chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain was spreading to lower arm; redness was spreading to lower arm; swelling at the injection site; redness at the injection site; pain/tenderness at the injection site; This spontaneous report was received from a pharmacist, concerning a 75 year old female patient.  Information on concurrent conditions, medical history or concomitant medications was not provided.   On 14-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S024808, expiration date:02-JUN-2021) 0.5 milliliter, intramuscular for prophylaxis.  (dose number, and anatomical location were not reported).  On 15-AUG-2020, The patient returned to the pharmacy after the vaccination seeking medical advice with complaints of redness, swelling, pain/tenderness at the injection site. The pharmacist recommended applying ice to the area and over-the-counter (OTC) pain medication (unspecified) for treatment of the reported tenderness in the affected arm (also reported that no treatment was given due to the events, conflicting information). The patient returned to the pharmacy on 17-AUG-2020 (also reported as today), reporting that the swelling had decreased, but she was still experiencing pain, and redness at the site and that it was spreading to lower arm. The patient would be referred to a healthcare professional (CHP) for further assessment. At the moment of this report, the patient was recovering from swelling at the injection site and had not recovered from the events.   The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Pt c/o bruised described as blood under the skin, starting day of injection. Then that went away quick, the c/o soreness for a couple day and muscle tremors 2 days after injection then pt had a syncope episode 2 days after injection.
Developed atrial fibrillation two days after vaccine - heart pounding and some chest discomfort..  Presented to ED the following day and was admitted and cardiologist consulted.
Pt developed right leg edema at knee. Mother stated it was approximately twice the size as it usually was. There was no redness at injection sites, only lower thigh and around knee. Mother denied any heat to touch at site or fever. Pt complained of mild discomfort. Pt continued to run and play. He was treated with Children's Motrin and cool packs to site.
This spontaneous report as received from a registered nurse refers to a 21 month old patient of unknown gender who on 26-MAR-2015 was vaccinated with a dose of PROQUAD (Merck) (lot # K022445, expiration date 13-MAY-2016) 0.5 ml, subcutaneous in the left thigh, concomitantly with a dose of VARIVAX (Merck) (lot # K015969, expiration date 23-SEP-2016) (dose and route were not reported) in the left thigh (overdose). No adverse effects were reported. The patient did not seek medical attention. Additional information has been requested.
Pt recvd vax & 3MAY93 underwent a salpingogram; 6MAY93 devel genralized red bumps, t100, generalized achiness & white bumps on tongue; pt was seen by MD the same day; lab eval revealed hemoglobin 13 & WBC count 3.6;
heart palpitations start few mins after the shot, gradual increased and still persist a day later (Reporting now)
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source.  Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful.  Follow up information has been received on 23-SEP-2014. Demographic details for each patient were provided.  This report referred to a 7-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the third dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 03-FEB-2014 at 5:02 PM. It was reported that this dose was spoiled since the refrigerator was too cold. The reporter stated that it ws declined to repeat vaccine. No adverse event was reported for the patient.  This is one of several reports from the same source.  Additional information is not expected since all follow ups requested to complete the case were received.
approximately 3am, about 14 hours post-administration, developed body aches (bones, joints, muscles), stabbing pains in shins, severe headache, fever and chils. Temp 102.6 This persisted for 24 hours. 2nd day of illness (1/28/21), temp 99.4-99.8 3rd day(1/29/21) headache continued, mental fogginess, fatigue, some trouble with words  Symptoms from day 3 are continuing to the point of date of filing this.    Missed 2.5 days of work. (Tried to work on the 2nd day of symptoms, left midday)
50 mm red, swollen, hard area, very hot to touch on left deltoid, Also c/o itching at site.  Recommended cool wash cloth, ibuprofen and Benadryl.
Pt received Flu vaccine at clinic at approximately 330 on 11/1/18.  Pt's father pt starting with hives around her face around 6-7 pm that evening.  They gave her Benadryl that did not help resolve hives.  Per pt's father they took her to the Emergency room on 11/3/18 around 8 pm as hives were all over her body and not resolving.  ER provider assessed patient and was sent home with a course of steroids.
Approximately 15"-1/2 hour later, felt throat close up/tighten; did not seek help and did resolve w/o intervention per patient.
Swelling in the left arm pit; Fever; Hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), LYMPHADENOPATHY (Swelling in the left arm pit) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN 70/30), METFORMIN, METOPROLOL TARTRATE (METPROLOL), LOSARTAN, AMLODIPINE, HYDRALAZINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced HOT FLUSH (Hot flashes) and PYREXIA (Fever). On 08-Mar-2021, the patient experienced LYMPHADENOPATHY (Swelling in the left arm pit). At the time of the report, HOT FLUSH (Hot flashes), LYMPHADENOPATHY (Swelling in the left arm pit) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included emergency pill when BP > 180 0.1mg on emergency.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
A non-serious spontaneous report of fever and vomiting has been received from a consumer concerning an 8-year-old male, subsequent to FLUMIST. Medical history and concomitant medication were not provided. On 28-Oct-2008, the patient received FLUMIST, intranasal administration. On 02-Nov-2008 the parent of the child reported his son was "having symptoms of fever and vomiting." The child was not hospitalized. Per the reporter both the fever and vomiting were resolved the next day and there was no need to seek any medical treatment. On 03-Nov-2008 the events of fever and vomiting were resolved. Follow-up information was received on 13-Jan-2009 and included event outcome information. This information has been incorporated into the above narrative.
Recieved Covid-19 booster dose Moderna on 11/4/2021. Presented to ED on 11/5/201: Patient is a 89 Years Old Male who presents today for follow up hospitalization for complete heart block. Patient initially presented to ED on 11/5/21 with syncopal episode x 2, workup in ED was negative but after workup completed patient had recurrence of symptoms, cardiac monitor showed intermittent complete heart block. Transcutaneous pacer pads applied and patient transferred and had temporary and then permanent pacemaker placement performed, and was discharged the following day.   Since discharge, is feeling much better. Patient's wife reports he sleeps more than usual but otherwise seems to be doing well.
Starting about 49 hours after receiving the vaccine, I woke up and when I went to sit up I felt like I had been hit by a truck and was experiencing flu like symptoms. I had minor dizziness for about 2-3 seconds so I laid back down. My husband got me water and ginger ale. I took a few sips and went back to sleep. 30 min later I woke up and felt better but felt unsteady. My husband walked behind me to keep me steady so I could use the restroom then he helped me back to bed. I went back to bed and woke up to eat lunch. As the day went on I would snack small amounts but rested most of the day. By the next morning, I woke up and felt fine. About 2-3 weeks after receiving the vaccine, I experienced some achiness and tiredness. Over the next 6 months I would experience burning nerve pain. I mentioned it to my doctor over a video visit. They didn't think much about it. All of my bloodwork would end up coming back normal. The more time that passed since receiving the vaccine, the less noticeable the burning sensation was.
Intractable vomiting, nauseous, diarrhea all for 6 days, elevated troponin level
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted and fell but was conscious and alert. EMT service was called and patient was evaluated. Patient was feeling better and did not need to be transported to ER. Patient was taken home by his mother. A follow up call to the patient was made 3 hours later. Mom inform Rph that patient was feeling fine and everything was OK.
I developed heart complications. They were gradual at first and then they became consistent. They would take my breath away. I would have chest discomfort but that wouldn't last long. It lasted for about three weeks. I seen a doctor and I wasn't prescribed any medications. I still have them they are just on and off now.
Severe redness at injection site within 24 hours Swelling, larger but lighter redness, and itching at injection site within 48 hours
C/o lightheaded essay. States she felt dizzy when standing in line. Hx chronic pain, diabetes, shoulder injury with residual weakness. BP 171/103, HR-106, O2-99% on room air. BS-238. Placed on stretcher and taken to another room for further evaluation. Sx resolved and client was discharged home at approx. 1pm.
mild red flat rash - abdomen  burny rash at areas of baseline eczema - arms, thighs Otherwise fine
On 02/12/2022 I had a Grand-Mal Seizure that lasted 5 minutes while shopping with my wife at a store. The seizure was caught and the EMTs that arrived, and my wife asked security to review the tapes while I was still unconscious. They claimed it was 5 minutes, with an additional 2 minutes of unconsciousness. I was taken by Ambulance to the ER, was given CT Scan(5mm cuts) - Normal outcome. No visible injuries. Made appointment with Neurology for 03-10-2022. They have set up dates to have MRI Scan of Brain(CPT) , and Sleep Deprivation Test done (EEG)  in the next few weeks. General consensus is the booster cause the seizure do to the fact I have severe Psoriasis which causes massive inflammation of the skin, and internal organs.  I should have not taken the booster shot due to this reason alone.
Information has been received from an office manager concerning a kindergarten age patient who on unspecified dates was vaccinated with a dose of VARIVAX (Merck) (lot# not reported). Subsequently the patient developed cellulitis at the injection site after being administered VARIVAX (Merck). No medical attention was sought. At the time of this report, the patient had recovered from cellulitis at the injection site. Follow up information has been received from the office manager who reported that a little girl was given VARIVAX (Merck) in the lateral thigh, MMR II (MSD) (lot#s not reported) in the lateral thigh and KINRIX in the deltoid all at the same time. She stated that these are the three standard immunizations given for children of kindergarten age. In the process of trying to narrow down which inoculation was causing the reaction, they moved the injection site of the KINRIX to the deltoid, and just "last week" a little girl experienced injection site cellulitis in the arm. So the office manager stated that it didn't appear that the patient previously reported had a reaction to VARIVAX (Merck), she had a reaction to the KINRIX. This is one of several reports from the same source. Additional information is not expected.
localized redness, swelling. This was also associated with fatigue and generalized malaise that waned over the course of the following three days
At 9:30PM, 6 hours post immunization, Patient started feeling very strong itch on the sole of her right foot, next hive appeared there, shortly thereafter, within another couple minutes 3 more prominent hives appeared on her left ankle (one) and left thigh (2). Her cheeks week bright pink. At 9:45PM she was given 10mg table of ZYRTEC. Doctor on call was consulted, decision to manage the outbreak at home was reached. By 10:25PM itch started to subside. Patient was monitored over night every 2 hours. Currently she is on ZYRTEC, her hives are not as big, but very visible.
This spontaneous report was received from a licensed practical nurse referring to a 4 month old male patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date at his 4 month visit, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose, route, lot # and expiry date were not reported) for prophylaxis. On an unknown date (5 days later), the patient was vaccinated with another dose of RECOMBIVAX HB in error (inappropriate schedule of drug administration). No details about the doses were known except that doses were 5 days apart. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Developed vomiting one day after receiving immunizations & was diagnosed with intussusception 2 days later. He required surgery & 5 inches of bowel was resected.
SARS-COV19 Infection. Cough Congestion,Runny Nose, Fever,Loss of Taste, loss of Smell, Headache,Sore Throat, Fatigue, Chills,Muscle Aches
edema, erythema, chills, nausea, vomiting, myalgias, joint pain
Mild wheezing and complaints of difficulty breathing Benadryl, 0.5ml, IM given at 01:35 PM
pt recv vax approx 12MAY96 & 3 wk p/vax exp ha/, nausea & fever & was hosp;blood test @ that time showed elevated liver enzymes;pt improved & was released from hosp;blood work performed 14JUN96 & liver enzyme were still elevated;
BLACK WATERY STOOLS; MOTION SICKNESS; STOMACH CRAMPS; NAUSEA; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 47 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included stomach cramps got progressively worse, and 6 episodes of diarrhea, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 and expiry date: not reported) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced injection site pain. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced motion sickness. On 02-APR-2021, the subject experienced stomach cramps. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced black watery stools. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 01-APR-2021, was recovering from headache, and had not recovered from nausea, motion sickness, stomach cramps, and black watery stools. This report was non-serious.
Started with fever on 10/27, which lasted several days; maximal temperature 101.8 degrees. Sluggish/decreased activity, decreased appetite. Restless sleep. No respiratory symptoms, gastrointestinal symptoms (other than 2 episodes of vomiting a day apart, each time shortly after being given TYLENOL) and no rash. Child was evaluated on 10/31, a little sluggish but responding appropriately, mildly ill-appearing. Exam otherwise normal except for enlarged lymph nodes, to 1 cm in cervical region, and 4 to 5 mm in inguinal region.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot  number FD0809. Guidance from the Department of  Health, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the  dose of vaccine that you received is valid
13 days post vaccination patient reported with new lesion. Appeared anterior portion of shoulder. Erythemic base. Dark red, crusted center. Very painful with uniform blouse being worn. Non febrile. Treated pain with Roxicett. Sent home for 2 days.
Patient presented back to pharmacy with skin rash around injection site that was red, scabbed and bloody.
I received the Pzifer vaccine for covid and now like a miracle I can taste I received the Pzifer vaccine for covid and now like a miracle I can taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No taste and smell" (unspecified if ongoing); "No taste and smell" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I received the Pzifer vaccine for covid and now like a miracle I can taste I received the Pzifer vaccine for covid and now like a miracle I can taste and smell".  Additional information: The patient had no taste or smell for several years. The doctors have been unable to determine the cause. The patient received the Pzifer vaccine for covid and now like a miracle the patient can taste and smell. This has been life changing for them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date, an unspecified patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date not reported). On an unknown date (reported as within a month after vaccination), the patient's spouse, who did not receive ZOSTAVAX, developed shingles. The pharmacist stated the vaccinated spouse may have transmitted the virus to the unvaccinated spouse. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Patient is an 73 y.o. female.      I personally interviewed patient, reviewed chart, and reviewed emergency room resident history and agree with it in its following entirety unless otherwise noted below.  "Patient is a 73 y.o. yo female presenting to the ED with planes of right-sided sharp chest pain.  Patient states that she woke up this Wednesday night and has been dealing with pain consistently since that time.  Initially thought was a pulled muscle however mom compresses, Tylenol and ibuprofen has not helped the pain at all.  Patient otherwise states increased pain with inspiration.  Patient denies any fever, chills, denies any nausea vomiting tissue today.  Patient denies any previous history of heart or lung problems.  Patient also denies any additional abdominal surgeries besides C-section in the past."   No rash over the chest wall.  No abdominal pain.   No left-sided chest pain.   No lower extremity edema.   No hemoptysis.   In the emergency room she is found to be Covid positive.   Denies any bleeding or urinary symptoms or vomiting.   When I am in the room she is saturating 92% on room air she looks uncomfortable   D-dimer was done which age-adjusted is normal
welt on lt arm (x2 hives w/some erythema; Atarax 25mg po q 6 hr;
Noticed swelling and redness 8 days after dose.  Itching at injection site as well.  Redness is improving, rash it new, and swollen.
Vacant stare with some twitching and eye rolled back for 2-3 minutes. Was normal during ambulance ride to Hospital Temp=102.7 RX=Zithromax
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy on or about 09-OCT-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-NOV-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed gabapentin and SILVADENE for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Received shot 11/6/16. Came into RX Dept 11/8 - red, warm raised area on bicep area (not deltoid where shot given). After consideration advised doc visit who diagnosed cellulitis + 8 and pt antibiotic.
patient began to have headache (pressure back of head), some shortness of breath with an elevated blood pressure. Patient stayed for monitoring for 30 mins and symptoms aleviated
tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, AMLODIPINE, PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 19-Apr-2021, the patient experienced FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) had resolved.            Treatment medication was not provided