chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced chest pressure, palpitation & dizziness; experienced chest pressure, palpitation & dizziness; experienced chest pressure, palpitation & dizziness; chest pain; racing heart beat; confusion; brain fog/a feeling of everything being foggy around me; This is a spontaneous report from a contactable consumer or other non-health care professional reported for herself (patient). A 36-years-old non pregnant female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 10:30 (Batch/Lot Number: ER8730) (at the age of 36-years-old) as dose 1, single and dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 10:45 (Batch/Lot Number: ER8729) (at the age of 36-years-old) as dose 2, single for covid-19 immunisation. Medical history included allergy towards penicillin, gluten, dairy, pollen, dust mites & cats from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for Covid-19 since the vaccination. On 26Mar2021 10:30, the patient experienced chest pressure, chest pain, racing heartbeat, confusion, brain fog, dizziness & a feeling of everything being foggy around her. The patient was visited for doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The patient underwent lab tests and procedures on 06Apr2021, which included Nasal swab test (sars-cov-2 test) resulted to negative. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
A report was received from a health care professional on 16Oct02, concerning a 6 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 16Oct02. On 16Oct02, the infant suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The infant had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200667, PJP200200666, PJP200200665, PJP200200664, PJP200200662, PJP200200663.
Starting the day after vaccination, the patient experienced fatigued and feverish. Patient remained in bed for a couple of days. Symptoms improved, but still ongoing.
Cluster of 2 patients (patient identification provided) developed sore throat, neck stiffness, swollen gland and fever, after receiving Menactra (lot number U1987AA), received from a health care professional in the USA on 02 May 2007. Case 1: A 17 year old, female patient (with an allergy to amoxicillin developed stiffness in the neck, fever, axillary swelling and pain, and sore throat, 3 days after receiving Menactra (lot number U1967AA, route not reported) in the right arm on 23 April 2007. She had a CBC with differential and PLT performed. At the time of the vaccination, she did not have any illness. It was reported that she recovered. Follow up information received on 12 July 2007 from a health care professional. The case was reviewed, and there was "no additional information." The second case from the same reporter is detailed in case 2007-01485.
Myalgia, Arthralgia, chills and soreness at injection site Narrative:
TWO STROKES; This spontaneous report received from a consumer via a company representative through social media concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  It was reported that, on an unspecified date, the vaccine caused blood clotting throughout the patient's body resulting in two strokes and ultimately her death on 19-AUG-2021. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On 19-AUG-2021, the patient died from two strokes. This report was serious (Death).; Sender's Comments: V0: 20210900460 - JANSSEN COVID-19 VACCINE Ad26.COV2.S- Two strokes. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: TWO STROKES
GOT SICK; This spontaneous report received from a health care professional concerned multiple patients.  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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got sick was not reported. This report was non-serious.
a patient was accidentally injected with expired Ipol/no AE; Initial information was received on 10-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a patient who was accidentally injected with an expired dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (lot, expiration date, route and site of administration were not reported).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  It was not reported whether the patient had any adverse effect.  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.  Information on the batch number was requested.
Pt recvd 1st dose of HEp B vax & immediately following vax pt exp dizziness & vomiting; the following day exp nausea;
Bad headaches right side of head. For 1 month now. MRA, medications, with no relief
Patient was given Pneumovax 23 first in the right arm and then Fluad in the left arm.  We talked for a few minutes after administration then I walked back into the pharmacy while patient was sitting in the chair.  Patient's wife came to the pharmacy and said he wasn't breathing.  I ran out to the patient where his face was bright red and he was having trouble breathing.  He was able to talk to me so I had our tech call 911 and we got the patient a cold compress.  He said his back was tingling and burning.  After about another minute, the patient's facial color starting returning to normal and his back pain was improving.  Patient was transported by EMS to a local hospital for evaluation.  Oxygen level and heart rate were normal when EMS arrived.
Initial report received from a health care professional on 25 April 2011. A 14-year-old male patient with a medical history of vasovagal syncope on 09 September 2010 (case 2011-01493) after receiving MENACTRA and an allergy to penicillin, received on 09 September 2010 a left deltoid injection of MENACTRA, sanofi pasteur lot number U3515AA. On 23 March 2011, the patient was taken to the Emergency Room (ER) where his mother stated the patient had complained of lightheadedness, loss of consciousness (LOC), palpitations, staring, and slurred speech episodes which were unrelated to exercise. This episode lasted for one minute. There was no trauma, no shortness of breath, no nausea or vomiting and no chest pain. The mother stated that this occurred also last Sunday. Upon arrival the patient stated to the physician that he felt well, was awake and oriented to time, place and person. His vital signs upon arrival to the ER were as follows: blood pressure (B/P) 110/81, heart rate (HR) 76, respiratory rate (16), temperature (temp) 98.3 and an oxygen saturation of 100%. On 23 March 2011, the patient had a basic metabolic panel which showed a low creatinine of 0.6 mg/dL, a complete blood count which was normal, blood parasite smear which was negative (none observed), estimated glomerular filtration rate which was normal, liver panel which showed a high albumin of 5.2 g/dL and high alanine transaminase (ALT) 29 U/L, Lyme IGM AB, Lyme IGG AB and Lyme IGA A which were all negative. The patient on 23 March 2011 had a normal electrocardiogram (EKG), and a normal computed tomography (CT) scan. Upon discharge he was awake, alert and oriented to time, place and person and no seizure activity or neurological deficit was observed. The patient was to follow-up with the neurologist to have an EEG and has a schedule magnetic resonance imaging (MRI) for Friday. The ER discharge diagnosis was seizures and syncope. On 25 March 2011, the patient had an MRI of the brain which showed a normal study. The mother was concerned that the patient may be having "absence" seizures because the patient was having very brief blank stares for which he was being evaluated by a pediatric neurologist. The outcome was not reported. The patient had another event on 09 September 2010 which was reported in case 2011-01493 (vasovagal syncopal episode, seizure activity). Documents held by sender: Emergency Room records.
This spontaneous report was received from a nurse practitioner concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored PEDVAX HIB (dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Client receieved Moderna booster, was monitored for 15 minutes. She then left and drove down the street. She began to feel short of breath and flushed and went to another vaccine site. The pharmacist there, who reported this information to me, administered a benadryl tablet, but the patient was not improving. An administration of Epipen was used and the patient responded. After staying in store and being monitored for approximately 30-45 minutes, patient felt well enough to leave.
R56.9 - New onset seizure (CMS/HCC) R56.9 - Unspecified convulsions N17.9 - Acute kidney failure, unspecified
patient got full dose instead of booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (patient got full dose instead of booster dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (patient got full dose instead of booster dose). On 02-Nov-2021, ACCIDENTAL OVERDOSE (patient got full dose instead of booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Patient is an 80-year-old male that is admitted for observation status for recent TIA symptoms and bradycardia.  He was seen in the emergency room this morning at approximately for complaints of posterior head and neck pressure, right arm numbness and tingling as well as a mild blurry vision in his right eye.  Patient states that the symptoms from the right arm and eye blurriness lasted less than 1 hour.  And has completely resolved at this time.  Patient states that he still does have some posterior neck tightness.  But most of this is on the left side at this point.  Patient denies any increase in physical activity that he could attribute to the onset of the neck pain.  Patient states that it does feel tight when he turns his head from side to side.  Patient states that he no longer has a headache.  He does have a history of a possible mini stroke approximately 10 years ago.  He has had no other recent cardiac problems, or any other strokelike symptoms since that time.  Patient takes medications for his cholesterol and a baby aspirin daily.  Patient is fairly active and continues to drive a semi-5 days a week.  TIA     Neurochecks every 4 hours     Carotid Dopplers 3/2 Bradycardia     Echocardiogram 3/2     Last echo 1/4/2019, EF 60% Discharged home 3/2/21.
Day 1 - 10, Elongated red rash on arm below injection site .  It went away but arm is slightly discolored. Day 1-4, Fever, achy all over, felt weak - went away on day 4 Day 2-10, heavy feeling on chest - like someone was sitting on me
pt exp cardiac arrest about 2 1/2 hrs p/vax; was sleeping @ time t99.0; ? SIDS
The next morning after the vaccine I woke up with a fever, no energy and feeling really drained.  4/1 I lost my appetite and still had the fever for several days.  The first week was basically fever, loss of appetitie and lack of energy.  By week 2 I started having headaches so I went to the healthcare facility and was prescibed Naprozen but it has been ongoing since.  I was diagnosed with a URI and was prescribed Mucinex which did help with the flim that I begin coughing up.  I have been struggling with my appetite and has noticed about a 5lb weight loss.  It is getting better but still not fully back to normal yet.
Injection site abscess; This case was reported by a nurse via sales rep and described the occurrence of injection site abscess in a adolescent female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of injection site abscess (1st dose received on an unknown date, for tolerance refer case US2019AMR176837).   On 25th September 2019, the patient received the 2nd dose of Bexsero. In September 2019, less than a week after receiving Bexsero, the patient experienced injection site abscess. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the injection site abscess was unknown.   It was unknown if the reporter considered the injection site abscess to be related to Bexsero.  Additional case details were provided as follows: The patient was 17 years or 18 years of age at the time of reporting. Age at vaccination was not reported. The patient came back for 2nd dose and they administered it in the other arm. The patient's mother told the reporter that, the patient again started to have abscess in this other arm. The reporter agreed to follow up. This case has been linked to US2019AMR176837, reported for the same patient.
pt reported soreness in left shoulder,and then neck beginning about the same day the flu vaccine was administered.Pt calledon 10/5 to report incident.was seen for same on 10/8 and again 10/23. was rx baclofen and ibuprofen
Local reaction at the site of injection, pain, itch with erythema, warmth. Induration 34 mm 24 hors later, 50 mm 48 hrs later. No other symptoms. Prescribed Keflex.
This spontaneous report as received from a 37 year old female pharmacist refers to herself. Patients current condition included simple partial seizures. No relevant medical history has been reported. Her past drug history was unknown. On 10-SEP-2014, the patient was drawing up ZOSTAVAX lot # K003596 expiration date: 12-MAR-2015 (unknown dose, units and frequency) (also reported as accidentally, route left eye). Concomitant therapies included KEPRA. On 10-SEP-2014, patient accidentally squirted in her left eye as she was drawing up ZOSTAVAX and it had a retractable needle. On 10-SEP-2014, she also reported that her eye burned a little but then she flushed it briefly and after flushing, her eye was red. It was unknown if there was any relevant laboratory data. It was reported that as of 10-SEP-2014 it was unknown if she will accidentally get ZOSTAVAX in her eye again. The outcome of the event her eye burned a little was reported as resolved. The outcome of the event after flushing her eye was red was reported as not recovered/not resolved (also reported as her eye continues to be red) and the outcome of the event accidentally squirted in her left eye was not reported. Causality between ZOSTAVAX and the events were not reported. Additional information has been requested.
9 month old patient was administered TENIVAC with no reported adverse event; Initial information received on 07-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves 9-month-old patient was administered diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Sep-2023, the patient received a dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection lot U7745AA expiry date: 20-May-2025 via unknown route in the right thigh for immunization and 9 month old patient was administered tenivac with no reported adverse event (product administered to patient of inappropriate age) on the same day following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 9 month old patient was administered tenivac with no reported adverse event.   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 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.
Site was mildly painful, warm, red, slightly swollen beginning first day after injection and continues to be on the 3rd day following injection without worsening or improvement. Redness/swelling extends out approx. 3". Have picture of affected area from 1/13/08 if needed.
Started feeling very nausea and woozy around dinner time the day of receiving the vaccine (vaccine was administered around 10:20AM on 10/20/20). Threw up twice, and had soft stools. Had some ginger ale to calm stomach. Went to sleep, woke up weak and dizzy the next morning (10/21/20). Almost fell down twice due to dizziness. Felt nauseous and dizzy on and off all day and didn't eat much. Slept well that night, and felt better the morning of 10/22/20.
Client reports he felt dizzy about 20 minutes after administration of first Pfizer COVID vaccine while waiting at the train station for train to arrive. Client reports the dizziness lasted about 1 hour and resolved on its own. Client denied any other symptoms at the time of the event and admits he did not have breakfast prior to his first dose appointment at 10:45 am. Client reports he did not follow up with PCP regarding adverse reaction.
INCORRECT PRODUCT STORAGE; OPENED YESTERDAY MORNING AT 9:00 AM AND STORED IN THE FRIDGE UNTIL ADMINISTRATION TODAY AT 12:00 PM; EXPIRED VACCINE ADMINISTRATED; This spontaneous report received from a patient concerned a 49 year old male. 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: 203A21A expiry: 08-JUL-2021) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced expired vaccine administrated. On 27-JUL-2021, the subject experienced opened yesterday morning at 9:00 am and stored in the fridge until administration today at 12:00 pm. On an unspecified date, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administrated, incorrect product storage and opened yesterday morning at 9:00 am and stored in the fridge until administration today at 12:00 pm was not reported. This report was non-serious.
ONSET SLOWLY PROGRESSIVE REDNESS AND LOCAL HEAT STARTED 04/11/12; FEW VESICLES NOTED BUT NOW RESOLVED, SOME SUBJECTIVE COMPLAINTS OF SORENESS/TENDERNESS - ON EXAM 6.5CM X 5CM AREA OF MILD INDURATION AND ERYTHEMA LEFT ARM BELOW DELTOID.
Pt had severe pain at injection site at time of injection. Starting about 6 hours later and lasting just over 24 hours, she reports complete paralysis of arm injection was given in. (I am reporting because 2 other patient with SHINGRIX have reported numbness or neurogeic pain for < 1 week following same vaccine).