chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urticaria on upper arms and upper tights and waist started Feb. 20.  I  took OTC Benaddryl and used hydrocortisone cream with no improvment. On Feb. 25 I saw an urgent care who gave me a course of prednisone with no help.  The urticaria continuly got worse and lasted all day with new areas effected. On  March 8, I woke up to my left eye swollen shut and my whole body covered in hives and on fire and itching. I saw urgent care again who told me to see a dermolotogist. MArch 9 saw sermotoligst who gave me a cobetasol cream and hydroxyzine 10mg. I was told to also take claritin 10mg daily. Hives improved less body area and no swelling eye but still serveer hives. March 19 my legs were swelling and  I incraesed my dose of hydroxyzine to 20mg  and claritin 30mg per my dermotoligst orders.   March 30 night I woke up to shortness of breath almost went to the ER. My dermotoligist orderd me an epi pen.  I had a CBC, complement 3 &4 lab, metobolic panel, ASA , and h.pylori labs done all were within normal limits or negative. I had 2 punch biospies done one from hives on each arm on March 25- results given April 15 of Urticardia.
mom noticed a bump on injection site on Right leg on 01/24/2023, patient followed up in office on 01/26/2023 at our office, bump was gone by then only keratosis pilaris was documented by Dr.
Patient came in to Health Department on 09/13/04 to have PPD read.  Showed nurse arm.  Arm slightly red and warm to touch.  Complained of arm soreness.  Told to continue arm movement and talk with MD if pain continues.  09/16/04 patient called stating arm hurting, red, and very swollen.  Patient instructed to see private MD about arm.  09/23/04 Patient called to state that MD put her on Prednisone 4 mg dosepack which she finished on 09/20/04.  Arm no better. 09/22/04, patient went to ER where instructed to use ice, alternated with moist heat, and exercise arm.  09/23/04 Patient called to report arm still sore and red, but "some better".
This is a spontaneous report from a contactable physician. A 44-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, Mar 2021, single dose; for COVID-19 immunization; and received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, Apr 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date (7 months post Sculptra aesthetic injection to temples, jawlines, cheeks and chin), patient experienced hard, spiderweb-like areas and nodule where Sculptra was injected. Outcome of the event: unknown. The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
Daughter called to rpt her father developed T 102 & angina pains, went to ER, MD admitted pt for test @ 300 pm, Tylenol given @ 600 pm, T nl & pt feeling OK, Put on 3 days of antibiotic as a precaution
22FEB96 pt recvd mom stated 1MAR96 during phone conversation pt was unable to walk downstairs;large hard area on lt leg where tetramune given, t102.0;taken to hosp adm under MD for testing; swollen upper thigh & fever was nl;
0.25 ml of Moderna Bivalent Covid-19 Booster vaccine was administered instead of 0.5 ml
This adverse event took place after I received my first shot of Moderna on March 12, 2021.  Immediately upon injection, my tongue felt a tingling sensation for about a minute.  Then it began to feel numb.  My heart also started to beat very fast.  I focused on my breathing and tried to remain calm.  Thankfully, I had no itching, no swelling, and no difficulty breathing.  While my tongue remained numb for a few days, I also started to experience painful headaches, fatigue, chills.  No fevers - just a general feeling of hotness.  But temperature never raised above 99.9 via ear thermometer.    However, another odd thing happened. About one week after I received my first dose.  I decided to retouch my gray roots with a hair color I have used before  and never experienced any side effects.  However, this time, I had to the ER.  I died my hair at night, and the next morning I had  redness and itchiness all over my face and arms.  My face and tongue also became swollen and my throat tightened.  At the ER, I was put on prednisone and antihistamines and observed for two years.  I remained on medications for three weeks.
Pt was given first and second dosed of varicella virus vaccine live on 01/27/1997 and 02/25/1997. On 05/12/1999 laboratory evaluation revealed a lack of response.
tired; tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 49-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8730, Expiration Date: unknown, Age at Time of Vaccination: 49-year-old), via left upper arm, on 26Mar2021 15:00 as dose 1, single for covid-19 immunisation. Medical history was not reported. The concomitant medications included vitamin D as 50 mcg every day and vitamin C as 282 mg every day, both ongoing from an unspecified date for immunity and to support immune system (Patient started taking vitamins since Covid started, for a year now). It was reported to ask if the patient needed to test negative before getting the second dose of the Pfizer Covid-19 vaccine on 16Apr2021. Reporter was a woman calling on behalf of husband to inform that her husband had his first dose of the Pfizer COVID-19 vaccine on 26Mar2021, and was tested positive for covid-19 on 03Apr2021. Patient has not yet received the second dose of the product. He went to an Urgent Care where they did the test. Patient was not hospitalized. Patient took no prior vaccinations (within 4 weeks). Patient experienced no adverse events prior vaccinations, he was tired after the covid-19 vaccine. Lab test included COVID-19 Test positive on 03Apr2021. The outcome of events were unknown.     No follow-up attempts are possible. No further information is expected.
Nine days after the injection was received an area 2 inches wide and 3 inches long around the injection site became raised, red, hard and very itchy. Patient used Benadryl to treat it. 2 days later the raised effect and hardness had gone away, however the redness spread over most of the shoulder area, and 2 days after that had spread halfway down her upper arm. The itch remained. Patient went to a previously scheduled appointment with our primary care physician who said that she had had a DAR (delayed anaphylactic reaction) and should not get the second dose of the vaccine.
Pins and needles in left arm, cramping in chest, dizzy, and nauseous.
Swelling to right upper extremity distal to injection site noted 24 hours following vaccination. Pt returned 3 days later given Keflex 1% and observation for worse signs and symptoms.
pt recv vax 9JAN94 & was hosp JAN98;blood cult during hosp were positive for S. pneumoniae;pt recovered & was discharged p/8 days;
Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a female (age unknown) who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently on an unknown date the patient experienced syncope. The outcome was not reported. This is one of several reports from the same source. Additional information is not expected.
pt called on 27MAY97 to report swelling/redness w/nodule approx size of silver dollar appearing on 24MAY97;no other sx @ this time will watch for further rxn & use ice/APAP;
5/28, mother called and reported that Kahlyndra c/o not feeling well approximately 2 hours after vaccine administration. Following am c/o nausea, and vomited x4 hrs, temp 101. Advised to see a physician if no improvement after 12 hrs. 5/29, mother states she took her to the dr, and he could not find any reason for symptoms, possible virus, no evidence vaccine related. Child is recovered.
female patient did not receive the full dose MENACTRA vaccine/ NO AE; while administering a Menactra  vaccine,  some of the vaccine it leaked from where the needle was attached to the syringe/ NO AE; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17-years-old patient to whom while administering first dose of 0.5 mL vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (frequency: once, lot number: U6585AA, expiry date: 11-Apr-2021 via an Intramuscular route in right Deltoid) some of it leaked from where the needle was attached to the syringe at hub or leur lock (syringe issue) so the patient did not receive the full dose (underdose) on 06-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA, HPV VACCINE (HPV VACCINE) and HEPATITIS A VACCINE (HEPA [HEPATITIS A VACCINE]) for prophylactic vaccination.  It was an actual medication error case due to vaccine underdose and syringe leak.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Few days after shot on left arm, armpit lymph node started to swell and is sore.
constant fatigue since 2nd injection, can only take 1 short walk per day and then rest of day no energy to stand. Must sit or lay down
immed following vax pt head slumped got pale. pt head snapped back, eyes rolled back & stated to have seizures.
A consumer obtained the information from a website concerning a female student patient who was an honor roll student in the seventh grade, failing in the eighth grade and starting high school in a special education class in diapers who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, dose and route not provided). On an unspecified date, the patient was reading at a fifth grade level with maybe the comprehension of fourth grader. She was kicked out of school that year in just the third week. At the time of this report, the patient's outcome was unknown. Upon internal review "she was reading at a fifth grade level with maybe the comprehension of fourth grader and she was kicked out of school" were considered to be disabling. No further information is available.
It was an administration error. The Pfizer vaccine is supposed to be diluted before giving the vaccine for 6 month to 4 years of age. And this was not diluted before being administered to the patient.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The medical history, current conditions and concomitant medication were not reported. On an unknown date the patient was vaccinated with first dose of GARDASIL (strength, dose, frequency, batch/lot number and expiry date not reported) intramuscularly for prevention of  HPV. On an unknown date (reported as next day), after the first dose of GARDASIL, the patient had a stroke. On an unknown date, the patient received the second dose of GARDASIL and had another stroke. On an unknown date, the patient was hospitalized. It was reported that the patient would not be receiving the third dose of GARDASIL. Therapy with GARDASIL was discontinued. The outcome of the events were reported as recovered. The patient had received the vaccines from her pediatrician. The causality assessment was not provided. Additional information has been requested.
was diagnosed with high-frequency hearing loss and tinnitus BEFORE vaccine. My tinnitus was not bad the day of or had flared up before taking the vaccine.   1-2 days after having the first dosage of the vaccine I noticed my tinnitus was a lot worse, more noticeable, extremely high pitched, and unbearable for most of the time, on top of the "sickness" and "sore arm" symptoms. This lasted a couple of days (about 3-4 days) after the vaccine. This also happened for the second dose I received on 4/1/21.  I did check in my symptoms on the v-check application (first dose only).
received a FLUZONE HIGH-DOSE QUADRIVALENT on 13 Oct 2020 and also received another FLUZONE HIGH-DOSE QUADRIVALENT on 19 Oct 2020 on accident with no adverse event; The patient was scheduled to receive a pneumonia vaccine on 19-Oct-2020 but was accidentally administered a flu vaccine instead with no adverse event; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from an other health professional (office manager) via call center .  This case involves a 66 year old female patient who received a fluzone high-dose quadrivalent on 13-Oct-2020 and also received another influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] on 19-Oct-2020 on accident (extra dose administered) and was scheduled to receive a pneumonia vaccine on 19-Oct-2020 but was accidentally administered a flu vaccine instead (wrong product administered).  The patient's medical history, concomitant therapy, past medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2020, the patient received on influenza quadrival a-b high dose hv vaccine (formulation, strength, batch number, expiration date, dose, frequency, route of administration was unknown) for prophylactic vaccination.  On 19-Oct-2020, 6 days after starting the suspect vaccine therapy patient received an influenza quadrival a-b high dose hv vaccine on 13-Oct-2020 and received another influenza quadrival a-b high dose hv vaccine on 19-Oct-2020 on accident (extra dose administered). The patient was scheduled to receive a pneumonia vaccine on 19-Oct-2020 but was accidentally administered a flu vaccine instead (wrong product administered). Patient had not reported any side effects at this time.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not applicable.  Disclaimer: 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 Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding batch number in this case.  No further relevant information was reported.
Patient started to feel dizzy approximately 2 minutes after receiving 1st dose of Pfizer COVID-19 vaccine, followed by headache/pressure on head.  Dizziness and then headache then pressure on head.  At 12:15pm, approximately 15 to 20 minutes after receiving vaccine, patient began feeling better.  BP 146/91  HR=63  O2 sats=96%.  At 12:22pm, still reports some mild dizziness.  BP 116/80  HR=63  O2 sats=96%.  Patient clinically stable.  Patiient released from clinic at 12:25pm.
Pt called stating she experienced a knot at site after getting vaccine (which is now about gone),  and about 7 days after administration has a pink, itchy rash that goes from shoulder to about 2 inches above elbow.  Her arm is slightly swollen.  Pt stated she did not have a fever or any streaking in her arm. Pt was advised to use ice and/or benadryl and to see dr or go to er to get checked out.
My arm is swollen; My arm is /red; My arm is/feverish; This case was reported by a consumer interactive digital media and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis  On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and fever. On an unknown date, the outcome of the swelling arm, erythema of extremities and fever were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient. Age at vaccination was not reported. The age grp was captured as an adult as per vaccine indication. Patient received shingrix shot and experienced arm swollen, red, and feverish. The reporter wanted to know how long would it take for the swelling to go down.
I had some mild symptoms that seemed more like a common cold. We have small grandchildren, so I took a home COVID-19 test. It came back positive, called the doctor and was prescribed PAXLOVID and benzonatate for the cough. I started to feel better and functioning in two days.
site of injection developed a bump and itchy rash.  The area became red and blotchy.  The bump disappeared after two days,  The rash and itch lasted 5 days, it disappeared the day after I took a Benadryl.
Information has been received from a 60 year old female patient referring to herself. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On 13-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and dose were not reported) subcutaneously in her "lower" deltoid muscle for prevention of herpes zoster. The injection was administered by a pharmacist. On the same day, the patient experienced injection-site soreness, itchiness, swelling, redness, warmth and headaches. No lab diagnostics studies were performed. Treatment was given for the events. The pharmacist told her that the symptoms would subside in seven days. At the reporting time, the patient didn't recover from the events. The causality was not reported. Additional information is not expected as there is no consent to follow up.
Information has been received from a health professional concerning a 24 year old white female who on 17-JUL-2007 was vaccinated with her first dose of GARDASIL (lot# 658490/0802U).  On 29-JAN-2008 the patient was vaccinated with another dose of GARDASIL (lot# 659439/1267U).  The patient reported on 29-JAN-2008 that since she began GARDASIL on 17-JUL-2007 she has had three full periods in a two month time frame.  Additional information has been requested.
[Pfizer COVID-19 vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Pfizer vaccine ndc 59267-1000-01 Patient received second dose of Pfizer COVID-19 vaccine on 03/04/2021 (first dose of Pfizer COVID-19 vaccine received 02/11/2021). On 03/23/2021, patient suffered massive stroke and showed no left brain activity per EEG administered in hospital. TPA was administered within 2 hours of event but patient suffered uncontrollable brain bleed during observation. Patient was intubated and made as comfortable as possible until decision made to terminate life support for QOL reasons on March 25, 2021.
I felt the following beginning Saturday morning;  ? Severe leg aches, in addition to pain & swelling in my knees and ankles ? Hot flashes and sweats throughout the day and night ? Extremely lethargic Notes: The arm of the injection site only hurt for 24hrs.  The effects above were extreme (bed ridden) from Saturday (22nd) to Tuesday (25th).   All have lessened but are still present with the addition of a constant, dull ache in my right arm (opposite the injection site).   I would just like to add that the ?side effects? I have experienced seemed to have intensified my existing ?aliments?.  Pre vaccination: ? Mild knee pain (from jogging).   ? Occasional night sweats - premenopausal symptoms
Patient who is a minor was due for MMR but was administer Proquad (MMRV). Parents notified of medication error. Patient monitored for 30 minutes post administration of Proquad and showed no signs or symptoms from vaccine administration. MMRV VIS provided to parent.
PATIENT STATES HAVING SOME DIZZINESS SINCE RECEIVING VACCINE ON 11/17/2020
Case previously recorded as MA2009-4266. Initial case report received from a health care professional via agency on 13 NOV 2009. A 18-month-old male patient was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 1013266P) i.m. on 13 NOV 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Cauasality: not applicable. Expectedness assessment according to foreign and local label: Off label use (child under 4 years old) is unexpected regarding vaccination with FLUVIRIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008215.
10min post vax pt became hyporesponsive;pt became pale in color w/lip sl blue;VS remained WNL;pt had not eaten in 4 to 5 hr a/visit upon responding pt was given Cola;color returned to nl & became more responsive;poss syncope episode;
I woke up to a red hard itchy spot at injection site a week after first injection.  I am still monitoring for further reaction. My initial reaction the day of the injection was typical; a few hours after I had a sore arm followed by a headache. Headache was intermittent   and soreness lasted about 24-30 hours.
No adverse event; HCP said that the patient received 1st dose of GARDASIL 9 at the age of 13. Patient received her 2nd dose today (07/12/2022) when she is now 16 years old.; This spontaneous report was received from a registered nurse and refers to a 16-year-old female patient. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On an unknown date in 2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 12-JUL-2022, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, prefilled syringe, 0.5 milliliter, lot # U008900, expiration date 12-AUG-2023 (strength, route of administration and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported (no adverse event).
On 2/19/21 was just the slightest headache, and tired.  Took 2 Tylenol and was in bed by 10. On 2/20/21 still a slight headache, took 2 Tylenol then went out and walked about a mile, visited family, then walked back home.  By the time I got home I was barely able to walk up the stairs.  Felt exhausted and nauseous.  Slept for a few hours and got up and just sat on the couch for another few hours and then felt that same nausea and exhaustion and went to bed. Took 2 more Tylenol. Started drinking more water.  On 2/21/21 felt pretty good -- stayed in all day -- ate a little -- but saw the site on my arm just under the injection site was very large, red, and hot to the touch.  The red welt area went from just below the injection in the left arm to just above the elbow.   On 2/22/21 (today) feel pretty good.  Drinking a lot of water and tool 1 Tylenol.
devel pain immed w/numbness & tingling w/in 30mins of inj;tx w/DPH & ice;pain subsided numbness cont 4wks later, cyclical, burning, waves of pain from elbow to hand;treated in ER w/percocet & flexeril;pain lessened, began P.T. for 4wks;
APPROX 30 MINUTES AFTER VACCINATION, CHILD VOMITED X 3; TAKEN TO ER BY MOTHER AND GRANDMOTHER. NO OTHER PROBLEMS; CHILD RECOVERED WITHOUT DIFFICULTY.