chrisvoncsefalvay/vaers-outcomes huggingface dataset:
acute stomatitis reaction; pain; her teeth hurts; felt like it was grinding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: STOMATITIS (non-serious), outcome "unknown", described as "acute stomatitis reaction"; PAIN (non-serious), outcome "unknown", described as "pain"; TOOTHACHE (non-serious), outcome "unknown", described as "her teeth hurts"; BRUXISM (non-serious), outcome "unknown", described as "felt like it was grinding". Therapeutic measures were taken as a result of pain. Additional information: Clinical course: Two weeks after receiving the Pfizer vaccine, the patient was having an acute stomatitis reaction. The patient was not taking Valtrex just ibuprofen and a tramadol for pain. The patient was due to receive the second vaccine on 07Apr2021 and was asking for advice. The patient also experienced that her teeth hurt and felt like it was grinding.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This individual stated that she felt light headed right after she got her vaccine, she also stated that she was fasting and did not eat or had a drink today. Vitals were taken, apple juice was given, and she stated that she felt better and left  at 1:18pm.
Patient had 3 hives when they arrived home. As time went on he had hives on chest and side. Belly covered after 1.5 hrs.
Onset of reaction: 1 wk  ADR experienced: double vision, lf eye droop, rt eye droop, myasthenia gravis
Information has been received from a RN concerning a 12 month old white female with no pre-existing allergies, birth defects, or medical conditions who on 29Mar05 at 10:30AM was vaccinated in the right leg with a first dose of varicella virus vaccine live (lot 648319/0441P). There was no illness at the time of vaccination. On 16Apr05 the pt developed approx 5 to 6 varicella lesions which were characterized as mild and widely scattered. She was see in the physician's office and checked by the doctor. Unspecified medical attention was sought. There pt did not have a fever and there were no other problems. The outcome was reported as recovered. There was no product quality complaint. There were no relevant diagnostic tests or lab data. There were no adverse events following prior vaccinations at the pt or her siblings. No additional information is expected.
Patient came into the pharmacy at 10:25 AM on 9/28/17 to report an adverse event from the shots he had received 2 days ago. The patient reported mild swelling in his left upper arm that night and also experienced muscle spasms and soreness over his entire body. He stated the muscle spasms and aches have mostly gone away. He reported using marijuana oil (called CBD oil) and applying topically which seemed to help. Mild redness present in left deltoid. Patient has no symptoms of respiratory distress, itching around injection site or nausea. Patient also reported having both vaccines before but no record of previous pneumonia on record in Alert.
having diplopia; cannot drive; cannot walk; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient stated having diplopia for a month and "nothing patient took to resolve it had worked patient still had double vision, cannot drive, cannot walk really patient can barely function. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a registered nurse (RN) concerning a 4 year old male with no pertinent medical history or allergies who on 20-JAN-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Concomitant vaccinations administered on that same day included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine inactivated (unspecified). The RN reported that on 29-JAN-2006, the patient's eyes were very red around the rim. Unspecified medical attention was sought. A diagnosis of blepharitis was made and the patient was treated with amoxicillin (+) clavulanate potassium (AUGMENTIN). On 07-FEB-2006, the patient developed a measles-like rash characterized by small red dots on his chin and chest. No laboratory/diagnostic tests were performed. At the time of this report, the patient's blepharitis and measles-like rash persisted. Additional information has been requested.
Patient received Moderna Booster shot on 11/12/2021. Patient came back to site today and complained of redness and itchiness at the injection site. Clinical staff suggested patient use cortizone cream and to contact a doctor if condition does not improve.
Employee is complaining of chills, headache, dizziness, fatigue and feeling faint.  She was tested for Covid on a rapid for the ID now and tested negative today.
Coomb's positive hemolytic anemia one week after getting Moderna booster vaccine. On prednisone still(tapering dose slowly) and folic acid; still anemic, but less so since starting prednisone.
Onset of redness and swelling with tiny clear fluid filled blisters, around mouth, on tongue, bilateral hands/digits and feet. Reported 4-5 larger blisters with creamy yellow fluid around mouth and on chin. Fine rash on upper and lower extremities. No fever. Received instruction by pcp to give children Benadryl by second dose rase was improved. Mom reports as of today (8-30-12) that hand and feet are peeling.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LOST APPETITE; This spontaneous report received from a consumer concerned a 57-year-old male, race and ethnicity unknown. 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: Unknown) dose was not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date in Mar-2021, the patient experienced aching muscles, dry cough, trouble breathing, and fever (suspected covid-19 infection and suspected clinical vaccination failure), and lost appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, lost appetite and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210856012- covid-19 vaccine ad26.cov2.s- suspected covid-19 infection. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Received PNEUMOVAX in right arm on 10/16. Friday 10/17 arm sore but not red or warm. Saturday AM 10/18 sore, red, warm on inside of arm. Went to urgent care. Provider prescribed azithromycin.
He has tremors in his right hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Lot number: EN6208) at the age of 69 years as dose 2, single for covid-19 immunisation; aciclovir (ZOSTER), administration date 28Jun2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lisinopril, notes: Has been taking Lisinopril for years. Vaccination history included: Bnt162b2 (1st Dose, Right arm in the morning, lot EN6201), administration date: 25Feb2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "Sore arm"; Shingles (1st shingles shot, Shingles), administration date: 04Jan2021, when the patient was 69 years old. The following information was reported: TREMOR (non-serious) with onset 2021, outcome "unknown", described as "He has tremors in his right hand".  Additional information: It is unknown if additional vaccines Administered on Same Date of the Pfizer Suspect. Prior vaccinations patient had a sore arm with the 1st COVID shot that started right away and lasted about 4 days and the 2nd one patient had no side effects at all.
Extreme headache causing inability to keep eyes open, extreme body aches all over, hot/cold flashes, bed ridden for 30 hours, extremely sore arm, had to use ice packs and IBprofrin for head and arm pain.
Receivd a Shingrix that was stored improperly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number ZG744, expiry date 28-AUG-2023) for prophylaxis.   In SEP-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Receivd a Shingrix that was stored improperly). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 02-MAR-2023 The pharmacist reported that a patient received his first dose of Shingrix at a different, but was informed that the vaccines were stored improperly.  The reporter did not know the temperatures the vaccine were exposed to. The reporter consented to follow up. Additional supportive information: The patient received Shingrix which was  stored improperly, which led to incorrect storage of drug.
STEMI requiring hospitalization and cardiac catheterization with stenting on 09/14/2023 around 2-3 weeks after vaccine adminstered.
Three days after the shot I started having what felt like a sudden heavy heartbeat almost like I had been frightened out of nowhere.  This continued until now but slowed down after 3 months.  I have also noticed that I often poop blood clots which has never happened until after the shot.  I feel like I?m running about 60 to 70 percent of my pre-shot ability.  I felt worse those first 3 months but I?m still under the energy level I had before the shot.  My heart tries to beat out of my chest for no reason.   I have fatigue like never before. I have blood clots in my stool or as my stool.
Just less than six hours later I woke up with terrible chills/shakes. Also had a headache. These lasted on and off about 48 hours. In addition, my body was sensitive to touch and all food and drink tasted strange for about the duration. I mention these side effects because they are not written under common side effects and I thought my experience should be reported
Patient received the vaccines on 11/06/2017 and started having reactions such as a fever, runny nose, and on 12/03/2017 she woke up at 4am with a seizure. Her fever has not gotten down past 101 all day.
After my second dose, I felt fin at around 10pm like the first dose my arm started to become achy.  I go to work around 230AM and when I was putting my contacts in my right eye had a huge busted vessel to the right side of my pupil.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.  Version created to amend previously reported information on 10-MAR-2021. Upon review the following information was amended: The event suspected covid-19 infection was downgraded from serious to non-serious and dose and route updated to unknown.; Sender's Comments: V1:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
sz pt seems more lifeless; no body control; no head control; floppy; sleeping as if drugged; brain damage
Patient described soreness and tenderness at the injection site starting the date of injection and progressively worsen to soreness of the entire left arm.  The site of injection is no longer sore as of 10/19/15 but her left shoulder and arm range of motion is decresed.
felt real cold; tongue was swelling a bit; 2 bouts of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (felt real cold), SWOLLEN TONGUE (tongue was swelling a bit) and DIARRHOEA (2 bouts of diarrhea) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced NASOPHARYNGITIS (felt real cold), SWOLLEN TONGUE (tongue was swelling a bit) and DIARRHOEA (2 bouts of diarrhea). On 10-Jan-2021, NASOPHARYNGITIS (felt real cold), SWOLLEN TONGUE (tongue was swelling a bit) and DIARRHOEA (2 bouts of diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported but it was mentioned that patient was under concomitant medications. Patient had Drank ice cold water which made her feel better. Patient reports diarrhea could be due to her eating habits.
Confirmed breakthrough case  COVID-19 (Moderna) 1  02/04/2021  Hospital Moderna 007M20A   COVID-19 (Moderna) 2  03/04/2021 Hospital Moderna 015M20A   COVID-19 (Moderna) 3  11/26/2021 Pharmacy  Moderna 039F21A
Patient started itching on 10/18/16, developed swelling of hands and right earlobe, she passed out on 10/18/16. She did not go to hospital and did not report to the office until 10/20/16 she developed rash on arms, neck, face, legs. Patient had appt. with Dr. and was given 40 mg DEPO-MEDROL on 10/21/16.
PT DESCRIBES GENERAL FLUSHNESS, TINGLEY FINGER. MEDICAL HISTORY INCLUDES ASTHMA. 1658 BP 128 HR 63 RESP 14 02SAT 97 SKIN SHOWS RASH, LIGHT REDNESS SPREADING FROM VACCINATION SIGHT DOWN ONE ARM DISIPATING WITHIN 10 MINUTES. NO NOTED PAIN TO PALPATION OF VAX SITE. NO SWELLING.REASSES AT 1715 BP 126/82 HR 61 RESP 14 O2SAT 99
Problems swallowing; Throat started feeling like it was starting to close up; Red blotches on both upper arms; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Problems swallowing), THROAT TIGHTNESS (Throat started feeling like it was starting to close up), RASH MACULAR (Red blotches on both upper arms) and HYPERSENSITIVITY (allergic reaction) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 003C21A) for COVID-19 immunisation.     Concurrent medical conditions included Allergy to vaccine (Every flu vaccine).   On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced HYPERSENSITIVITY (allergic reaction). On an unknown date, the patient experienced DYSPHAGIA (Problems swallowing), THROAT TIGHTNESS (Throat started feeling like it was starting to close up) and RASH MACULAR (Red blotches on both upper arms). The patient was treated with CORTISONE for Allergic reaction, at a dose of unknown. At the time of the report, DYSPHAGIA (Problems swallowing), THROAT TIGHTNESS (Throat started feeling like it was starting to close up), RASH MACULAR (Red blotches on both upper arms) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   During emergency room visit they gave her prescription for some kind of steroid for 5 days. No concomitant medication information was provided.   This case was linked to MOD-2022-453776 (Patient Link).
Mom reported PT having rash after shots last week, just a few bumps, no f/c, no appetite change. Playing with cousin, feels well, no n/v. mom putting gentian violet on lesions, asks for something for itch Provider verified both telemedicine and in clinic post varicella mild infection, reassurance (vax is live attenuated), enc booster as scheduled, continue gentian violet to avoid superinfection and add PO Benadryl 25mg q6h. school note to return on Monday, is past infective stage at this point b/c crusted over.
Sick after vaccination.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after vaccination.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick after vaccination.). At the time of the report, ILLNESS (Sick after vaccination.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Large area of erythema and swelling  - from right arm shoulder to elbow feels achy, headache. Began evening of injection.
pt mom stated that evening about 7pm pt presented with tonsil swelling eventually leading to sob nasal flaring and difficulty breathing. pt had lymph nodes swollen down side of face from back of ear to left side of neck-mom brought pt to ER pt given antiinflammatories, tested also for mono spot, was positive. cbc was done and was normal.released to go home. pt remains afebrile at this time-- swelling of tonsils and lymph nodes still present.
shingles; This is a spontaneous report from a contactable consumer (parent). A 23-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication includes unspecified birth control and patient is on IUD. The patient previously received chickenpox vaccination and booster dose. In the afternoon of 24Mar2021, the patient came down with shingles/rash like shingles, even though she had her booster. The patient was not on any antiviral medications at the time of report. She was using a triple antibiotic cream. The shingles was on the right side only on her belly and painful. The outcome of the event was unknown.   No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Had known possible exposures, developed some short-lived chest congestion As of report date (4/2/21), reports feeling well
red ring the size of a tennis ball, arm redness; arm lumpy; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red ring the size of a tennis ball, arm redness), VACCINATION SITE MASS (arm lumpy) and PAIN IN EXTREMITY (Arm sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ERYTHEMA (red ring the size of a tennis ball, arm redness), VACCINATION SITE MASS (arm lumpy) and PAIN IN EXTREMITY (Arm sore). At the time of the report, ERYTHEMA (red ring the size of a tennis ball, arm redness), VACCINATION SITE MASS (arm lumpy) and PAIN IN EXTREMITY (Arm sore) outcome was unknown.            No concomitant medications were provided by the reporter.   Treatment information was not provided.
Information regarding PREVNAR 13 was received from a nurse regarding a 3-year-old male patient who experienced leg hurt badly, crying, lethargic and acting very strange. At 3 years of age, the patient received a dose on 25-Oct-2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on 25-Oct-2010. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Haemophilus Influenzae. Concomitant medications were not reported. The patient experienced leg hurt badly and crying in Oct-2010 and lethargic and acting very strange on 26-Oct-2010. Outcome for all events was unknown. No additional information at the time of this report. See related case (s): US-WYE-H18418010 (adverse event, non-expedited). Follow-up (17Nov2010): This nurse reports additional information. The patient had no relevant medical history. The patient was 38 weeks gestation and 8 lbs at birth. The medication was stored as per manufacturers instructions, was not altered in any way and was administered by a health care professional. The patients developmental milestones were within normal range. The patients physical growth has been normal and the patient has recovered from the events.
10/07/10 NAUSEA ALL NIGHT; 10/08/10 CHILLS AND FEVER FROM 7 AM - 9 AM; STARTED SWEATS AND FEVER; CLEAR BLISTER BROKE OUT IN MOUTH, ON NOSE AND CHIN 10/0/10; STAYED UNTIL 10/18/10.
Case number PHEH2013US021634 is an initial spontaneous report received from a health care professional on 15 Oct 2013, with a follow-up received on 13 Nov 2013. This report refers to an 84-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309001, expiry date: Apr 2014) intramuscularly at a dose of 0.5 ml on 07 Oct 2013. It was reported that the patient received FLUVIRIN that had been stored at a room temperature for up to 24 hours. It was reported that the patient had no adverse reaction following this medication error. Follow-up was received on 13 Nov 2013: Information that the patient had not experienced any reaction was updated.
Throat swelled, acute loss of voice, spent night in hospital.  12/02/09 ED notes received DOS 11/21/09. DX: allergic reaction. Pt c/o allergic reaction, chest tightness, throat tightness, hoarse voice. On examination: laryngeal cord edema. tx: Albuterol, Zantac, Solu-Medrol, Benadryl. Pt improved and discharged home.