chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: pt developed a staph infection-Severe, Additional Details: Patient brought it to my attention that his arm was really painful, swelled up and couldnt lift it. I suggested he follow up with MD for professional judgement. He did make an appointment and later had a scan and they drained fluid from the area to send to the lab. Once they determinded he had a staph infection they treated him with Bactrim DS and Oxycodone . He said the md told him it was likely due to a dirty needle, swab or possibly the vaccinater was a carrier.
Patient presented with round, reddened, somewhat raised area of upper left arm the morning after injection.  Area is about 4 inches in diameter.  Reported  10/31/23 by nurse I recommended treatment with cool compress and continue to monitor.  The nurse will escalate  care if condition worsens.
CHEST PAIN; ITCHY (FEELS NEED TO SCRATCH BODY); HEAVINESS IN THE CHEST; NUMBNESS AND TINGLING IN THE ARMS AND LEGS; SORE ARM; HEADACHE; MUSCLE ACHES; 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: 1855194, and expiry: UNKNOWN) dose was not reported, administered on 28-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-DEC-2021, the patient experienced sore arm, headache, and muscle aches. On 31-DEC-2021, the patient experienced chest pain, itchy (feels need to scratch body), heaviness in the chest, and numbness and tingling in the arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, headache, and muscle aches, and had not recovered from numbness and tingling in the arms and legs, chest pain, itchy (feels need to scratch body), and heaviness in the chest. This report was non-serious. This report was associated with product complaint number.
Hx stage 4 CA, just finished radiation . Developed expressive aphasia, confusion. Came to ED. No respiratory symptoms. COVID tested for admission. Positive breakthrough case
Patient is having a flair of his Guillian-Barre Syndrome.  He is having an increase in ascending weakness in the bilateral lower extremities from the feet up into the lower legs
Fever; Chills; Frozen shoulder in the arm of the injection; This case was reported by a consumer and described the occurrence of fever in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, chills and frozen shoulder. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the frozen shoulder was unknown.   It was unknown if the reporter considered the fever, chills and frozen shoulder to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in an unknown arm. The patient experienced fever and chills. The patient took tylenol and side effects went away. The patient developed a frozen shoulder in the arm of the injection and now under going physiotherapy treatments. The patient was due for second follow up injection and woul not receive it in that same arm. The patient asked would they recommend another larger muscle (like the thigh) besides the one in the other arm.
Information has been received from a physician concerning a 4 year old male who in 2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced 5 to 10 pox believed to be chicken pox. Unspecified medical attention was sought. No product quality complaint was involved.  Additional information has been requested.
Patient given 0.2ml dose of undiluted vaccine. No symptoms or side effects noted.
Patient admitted on 4/19/2022 at Medical Center with SOB and elevated troponin.
Pt recv vax on 12/28/95; on 1/13/99 pt exp chicken pox
Case number PHEH2013US008321 is an initial spontaneous report received from a consumer on 09 Apr 2013. This case refers to a 66-year-old male patient. His medical history and concomitant medications were not reported. His vaccination history included of flu vaccinations in previous years without any reactions. He was vaccinated with FLUVIRIN (batch number: 123023) in his right arm on an unspecified date in Oct 2012. On the same day he was also vaccinated with ZOSTAVAX (batch number: 8012576, expiration date: Sep [year:unknown]). Three to four days after vaccination, he experienced a rash with itchy blisters on his right arm, right shoulder, back and few on his left arm. He had scars at places where he had blisters. He still had some blisters but the reaction seems to be tapering off. The patient saw his primary care physician initially and a dermatologist three times. His primary care physician gave him 4 to 5 different ointments/lotions but nothing helped. He also tried over the counter allergy medicine. He was also suggested light therapy by his doctor. The final outcome was reported as ongoing at the time of this report. The seriousness and causality were not reported.
An improperly stored vaccine was administered to 10 separate patients. No additional AE reported; An improperly stored vaccine was administered to 10 separate patients. No additional AE reported; This spontaneous report has been received from an office manager, concerning a 9-months-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  The Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number T042013 underwent a temperature excursion of 11.43 degrees Celsius (C) for a time frame of 4 hours and 45 minutes; no previous temperature excursion (product storage error).   Consequently, on 04-MAY-2022 the patient was vaccinated with the inappropriate storage Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number T042013 has been verified to be a valid lot, expiration date reported and stablished as 22-JUL-2023) as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA003266: US-009507513-2205USA003043: US-009507513-2205USA002913: US-009507513-2205USA002988: US-009507513-2205USA002848: US-009507513-2205USA003131: US-009507513-2205USA003118: US-009507513-2205USA002951: US-009507513-2205USA003121:
Information has been received from a consumer (also reported as mother of patient and office manager), and a physician, concerning the consumer's daughter, who at the age of 15 months, in approximately December 1983, was vaccinated with a dose of MMR (the physician could not provide lot #). Subsequently, the patient developed fever of 104F, total body rash, and pneumonia after vaccination. The mother reported that her daughter was taken to the emergency room and was treated with acetaminophen. The physician confirmed that the patient's experience was neither life threatening nor disabling and that the patient was not hospitalized following vaccination with MMR. It was also noted that as an adult, she became pregnant and miscarried. A rubella titer was then done and came back low. There was no product quality complaint involved. Upon internal review, the patient's miscarriage was considered to be an important medical event (OMIC). Additional information has been requested.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that an unspecified patient was administered with GARDASIL about 1.5 years ago (approximately in March 2012). The second dose of GARDASIL was administered to the patient on an unspecified date about a week ago (approximately 23-SEP-2013). No indication , lot number or dose information was provided. No adverse effects were reported. No further information was provided. Additional information has been requested.
about 10PM on 2/18/21 (~12 hrs following injection) woke from sleep with dry mouth and chills--no fever registering; chills remained intermittent for roughly 2-3 hours; ~ 5 AM fatigue, accompanied by global body muscle aches throughout day varying in intensity  followed until ~6PM 2/19/21 with more intense painful Left arm/especially at site of injection-Left Deltoid; 2/19/21 ~1030PM noted injection site reddening/warmth/swelling/more localized pain  Initial symptoms improving  by 2/20/21; injection site symptoms improving by 2/21/21, though site remains somewhat warm, painful, rashy at the time of this note
Patient was given the adjuvant suspension component (vial 1 of 2) but it was not reconstituted with the antigen component.  No adverse reactions or symptoms experienced by patient.
patient had a seizure that lasted less than 15 seconds and then ems took her to hospital
This case was reported by a consumer via call center representative and described the occurrence of weird feeling in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received the 1st dose of SHINGRIX. On 4th February 2019, 15 min after receiving SHINGRIX, the patient experienced weird feeling and blurred vision. On an unknown date, the outcome of the weird feeling was unknown and the outcome of the blurred vision was recovered/resolved. It was unknown if the reporter considered the weird feeling and blurred vision to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. In the morning, the patient received a dose of SHINGRIX. The patient was driving to home about 15 minutes later a vaccination the patient experienced feeling weird. The patient also felt like almost blurred vision and then the patient thought he was going to see double but that did not happen. It was lasted for 10 to 15 seconds. The patient wanted to know, if this events were normal. The medical representative did not see any changes in vision in the literature, therefore it was not something that we would had expected. The medical representative advised the patient to report it to patient's physician. The contact details of the physician was provided.
Became unconscious and collapsed onto the floor.  Unconscious for approximately 3 minutes.  After waking, patient reported feeling hot.
pt exp swelling & erythema @ inject site p/receiving flu vax; reaction lasted a couple of days;
Diagnosed with Cellulitis Extreme swelling, redness, hardness, heat, tender, ache, unable to lift arm above a certain point  Swollen lymph nodes Pain into clavicle   Received oral keflex - 4 times a day for 10 days - still taking
Pt had presented for #2 Moderna to observation area @1120 am via motorized scooter accompanied by her daughter. @1130am pt was eating roasted salted almonds and taking home medications having conversations with daughter and staff. @1140 pt began to c/o left leg heaviness and "feeling different". Slight SOB. Pt was able to stand but w/labored effort worsened SOB and w/increased left leg heaviness and numbness-pt had slight slurred speech and c/o "feeling woosy". Pt took 2 Albuterol inhaler puffs 1144 911 called. Advised to take 2 Atrovent inhaler puffs also. @1145 AED obtained, BP 158/81 P 96 pulse ox 100%. 1158 EMS arrived and took over care, pt agreed for transport to nearest emergency facility, pt to be transported to GA AUC, daughter took personal belongings. Pt was AAOx3 entire vaccine and observation area visit time and at time of d/c.
high fever 103.9 C; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever 103.9 C) and HEADACHE (terrible headache) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (high fever 103.9 C) and HEADACHE (terrible headache). At the time of the report, PYREXIA (high fever 103.9 C) and HEADACHE (terrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that he had fever of 103.9.  No concomitant medications were reported.  No treatment information was reported.
Vial was stored in the refrigerator beyond 30 days; All patients received Expired Moderna COVID-19 vaccine from a vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
Painful cystic/lump to area around injections site. No response to KEFLEX. Had sx started 3 wks after injection - ??
Redness and itching to administration site. Quarter size area w/sm papules/bumps.
severe stomach pains, swelling on right side of head, headache, nodules in lungs, infection in body,
mild soreness at the site; 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 VACCINATION SITE PAIN (mild soreness at the site) 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.  Concomitant products included PIRFENIDONE (ESBRIET) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild soreness at the site). At the time of the report, VACCINATION SITE PAIN (mild soreness at the site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by the reporter.
Headache, Myalgia, Fever, NauseaVomiting, fatigue/ chills/ redness/ swelling Narrative:
This spontaneous report as received from a physician refers to a female patient of unknown age. Patient's relevant medical history and concurrent condition was unknown. On an unknown date the patient was vaccinated with GARDASIL (dose and frequency unknown). Patients concomitant medication was unknown. On an unknown date the patient experienced change in pap smear after administration of GARDASIL. patient's diagnostic tests were unknown. The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. Additional information has been requested.
SKIN ON FIRE; LOST TASTE; VERTIGO; SPINE BACK PAIN; CHILLS; NUMBNESS IN EXTREMITIES; DEEP MUSCLE PAIN; NAUSEA; FATIGUE; WEAKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) 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 AUG-2021, the patient experienced skin on fire. On AUG-2021, the patient experienced lost taste. On AUG-2021, the patient experienced vertigo. On AUG-2021, the patient experienced spine back pain. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced numbness in extremities. On AUG-2021, the patient experienced deep muscle pain. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep muscle pain, skin on fire, lost taste, numbness in extremities, vertigo, chills, nausea, fatigue, weakness, and spine back pain. This report was non-serious.
Did not feel well all day, nauseous - dizzy and diarrhea - all sx subsided in 5 days.
Narrative: Patient after 1st covid 19 vaccination experienced balance problems, dizziness, sweating, myalgias. Symptoms resolved after a few days.
Swelling, pain, reddened, indurated (+) CSMT to right finger, hot to touch, red hot upper arm axilla tender.
lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 04Jan2021 10:45, at single dose, for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), on an unspecified date, at single dose, for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The vaccine was administered in the hospital. 3 weeks after the 2nd dose, on 27Jan2021 the patient lost taste and smell. Her PCR nasal Covid swab was negative on 27Jan2021. The patient had not recovered from the adverse events. No treatment was received for the adverse events.  Information about the lot/batch number has been requested.
Pt seen as walk in due to immunization reaction-immunizations 2 days ago. Rash on legs started yesterday. Redness worsened over day, child felt low energy. No fevers, but felt warm. Mother put cool clothes on legs. Mother gave baby ASA, but didn't have money for TYLENOL or ibu. Denies SOB, has little cough but started prior. No other SXS.
ALLERGY SYMPTOMS; This spontaneous report received from a consumer 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  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 13-APR-2021, the subject experienced allergy symptoms. Treatment medications (dates unspecified) included: dequalinium chloride. The action taken with covid-19 vaccine  was not applicable. The outcome of allergy symptoms was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be while a positive covid-19 test result was received after vaccination, insufficient time had elapsed for immunity to develop. approval to void this record due to no pqc identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Chills; Shaky; temperature is 55.6; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NERVOUSNESS (Shaky) and BODY TEMPERATURE ABNORMAL (temperature is 55.6) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced CHILLS (Chills), NERVOUSNESS (Shaky) and BODY TEMPERATURE ABNORMAL (temperature is 55.6). At the time of the report, CHILLS (Chills), NERVOUSNESS (Shaky) and BODY TEMPERATURE ABNORMAL (temperature is 55.6) outcome was unknown. Unknown          This case was linked to MOD-2021-054712 (Patient Link).
Woke up at 4AM on the day after receiving the second dose of the Moderna vaccine with chills, intense muscle aches, intense headache, constipation, dizziness, brief nausea. Was unable to get myself out of bed until around 11AM after taking a nap. Used naproxen to bring the symptoms down to a manageable level, but despite taking 440 mg total (220 around 11am, 220 around 8pm), I was mostly bedridden throughout the day. I had very little energy, and moving too much caused dizziness. All symptoms lasted from 4AM on the day after the second dose until waking up the day after that.
Hives within an hour after administration of vaccine.  5 days post vaccine began having chest discomfort, shortness of breath, 7 day post vaccine went to the ER with elevated BP and tachycardia. BP normalized & tachycardia resolved within 4-5days post ER visit.  EKG completed and ECHO. 15 weeks pregnant at the time of vaccination,  G4P2, DUE May 2022 fetal HR detected at the ER. 2 normal uncomplicated pregnancies & deliveries, 1 ectopic.
High blood pressure. My dose had been 1 irbesartan 150 mg. Everyday. October 9 my dr increased irbesartan 2 tablets, one morning and the second pm.  October 26 my blood pressure was still uncontrolled and my doctor added another medication amipdipine 5 mg take one tablet each evening
Awaken by cramping down neck into shoulder blade and shoulder and sharp pain down right arm.  11/03/2009 3:20 PM continues to have cramp in neck,less pain and hurts to move neck.
Given PNEUMOVAX 12 Oct, sore throat night - next day fever, induration, chills and lethargy. No other vaccines given this year.