chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The doctor determined that patient had "skin necrosis"; Injection site became sensitive and a thin film developed on the skin; Injection site swelling; Injection site was hard; consumer started having headaches and body chills; consumer started having headaches and body chills; This spontaneous report was received from a 60 year old, former smoker female patient reporting on herself. The patient's concurrent conditions included allergy to sulfamethoxazole, trimethoprim (BACTRIM), the patient developed rash due to "antibiotics ointment". The patient's pertinent medial history was not reported.  On 31-AUG-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S029542, expiration date reported as 06-OCT-2021, but upon internal validation established as 10-JUN-2021 (dose and route were not reported)  for prophylaxis. Concomitant therapies included potassium citrate, atorvastatin, thyroid (ARMOUR THYROID TABLETS), hydrochlorothiazide and "Duprofidon".     On 01-SEP-2020, the patient started having headaches and body chills (chills). The patient took ibuprofen (ADVIL). The next day on 02-SEP-2020, the injection site was hard (injection site induration) and swollen (injection site swelling). The patient contact with her doctor who prescribed her "PREDNOSONE" for 5 days. The swelling went down, but then on 07-SEP-2020 the skin at the injection site became sensitive (injection site hyperaesthesia) and a thin film developed on the skin. The patient stated that her doctor prescribed an unspecified antibiotic and did a biopsy of the skin. The doctor determined that she had "skin necrosis" (injection site necrosis) and then sent the patient to a surgeon who on 11-SEP-2020 removed the skin.  At the time of the report, the patient was recovering from the events. The relationship between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.  "Skin necrosis" and then sent the patient to a surgeon who on 11-SEP-2020 removed the skin was considered to be medically significant by the reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Severe joint and muscle pain in upper body. 8 days after 1st shot, 3 days after 2nd, and persistent joint pain in shoulders and elbows through present; Severe joint and muscle pain in upper body. 8 days after 1st shot, 3 days after 2nd, and persistent joint pain in shoulders and elbows through present; Severe joint and muscle pain in upper body. 8 days after 1st shot, 3 days after 2nd, and persistent joint pain in shoulders and elbows through present; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Apr2021 17:00 (Lot number: ER8731) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRETOR; LEXAPRO; WELLBUTRIN.  The following information was reported: PAIN (non-serious), ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 14Apr2021 20:00, outcome "recovered with sequelae" (Apr2021) and all described as "Severe joint and muscle pain in upper body. 8 days after 1st shot, 3 days after 2nd, and persistent joint pain in shoulders and elbows through present". Therapeutic measures were not taken as a result of pain, arthralgia, myalgia.  Additional Information: Patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 17:00 (Lot number: ER0158) as dose 2, single for covid-19 immunisation. The outcome of event was recovered with lasting effects. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
pt recv vax; devel fever of 103; swollen glands, fatigue, HA & pinpoint rash on body; required MD visit;
Left thigh-swelling, redness, warmth to half of upper thigh. Duration of 48 hours.
extreme constant heart palpitations in upper chest and neck.  they may stop for just a few minutes and then restart.  went for ekg looked abnormal but after stress test dr. said not . he is a cardiologist and did both tests.  palpitations will not stop . Im very concerned. feel tired and fatigued and short of breath. No energy.
Arm swollen; Arm had welts and looked like hives; Arm pale; vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), URTICARIA (Arm had welts and looked like hives), PALLOR (Arm pale) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen), URTICARIA (Arm had welts and looked like hives), PALLOR (Arm pale) and VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, PERIPHERAL SWELLING (Arm swollen), URTICARIA (Arm had welts and looked like hives), PALLOR (Arm pale) and VACCINATION SITE ERYTHEMA (vaccination site erythema) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment medication details was reported.
SORE THROAT; MIGRAINE; DRY MOUTH; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced dry mouth. On 09-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced migraine. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 12-APR-2021, and had not recovered from dry mouth, and migraine. This report was non-serious.
Shingles virus infection. Abnormal for this age, can come at times when immune system is compromised
EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 04-AUG-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210916697, 20210915646, 20210916808, 20210915661, 20210915623, 20210915748, 20210916228, 20210916300, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916520, 20210916553, 20210916584, 20210916658, 20210916768, 20210916811, 20210916849, 20210916907, 20210916910, 20210916959, 20210916965, 20210917074, 20210917160, 20210917226, 20210917500, 20210917515, 20210913164, 20210916715, 20210915731, 20210916129, 20210915852 and 20210917603.
Systemic: Flushed / Sweating-Medium, Additional Details: Patient experienced night sweats with each dose of Pfizer Covid vaccine
Breakthrough Covid+ 53 y/o male who presented to ED via EMS d/t decreased responsiveness. Pt c/o weakness, subjective fever, chills, and wheezing; but he denies syncope, night sweats, sore throat, productive cough, CP, palpitations, or dyspnea.  Patient did report some blood in his stool.
Had surgery on 12/12 and went home on 12/13. 12/14 I began not feeling well. Progressively began feeling worse and developed shortness of breath and cough. Went to ER per surgeons instructions, and tested positive for COVD-19. Symptoms have maintained. Antiviral was contraindicated due to medications I take. I was prescribed TESSALON PERLES for the cough. They did a chest X-ray that showed mild infiltrates. Also began taking SYMBICORT and XOPENEX rescue inhaler. Not getting much relief from symptoms.
pt recvd vax on 31AUG93 lt arm - 24 hrs p/inject arm became red, swollen, hot to touch & painful; mom started on APAP; pt able to sleep fairly well; no fever; came into office as emergency on 2SEP93 12noon;
The patient is a 78-year-old male who presents to the hospital with weakness and fever 1 day  following his second COVID-19 vaccine. Noted o have a transient thrombocytopenia. Presented  with severe weakness and unable to get up. He was able to provide some history. His wife provided  additional history. He received second dose of mRNA vaccine on 6/5. Developed weakness afterwards and brought  to the hospital for further evaluation. Admitted with dehydration low-grade temperatures. Tmax 100.4.      Denies bleeding.
Information has been received from a nurse in employee health concerning a 47 year old female patient who in 1989 was vaccinated with a first series of hepatitis B virus vaccine rHBsAG (yeast). Manufacturer and lot number unknown. On 07/16/04, the patient had a titer result of 4.4, which is considered negative by the lab doing the test. The nurse reported that recently (approximately August 2004) the patient had received treatment with steroids for a respiratory disorder. There was no product quality complaint reported. Follow up information was received from a RN who reported that there is no additional information available as the vaccine had been administered at three different organizations. The patient sought unspecified medical attention. No additional information is expected.
Erythema & tenderness over entire anterior left upper arm that progressed for 1 day marginally improved the 2nd day.
The adverse event was NOT after a COVID vaccination.  I have had 2 Moderna vaccination and 2 Moderna boosters. 1st vac 2/4/21, 2nd vac 3/4/21, 1st booster 11/23/21, and 2nd booster 4/26/22. I tested positive for COVID on 7/20/22 but had symptoms starting 7/19/22. Since I was high risk, my doctor prescribed Paxlovid
Kinrix as 2nd dose on DTap series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 09-NOV-2022, the patient received Kinrix. On 09-NOV-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrix as 2nd dose on DTap series). The outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-Apr-2023 On 9-Nov-2022 Kinrix was administered to a patient as the 2nd dose of the DTap series instead of being the 5th dose of the series.  Consented to follow up. The reporter said to HCP that such thing had also happened to a lot of other patients, but in that moment, she only had available the information of one patient The patient received Kinrix as 2nd dose, which led to Inappropriate schedule of vaccine administered.; Sender's Comments:  US-GSK-US2023AMR055143:Same reporter. Other patients master case.
Patient felt dizzy and lightheaded upon standing up after receiving the vaccine. Patient became very pale and reported foggy vision. The patient was sat down and given some water and juice.
Patient complaint of having swelling warmth, redness and pain where shot was given. Rph recommended her to put ice pack on the site and take TYLENOL or ASA.
sleeps from 5PM to 6AM in the morning; very fatigued/Extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleeps from 5PM to 6AM in the morning) and FATIGUE (very fatigued/Extreme tiredness) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleeps from 5PM to 6AM in the morning) and FATIGUE (very fatigued/Extreme tiredness). At the time of the report, SOMNOLENCE (sleeps from 5PM to 6AM in the morning) and FATIGUE (very fatigued/Extreme tiredness) had not resolved.            No concomitant medication information was provided. No treatment medication information was provided.   Reporter did not allow further contact
Lump under left armpit which is same side as she received vaccine, lump was about size of a golf and paining.; This is a spontaneous report from a contactable nurse (patient) via information team. A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL0142), via an unspecified route of administration at left arm on 04Feb2021 (at the age of 33-year-old) as a single dose for COVID-19 immunization. The patient had no medical history and concomitant medications. On 05Feb2021, the patient found a lump under her left armpit which was the same side she received the vaccine on. The lump was about the size of golf ball, at first it was not movable but now it was movable, and pain of the lump stayed same as well as the size. The outcome of the event was not recovered.
On 7-25-07 after receiving 2nd Gardasil, patients mom reported that on last Gardasil given on 5-30-07, patient started spotting blood that same evening. Mom stated patient spotted blood off and on for approx. 1 week. Mom stated patient had never done that prior to Gardasil. No treatment did not see physician.
IRREGULAR PERIOD; BODY ACHES; FEVER; MASSIVE 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, route of admin not reported, batch number: unknown) dose, 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, the subject experienced irregular period, body aches, fever, and massive headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from irregular period, and the outcome of fever, body aches and massive headache was not reported. This report was non-serious.
05/19/21  Rash, 05/20/21  Earache (resolved 05/22/21), 05/21/21 Diarrhea (resolved 05/21/21),05/23/21 dizziness,nausea,ringing in the ear ,room spinning,not able to balance and walk(still not resolved as of 05/24/21) Arm warm to touch still not resolved as of 05/24/21.Advised to see MD if condition does not resolve.
Dizziness, Fever, LIGHT HEADED, CHILLS, FATIGUE, REDNESS, TENDERNESS AT INJECTION SITE LEFT DELTOID Narrative:
Fully vaccinated with booster 10/12/21.   COVID breakthrough infection with inpatient hospital stay.
4.3.21:  soreness throughout body, fever 4.4.21: fingers turned blue 4.5.21: tongue swelled and turned bright red fingers mottled for 5 days intense body aches for 6 days 4.26.21: antecubital fossa hot, swollen and red, significant pain 4.27.21: pain extends down into forearm and red and streaked 4.30.21: pain continues
12 hours after vaccine administration I felt intense heat throughout my body and my heart rate increased to 167. This happened 4 times in 1 hour then ended. I called 911 fearing of a heart attack.
Injection site: very pain full to move arm, swollen, hot to touch.  Fever reach 102.1, chills, extreme headache, nausea with vomiting, extreme joint pain, scale of pain 6.5, muscle pain, lethargic.  Have been taking acetaminophen 2 - 500mg tabs every 6 hours.  Has help to keep fever below 100 and reduce pain to a 2.5 to 3.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's brother) reported that a male patient of unspecified age and race/ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient convulsed after vaccination, on an unspecified date. Event outcome was not reported. The reporter added that the benefits were clear as were the possible side effects and thought for most people that PREVNAR 13 would be good but the reporter never went out so contact with others was limited and in the past family members have had reactions (brother convulsed etc.). No follow-up attempts are possible, information about batch number cannot be obtained.
severe allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had severe allergic reaction after the first shoot of Shingrix vaccine. The patient asked what was the percentage of coverage after just one shot.
p/vax pt presented to clinic w/localized rxn to rt upper arm;approx 2 1/2cm in diameter w/induration & erythema;no open areas or other complaints;tx ice, allegra;to return to clinic if sx worsen or do not improve;
This is a spontaneous report from a contactable nurse. This nurse reported the same event for 3 patients. This is the 3rd of three reports. A patient of unspecified age, race and gender received PREVNAR 13 (NDC number 0005197102, Lot Number: M98915, Expire Date: Sep2017), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history was not reported. Concomitant medication included AFLURIA (NDC number 3333201601, Lot Number: WT58708, Expire Date: 30Jun2017) via an unspecified route of administration on an unspecified date for immunisation. The patient experienced increased redness at the injection site of the Prevnar 13 on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016527789 Same reporter/different patient, same product, same event; US-PFIZER INC-2016527786 Same reporter/different patient, same product, same event.
Received first dose of Moderna COVID-19 vaccine on 1/26/2021.  Patient currently takes Humira for Crohn?s Disease (this is a biologic agent that lowers immune response). Patient was started on prednisone 40mg on 1/30/2021 for GI flare.  Patient?s wife states that he began to have trouble walking and concentrating/focusing.  Patient was admitted to the ED four days prior and found to have dehydration and prednisone was stopped completely on 2/13/2021 and patient discharged on 2/14/2021. Morning of 2/16/2021 patient?s wife contacted PCP stating patient has gotten worse and can ?hardly watch TV due to the stimulation? and wife is unable to get ?one word? out of him.  RN advised wife to take patient back to hospital for further testing and wife verbalized understanding. Patient presents to the ED on 2/16/2021 and is admitted due to acute encephalopathy.  Hospital course was acute encephalopathy secondary to non-convulsive status epilepticus and patient was discharged on 2/24/2021 with new Keppra prescription for new seizure disorder.  Etiology of seizures unclear, received Moderna COVID-19 vaccine on 1/26/2021 prior to onset of symptoms on 2/2/2021 but significance unknown.  This event followed a COVID-19 vaccine and another case of non-convulsive status epilepticus was seen for another patient who had just previously received the vaccine, prompting the suspicion this could be related to the vaccine.  Unknown if PCP aware of vaccine administration.
Having cardiac complication that is new condition and Faint feeling while at work, low blood pressure and high heart rate. 1st time was 01/10/2022, 01/11/2022 workplace at hospital called code 01/23/2022 taken to er to check for blood clots and heart monitoring and was admitted for two days.
Monday: General muscle body pain. Some congestion and stomach discomfort. Pain and swollen area where shot was administrated.  Tuesday: Better but same symptoms. Wednesday: Better but still stomach discomfort , some muscle pain all over body, swollen, red and hard on area where shot was administrated. Tired. Today: Still same as Wednesday, some light head, need to rest, feel some nausea or some stomach disconfort.
This spontaneous case was reported by a patient and describes the occurrence of LEUKOCYTOSIS (my white blood cell count was slightly elevated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LEUKOCYTOSIS (my white blood cell count was slightly elevated). At the time of the report, LEUKOCYTOSIS (my white blood cell count was slightly elevated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: slightly elevated. No concomitant medication was reported. It was reported that after patient had second Moderna booster shot, patient's white blood cell count was slightly elevated. The event had caused patient to seek medical care.