chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 43 years old female patient who received vaccine FLUZONE QUADRIVALENT lot UJ040AA, expiry date: 30-JUN-2019 via unknown route in the left deltoid on 19-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitants medications were given. It was actual medication error due to vaccine underdose and exposure via skin contact. It was reported that some of the vaccine leaked from the patients arm. No known reported symptoms. 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. Documents held by sender: none.
I have a rash and hives on my chest, back, arms, and neck. The rash feels prickly like needles. With the first dose I experienced the rash on my sternum, diarrhea, and slight fever. The second dose I got the rash from waist up. It started on my sternum and spread out from there. The rash lasted 3 days and felt like sunburn. I also had a mild fever and diarrhea the first day.
PATIENT RECIEVED THE DOSE AFTER MANUFACTURER RECOMMENDED FREEZER STORAGE DURATION.
SEVERE INCHES WIDE RED GIANT LUMP AT VACCINE ADMINISTRATION LOCATION ON ARM; PAIN AT VACCINE ADMINISTRATION LOCATION ON ARM; This spontaneous report received from a consumer concerned a 43 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: UNKNOWN) dose was not reported, administered on 19-FEB-2022 for prophylactic vaccination. No concomitant medications were reported.  On 19-FEB-2022, the patient experienced severe inches wide red giant lump at vaccine administration location on arm, and pain at vaccine administration location on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at vaccine administration location on arm, and severe inches wide red giant lump at vaccine administration location on arm. This report was non-serious.
She got her vaccine, she was fine, did her normal activities.   Last night in the late afternoon she had a sore throat, scratchy throat.  Around midnight she woke up with a lot of mucus and was expectorating it, and was up a lot during the night.  She took an allergy pill, cough drops and some cough medicine, and doesn't know if it's the vaccine or change in weather.  Today she is much better, a little weak from lack of sleep.  She still feels somewhat congested.
This spontaneous report as received from a medical assistant refers to a 2 month old female patient with familial risk factor. The patient did not have any pertinent medical history, drug reactions or allergies. On 27-JUL-2015, the patient was vaccinated with the first dose in the series of three RECOMBIVAX HB, lot # K026666, expiry date: 22-OCT-2016, 0.5 ml, intramuscular. None concomitant medication was reported. On the same date, immediately following vaccination, the patient experienced extreme agitation and irritability. It was reported that the symptoms lasted between 5 to 6 hours in duration and as of 29-JUL-2015, reported as "currently", the patient was not experiencing any symptoms of irritability or agitation. The patient was treated with TYLENOL. None laboratory studies were performed. The patient was seen in the medical office. The medical assistant also reported that the first dose of RECOMBIVAX HB was delayed and not given according to the recommended dosing schedule due to a family history of unspecified neurological problems. The outcome of agitation and irritability was reported as recovered on an unknown date in July 2015. Additional information has been requested.
Started feeling achy, cold, and nauseous.  I threw up twice and had a fever of 103.5.   Started feeling better during the night around 2am.   I felt tired that next morning.   I started hurting on the right side around 10am which ended up going to the emergency room which turned into a kidney stone.
Eight days after Shingrix vaccine,  I got Shingles on my scalp. Never had it before.
I was 39 weeks along when I was vaccinated and my baby was born at 41 weeks and weight was 8 lbs 8 ounces. I contracted COVID in March in 2022 my baby was born in May 1st of 2021. I felt symptoms on a Thursday with flu like symptoms and by Monday I didn't feel like I didn't have any more symptoms but the following Thursday I felt like a pulled a muscle in my abdomen and it hurt so bad I was in tears and went to urgent care and found out my spleen was swollen and they gave me ibuprofen for the pain due to still breastfeeding. They said the infection had spread to my spleen but said it was not in danger of rupturing and should be fine.
Information has been received from a physician concerning a 16 year old female with an allergy to penicillin who on 05-OCT-2007 was vaccinated with her first and only dose of GARDASIL vaccine (yeast) ( lot and batch # not specified). There was no concomitant medication. On 05-OCT-2007 the patient developed a rash within a few hours of the vaccination on her arm and hand. Eventually the rash also appeared on the other arm and her legs as well. It all appeared on the same day as the vaccination. Unspecified medical attention was received. She still has some rash, but not as extensive and was reported as recovering. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 11/14/2007. On 02-NOV-2007 follow-up information was received that the patient received first GARDASIL on 05-OCT-2007-several hours later complained of red rash on hands, gradually moving up arms to neck and down legs, some pruritis helped minimally by BENADRYL. Rash still present on 16-OCT-2007 although less noticeable. Additional information has been requested.
Pt who recvd killed virus vax in 1960's did not devel immunity & recvd measles vax on 30APR91 & 6 days following vax pt devel 6-8 cm firm, erythematous area @ left deltoid w/swelling; also exp fatigue; 17JUN91 only a sl lymphadenopathy;
after receiving vaccine, she slumped in the chair, pupils were fixed eyes became red and tearing, she had a change in mental status was slow to respond to questions, body was shaking, it was difficult to keep her awake, focused, and talking
After 30 minutes I felt my lips tingling but they were not swollen - this stayed with me for the next three days.  I had the same reaction with the first shot given on 3/1/21 but that was the only reaction for the first dose.  The second dose on 3/29 my lips were tingling/itchy like when I eat frozen, not fresh caught shellfish.  I also got chills, muscle/bone aches for the next two days.   I do carry an epi pen after having symptoms when I got stung by a yellow jackets.  I
Approx. 5 minutes after giving vaccine mom called out from room stating pt. had fainted. Support Staff and provider assisted, gave pt. apple juice and monitored until pt. felt ok to leave clinic. Approx. 1 hour after pt. left clinic they came back because when in parking lot pt. began to vomit and wouldn't stop.
Headache, Myalgia, Fever, Sore arm, fever 101.3, neck/back/body pain, quarter sized hive on right medial arm extended to medial bicep to antecubital, right axillary pain, occasional shooting pain to shoulder/ neck and upper back with tingling. Day 5 Narrative:
TRANSIENT CEREBRAL ISCHEMIA NEUROPATHY 3/2/2022 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report was received from the registered nurse regarding a 6 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 08-AUG-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
vaccine was expired, no temperature excursion occurred and moderna determined the vial "maintained the activity necessary to protect against SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
WITHIN MINUTES OF TAKING THE FIRST DOSE, MY BLOOD PRESSURE AND PULSE DRAMATICALLY INCREASED. I FELT DIZZY, AND MY FACE WAS NUMB. WITHIN MINUTES OF TAKING THE SECOND SHOT, MY BLOOD PRESSURE AND PULSE SPIKED. SINCE THE SHOTS, I HAVE EXPERIENCED DIZZINESS, FEELING OF FAINTING AND ELEVATED BLOOD PRESSURE. I HAVE EXPERIENCES PIERCING PAIN IN MY HEART,  PRESSURE IN MY CHEST AND INCREASED PULSE EVEN WHEN RESTING. I HAVE EXPERIENCED HEADACHES, BLURRED VISION.
This spontaneous report as received from a medical assistant regarding her daughter via company representative refers to a 11 year old non pregnant female patient. The patient is allergic to sulfa drugs. On 03-JUN-2015 the patient was vaccinated with GARDASIL (dose strength unspecified) dose 1, intramuscularly. Other suspect included GARDASIL 9 ((dose strength unspecified) dose 1, intramuscularly). The reporter also stated that the patient received first dose of GARDASIL and she has not had the other two doses yet. On 03-JUN-2015, the patient experienced "extended" redness at the injection site and down the left arm after receiving GARDASIL. The patient was not treated for the event reported. The outcome of the erythema and injection site erythema was reported as recovered/resolved on 10-JUN-2015. It was not confirmed whether the product involved was with GARDASIL or GARDASIL 9. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
positive covid result after being vaccinated; positive covid result after being vaccinated; This is a spontaneous report from a contactable consumer reporting for a patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and concomitant medications were not reported. The patient experienced positive COVID result after being vaccinated on an unspecified date. Outcome of the events was unknown.  Information on the lot number has been requested.
weak in arms and legs; tingling (pins and needles) in left leg which spread to face and right side; numbness; difficult to walk; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00334283) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 29 year old female patient who had numbness (hypoaesthesia), difficulty to walk (gait disturbance), weakness in arms and legs (muscular weakness) and tingling (pins and needles) in left leg which spreaded to face and right side (paraesthesia) while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  She received no other medications or vaccination at that time.  On 09-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UT7058KA, expiry date: 30-Jun-2021) once via unknown route in the left arm for prophylactic vaccination.  On 22-Oct-2020, the patient developed a non-serious numbness (hypoaesthesia), difficulty to walk (gait disturbance), weakness in arms and legs (muscular weakness) and tingling (pins and needles) in left leg which spreaded to face and right side (paraesthesia)13 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  She stated that she's been to the emergency room (ER) several times and seen a neurologist.  On an unknown date, the patient developed a non-serious weakness in arms and legs (muscular weakness) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included: Computerized tomogram and magnetic resonance imaging (results awaited)  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from paraesthesia, hypoaesthesia and gait disturbance.  At the time of report, the outcome of muscular weakness was unknown.
Pain starts in left arm the day of vaccinated (3/3/21) around 8; 30 p.m.  after few days it radiated all the way down to forearm.
Patient with a hx of COPD and CHF presented to Medical Center on 12/31/2021 with SOB.   In the ED patient was placed on BiPAP.  Patient was started on Lasix for volume overload, procalcitonin was elevated, started on empiric meropenem.  Patient tested positive for COVID 19 on 01/05/2022.  Patient remained in hospital for isolation until 01/17/2022 and discharge to skilled nursing facility with possible hospice.  Patient then admitted to Health Center with acute and chronic respiratory failure, acute on chronic systolic heart failure, COPE, CKD IV.  Patient expired at facility on 01/28/2022.
She got pain in left hip bone; This is a spontaneous report from a contactable pharmacist. A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA74E4), via an unspecified route of administration in arm left on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, when probed for concern, stated that, the reporter was a pharmacist from # pharmacy. Stated that, a young lady was there, she just got the second dose of the Pfizer and 2 minutes after getting the second dose, she felt pain in the left hip bone and she got the shot left shoulder. She was walking and the pain in not preventing her to walk normally and the mom said her daughter was having the pain. We don't know what it was. Stated that, she has never had any issue, any medical conditions. She wanted to speak to you guys to see whether it was a side effect that happen for this patient and what do you recommend we do. The outcome of the event was unknown.
This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced low grade fever and cellulitis like reaction. The patient received a dose on an unspecified date. The patient experienced low grade fever and cellulitis like reaction. Treatment and outcome were not reported. No additional information was available at the time of this report.
On 03/13/2003 I administered DTAP #2, Hib #2, IPV #2, Prevnar #2.  On 04/20/2003, mom reported that the child had an episode of shaking, and abnormal eye activity after taking a bottle.  Fifteen minutes later a similar episode happened.  On the following day mom brought the child to another physician and was referred to a pediatric neurologist.  The neurologist started the child on phenoburbital based on his finding on EEG.  The mother is claiming that this is related to his immunizations.
SORE LEFT DELTOID MUSCLE. 1ST WEEK A 7-8 ON PAIN SCALE 2ND WEEK - A '5' ON PAIN SCALE 5TH WEEK - '3' ON PAIN SCALE GETTING BETTER
Directly after the vaccine, within less than an hour, I experienced a tightness in my throat, and swelling of my lymph area around my throat. I still had air, but was concerned for the noticeable tightness of throat which continued for hours. This was better the next day, but since then, I have not stopped ?spotting? in an irregular menstrual spotting and has not ceased. Yesterday however,  7/7/21,  I was too tired to keep my eyes open in the afternoon, laid down for a power nap,  and there was a noticeable irregular heartbeat twice, in which I was awoken from my nap twice due to what seemed to my heart not beating normally,  my chest seemed heavy, and both times after waking from a nap and noticing, I noticed my left arm in the vein area slightly uncomfortable.  I have also had to take ibuprofen for a headache yesterday and on one other occasion ,  and yesterday my lymph in my throat were swollen slightly again- and neither of these symptoms are normal for my own body .  I did not get the 2nd dose yet , but due to tightness of throat, I don?t plan to either. I just feel like I should say something.
Asthenia; Dysstasia; Dyskinesia; Chills; Headache; Gait Disturbance; Limb discomfort; Sore arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Sep-2021. The most recent information was received on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Asthenia), DYSSTASIA (Dysstasia), GAIT DISTURBANCE (Gait Disturbance), LIMB DISCOMFORT (Limb discomfort) and DYSKINESIA (Dyskinesia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, ATENOLOL, ATORVASTATIN, FISH OIL and CALCIUM for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced MYALGIA (Sore arm). On 14-May-2021, the patient experienced GAIT DISTURBANCE (Gait Disturbance), LIMB DISCOMFORT (Limb discomfort), CHILLS (Chills) and HEADACHE (Headache). On 15-May-2021, the patient experienced DYSKINESIA (Dyskinesia). On an unknown date, the patient experienced ASTHENIA (Asthenia) and DYSSTASIA (Dysstasia). On 15-May-2021, DYSKINESIA (Dyskinesia), CHILLS (Chills) and HEADACHE (Headache) had resolved. On 16-May-2021, GAIT DISTURBANCE (Gait Disturbance) and LIMB DISCOMFORT (Limb discomfort) had resolved. At the time of the report, ASTHENIA (Asthenia), DYSSTASIA (Dysstasia) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment medications were not provided   This case was linked to MOD-2021-325844 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant follow up
Pt had DTAP vaccine 6/29/09 @ Lt thigh and developed redness, swelling, and hardness 7/1/09 per Pts. mother
I was in a wedding on the weekend of the 11/26/22 by the 11/28/22 I wasn't feeling well but I was testing negative. By 11/30/2022 I felt much worse, this time I did test positive. I called my doctor and was prescribed PAXLOVID and amoxicillin for a sinus infection. I started both medications immediately; it took four days before I felt better. I do feel better now.
mid sternal non-radiating chest pain, generalized weakness, elevated Troponin, Left heart catheterization
Incorrect mRNA COVID-19 product inadvertently administered for the 2nd dose in the primary series:  Patient came to pharmacy requesting first dose of Pfizer vaccine.  After receiving the Pfizer vaccine he then stated that he had the 1st dose of Moderna vaccine on 04/16/2021.  He indicated that when he had the Moderna vaccine, he was nauseated and felt dizzy the following day.  His primary care physician had instructed him to wait 6 months and restart with the Pfizer vaccine.    Per agency guidance, pharmacy advised him the following: (1) Pfizer dose that he received will then count as his 2nd dose in the primary series (2) Do not repeat dose (3) Wait 6 months and receive Pfizer booster dose
Diarrhea; Arm was dead weight; Achnyess; Low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (Arm was dead weight), PAIN (Achnyess), PYREXIA (Low grade fever) and CHILLS (Chills) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus erythematosus and COVID-19. Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (Arm was dead weight), PAIN (Achnyess), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea), MUSCULAR WEAKNESS (Arm was dead weight), PAIN (Achnyess), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Patient had gotten off of the elevator 30 minutes after vaccination and fallen down. She bumped her head and had a bloody nose
Patient was administered 5 doses of the Janssen vaccine instead of one dose. This was an administration error. Follow up was completed with patient and patient had no side effects or long term effects.
Mom noticed red raised lesions on face & legs about 48 hrs after vaccines. No temp except evening of shots. Papular lesions appear to be contact vs insect bites. Advised monitor only.
Patient had sever bruising on arm from Shoulder to hand X 5 days post injection.  Resolving patient said better now.
N 26 hours after Flu vaccine right arm felt like it was "on fire", stinging. Had well demarcated raised very erythematous 5cm X 8cm (prox-distal) hot to touch area over most of the upper lateral arm starting at sire of injection. 36 hours later decreased symptoms with redness, swelling, fading. Benadryl given PRN
Information has been received from a consumer concerning her child who in earlier 2009 was vaccinated with MERUVAX II (lot number, route and site not reported).  Subsequently patient developed a bad fever and was "all out of sorts" after getting vaccine.  It was unknown if the patient sought medical attention.  The outcome was not reported.  The patient also had a reaction to ATTENUVAX (MSD, WAES0905USA03195).  No further information is available.
Next morning after vaccine, awoke w/blanched face & red raised small spots covering entire face. Also, rash on abdomen. Areas on face were pruritic. Seen by Dr on 11/11, he felt these symptoms were related to vax.