chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLU LIKE SYPMTOMS ALONG WITH RUNNY NOSE AND CONGESTION. PT REPORTS MINOR SWELLING ON LEFT SIDE OF FACE.
This case was reported by a nurse and described the occurrence of dazed in a 4-month-old male patient who received PEDIARIX (batch number 436M4, expiry date 30th August 2016). Co-suspect products included PEDVAXHIB (batch number J014281, expiry date 16th September 2016) and PCV13 (batch number H47689, expiry date May 2015). On 16th July 2014 11:15, the patient received the 2nd dose of PEDIARIX .5 ml. On 16th July 2014, the patient started PEDVAXHIB at an unknown dose and frequency and PCV13 at an unknown dose and frequency. On 16th July 2014, less than a day after receiving PEDIARIX, the patient experienced dazed, pallor, lethargic, difficulty feeding and fever. Rechallenge with PEDIARIX was negative. On an unknown date, the outcome of the dazed, pallor, lethargic, difficulty feeding and fever were recovered/resolved. The reporter considered the dazed, pallor, lethargic, difficulty feeding and fever to be possibly related to PEDIARIX. Additional information received on 07 October 2014: The patient wouldn't look at parents and seemed pretty out of it. These symptoms occurred soon after the vaccine was given and lasted 5-7 days. The reporter stated onset date unknown, but she would guess the adverse events onset date is the date of vaccination, 16 July 2014. The child also had fever that lasted less than 72 hours. The child just came in for 6 month visit and mom declined to continue to vaccine.
4 weeks after 2nd dose, suffered minor head ?cloudiness? and numbness in right hand. Lasted about 1 hour
Saturday had arm pain, fatigue, headache, nausea. Saturday PM had heart palpitations and chest pain. Sunday morning had severe arm pain. Extending through joints, especially in the left arm.  Pain wrapping around into my shoulder and across the left side of my chest.  Sunday evening had heart palpitations again with severe arm pain through my bicep and shoulder into the evening. Mid-abdominal pain on the left and right sides periodically. Sunday night woke up every 30-90 minutes from my body jerking.  Pain preventing me from going back to sleep and I would wake up again from the jerking.  Heart racing and heart palpitations. Monday night woke up with the continued severe pain in my bicep. Every time I lifted my left arm, i had deep burning pain through my bicep that lasted 3-5 minutes.  Continued chest and shoulder pain.  Severe neck pain through my left side and into my jaw.  Periodic mid abdominal pain
Information has been received from a licensed practical nurse concerning a 13 year old female with no known drug allergies and migraines who on 28-AUG-2007 was vaccinated with a dose of GARDASIL, 0.5ml, intramuscularly, in the right arm (Lot#658556/1060U). Concomitant therapy included MENACTRA, ADACEL and VARIVAX (also in the right arm) on that same date. On 30-AUG-2007, the patient's mother called to report that the child developed a swollen, red area on her right arm. On 31-AUG-2007, the patient's mother called back to report the child's arm at the injection site was hot, swollen, and red with the area about 2 inches by 2 inches. It was treated with compresses. The outcome was not reported. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 10/8/2007.  Follow-up information was received. The patient did not have any illness at the time of vaccination. On 04-SEP-2007 the patient stopped complaining and the mom has not checked the area. The patient recovered on 04-SEP-2007. Additional information is not expected.
Information has been received from a RN concerning a 79 year old female who on 11/06/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On approximately 11/06/03, the pt developed redness, edema, and pruritus at the injection site. Unspecified medical attention was sought and no treatment was required. A product quality complaint was not involved. Additional information has been requested.
Received vaccine between 2-2.30pm, noticed a bit of itching on ankles around 9-10pm  (Note that I had bad poison ivy which had caused sympathetic itching/rash on different parts of the body and at first wasn't sure if it was just further poison ivy). By Thursday morning, could tell it was different as spread to other parts of body - neck, trunk, behind knees. Was decently bothersome until Monday afternoon/eve when it lifted - 5 days
This spontaneous report as received from a nurse refers to a 65 year old female patient. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (injection , dose route and frequency were not provided). The patient then called the physician's office on an unspecified date and stated that she, the patient, had an unspecified allergic reaction to the PNEUMOVAX 23 and visited an unspecified emergency room. The patient was not admitted to the hospital. The patient also stated that she did not feel well after receiving the vaccine. The outcome of the events was not provided. Additional information has been requested.
and the nurse ended up sticking herself; Hives; A spontaneous report was received from a nurse concerning a 49 year old, female patient who received 2 doses of the vaccine in a fairly quick succession and experienced hives.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 09-FEB-2021, at approximately 9:29AM for prophylaxis of COVID-19 infection.    A nurse from the Health Department stated that a patient called her complaining about receiving two doses of the Moderna Covid-19 vaccine too close together. The patient stated that the nurse who administered the vaccine to her stuck her, the patient felt a sting and jumped, and the nurse ended up sticking herself. The syringe was immediately discarded into the sharps container and the patient was given another dose of the vaccine. The patient was asked to wait for 10 minutes and as she was leaving, she noticed hives. But the next day when she called the nurse at the health department, she was better. Patient (PJ) is a 49-year-old female. Patient received the vaccine at her workplace RHA health.   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The event, person who received 2 doses of the vaccine in a fairly quick succession, was considered recovered/resolved on 10-FEB-2021. The outcome of the event hives was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a medical assistant (also reports as healthcare worker) refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # L014428, expiry date 12-MAR-2018, with temperature of 1.8 degree centigrade, time frame of 92 hours, 40 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Rash under the right arm pit  after 18 hours of administering the vaccine shown to the doctor. The indicated that he has active herpes. Treated with acyclovir 800mg ( 1 tablet 5 times a day for 10 days).
Chills, tingling feet & legs, nausea, fever. Pt. was calling dr.
Information has been received from a pharmacist concerning a male who in approximately 1987 was vaccinated with an "unknown" vaccine, which was possibly either MMR II or DTP (manufacturer unknown). In approximately 1987, the patient experienced encephalitis and was mentally impaired as a result, which persisted. The mental impairment and encephalitis were considered to be disabling. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
6 days after the vaccine, I had 4 days of nausea and vomitting.
@ approx 3PM on 19JUN91 6.5 hrs post vax pt temp elevated to 102 R; Mom gave APAP & cool bath; pt pleasant, alert; @ 10PM mom notes child vomited, was very pale, & shaking; t103 R; Taken to ER;
Fever; body aches; vertigo; Dizziness; This is a spontaneous report received from a contactable patient. A 25-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 02:00 PM (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient did not have allergies to medications, food, or other products. Medical history included asthma. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN), Ibuprofen (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN). Prior to the vaccination the patient was diagnosed with COVID-19 on unspecified date. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021, the patient had PCR saliva test and the result was negative. On 17Mar2021, the patient experienced body aches, dizziness, fever and vertigo. The clinical outcome of body aches, dizziness, fever and vertigo was unknown at the time of report. No follow-up attempts are possible; information about lot number cannot be obtained.
Patient states the day after vaccine received she has a headache and fever of 101.9 and hot flashes, She states she was attempting to go to bed and she felt hot, dizzy and passed out and fell and hit head. She states she was checked by her PCP the following Monday with no further symptoms.
approx 10-15min p/vax noted stuffy nose, h/a, & drainage down the back of throat;itchiness & watering rt eye & tingling along top of rt hand & along fingertips of rt hand;chills,nausea;throbbing pain of skull & spine & shoulder;flu like sx;
OCCASIONAL HIDRADENITIS SUPPURITIVA FLARES; SICK; BRUISES EASILY; This spontaneous report received from a consumer via other manufacturer via a company representative concerned a 3 decade old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hidradenitis suppurativa. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 01 in total administered, on an unspecified date in AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: unknown, expiry: unknown) citrate free, dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa. Age at time of vaccination 21 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced occasional hidradenitis suppuritiva flares, sick, and bruises easily (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the sick, bruises easily and occasional hidradenitis suppuritiva flares was not reported. The patient received Moderna COVID-19 vaccine (elasomeran) (dose number in series 2) (form of admin was not reported, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, booster dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with Moderna COVID-19 vaccine (elasomeran) (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220515392.
vaccines,had emperature excursion with no reported adverse event; vaccines being given post temperature excursion with no reported adverse event; Initial information was received on 06-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient, vaccines being given post temperature excursion with no reported adverse event and vaccines had temperature excursion with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant Vaccines included: Rotavirus vaccine; Pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and Hepatitis B vaccine for prophylactic vaccination.  On 04-May-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine 0.5 ml (Batch number: UJ625AAA, expiration date: 07-Dec-2022) via intramuscular route in the right thigh for prophylactic vaccination.  On 04-May-2022, vaccines being given post temperature excursion with no reported adverse event (product administration error) (latency: same day). On an unknown date, vaccines had temperature excursion with no reported adverse event (product storage error) (unknown latency).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the events.   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.
Moderna COVID?19 Vaccine EUA  Itchiness and redness around injection site.  Slight rash about 5-6inches in diameter.  Area directly around injection site (about 1/2inch diameter) is slightly raised/puffy.
PATIENT DEVELOPED HIVES (2 MM DIAMETER) ON FACE ABOUT TEN MINUTES AFTER VACCINATION. APPEARED ALONG HAIRLINE DOWN TO NOSE. DID NOT GO PAST CHIN. DID NOT SPREAD TO NECK OR TORSO.  AIRWAY AND LUNGS WERE CLEAR. NO HISTORY OF ALLERGIC REACTION. ADMINISTERED 12.5 MG OF CHEWABLE BENADRYL PER STANDING ORDERS. MONITORED PATIENT FOR ADDITIONAL 20 MINUTES AND HIVES RECEDED. NO  SPREADING OR ADDITIONAL SYMPTOMS OBSERVED. MOTHER EDUCATED ON STEPS SHE SHOULD FOLLOW IF SYMPTOMS REAPPEAR. PATIENT HAS PEDIATRICIAN TO FOLLOW UP WITH AS NEEDED. MOTHER VERBALIZED UNDERSTANDING.
Received 4th Anthrax (LOT #FAV075) 4OCt03 and began having multi joint pain and stiffness lasting 4 days on 5Oct03. Received 5th Anthrax 26Apr04 (LOT# FAV077) and on 27Apr04 again began multi joint pain and stiffness.  Joint pain continues however not as severe as initial.
MENVEO was administered on (R) deltoid region on 5/27/14. Developed pain tenderness which progressed in 24hrs. area of induration on 5/28/14 12". No fever. No other constitutional lymph. Started improving in 48 hrs.
The vaccine was administered incorrectly and they received the adult version instead of the children's with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the consumer or non-healthcare professional via the Regulatory Authority (Reference number: 00845187) and transmitted to Sanofi on 05-Nov-2021.  This case involves a 11-year-old female patient receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] incorrectly and they received the adult version instead of the children (product administered to patient of inappropriate age).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient past medical treatment, vaccination, concomitant medication and family history were not provided.  On 04-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [Frequency: once, Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test, Strength: standard, lot number and expiry date not reported] via unknown route in the left arm for prophylactic vaccination.  It was an actual medication error case due to Inappropriate age at vaccine administration (latency: same day).  It was reported "Caller stated that his son and daughter ages 11 and 6 received FLUBLOK yesterday. Caller stated that the vaccine was administered incorrectly and they received the adult version instead of the children."   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.  There will be no information available on the batch number for this case.
Left side of tonugue felt like it was selling up on 06/05/2017. 06/06/2017 left underneath of tonugue had bright red sore patch on it & bed of mouth sore. So I called Dr. & made appt. He said it was an adverse reaction to varicella virus live vaccine. And prescribed two prescriptions. Magic Mouthwash & Fluocinonide Gel. After buying I found out this gel is for external use only. So was told not to use it. I used the Magic Mouthwash.
Confusion, equilibrium severely off. Headaches, severe brain fog, heightened anxiety, my tremors have greatly increased. ( I have essential tremors.)   I?m having memory issues also.
Pt received more concentrated dose of Pfizer Covid vaccine. Vaccine was diluted with only 0.8mls and not 1.8mls of .9 NS.  Pt was monitored post vaccination and contacted about vaccine dose error.  Pt denies any adverse reactions to dose.
Severe stomach cramping; This case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th February 2020, the patient received the 1st dose of Shingrix. On 3rd March 2020, 3 days after receiving Shingrix, the patient experienced stomach cramps. On 5th March 2020, the outcome of the stomach cramps was recovered/resolved.   It was unknown if the reporter considered the stomach cramps to be related to Shingrix.  Additional information was provided as follows: The patient received first Shingrix vaccine on saturday and had some severe stomach cramping on tuesday and wednesday.  The patient felt fine at the time of reporting so far and was wondering if these symptoms could be related to the vaccine
Swelling of face and eyes - problems breathing - seen at Hosp -ER after 7pm 11/26/2007
COVID VACCINE: I began with a discomfort in my axillary area. Then it got worse and has caused swelling on my axillary area and upper left chest area. I have lost ROM on my left arm and seen a provider to get anti-inflammatory medication.
Mini Stroke; Rash; This is a spontaneous report from a contactable consumer (patient). An 81-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809 and expiration date: 20Jun2021) via an unspecified route of administration administered in the left arm on 07Feb2021 12:30 as a single dose for COVID-19 immunisation. Medical history included Heart attack from 18Feb2018, ongoing Spondylosis of Back, ongoing 5 Inherited disc in Neck, Heart burn, Allergies, blood pressure abnormal (blood pressure), blood cholesterol abnormal (cholesterol). Ongoing concomitant medications included omeprazole for Heart burn; loratadine (CLARITINE) for Allergies, acetylsalicylic acid (BABY ASPIRIN) for blood thinner, eicosapentaenoic acid ethyl ester (VASCEPA) for Cholesterol; losartan for blood pressure. The patient experienced mini stroke on Feb2021 (reported as 03Feb2021) and rash on 08Feb2021. The patient was hospitalized for mini stroke for 1 1/2 days on an unspecified date. The patient went to the emergency room for the event mini stroke. The patient underwent lab tests and procedures which included Covid-Rapid Test which was negative on 05Jan2021. Therapeutic measures were taken as a result of mini stroke which included initiation of new medication clopidogrel (PLAVIX) and atorvastatin (LIPITOR) and for rash includes antibiotic cream. The outcome of the event rash was recovered on an unspecified date while the outcome of the event mini stroke was recovered with sequelae on an unspecified date (reported as 03Mar2020).
My period stopped for 78 days; hot flashes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: ER8734) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 19Apr2021, outcome "recovered" (2021), described as "My period stopped for 78 days"; HOT FLUSH (non-serious) with onset 19Apr2021, outcome "recovered" (2021), described as "hot flashes". Therapeutic measures were not taken as a result of menstrual disorder, hot flush.  Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.
I got the second vaccination and the next day I didn't suffer any pain, I was tired. I would sit down and fall asleep sitting down in the late morning. I found it difficult to do things from being so tired, it lasted for a good 2 months. I was uncomfortable. The tiredness did not discontinue but was overshadowed by a rash about a week later. The itch continued very light, slight itch until May 15. Then I got a bumpy rash the size of my hand on my leg. It spread to my other leg and side. The doctor did not know what it was, they gave me Betamethasone VI propionate ointment. I didn't really do anything so I didn't take it very long. Hydrocortisone 2.5% topical lotion was also given, it kind of helped a little but not much. A dermatologist that I went to advised Zyrtec. Fluocinonide topical lotion was also given on June 4th. It did not help. Each doctor had no idea what it was. After about a month it left my legs and moved to a larger size area on my side and back. And my scalp itches. I went to urgent care in April and they told me my lymph nodes were swollen. My scalp is still bumpy. I used the hydrocortisone on my back daily and it helped a little bit. The rash diminished about August 25th, it is very very mild now. It hasn't completely gone away but I can tolerate it. When it was in full bloom I was exhausted, in misery with the rash and the itch. It was severely debilitating from May to the end of August.  I have never had a rash before or allergic reaction.
Patient had a bad reaction with swelling and redness that followed all down her muscle in the left arm. She went to a rapid care clinic and got shots and a MEDROL DOSEPAK.