chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; Symptoms of shingles; 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 HERPES ZOSTER (Symptoms of shingles) and RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced HERPES ZOSTER (Symptoms of shingles). On an unknown date, the patient experienced RASH (Rash). At the time of the report, HERPES ZOSTER (Symptoms of shingles) and RASH (Rash) outcome was unknown.            Reporter did not allow further contact
AFTER RECEIVING SHOT C/O CHEST PAIN.  PRONOUNCED SAME DAY AT FACILITY.
Axilar lymph node swollen  and painful, pain in the injection area (after 12 hours) symptoms went away after 48 hours. After a week the axilar lymph nodes became painful and swollen again and the area of the injection became  swollen, warm, red and itchy.
Due to staff error patient received almost 3 times regular dose of vaccine. Patient waited in office for 15 mins after vaccine and left with now adverse reactions. Error was not discovered until later after the patient left. Patients PCP contacted patient to notify her of the error. Patient stated she feels fine and further denied headaches, chills/fever, pain at injection site, nausea, vomiting, myalgia, or arthralgia. Patient given office phone number by the Doctor should she develop any worsening aforementioned symptoms.
bronchitis; Persistent cough.; This is a spontaneous report via from a contactable consumer. A 35-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0217) via an unspecified route of administration in right arm on 11Jun2021 16:00 (at age of 35-year-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available), additional vaccines administered on same date of the Pfizer suspect, all vaccines administered on same date with the Pfizer vaccine considered as suspect, AE(s) following prior vaccinations was none. On 20Jun2021, the patient experienced bronchitis, persistent cough. It was reported that she came down with bronchitis and was unable to receive her second dose of the Pfizer COVID-19 vaccine which she was scheduled to receive on 02Jul2021. She was very angry and was really frustrated at the different pharmacists because they are refusing to vaccinate her and its the third place in city that had refused to vaccinate her and she was begging to get vaccinated and seeked guidance on alternative dosing. States that she got bronchitis 2-3 weeks after the vaccine, so it did not have anything to do with the vaccine. States that she got bronchitis a couple days before she was supposed to get the 2nd dose of the Vaccine. She started had symptoms around 20Jun2021. She had a persistent cough until last week, end of Jul2021. States that she was fine 2 weeks before that, but could not get the vaccine with a persistent cough. The event bronchitis result in physician office visit. The patient underwent lab tests and procedures which included Tested her for Covid: negative on an unspecified date 2021. Treatment received was cough suppressant and a Z-pak received. The outcome of event bronchitis was not recovered and for persistent cough was recovered on Jul2021.  Follow-up attempts are completed. No further information is expected.
Mother reported that child had severe red inflamed area at the site of the injection, however it was not present on 10/31/03 when the next dose was due.
My flu vaccine didn't work with no reported adverse event; Initial information received on 05-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient for whom influenza vaccine didn't work with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination which didn't work with no reported adverse event (vaccination failure).  Action taken with influenza vaccine was not applicable.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   At time of reporting, the outcome was Unknown for the event my flu vaccine didn't work with no reported adverse event.  Seriousness criteria: The event vaccination failure was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 10-Jan-2023: This case involves an unknown age and gender patient for whom influenza vaccine didn't work with no reported adverse event. Based on information provided, the causal role of company suspect vaccine cannot be excluded. Case will be re-evaluated post further update on information regarding underlying disease, risk precipitating factor, other concomitant medication, past medical history and patient lifestyle which will aid a comprehensive assessment of this case.
other zoster-related conditions; shingles; Information has been received regarding a case in litigation from a lawyer referring to a currently 71 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) at a medical office by a physician for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a physician for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was unknown.
Severe extreme migraine, nausea, heartburn, tiredness, body aches, chills
At 15:00, gave injection of DTAP and HIB (2 different sites, same right thigh) leg became bright red in color, a few bumps noted; I got the doctors to look at baby and we administered 1/2 tsp Benadryl. The pt is to follow-up with an allergist.
Racing and skipped heart beats, palpitations, some breathiness, fatigue, Mild headaches as reported in V-Safe application which continues On/off Fatigue  Also, diagnosed in October 2021 with thyroid nodule which was biopsied and positive for papillary cancer.  Partial thyroidectomy surgery on January 18, 2022. Surgery was delayed due to cardiac evaluation/workup for palpitations
Swelling of arm-sever from shoulder to wrist and blisters (burn-like reaction) over large area surrounding site of vaccine administration. Patient required oral steroids and topical treatment to reduce pain, erythema, swelling, and sloughing of skin at blisters. Resolved with oral steroids and topical treatment within 1 week. (Still with discoloration at 3 wks.)
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm) in a male patient of an unknown age 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 PAIN IN EXTREMITY (soreness in his arm). At the time of the report, PAIN IN EXTREMITY (soreness in his arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. No treatment information was provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This spontaneous report was received from a pharmacist and refers to a unspecified number of patients patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The pharmacist report that on an unknown date, the patients were vaccinated with ZOSTAVAX, subcutaneously in the triceps region of the arm  instead of the deltoid region of the arm , for prophylaxis, (strength, dosage, frequency and lot# were not provided). Concomitant therapies were not provided. Additional information has been requested.
2 days, post vax, pt had pain in buttocks and into right leg, then numbness in anterior right shin and into right foot. He had a metallic taste in mouth and slightly blurred vision. 8/2/00, has improved. No treatment required.
9/9/04 When child presented for PPD reading on arm, red area on left upper arm about 2 1/2 inches in diameter noted. Child told mother it hurts a little (in Spanish). Mother instructed to try using warm compress to area for relief in next couple of days.
Golf ball size swelling lymph nodes. Swelling in shoulder, chest, N/V.
Myalgia, Arthralgia, Fever, Diarrhea, Fatigue Narrative: Reports fever on 3/5 at night into 3/6, diarrhea on 3/7. Myalgias, arthralgias, and fatigue on 3/5, 3/6, and 3/7. All resolved on 3/8.
Pain and later swelling at injection site.  Later fever and chills around 10:00 PM.  Very intense back pain began around midnight lasting a few hours disrupting sleep, improved by 4:00 Am on 03-06-2013, finally allowing sleep.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned an adult 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: 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 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. This report was associated with product quality complaint: 90000188117; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Right groin lymph node swollen size of large Grape.  Left supraclavicular 2 lymph nodes swellings size of large lima beans.
Vaccinated 9/30, onset of symptoms consistent with upper respiratory infection 10/6 pm or 10/7 am: fever, cough, malaise, aches, sore throat. Onset of CHEST PAIN 10/9 PM, resolved with tylenol.  Further chest pain early am 10/10, for which he went to ED.  Reported substernal chest pain 10/10 radiating to arm with shortness of breath, EKG: STEMI.  Taken to cath lab, showing no evidence of coronary artery disease.  No personal hx of cardiac dx, no family hx of early onset cardiac diseases.  DOES have hx of prior COVID infection December 2020 with malaise, myalgias, arthralgias, anosmia, non productive cough, nasal congestion, sore throat, and diarrhea. Managed supportively adn recovered well.
On March 18 woke up with swollen area of shot site. Red , hard and sore
Information has been received from a nurse referring to a patient of unknown age and gender. On 09-JUN-2015, the patient was administered with improperly stored dose of MMR II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Administration error, an incomplete influenza vaccination was given due to syringe failure, most of the vaccine exited the hub and ran down patient's arm.  The dose was repeated during the same visit, in the same arm, 1 inch away, so that patient would receive a complete dose
Face flushed; lips and eyes swelled; lips and eyes swelled; lips and tip of tongue because numb; This is a spontaneous report from a contactable consumer (reported for herself). A 35-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: PFIZEREN6207/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm right on 11Mar2021 at 14:45 (at the age of 35-years-old) as dose 1, single for covid-19 immunisation. Medical history included allergy to immunoglobulin therapy from an unknown date and unknown if ongoing (Anaphylaxis with allergy immune therapy), gluten sensitivity from an unknown date and unknown if ongoing (known allergies: Gluten) and food allergy from an unknown date and unknown if ongoing (known allergies: some shellfish). Concomitant medication(s) included phentermine (PHENTERMINE), topiramate (TOPIRAMATE), cetirizine (CETIRIZINE), diphenhydramine hydrochloride (BENADRYL) and ibuprofen (IBUPROFEN), all the drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 15:15, the patient experienced face flushed, lips and eyes swelled and lips and tip of tongue because numb. No treatment was given for the events. The outcome of the events was resolved on an unspecified date in Mar2021.  No follow up attempts are Possible. No further information is expected.
Pt requested vaccine in right gluteus. Vaccine was administered in gluteus before information was given that it was not to be administered in the gluteus.
immun given @ 2PM began running w/fever @ 11PM; mom gave APAP; 3AM pt had a fever of 105 & vomiting taken to ER; pt was sent home on APAP;
Patient was not supposed to receive this 3rd dose. Patient was vaccinated with J & J on 5/13/21, received a Pfizer booster on 1/3/22 and then this 2nd dose of Pfizer on 2/10/22
Syncopal episode, 5-10 minutes after vaccine administration.  Fell to ground from standing position, hit head.  Skull fracture, subdural hematoma.  Required intubation, ICU admission.
I feel like I got COVID after receiving the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I feel like I got COVID after receiving the Moderna vaccine) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (I feel like I got COVID after receiving the Moderna vaccine). At the time of the report, SUSPECTED COVID-19 (I feel like I got COVID after receiving the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment This case concerns a female patient of an unknown age with no reported medical history, who experienced the non serious, unexpected AESI of Suspected COVID-19. The event of occurred on an unspecified date after an unknown dose sequence of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age with no reported medical history, who experienced the non serious, unexpected AESI of Suspected COVID-19. The event of occurred on an unspecified date after an unknown dose sequence of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Spotting beginning day 2 post vaccination. I am breastfeeding 10 month old and have not change my nursing/pumping schedule and have not been menstruating so this was unusual.; Spotting beginning day 2 post vaccination. I am breastfeeding 10 month old and have not change my nursing/pumping schedule and have not been menstruating so this was unusual.; Spotting beginning day 2 post vaccination. I am breastfeeding 10 month old and have not change my nursing/pumping schedule and have not been menstruating so this was unusual.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 09:45 (Lot number: EW0164) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS]. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 23Apr2021, outcome "unknown" and all described as "Spotting beginning day 2 post vaccination. I am breastfeeding 10 month old and have not change my nursing/pumping schedule and have not been menstruating so this was unusual.". Therapeutic measures were not taken as a result of off label use, product use issue, menstrual disorder.  Additional Information: No other vaccine taken in four weeks. Adverse event was Spotting beginning day 2 post vaccination. Patient was breastfeeding 10 month old and had not change in her nursing/pumping schedule and had not been menstruating so this was unusual. No Covid prior vaccination. No Covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021467376 different patient, same drug, same event (split)
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Hypotension-Medium
Pt called back about 2 hrs later and said her right arm and shoulder was hurting very bad and her right had was tingling. Pt received injection @ 12:20 pm and she said this start about 30 minutes later. I apply LIDOCAIN JELLY to the site per Dr. verbal order. Pt was given prescription for LORTAB 5/500 mg. Dr told her he was working tomorrow if she needed  him. He also told her it might take a couple of days to improve, but if not improving or getting worse please contact us. Called pt before we left tonight no answer. I called pt on Monday morning 4/26/10 to check on her. Pt states she feels fine now, and the pain was gone. Pt states she took 1 of the LORTAB on Friday for pain, 1 on Saturday and has not needed anymore.
SWELLING LIPS,  NAUSEA AND HEADACHE.   NOT FEELING WELL.
Arm pain at injection site with heaviness on arm, pain on shoulder and back, next day skin rash on legs, arm and mostly on my chest, took over the county medications and not going away, went to doctor and prescribed steroids.  Headache/tiredness
Patient received the Moderna as a first dose but when she came back for second dose instead of receiving moderna second dose she recieved pfizer.  Patient is aware of this and had no side effect from either vaccine.
Redness, hot, tender, swollen - all local. Unknown if cellulitis or vaccine reaction. Rx for cephalexin 500 mg TID x 10 days from covering PCP for Dr.
Localized erythema and tenderness at injection site. Treatment with warm compresses; will start BACTRIM if increases in size.
The day after vaccine the patient was noted to have an erythematous, papular rash over both legs. One week after vaccine, the rash had spread to the buttocks and torso. The patient was diagnosed with exanthem secondary to MMR.
day following vaccine patient reported chills and diffuse rash on her arm- covering the upper half of the upper arm- resolved on it's own in 3-4 days
Client received first COVID dose on Friday 01/08/2021. Reports that as she tried to get out of bed the following morning, her right leg buckled, she had pain in her right knee and she couldn't walk. She treated this with ice and Advil. This episode lasted all day. The knee was somewhat improved the next day, but still painful and the difficulty walking remained. She was seen at clinic where an x-ray showed arthritis. She received a prescription for meloxicam 15 mg q.d. and was referred to a physician. She saw the physician on 01/12/2021. Treatment recommendations included wearing a knee brace, physical therapy, and to continue the anti-inflammatory medication. Client has continued physical
Information has been received from a mother concerning her 13 year old (reported as "16 year old") daughter with no medical history or drug reactions/allergies, who on 02-MAY-2008 was vaccinated with a 0.5 ml primary dose of VAQTA (lot # not reported) intramuscularly. Other suspect therapy included hepatitis B vaccine, recomb (MSD, lot # not reported) on the same day. There was no concomitant medication. On an unspecified date, the patient received a 0.5 ml booster dose of VAQTA (lot # not reported). The mother stated that her daughter began vomiting after the injection on 02-MAY-2008, developed transverse myelitis and had spinal cord damage t4-t12 around 09-MAY-2008. The mother also stated that her daughter required periodic hospitalization. The patient had blood work and a magnetic resonance imaging (MRI) (results not reported). The patient was given steroids for transverse myelitis. The patient's vomiting and transverse myelitis and spinal cord damage t4-t12 persisted. No further information is available.
Patients administered Moderna vaccine while temperature excursion assessment was ongoing; Patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 63-year-old male patient 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Patient didn't report any adverse events.
The patient received the varivax vaccine 4 years ago & developed chicken pox. ? vaccine failure.
4 hrs p/inject devel swelling & induration lt deltoid (2" x 2 1/2") w/heat, local tenderness, pain in arm from above elbow down to above waist whole arm felt heavy; (no redness or itching); all sx cleared gradually in 2 days;