chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE's; she states that the prescribing information has lots of gaps and misleading information; she states that the prescribing information has lots of gaps and misleading information; This spontaneous report as received from a 45 year old female consumer referring to herself. No information regarding her concurrent conditions, pertinent medical history or allergies and concomitant therapies was provided.   On 21-JAN-2020 the patient was vaccinated with the 1st dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and administration site, indication lot # and expiration date were not reported). On 23-MAR-2020, she received second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and administration site, indication, lot # and expiration date were not reported). The patient called to inquire if her last dose of the suspect vaccine  was safe for her to get 1 month late. She also wants to know if it is safe to get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) done earlier than recommended. She wanted to know this because; "These vaccinations  going in my body and I wanted to know what happened if taken too late or too soon." The patient wanted to know if  the third dose need to be done at 6 months, or it need to be 6 months from the 2nd shot. She checked her resources, and advised her from that source. She was not satisfied and was very rude and frustrated that she couldn't give her anymore information other than what is on the PI. Patient stated that she had read the PI and it did not provide the proper information that she needed to know. She stated that the prescribing information has lots of gaps, and misleading information (onset of the event was also reported as month ago). She was scheduled on 28-AUG-2020 (Friday) to have the third dose done (therapy was not discontinued), and wanted direction from someone before then. No other adverse event was reported.
Report. One day after receiving his DTaP and hepatitis A immunizations, the patient developed a 10 cm x 7 cm ovoid area of warmth, erythema, and edema around the injection site in the lateral right thigh. He has been ambulating normally and the area is not painful to touch. There is no tenderness to palpation, no induration, no drainage, no Nikolsky sign. In the ED, he was given a dose of diphenhydramine. The parents were advised to apply cool compresses to the area and administer acetaminophen or ibuprofen as needed to control discomfort.
patient received vaccine 3/24/21, presented to the hospital with pulmonary embolism
Received influenza vaccine to right arm severe pain to arm lasting for over 6 months continues painful and uncomfortable today.
Welt on right arm appeared the morning after I received the shot. About 2 inches in diameter (circular). It is a raised welt and is slightly itchy. Pain in about 4 on a 1-10 scale. Feels mostly like a bruise is being pushed on. I do have very sensitive skin so it is probably a slight allergic reaction. The doctor did an awesome job with the shot (10/10 hope she does it again). I feel great other than my arm being a little sore. No fever, headaches, etc. My arm has get slightly tingly today but nothing concerning. Definitely not a bad enough reaction to deter from getting the 2nd dose! :D
One week after the shot, on February 2nd, I developed an itchy rash in my groin area which in the next couple of days spread to my abdomen and chest/shoulder area. My lips began to swell on February 3rd, and by February 4th, this swelling eventually included my tongue and gums.
Had pea sized lump under skin at vaccine site after HPV vaccine RUE    then slept on floor 1/3/08 at friends and next am site sore and red worsened over next few d still looks red, tender no fevers no d/c. 2 cm area erythema, induration, warmth, tenderness R deltoid c/w injection site. No fluctuance appreciated.
nurse c/o dizziness, lightheadedness, very weak.  Nurse instructed to sit down and drink water by flu nurse.  Flu nurse stayed present for over 20 min until nurse said she felt better, but remained slightly dizzy.  B/P 126/80, 86, 100% O2 rate upon completion of injection.  Later found nurse in ER still encouraging fluids, was given steroids and BENADRYL @ ER and given Rx as well when discharge to home.
Patient discharged after (4) day in patient admission.  84-year-old female with past medical history of TIAs, peptic ulcer disease, coronary artery disease status post drug-eluting stent, polymyalgia rheumatica on chronic prednisone, hypertension, of hypersensitivity pneumonitis on chronic CellCept, immunosuppression and hypothyroidism.  Patient presents to the emergency department with worsening cough and fever.  She was vaccinated with J&J in April.  Emergency department she tested positive for COVID.  Chest x-ray showed bilateral patchy airspace disease consistent with COVID pneumonia.  Patient was hypoxic in the 80s and required supplemental oxygen.  She was admitted and started on Decadron.  She had reported acute on chronic cough for approximately 2 weeks and thus was not started on remdesivir at time of admission.  However due to vague differentiation between her chronic cough and worsening symptoms it was decided to consider symptom onset when patient began having fevers on 11/22 and thus remdesivir was started.  Family requested monoclonal antibodies however given hypoxia patient did not meet criteria.  Since patient had improvement in symptoms but continued to require 2 L of oxygen.  She was evaluated by Pulmonary Rehab who recommended 2 L of oxygen at rest and with activity which was arranged for the patient.  She was instructed to follow-up with PCP for weaning of oxygen as well as ongoing blood pressure control.
Keratitis/My symptoms flared up after the second dose of the vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISOLONE taken for ocular hyperaemia, start date: 22Dec2020; TOBRAMYCIN taken for photophobia, start date: 22Dec2020; ARTIFICIAL TEARS [GLYCEROL;HYPROMELLOSE;MACROGOL], start date: 22Dec2020; DOXYCYCLINE HYCLATE taken for inflammation, start date: 25Mar2021, stop date: 25Apr2021; RESTASIS taken for inflammation, start date: 01Jan2021 (ongoing). Vaccination history included: Bnt162b2 (dose 1, Event onset date 30Dec2020, Outcome: Not recovered), administration date: 17Dec2020, for COVID-19 immunization, reaction(s): "meibomian gland dysfunction", "Eye redness, dryness pain, photophobia", "Eye redness, dryness pain, photophobia", "Eye redness, dryness pain, photophobia", "Joint pain and swelling 3 days after the first dose. Affected joints: right elbow, right wrist and right third interdigital joint", "Joint pain and swelling 3 days after the first dose. Affected joints: right elbow, right wrist and right third interdigital joint". The following information was reported: KERATITIS (non-serious), outcome "not recovered", described as "Keratitis/My symptoms flared up after the second dose of the vaccine.". Therapeutic measures were taken as a result of keratitis.  Additional information: Diagnosed with keratitis on 26Dec2020. Treated with steroid drops and antibiotic ointment with mild improvement. Her symptoms flared up after the second dose of the vaccine. Eye just had anadditional treatment by (name withheld). She received IPL x 1 treatment and will need 3 more treatments. She received also Blex Ex treatment x 1. These therapies are not covered by her insurance. Each treatment costs Dollar 300. Her cost will be Dollar 1200. Please refer to an article. Nature scientific reports meibomian gland dysfunction is caused by the spike protein.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
15 hours following shot, a nickel-sized welt appeared on my leg. It was red, round, and slightly scaly. Three or four additional red spots that looked like chicken pox were also observed on my abdomen. The pots multiplied and are currently covering almost my entire body. I was diagnosed with Pityriasis Rosea.
The pt experienced a fever and was given Tylenol around the clock. The pt awoke fussy in the middle of the night, vomited then had perioral cyanosis and lethargy. The pt experienced decreased responsiveness and was hard to arouse.
Initial Fever, chills, all over muscle aches, but my lower back really ached. Then a terrible headache, nausea, vomiting, lethargic, couldn't hold anything down, whole body in pain. This lasted 24 hours, fitful sleep the next night, vomiting was done, could sip water, still a terrible headache/ low grade fever. On 3/2/2016 I did return to work, but was falling asleep in my office. Food was of no interest, I was working on rehydrating. On 3/3/2016 I was better, I slept I had an egg, my headache was gone.
Caller experienced swelling of the eyelid after receiving the second dose of the vaccine; swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21May2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) for covid-19 immunization. On 21May2021, the patient experienced swelling of the eyelid after receiving the second dose of the vaccine and also experienced swollen lymph nodes and has been using cold compresses and tea bags to remedy the swelling. Patient also mentioned that she had the photos of the AE she experienced take last Wednesday (19May2021) and yesterday (21May2021). Overall safety summary included in clinical studies, adverse reactions in participants 16 years of age and older included injection site swelling (10.5%). Clinical trials experience solicited local and systemic adverse reactions across both age groups, 18 through 55 years of age and 56 years and older, mean duration of swelling 2.3 days (range 1 to 34 days). No information found for swelling specifically in the eyelid area. Referred to HCP. The events were considered as non-serious. The outcome of events was unknown.   Follow up attempts are needed. Further information has been requested.
My son had some allergic reaction to his first dose of vaccines.  Today I realized it may have been from the Rotavirus.  After my son was given the first dose of rotavirus his breathing changed and I could hear mild wheezing.  He also seemed to have strong abdominal cramping followed my heavy bowel movements, and some random hives.  This happened again with the second dose.  The third dose just seemed to make his voice a little raspy.  My husband and I also got a case of diarrhea on each dose.  I reported the first dose symptoms in September 2007. Since they were mild acording to the advise nurse, she had Dr. call me.  He advised to watch for breathing problems, but also assured me that my baby was colicky and his reaction normal. Today I found out that my son is allergic to egg white, and upon surfing the web I found out that rotavirus vaccines are grown in eggs.  I did not have this information prior to vaccinating my son. Thus, I hope this report helps alert other parents whose children may have a similar egg allergy.  I don't know if I would have chosen to skip the rotavirus vaccine had I known that my son had an egg allergy, but I would have liked to have had prior knowledge of the link between egg allergies and rotovirus vaccines when I called facility in September.
Patient has a large bruise on her arm that has begun to radiate down her arm. She said it was not hot, when I touched it, it seemed warm. She reports no fever and no other allergic type of reaction.
Red, Warm to the touch, Tender, Sore. Advised to use cool compress and Benadryl.
A nurse reported via a company representative that upon administering a dose of Flumist to a pt she experienced lightheadedness, headache, and skin peeling on her hand. A nurse experienced lightheadedness, headache, and skin peeling on her hand on 11/7/03 upon administering a dose of Flumist to a pt (accidental exposure). The nurse has recovered.
On 11/08/2000 the patient was seen at the physician's office and had developed conjunctivitis and chicken pox with about 30 poxes over his abdomen, arms, back and legs with variety of sizes of red vesicular lesions and 2 with scabs. The patient had no fever and the lesions were itchy. No further information is expected.
Hives, I Have taken antihistamines for this, they have reduced the itchiness and inflammation, but the symptoms are still occurring
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EM9809), on 24Feb2021 as dose 2, single (Lot number: N6203) and on 08Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Drug ineffective "; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: test positive; negative, notes: negative on Days 5 & 6. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included Rebound Covid- Symptoms mild, occurred 5 days after last dose of paxlovid, in home test positive on Day 1 of rebound and negative on Days 5 & 6. No other medication in 2weeks.  known allergies: penicillin; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2  to the reported events Vaccination failure and COVID-19 cannot be ruled out.
The vaccine gave me body aches, a fever, and then it triggered an outbreak of genital herpes that I had previously never been diagnosed with until now.
Skin reaction developed approximately 12-24 hours following 2nd dose of Moderna COVID19 vaccination. Significant fatigue also occurred. No side effects were noted following 1st dose (one month prior to 2nd dose).  Severe skin reaction primarily concentrated at both palms (redness, irritation, minor painfulness) and both feet (irritation, visible rash). Skin reactions also occurred on upper chest and full back (redness, itchiness). Reactions are still present but have begun to subside about 120 hours after injection.
Patient had previously received PPV23 in the past on 1/14/2007. 50 y/o female w/ DM and HTN. Age of patient at time of event: 50. Type of Event: Extra dose.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: UNKNOWN SIDE EFFECTS AT THIS TIME, COMPLAINT OF VACCINE ADMINISTERED TOO HIGH.
Pt recvd 2nd doses of Hep B vax 18MAR91 & 21MAY91 following 2nd dose pt exp malaise;
Arm (left) that was shot by the vaccine started to itch about 4 hours later, then redness & heat. The arm stayed swollen.
Patient experienced a golf ball sized red area at injection site which grew the next day to the size of a baseball which was slightly tender and itchy; also complained of nausea and chills; advised to take Benadryl, unknown if actually taken.
Patient reports she received 2nd dose Moderna vaccine Lot #013L20A on 1/30/2021. Monday 2/01/21, patient reports she developed a rash states "it's all over my body." Patient reports she left work early at 10 AM that day. Patient reports she has been self managing with Benadryl and hydrocortisone cream. Patient states "it seems a little better today. Feels less itchy." Patient denies to see EHS. Patient has contacted her PCP who suggested patient go to the ED. Patient does not plan to go to the ED at this time. Patient wishes to continue to self manage. Plan is for care management follow up tomorrow 2/5/2021. VAERS.
Patient experienced muscle soreness, fatigue, body aches after both doses. In addition: Immediate sharp pain after 2nd dose.  Experienced sharp needles on upper extremities for several weeks.  Muscular sensation difficult to describe, best describe as increased anxiety on arms and trapezius region.  Needle sticks on arms resolved after a couple months, but weakness on upper extremities is persistent.  Physical exam shows tension on shoulder/neck region, thoracic, and lumbar region.  Normal neuro exam.  Romberg negative.  Strength equal bilaterally.  DTRs okay.    No limitation sin ROM.
Menactra administered to a patient today was expired/expiration 22apr2022 ,with no reported adverse event; Initial information received on 25-May-2022 regarding an unsolicited valid non-serious case received from a physician via call center (web/email communication).  This case involves an patient of unknown gender and age who reported  menactra administered to a patient today was expired/expiration 22apr2022 ,with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-May-2022, the patient received a 0.5 ml total dose of suspect meningococcal a-c-y-w135 (d conj) vaccine, frequency: once, lot UA6920AA, expiry date: 22-Apr-2022 (unknown: strength and formulation) via unknown route in unknown administration site as Immunization.  On 25-MAY-2022 the patient developed a non-serious event menactra administered to a patient today was expired/expiration 22apr2022, with no reported adverse event (expired product administered) (latency: same day) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Received Gardasil injection #3 on 2/7/08.  Few days later developed neck stiffness and joint pain/stiffness, tightness both legs & L arm where inj./fever on 3rd day x24 hrs.  Can barely walk.  Sent to ER.  03/17/2008 MR recieved for DOS 2/18-21/2008 with DX: Severe polyarthragia and weakness 2' to SLE. Systemic Lupus Erythematosus. ADD. Anemia. Pt presented with hisory of joint pain and swelling, generalized weakness progressing to the point of having difficulty getting out of bed.  PE (+) for tenderness of both feet, ankles and hands.  Decreased hand grip.   Rheumatology consult with assessment of polyarthralgias, fevers, myalgias and hypocomplementemia.
Fever, sorness in the injection site, chills. Started to occurs between 4- 7 hours after the injection.
swollen red arm per pt;swollen arm pit, lt side of chest below lt armpit;shoulder lt, lt bicep, lt forearm, lt hand & forefinger middle finger & thumb;all on lt arm;swelled arm pit & lt side of chest has been swelled & in pain since 21JAN98
Info has been received from a physician concerning a pt who on an unspecified date was vaccinated with a 2nd dose of MMRII. Recently, in approximately March 2006, the pt was seen by the physician and determined to have developed mumps. The pt was getting better and was doing fine without treatment and was at home. Additional info has been requested.  This is in follow-up to report (s) previously submitted on 5/19/2006.  Info has been received from a physician concerning a pt who on an unspecified date was vaccinated with a 2nd dose of MMRII. Recently, in approximately March 2006, the pt was seen by the physician and determined to have developed mumps. The pt was getting better and was doing fine without treatment and was at home. Additional info has been requested.  No further information is available.
Lymph node in the right armpit swells intermittently & randomly for 2 months now.
On 10/07/2023 around 11PM, I noticed swelling and warmth near the injection site. I figured it was a normal reaction but still marked the area. I checked an hour later as my arm was very sore and it had spread./ By that point, I was feeling the effects of the vaccine- chills, fatigue and body aches so I went to bed. I checked again when I woke up on 10/08/2023. It had spread further. I put ice on it, and monitored throughout the day. It continued to hurt. I monitored the following day on 10/09/2023. On 10/10/2023 I decided to go into urgent care, who prescribed antibiotics for cellulitis. The injection site is swollen, red and warm to the touch, about 3 inches in diameter. My entire arm hurts and it itches as the skin is stretched. The itching didn't begin until 10/09/2023.
Lightheaded and unsteady immediately. Heart palpitations and fluttering feeling in chest started within 2 weeks after second shot
DEATH Narrative:  73 y.o. male with pmh severe COPD, CAD, HTN, hypothyroidism, OSA treated with CPAP, obesity. Noted to have engaged with Pulmonary clinic in December 2020 for worsening respiratory status. No PFTs since 2015. Was found slumped over deceased in his home on the afternoon of 2/24/2021. Medical Examiner notified. Request sent to ME office for report if one exists. No drugs or alcohol were found on the scene andno sign of trama. Hypertensive cardiovascular disease were reported as an adequate cause for death. "pathologist" reported that Covid vaccine does not need to be listed as it was "more than 24 hours since the shot".
Pt felt dizzy during the observation period post covid vaccine administration.  No LOC.  Pt is diaphoretic.  Didn't eat breakfast.  AOx4.  Denies SOB/CP/HA/nausea.  Pt states this happens when he gets blood draws and vaccines, he gets nervous.  Observed pt for 35min, symptoms resolved.  Advised pt to eat before coming for dose #2 and notifying staff of his hx before vaccine administration.  Reviewed ER warning signs, pt correctly repeated instructions and has no further questions. Pt discharged home in stable condition.