chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore throat; Ulcers on the side of the mouth; blister on the side of the tongue; Inflammation of the gum; Swollen glands; Sores in the mouth, Pain in the left side of the mouth, Thrombin pain in the mouth; Gum is swollen; Body ache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache), OROPHARYNGEAL PAIN (Sore throat) and MOUTH ULCERATION (Ulcers on the side of the mouth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN and FEXOFENADINE HYDROCHLORIDE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache), OROPHARYNGEAL PAIN (Sore throat), MOUTH ULCERATION (Ulcers on the side of the mouth), TONGUE BLISTERING (blister on the side of the tongue), NONINFECTIVE GINGIVITIS (Inflammation of the gum), LYMPHADENOPATHY (Swollen glands), ORAL PAIN (Sores in the mouth, Pain in the left side of the mouth, Thrombin pain in the mouth) and GINGIVAL PAIN (Gum is swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache), OROPHARYNGEAL PAIN (Sore throat), MOUTH ULCERATION (Ulcers on the side of the mouth), TONGUE BLISTERING (blister on the side of the tongue), NONINFECTIVE GINGIVITIS (Inflammation of the gum), LYMPHADENOPATHY (Swollen glands), ORAL PAIN (Sores in the mouth, Pain in the left side of the mouth, Thrombin pain in the mouth) and GINGIVAL PAIN (Gum is swollen) outcome was unknown.            This case was linked to MOD-2021-262267 (Patient Link).
A day after receiving the vaccine the patient noticed a rash developing on his neck and chest. He went to the urgent care where they gave him prednisone to treat the rash. As of today he states the rash doesn't seem as bad but may be a little larger area than it was. Patient is going to contact his primary physician.
headache, fatigue, body aches, left arm pain, really tired, nausea. All lasted for 2 days after second shot.
Pediarix was given in error instead of the five year old DTAP that was suppose to be given along with her 5 year boosters that included that day MMR, Polio and Varicella.  Mother was contacted day of error and informed of the error and again on 8/18/2008. Mother described a low grade fever of one day the day following vaccine administration which mother indicates is a normal reaction for her daughter whenever she receives a vaccine. Mother gave daughter Motrin. No redness or soreness at sights of vaccines.
Heart inflammation; Dry mouth; Sore throat; Chills; Nausea; Fatigue; Cramped legs; Sore arm; Joint pain; Muscle pain; Extreme anxiety; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:30 at 35-years-old (Batch/Lot Number: ER8729) as 1st dose, single for COVID-19 immunization. There was no medical history. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included paracetamol (TYLENOL). The patient had dry mouth, sore throat, chills, nausea, fatigue, cramped legs, sore arm, joint pain, muscle pain, extreme anxiety, chronic chest pain lasted for 5 days constantly and ER visit Dr. says it was due to the vaccine: heart inflammation. Happened to 50% of chest pain ER visitors due to vaccine 3-4 days after vaccine dose. And should only last 6 days. Heart inflammation should be added to info packet and more studies should be done asap. All events started on 22Apr2021 03:30. No treatment given. Outcome of events was recovered in 2021.
got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient received the shot and then got shingles.
Lymph node issue where armpit swelled up to 3 times, the normal size; This is a spontaneous report from a contactable consumer (friend of patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lymph node issue where armpit swelled up to 3 times, the normal size on an unspecified date. Caller stated her symptoms went away after 3 days. Reporter seriousness for Lymph node issue where armpit swelled up to 3 times the normal size was unspecified. The outcome of event was unknown.  Follow-up activities closed. Batch/lot number not available.
Abnormally sore arm after shot. Went back to work section and through the rest of afternoon arm became more sore, began feeling feverish though did not take temp, went home, went to bed. Woke up at 2330, shaking, feverish, joints not moving well and painful. Continued all of Saturday. Sunday all symptoms improved except continues to experience extreme fatigue. Monday all symptoms continue to improve but still very fatigued.
INTENSE BURNING; RAISED BUMPS, RASH ON ABDOMEN AND LOWER ARMS; SKIN REDNESS ON FEET; ITCHINING ON TOP OF FEET; SORE ARM; 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 patient have no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. On 06-MAR-2021, the subject experienced itchining on top of feet. On 11-MAR-2021, the subject experienced skin redness on feet. On 14-MAR-2021, the subject experienced intense burning. On 14-MAR-2021, the subject experienced raised bumps, rash on abdomen and lower arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense burning, sore arm, itchining on top of feet, skin redness on feet, and raised bumps, rash on abdomen and lower arms on MAR-2021. This report was non-serious.
Mother brought twins a male & a female on Monday, Sept. 14th to get 1 yr. immunizations. Mother had her cards we had given when we gave them prior vaccines. The CDP that was printed didn't match her card. I looked past encounters to find out when the history was given to us. the information was not provided by the parent when she had come in for immunizations so I was not sure if it was entered by mistake. I tried look up both children was unable to access them at the time. I did read the note in CDP by agency that history given by MD office was entered in CDP on 022609 and they needed one year immunizations.   (SMC did give an extra set of immunizations on Mar. 13th when only a Hep B was the only vaccine needed). The immunizations I gave with current information I had led me to believe the one year immunizations were due then. Later I was able to pull up information on the female twin only and found that another clinic had given her 2, 4, 6 mos. & 1 yr immunizations which is what we had done due to not having history. Before giving any immunizations on 091409 I asked the mother if any other vaccines had been give to them besides the ones on the card the mother said "No". When I asked about the dates recorded from September she said, "They were done that one time" (when he went to Clinic). No medical treatment required.  Follow-up - I tried to call the mother the next day to find out how the twins were doing. Mom was not available to spoke to me the aunt was the only one who spoke English and she said they were doing fine. Corrective action - I left message with Dr. at Clinic to let her know what had happened to her patients. The twins still need the second dose of Hep A six months after Sept. 14th, 2009. Their records states Hep A was given July 28th 2009 which will be too early if mother comes in for second dose the end of January. Call 3 days later no problems reported.
TINGLING IN ARMS RADIATING FROM DELTOID DOWN TO FINGERTIPS; This spontaneous report received from a pharmacist concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced tingling in arms radiating from deltoid down to fingertips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling in arms radiating from deltoid down to fingertips was not reported. This report was non-serious.
pt recvd vax & exp persistent unconsolable crying for more than 4 hrs;
01/20/22 presents to ED for "shortness of breath associated with COVID-19" "tested positive at urgent care" . PMHx of "tobacco use"
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with GARDASIL (lot#, expiration date, dose and route unspecified), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
pain in shoulder & gland & upper part of back; saw MD & was told to take APAP; should go away in couple days;
Information has been received from a physician concerning a 16 year old female with no pertinent medical history and drug reactions/allergies who on 15-JUN-2007 was vaccinated with Gardasil (lot# 657617/0384U) "single dose" in the left arm IM. There was no concomitant medication. The patient is currently pregnant. The date of the last menstrual period was in "early June 2007". Medical attention was sought. On an unspecified date the patient had a urine beta-human chorionic gonadotropin test performed and the results were positive. No symptoms have been reported. No further information was available. The estimated date of delivery is 07-MAR-2008. Follow-up information was received from the physician via telephone. The physician reported that the patient was going to be terminating her pregnancy. No further information was provided. Follow up information was received from a registered nurse via telephone. The patient was a white female who was seen in the office on 15-JUN-2007 at which time she was menstruating. The patient reported that she was not sexually active. The patient was vaccinated with Gardasil. On 10-AUG-2007 the patient returned to the office at which time she reported that she had become sexually active. A urine beta-human chorionic gonadotropin test sample was taken which was positive for pregnancy. The patient did not receive the vaccination. On 24-AUG-2007 a telephone call was placed to the patient and the physician's office was told that the pregnancy had been terminated electively. The patient was reported to be doing well. The nurse reported that the series of vaccinations will be continued when the patient returns to the office. Upon internal review elective abortion is considered to be an other important medical event. Additional information has been requested.
11PM 21OCT93 spoke to MD seen on 22OCT93; given cortisone shot in hip & 2 days of Pred; started w/extreme pain in rt arm & sl swollen; next day t101; arm warm devel 5x3 lump above crook of elbow; limited ROM;
Pt. developed arthralgias in upper and lower extremities, fatigue, and dizziness the day following the covid vaccine. Due to intensity of symptoms and elevated crp (24)/esr(64). Pt was treated with Predinisone toper for several months. The joint pain improved over a few weeks but had persistant pain and weakness in right arm and dx with brachial neuritis based in exam/history and MRI.  Pt improved over 8 months with  steroids, PT, and hyperbaric oxygen.
1 of 3 non-responders reported who recvd Engerix-B; reporter stated one recvd in buttock; clarification is being sought;
This spontaneous report as received from a medical assistant (also reported as Licensed Practical Nurse) refers to an unknown number of patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these patients' were vaccinated with improperly stored doses of VAQTA (lot # M018644, expiry date 20-SEP-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported in any patient. The vaccine was exposed to the temperature of -0.1 degree Celsius for 1 hour 9 minutes; 1.5 degree Celsius for 23 minutes; 1.5 degrees Celsius for 25 minutes; 1.7 degree Celsius for 21 minutes; 0.7 degree Celsius for 50 minutes; and -0.3 degree Celsius for 1 hour 25 minutes. No product quality complaint was involved. This is one of the 3 reports received from the same reporter source. Additional information is not expected as the reporter did not wish to be contacted.
Patient lateral thigh red, slightly swollen at site warm to touch for 24 hours, ice applied for 15 minutes four times a day, BENADRYL liquid given every 8 hours on occasion requires.  No respiratory distress or fever noted.
11PM the night of immunizations given-mom noticed a large red area around the injection site.  L/g fever, slightly fussy, no other symptoms, an area was larger, came to MD office.
Mother states she had fed the baby and the baby started looking at one direction and twitching and moving the body to the right side.  She called the EMS and was having "partial seizures".  During trip to hospital she was "looking in one direction and twitching upper and lower extremities".
Tested positive for Covid on 08Nov2022; Tested positive for Covid on 08Nov2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 05May2021 as dose 2, single (Lot number: EW0167), in left arm, on 18Nov2021 at 10:15 as dose 3 (booster), single (Lot number: FN2908), in left arm and on 02Jun2022 as dose 4 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "brain aneurysm" (unspecified if ongoing), notes: brain aneurysm. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy", notes: Sensitive to aspirin; Ibuprofen, reaction(s): "Allergy", notes: Sensitive to ibuprofen. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Nov2022, outcome "not recovered" and all described as "Tested positive for Covid on 08Nov2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 for which included  PF-07321332, ritonavir (PAXLOVID) from 08Nov2022 to 12Nov2022.  No follow-up attempts are possible. No further information is expected.
pt recv vax & 19AUG98 pt exp strong flu-like sx including nausea, severe h/a, dizziness, body aches, pains, bowel problems, flush feeling & general fatigue & discomfort;21AUG98 exp profuse sweating & heat flashes;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "I am having inflammatory responses"; JOINT SWELLING (non-serious), outcome "unknown", described as "swelling in my knees"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; ALOPECIA (non-serious), outcome "unknown", described as "her hair fell out just like my hairs are falling out in clumps". Additional information: The patient reported that this Saturday it will be 2 weeks that she had her 4th Covid vaccine or booster (confirmed booster shot as Pfizer Covid-19 vaccine), she had 2 vaccines of Pfizer and then she just had her second booster with her husband and both had hair fall. Dose number not captured as it s not specified DOSE 3 or 4. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, pain, and redness at injection site. Peeling of skin on opposite arm. Fatigue, leg pain, diarrhea, headache, chills,nausea.  Began 24 hrs after injection.
APN advised patient desired vaccines, indicating which vaccines to be given by circling names on vaccine sheet. It was noted patient had Tdap in 2012 and needed TD rather than Tdap. When vaccines were pulled from pharmacy, Tdap and TD both were pulled and given.  Patient notified 09/15/2023 of error and denies any adverse signs or symptoms.
ALTERED SMELL SENSATION (SMELLED SMOKE FOR 3 DAYS); SHARP PAIN DOWN THE MIDDLE OF HEAD DOWN INTO FOREHEAD LIKE A BRIGHT WHITE LIGHT WHICH WAS SIMILAR TO A STROKE AND HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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, intramuscular, batch number: Unknown) dose was not reported, administered on 03-MAR-2021 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 altered smell sensation (smelled smoke for 3 days), and sharp pain down the middle of head down into forehead like a bright white light which was similar to a stroke and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sharp pain down the middle of head down into forehead like a bright white light which was similar to a stroke and headache and altered smell sensation (smelled smoke for 3 days) was not reported. This report was non-serious.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via another manufacturer (Pfizer) via company representative concerned a 53 year old female of an unknown race. Initial information was processed along with the additional information received on 17-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: unspecified allergy, and other pre-existing medical conditions included: Patient was on other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, 01 total, administered on 01-APR-2021 for prophylactic vaccination at right arm. The batch number was not reported and has been requested. Age at time of vaccination 52 years old. Concomitant medications included bupropion and paxlovid.  On 06-MAY-2022, laboratory data included: COVID-19 (Coronavirus disease) virus test (NR: not provided) Negative. On 08-MAY-2022, patient experienced sore throat (suspected covid-19 infection) and laboratory data included: COVID-19 virus test (NR: not provided) Positive (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000231563.; Sender's Comments: V0:20220530376 -Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. The event(s) has a compatible/suggestive 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. Therefore, this event(s) is considered not related.
Per client 4 hours after vaccine given, felt SOB, increased RR, increased HR then had flu like symptoms - vomiting and diarrhea for 2 days. States her stool was "fluorescent green" and stated "I felt like I would die".
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Antiviral details Product: Paxlovid, COVID 19 Treatment: Treatment start date: 05Sep2022 Indication: Treatment of COVID-19. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.