chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started running a fever of 102 by 10 pm; flu - pure poison; feel like crap; This is a spontaneous report from a contactable consumer. A 54 year old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 10Jun2021 (at the age of 54 year old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and COVID-19. The patient received an unspecified medication within two weeks of vaccination which was unspecified. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 20May2021 (at the age of 54 year old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. On 10Jun2021 at 22:00, the patient had running a fever of 102 by 10 pm, like had the flu, pure poison and missed another day of work and had been in bed for 24 hours and still felt like crap. The patient hope by next day that would pass. On 10Jun2021, the patient checked body temperature and the result was 102(unspecified units). The clinical outcome of the events were unknown at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 08-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Low grade fever. Normal body temperature is 97.6°F, 99.8°F twenty four hours after injection.
Tingling in finger tips on left hand and next day tingling in finger tips on right hand Still very intense tingling in finger tips 3 weeks later
I received my vaccine at 5;35pm on Thursday 4/8/21. I started feeling arm soreness in both arms and developed a headache, I took  Tylenol at 10pm. I woke up at 3am Friday morning with body aches and still had the headache. I took more Tylenol. By 9am Friday morning I had severe adverse reactions. I still had a severe headache and body aches with muscle soreness and extreme fatigue. I also experienced chills, light sensitivity and brain fog. Around 4:30 pm I developed chest pains that lasted about one hour. My headache, body aches and fatigue have not subsided as of today. I have had a televisit with my physicians office on may 10 where bloodwork. Some of my headaches rk was requested. The results showed elevated kidney function due to the amount of Advil I had taken to control the headache and muscle soreness. The recommended Tylenol did not alleviate my headache or muscle soreness so I have not taken either medicine.  Some of my headaches have been accompanied with nausea and light sensitivity. I went for a physical exam on 5/18/21 and more bloodwork was requested. It has been 6 weeks and these adverse effects have not subsided.
Vaccine administered inadvertently to unapproved age category. Patient did not experience any reaction.
Paresthesias in hands, feet and face.  Muscle fasiculations.  Fatigue, nausea.
inside of both lips began to swell and have remained swollen to date; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 3, manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for Covid-19 immunisation. The following information was reported: LIP SWELLING (non-serious) with onset 22Sep2023, outcome "not recovered", described as "inside of both lips began to swell and have remained swollen to date". Therapeutic measures were taken as a result of lip swelling.  Additional information: The patient received 5th Covid shot on 18Sep2023, on 22Sep2023 the inside of both lips began to swell and have remained swollen to date. Patient doctor hasdtried Duke's Magic mouthwash, valacylovir 1 gm, and methylprednisone 4 mg (21 pack). To date, nothing has helped with the swelling. Looking for any advise as to how patient can get rid of the swelling.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Rash appeared on chest not long after the first dose of the vaccine, and slowly subsided before receiving these second dose of the moderna covid-19 vaccine.  After the second dose, it reappeared, but was more widespread.     It has continued to spread since the second dose on 02/09/21.
Raised, red, hot, hard, itchy patch, 2 inches x 3 inches in size next to injection site, occurring 7 days after receiving the vaccine and lasting 2 days so far.
Right deltoid area of arm developed redness, induration and color (12x12cm) on 9/10/04.
use of Arexvy in pregnant patients; 39 year old recieved Arexvy; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 39-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5H3BB, expiry date 23-MAR-2025) for prophylaxis.   On 06-NOV-2023, the patient received Arexvy. On 06-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 39 year old recieved Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: use of Arexvy in pregnant patients). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.    Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 09-NOV-2023 A registered nurse contacted to inquire about Arexvy and what information was available for the use of Arexvy in pregnant patients and also asked if any of the components could be harmful to the mother or fetus. Partial information given about vaccine, patient and event. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter. The 39 years old pregnant patient received a dose of Arexvy, which led to inappropriate age at vaccine administration.
Case number PHEH2012US016068 is an initial spontaneous report received from a medical assistant on 08 Aug 2012. This case refers to an 18-year-old female patient. She was vaccinated with MenCYW-135 liquid conjugate component of MENVEO (batch number: X10062) intramuscularly on 02 Aug 2012. The patient did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following vaccination. No other information was available.
Pruritus - whole body. 2mL Diphenhydramine (L) D given Lot# 070350 Ex: 7-2012.
Pt reported HR 100, temp. 100 degrees F, red blotchy rash around eyes, pale face, sore throat @ 0800 on 8/14.  Pt. reported to provider 8/14 @ 2:30.
Had eruption of chickenpox greater than 50 lesions, red base with vesicle in central area. No fevers. Treated with Benadryl and Aveeno bath.
Patient was injected with only the adjuvant suspension. Once the error was discovered the pharmacist reconstituted the vaccine as it should be and gave patient the vaccine. So, pt received 2 adjuvant....one by itself and the second in the reconstituted vaccine.
Arm pain; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration, on 31Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID vaccine last Thursday (31Dec2020) and just wanted to know that he/she was still having some arm pain since an unspecified date and the patient wanted to see if that is normal. The patient had not recovered from the event.
Large, swollen rash appeared on injection site ~7 days after injection. Rash is red, raised, and at times, itchy, swollen, and hot.
Post vax, the pt developed swelling, redness, and warmth in her arm, below the injection site near her elbow.
Lack 0f Response - Information has been received from a consumer concerning her son with asthma and possible allergies to ephedrine and tetracaine hydrochloride (pontacaine) who in December 1999 was vaccinated with the second dose of varicella virus vaccine live according to the recommended schedule.  concomitant therapy included predocromil disodium (Tilade) and albuterol sulfate (Proventil).  The patient sought medical attention and a titer showed that the patient did not convert.  the patient's mother also had a similar experienced waes 000320941.  no further information is available.
Initial report received from a health care professional on 22 December 2010. A 16-year-old patient (sex not provided) received on an unknown date an injection (route and site not reported) of ADACEL, lot number not reported. The patient was seen in an allergy clinic for food allergies and other allergic diseases (not specified). On an unknown date and within one hour of vaccination, the patient developed respiratory distress as part of an allergic reaction. No further information was provided. The outcome was not reported. The reporter in this case also reported another adverse event following ADACEL; information for this patient can be found in case 2010-07120. Documents held by sender: None.
About 5-10 minutes after giving Patient her second Moderna vaccine, her husband reported to the drop-off window to let us know she was not feeling well. I immediately went out to check on her and to ask her how she was feeling exactly. She stated she did not feel well; she was dizzy and lightheaded, a little sick to her stomach, she was fanning herself like she was hot, and stated she felt like passing out. I proceeded to ask her if she was having any trouble breathing or swelling of the throat/tongue and she stated no. I also observed her while we were talking and did not notice any respiratory issues or facial swelling, but I could tell she was anxious. Her husband asked if I could lay her down in the immunization room, but I didn't want to move her just yet in case she were to pass out and fall upon standing. She stated that she needed some water so her husband went to get her some after I got the BP monitor out of the immunization room. I checked her BP and it was 150/63 with PR of 94, which was elevated for her according to her and her husband, and she confirmed she was not on any blood pressure medicines. While I was checking her blood pressure, she kept repeating that she really was not feeling well, so I told her we would call EMTs and had my tech call while I stayed with her. Then she said she really wanted to lay down away from the people in the waiting room to see if that helped, so I went to ask my store manager if she could lay in one of the offices or conference room where there was more space. I went right back to the patient at that time and then she stated that she felt like she was starting to have a little trouble breathing. My manager had followed me back to the patient to guide them to her office. She still wanted to go lay down though, so her husband helped her to the office with my manager while I went into the immunization room to grab the epipen, diphenhydramine. supplies, and protocol to bring to the office. When I got to the office with the supplies, she was already laying down for about a minute and stated that she was already feeling better and actually did not feel like she was having trouble breathing. I hung around for a minute and she said she was still feeling a little better, so my manager wanted me to go ahead and give her and her husband a little space. She kept an eye on them while I went to check on things in the pharmacy. I took a few minutes to take care of a few things needed in the pharmacy and then went back to check on the patient. The paramedics had arrived and were already assessing her, so I went back to the pharmacy again for a few minutes. When I went back to my manager, she said the paramedics think the patient just had an anxiety attack and that she was doing much better, so I went back to the pharmacy to stay this time, and shortly after, my manager came by to let me know the patient was okay and her and her husband were able to get up and walk out on their own.
Within 24 hours of vaccine, injection site is red, swollen, painful, warm to touch, enlarged knot/bump. Rash started to spread on arm. 10/3/21 - injection site swelling and redness is even larger
Posterior right arm swollen, erythematous, extremely tender to touch, painful to move.
Non-pruritic maculo-papular eruption on right later thigh started 3/29/21 Rash spread to right lateral pelvis and right flank over the next 36 hours. Rash persists today. No excoriations. Possible tiny/tiny vesicles on right thigh today.
Patient received her second Moderna COVID vaccine on 6/7/21. The patient states that she developed left shoulder pain later that same day. The patient reports that she did come to work the following day but, left work at about 6:30 am due to the left shoulder pain. The patient is required to lift up to 70 pounds at work, drive machinery, and use a scan gun but, since she did not trust her left arm was concerned about attempting to come to work due to no light duty positions available. The patient called the health center on 6/9/21 and I instructed her per research about injection site reaction post COVID vaccine, to apply cool compresses to the left shoulder, take either ibuprofen or naproxen per package instructions, and perform arm exercises every couple hours.  On 6/16/21, disability paperwork was completed for the patient and prednisone, 30 mg daily for 5 days was prescribed. Patient reported being able to move her arm up to 90 degrees reporting that the left shoulder has improved but, still with pain with movement above 90 degrees at a level of 4 - 5/10.
On tenth day, woke up with large red, itchy rash around vaccination site.  Applied an ointment with cortisone in it.  Not a major problem. Later in the evening, started  seriously itching about the neck and face; got worse with time; no sleep that night; continued all next day; doctor prescribed a six day series of steroidal pills; it SEEMS, after 16-18 hours that the itching is easing..
Pain, erythema and swelling in left arm from about 2 inches below shoulder to about 1 inch below elbow.
fever, abdominal pain, diarrhea, nausea, vomiting, weakness
Moderna COVID Bivalent administered on 10/21/22. On 10/22/22 Employee reports the day after vaccination that he developed right-sided facial numbness and his ear feels clogged and full of fluid.
Patient went flaccid immediately following injection; Symptoms resembled seizure with patient going rigid briefly. Patient hallucinated, blood sugar=60; all other vitals signs wnl.
pt recv vax 4SEP97 & 4OCT97 exp asthmatic spasm w/diff breathing & taken to ER;also exp rash that came & went over entire body, chronic fatigue,weight loss, failure to thrive, joint pain;fingers & toes turned blue & became itchy & swollen;
Day 1- Excruciating bone pain in ribs, pelvis, and shins that felt like drill holes. My back felt shattered. Muscles seized up and vein throbbed from inflammation. Lymph nodes swollen and throat was slightly raw. Could choke on water. Body temperature dropped, not chills, but icy cold. Took sleeping pills at 11 pm and never slept from the pain. Started dosing with turmeric and alka seltzer to douse the acidity inside body. Then did ibuprofen at 5 am not able to have BM  Day 2- Tiredness, Broken vessels behind right knee that weren?t there before. Abdominal cramping in the uterus area. Still had bone pain. Restless leg symptoms. Not able to have BM  Day 3 - a cough has started but only bone pain is In shin.
Information has been received concerning a student who was vaccinated with two doses of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). In 2007 the patient developed mumps. It was unknown whether medical attention was sought. The outcome was unknown.
After receiving the shot I became flushed, symptoms promptly resolved. At around 9 pm I began with body aches and chills. At 4 am I woke to take my temperature and it was 101.7. Nausea, vomiting as well
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose and frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 5 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and type of excursion (R/F) for each time were 96, 30, -1.111111111 and R; 120, 29, -1.666666667 and R;  24, 33, 0.555555556 and R; 320, 31, -0.555555556 and R; 160, 32, 0 and R. This is one of several reports received from the same source. Additional information has been requested.
Vomiting; Weakness; Loss of balance; Nausea at very little; Fell on bathroom floor; Could not get up; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Feb2021 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing); "ulcerative colitis" (ongoing); "Crohns" (ongoing); "Pulmonary Embolism" (ongoing). Concomitant medications included: MERCAPTOPURINE taken for crohn's disease, colitis ulcerative, start date: Feb1993 (ongoing); ELIQUIS taken for pulmonary embolism, start date: Jan2016 (ongoing); PAROXETINE HCL taken for depression (ongoing); BUPROPION HCL taken for depression (ongoing). Vaccination history included: BNT162B2 (Dose 1, single (Lot Number: Not provided)), administration date: 25Jan2021, when the patient was 81 years old, for COVID-19 immunisation, reactions: "Sick with diarrhea", "Dry heaves", "She went to living room and fell", "Couldn't get up", "Tiredness", "She has a sore throat", "Fever blister on her mouth", "Severe headache", "Muscle pain in back of her neck and back", "Violent chills", "Almost 10 pounds in the two and half weeks with all this stuff", "Nausea", "weakness", "loss of balance". The following information was reported: NAUSEA (non-serious) with onset 18Feb2021, outcome "recovered" (21Feb2021), described as "Nausea at very little"; VOMITING (non-serious) with onset 22Feb2021 12:00, outcome "unknown", described as "Vomiting"; ASTHENIA (non-serious) with onset 22Feb2021 12:00, outcome "unknown", described as "Weakness"; BALANCE DISORDER (non-serious) with onset 22Feb2021 12:00, outcome "unknown", described as "Loss of balance"; FALL (non-serious) with onset 2021, outcome "unknown", described as "Fell on bathroom floor"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Could not get up".  Additional Information: On 18Feb2021 to 21Feb2021, the patient experienced nausea at very little and on 22Feb2021 at 12:00PM, she experienced vomiting, weakness, and loss of balance. The patient fell on bathroom floor, could not get up, and slept on the floor for about 3 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148886 Same patient and drug; Different dose and events
suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient got two shots, and still experienced shingles. The case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not given.