING TOWARDS TOES ALTERNATING BETWEEN LEGS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced pain in ribs. On APR-2021, the subject experienced pain in back. On APR-2021, the subject experienced pain in legs going towards toes alternating between legs. On APR-2021, the subject experienced feeling weak. On APR-2021, the subject experienced pain in knees alternating. On 10-APR-2021, the subject experienced generalised aching. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever on saturday night. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, generalised aching, pain in ribs, pain in back, pain in legs going towards toes alternating between legs, and pain in knees alternating, and the outcome of fever on saturday night, chills and feeling weak was not reported. This report was non-serious.
pt recv vax;2 mo later,gave blood & discovered she had a serum alt of 68;
little aches; small fever; Pfizer Bivalent GH9693/ Flu shot injection; Pfizer Bivalent GH9693/ Flu shot injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 4 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 31Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Date: 26Feb2021, Anatomical site of injection: Right arm, Lot# EN6200), administration date: 26Feb2021, for COVID-19 immunization; BNT162b2 (Dose: 2nd , Date: 19Mar2021, Anatomical site of injection: Left arm, Lot# EN6207), administration date: 19Mar2021, for COVID-19 immunization; BNT162b2 (Dose: 3rd , Date: 28Oct2021, Anatomical site of injection: Arm, Lot# FF2589), administration date: 28Oct2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 31Oct2022, outcome "unknown" and all described as "Pfizer Bivalent GH9693/ Flu shot injection"; PAIN (non-serious), outcome "unknown", described as "little aches"; PYREXIA (non-serious), outcome "unknown", described as "small fever".  Additional information: Vaccine was not administered at military facility. Dose 4 given at their clinic at the mall. Doses 1, 2, 3 was the worse. Dose 4 little aches, small fever. Not in bed all day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201232892 same patient/drug/event, different dose;US-PFIZER INC-202201233151 same patient/drug/event, different dose;US-PFIZER INC-202201233152 same patient/drug/event, different dose;
Jan 27th  Began to run fever from the shot Jan 28th  Continued to experience fever,  uncontrollable chills, upset stomach, diarrhea through the day                       around 6PM I began to sweat,  my stomach became upset again, diarrhea grew worse.  Chest pain began and                      call to 911 was placed.  Taken to hospital by flight
Left arm swollen (upper arm to below elbow), hot to touch, itching to arm.
Healthy, 30-year-old  patient who received SPV on 1 May 2019. Patient was assessed for take on 8 May 2019 with "major take"  On 10 May (PVD 9), patient presented with robust response at SPV site plus secondary lesions. surrounding site. Patient had low-grade fever, otherwise no systemic systems. No axillary lymphadenopathy. No other lesions away from smallpox vaccination site.  ---------- 30 May 2019, Follow-up report on patient's reaction:   100% clear with no residuals aside from resolving scar.      In further conversation with patient; he revealed that he failed to follow post-smallpox vaccination care instructions and left the initial bandage in place for greater the 7 days because he went to work and left his bandages at home.        At no time did he voice any other concerns, CP/Dyspnea/fevers.   Symptoms: UNSPECIFIED SKIN CHANGES(R239), EDEMA, UNSPECIFIE
No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 2-year-old (also reported as 22 months) female patient. The patient's illness at vaccination were reported as none. The pre-existing allergies, birth defects and medical conditions included optic nerve hypoplasia. The birth weight was 8 lbs and 3 oz. The patient had one brother. Concomitant therapy included sterile diluent (manufacturer unknown), hepatitis a vaccine inact (HAVRIX), hib vaccine conj (tet tox) (HIBERIX) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX).    On 01-JUN-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U029496, expiration date: 21-SEP-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at left thigh for prophylaxis at a private doctor's office (Product storage error). No adverse event was reported (no adverse event). The vaccine was purchased with public funds. The vaccine was used according to the instruction leaflet. The vaccine was in freezer and available for return/evaluation.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001254: US-009507513-2206USA007524: US-009507513-2206USA007508: US-009507513-2206USA007510: US-009507513-2206USA007511: US-009507513-2206USA007512: US-009507513-2206USA007513:
Began ill on 11/24. Started getting a sore throat and cough. My husband had tested positive. Called clinic and was prescribed PAXLOVID. Symptoms improved with medication. Symptoms resumed on 12/05 with a slight rebound of symptoms. Symptoms were sore throat, low grade fever, cough, and congestion.
I wanna pass out; My stomach hurts; diarrhea; I wanna puke; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in arm right on 19May2021 12:00 at single dose for COVID-19 immunisation. Medical history included empty sella syndrome. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included levothyroxine. Patient previously received COVID-19 Vaccine - Manufacturer Unknown on 27Apr2021 for COVID-19 immunization. The patient's stomach hurt, she had diarrhea, she wanna puke, and wanna pass out on 20May2021 08:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for these events. Outcome of the events was not resolved.  Lot/batch number has been requested. Additional information has been requested.
Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022; No adverse event; administered an expired vaccine to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to patient), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 prophylaxis.     Patient neither diagnosed with COVID-19 nor tested positive.  It was unknown whether patient had any acute illness at the time of vaccination and up to one month before, chronic or long standing health conditions and prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination and or at the time of the adverse event.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (at 7:43 AM,1st  dose, 0.3 milliliter, IM route on left arm, lot number EL9266) on 02-Mar-2021, COVID-19 VACCINE (at 10:34 AM 2nd dose, 0.3 milliliter, IM route on left arm, lot number EP7534) on 23-Mar-2021, COVID-19 VACCINE (at 08 :45 AM 3rd dose, 0.3 milliliter, IM route on left arm and lot number 32030BD) on 01-Nov-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On 07-Jun-2022 at 1:25 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 07-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to patient), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine to patient) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) to have an unknown relationship.    Concomitant products were not reported.  It was reported that event did not cause the patient to seek medical care. It was unknown whether there are any other potential causes for the event to occur and patient experienced any similar event in the past.  Date of the vial was initially stored in the refrigerator was reported as 21Jan2022. The used vial was stored in refrigerator on 07Jun2022.  The vial did not undergo any temperature excursions.  Treatment information was not reported.
Allergic reaction on arm with both shots on both arms. Worse with the second dose. Warm to touch, hard, sore, itchy, red, spreading across my arm, swelling.   Intense pain across whole body, particularly in pelvic and low back areas and joints.   Fatigue  Bloating
Muscle twitching, numbness in left arm and leg, loss of balance, feeling of shocks going through entire body, weakness in left arm and leg, bad muscular leg pain.
pt recvd vax & w/in 15 seconds p/vax pt exp feeling of weakness, pain in joints & was shaky; f/u from the pts MD stated that pt did not know of such a pt; No further info is available;
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna Product on 12/31/2020, 01/28/2021, and 11/02/2021. It is not known if the individual had a specific symptom onset date. They tested positive for COVID-19 via antigen test on 11/09/2021 at the skilled nursing facility at which they were a resident. They were hospitalized 11/26/2021 until their death on 12/02/2021.
Pt signed up for tetnus. At the counter Pt told THE CLERK she wanted the flu shot.  We stickered the form for the flu.  We processed it for the flu and went through Medical.  I confirmed with the pt she was getting the flu shot and she said yes.  Only after she asked i got the flu shot? She said she already got it last month.
Email received on 9/25/2023 at 12:13PM from Merck Employee with an AE/PQC report for GARDASIL 9. Email verbatim: "My daughter went to get her second Gardasil injection on Friday afternoon and the syringe failed to deliver the; Product use issue; Circumstance or information capable of leading to medication error; No other AE/PQC.; This spontaneous report was received from Company Representative and refers to a female patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-SEP-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 25-SEP-2023 at 12:13 pm, email was received from Merck Employee with an AE/PQC report for GARDASIL 9. Email verbatim: "My daughter went to get her second Gardasil injection on Friday afternoon and the syringe failed to deliver the entire dose of the drug. The nurse went to consult with the doctor and the rest of the dose was readministered from the vial. This issue was communicated to me by my spouse and daughter so I wasn't physically present for the appointment. Thus, I'm not sure if this was user error or if the doctor's office used a faulty syringe but wanted to make you aware of the situation. Happy to follow-up with the team if additional information is required." See attached. Company awareness date reflects the date the email was received. Employee did not specify when he received this information. Employee did not say if product is available for retrieval or if pictures of the product are available. Will follow up with the employee. No other AE/PQC. HCP called back in response to voice message request to follow up with AE/PQC details. HCP stated that they were unaware of this event. HCP confirmed that the documentation of reported encounter states that "0.5ml dose of GARDASIL 9 was administered to patient on 22-SEP-2023." HCP confirmed that they will follow up with the Nurse that administered the dose to the patient for additional details and will call back to determine if event was user error or PQC.
Fever - 102, Severe Itching, Severe Headache, Body Aches -- Hives
Within 15 minutes numbness in vaccine arm and side of face on that side. Called dr after 1 hr called again after 1wk and referred to neurologist. Numbness and muscle weakness in left arm; 2-3 week numbness & weakness in arms and legs; finally in groin and abdomen. Mostly resolved at 4wks with lingering facial and abdominal numbness & occas limb weakness.
patient who recieved first dose 3/20 and tested positive for covid 2 days later; This is a spontaneous report received from a contactable Other HCP (nurse) via Pfizer sponsored program. A unspecified age and gender of a patient received first dose of BNT162B2(BNT162B2,Covid-19 Vaccine, formulation solution for injection lot number and expired date was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. Lab test included covid positive after 2 days later, the patient tested positive for covid. nurse calling for patient who recieved first dose 3/20 and tested positive for covid 2 days later, would like to know if ok to administer second dose read ISI, cold transfer due to hold time to PMI,The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever, swollen arm at site of injection, nausea, vomiting, fatigue, difficulty breathing.
Cycle started on cycle day 25 . It's been extremely heavy extremely hard cramps; Cycle started on cycle day 25 . It's been extremely heavy extremely hard cramps; spotting; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 15:45 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromium, colecalciferol, copper, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese, nicotinamide, potassium iodide, pyridoxine hydrochloride, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, zinc (PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;S) taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Patient pregnant was unknown and pregnant at the time of vaccination was unknown. The patient previously received first dose of BNT162B2 (Lot number: EN6204) via an unspecified route of administration, administered in Arm Left on 13Mar2021 06:45 PM (at the age of 37-year-old) for COVID-19 immunization. Facility type vaccine was other. The patient did not receive any other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. Reported that started spotting on cycle day 23. Cycle started on cycle day 25. It's been extremely heavy extremely hard cramps (06Apr2021 06:00). I was always on time. Never early or late. My cycles were like click work at 28 days. There was no treatment for the events. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
As soon as i got the shot I felt a rush of heat, then itchy started to turn red but no hives yet.  About 7 minutes later i felt a sharp cramp and knew i was having allergy reaction, my scalp and rest of my body got really itchy. I rush out of the store. Went home to severe diarrhea. After that the itching got worse with hives. Took a Zyrtec, the itching lasted another 1.5 hours after taking Zyrtec. Throughout the day every time I ate I had cramps and ache in my stomach.
Tightness in chest couldn't breathe, headache, tightness in throat, went to ER was given steroids & BENADRYL.
Arm became swollen from elbow to shoulder and redness the size of a dime at the injection site. He is running a fever up to 103.6 and is complaining of stiffness all over in all joints.