chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to unknown number of patients with unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL lot # J015378, expiration date: 09-APR-2016 (strength, dosage, frequency and route unknown). There was temperature excursion during vaccine storage. The patient was vaccinated at private doctor's clinic/hospital with public funds. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt seen for first time in our office 9/3/13. Had imms (L) thigh 7/12/13 - PEDIARIX and HIB. Swelling and redness noted MD August. KEFLEX given - no help. Seen here 9/3 -> for U/S - > showed small abscess -> I and D by Dr with resolution. Cx grew coag neg staph, strep viridans.
The pharmacist injected me way too deep in the muscle; Heart racing; body aches; muscle spasms; Headaches; pain behind my eyes; Bled and could barely move my arm for 5 days; Bled and could barely move my arm for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "had zero side effects"; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "had zero side effects"; Covid-19 vaccine (Dose: 3, 1st booster, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "had zero side effects". The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "The pharmacist injected me way too deep in the muscle"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; PAIN (non-serious), outcome "unknown", described as "body aches"; MUSCLE SPASMS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; EYE PAIN (non-serious), outcome "unknown", described as "pain behind my eyes"; VACCINATION SITE HAEMORRHAGE (non-serious), MOVEMENT DISORDER (non-serious), outcome "unknown" and all described as "Bled and could barely move my arm for 5 days".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was admitted to a local Hospital on 11/7/2021 for COVID related symptoms. This is considered a breakthrough case.
Fever, chills, body aches, nausea, headache, the evening I received the shot March 24th. March 25, higher fever, body aches, nausea, and headache, and flush. March 26th better but low grade fever, body aches, nausea and headache. March 27th, headache and slight fever.  Afternoon on the 27th feeling next to normal.
Pt exp local rxn-deltoid muscle rt tender, swollen, plus tender, slightly erythematous rt axillary region;
Patient received his MMR vaccine on 04/19/05 and admitted to hospital with H/O progressive lower limb and upper right limb. No pain associated with muscle weakness. Patient had H/O dirrhea few days before admission. Patient discharged on 05/25/05 and transferred to rehabilitation center. In hospital, patient diagnosed with Guillain- Barre Syndrome. Spinal tap result: Increased WBC Treatment:Plasmaphoresis Since last week patient developing right upperarm symmetrical atrophy.
Janssen COVID-19 Vaccine EUA - headache, chills, muscle ache, tired all day on Saturday (vaccine was Friday night).  Felt much better on Sunday with a headache that only hurt if I coughed or bent over. Today is Monday and headache is gone as well. Some mild tenderness in left arm at injection site.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received HAVRIX 1440 (batch number 9927T, expiry date unknown). On 30th May 2017, the patient received the 2nd dose of HAVRIX 1440 (subcutaneous) 1 ml. On 30th May 2017, immediately after receiving HAVRIX 1440, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain to be related to HAVRIX 1440. Additional details were reported as follows: The patient received HAVRIX on left arm. The patient reported that the HAVRIX was inadvertently administered via subcutaneous route instead of intramuscular route, which led to inappropriate route of vaccination. The patient experienced injection hurt during administration. The patient planned to follow-up with her physician on an unknown date. The expiration date of the vaccine administered was not provided.
28FEB96 pt recv vax & 5APR96 mom called & stated took pt to hosp ER & MD dx pneumonia 2MAR96;unable to obtain any other info
This spontaneous report received from a consumer via social media (Facebook) concerned a patient of unspecified age and sex with unknown ethnicity and race.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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, two weeks later the vaccination, patient was in emergency room with severe pain and bleeding in upper leg. On discharge paper, it was mentioned that patient had probable exposure to COVID-19. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe pain and bleed in upper leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210644813-covid-19 vaccine ad26.cov2.s-Bleeding upper leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Fever,swelling,pain, flu symptoms; Fever,swelling,pain, flu symptoms; Injection site is feverish and really red; Fever,swelling,pain, flu symptoms; report a side effect; Injection site is feverish and really red; Fever,swelling,pain, flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Fever,swelling,pain, flu symptoms), INFLUENZA (Fever,swelling,pain, flu symptoms), INJECTION SITE WARMTH (Injection site is feverish and really red), PAIN (Fever,swelling,pain, flu symptoms) and VACCINATION COMPLICATION (report a side effect) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Multiple sclerosis, Fibrillation and Congestive heart failure. Concurrent medical conditions included Penicillin allergy, Tetanus, Contrast media allergy (IVP Dye) and Allergy to antibiotic.    On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Fever,swelling,pain, flu symptoms), INFLUENZA (Fever,swelling,pain, flu symptoms), INJECTION SITE WARMTH (Injection site is feverish and really red), PAIN (Fever,swelling,pain, flu symptoms), VACCINATION COMPLICATION (report a side effect), INJECTION SITE ERYTHEMA (Injection site is feverish and really red) and PYREXIA (Fever,swelling,pain, flu symptoms). At the time of the report, SWELLING (Fever,swelling,pain, flu symptoms), INFLUENZA (Fever,swelling,pain, flu symptoms), PAIN (Fever,swelling,pain, flu symptoms) and PYREXIA (Fever,swelling,pain, flu symptoms) had not resolved and INJECTION SITE WARMTH (Injection site is feverish and really red), VACCINATION COMPLICATION (report a side effect) and INJECTION SITE ERYTHEMA (Injection site is feverish and really red) outcome was unknown.            No Concomitant medications were provided. No Treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Additional information received on 21/Jun/2021: Contains no new information.
Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ALLERGY TO VACCINE (Allergic reaction). At the time of the report, ALLERGY TO VACCINE (Allergic reaction) 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.
W/in 24 hrs p/immun, infant experienced an inject site rxn consisting of erythema, pain, swelling, increased warmth & induration w/out abscess. Neurological sx included drowsiness, in a trance & unable to arouse. sx lasted 7 days.
Vaccine that underwent temperature excursions could have been administered to patient; No adverse event; Vaccine that underwent temperature excursions could have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19.     On 23-Sep-2022 at 1:57 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 1:57 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine that underwent temperature excursions could have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine that underwent temperature excursions could have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine that underwent temperature excursions could have been administered to patient).    No concomitant product reported by the reporter.  Patient had received previous 3 doses of Moderna vaccine via intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported for the patient. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion.  No treatment medication reported by the reporter.
watering mouth; nausea; vomiting; chills; headache; fever; fatigue; sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SALIVARY HYPERSECRETION (watering mouth), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SALIVARY HYPERSECRETION (watering mouth), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache), PYREXIA (fever), FATIGUE (fatigue) and HYPERHIDROSIS (sweats). At the time of the report, SALIVARY HYPERSECRETION (watering mouth), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache), PYREXIA (fever), FATIGUE (fatigue) and HYPERHIDROSIS (sweats) outcome was unknown. Not provided.
This spontaneous report was received from a other health professional and refers to multiple patients of unknown age. On unknown dates, those patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M045874 for prophylaxis. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA010565: US-009507513-1708USA010566.
Received vaccine Hepatitis A - given right deltoid IM. Polio given left deltoid sq and Tdap given left deltoid IM on 3/13/08.  Had right arm pain immediately following vaccine.  Swelling at site and a rash started on 3/23/08.  Went to Emergency room at Hospital because pain had intensified and rash was worsening. Benadryl and Naproxyn were given for treatment. Patient has an allergy to Penicillin.
Patient started acting lethargic the morning of 12/7/2021 and developed a low fever (100). The fever increased to 101, a dose of Tylenol was given, and about 10 minutes later he had a seizure lasting ~3.5 minutes at 3:45pm. An ambulance was called and he was taken to the hospital. Temp in ER was 102. They treated with Ibuprofen. Tests for Covid, flu A & B, and RSV were negative. Doctor ruled out ear infection and throat infection with examination. We were discharged after 3 hours when fever was 99.9. Treatment at home was alternating Ibuprofen and Tylenol every three hours. When weaning off of medication, fever returned to 101.3 at 8pm on 12/7/2021. Treating now with Ibuprofen every 6-8 hours. No other symptoms besides fever and fatigue.
Symptom onset 7/22/2021 included fever (highest recorded at 99), chills, wheezing, nausea, headache, shaking, fatigue, midriff rash. Patient was still symptomatic on 7/26/2021 when disease investigation was completed.
On day 9 post-vaccine, my right arm become swollen, warm, indurated. erythematous, pruritic, and tender to touch.  Area becomes progressively worse.  On day 10 post-vaccine, area on arm continues to spread  but is less swollen and indurated while remaining to be warm, pruritic, and tender to touch.  Erythema continues but isn't quite as angry.  I become fatigued with a horrible migraine,  feeling feverish but no fever, and had chills.
devel morbilliform rash & fever 8 days p/vax;9 days p/vax devel rt focal sz, apneic & required endotracheal intubation & hosp admission;negative vesicular rash;
Covid vaccine monitoring. PT admitted 8/13/21 with diagnosis of covid 8/1/21. Prior to admission PT was in rehab facility. Documentation states the pt lost taste. Upon admission, SARS-COVID-19 resulted positive 8/14/21 PT completed Pfizer vaccine. Dose 1 received 1/26/21, Lot EJ1686 Dose 2 received 2/19/21, Lot EL3302   Patient currently admitted.
Patient reported vertigo and nausea within 15 minutes of vaccination, followed by vomiting.  Patient was given Benedryl and then Zofran and transported to ER by EMS.
At approximately 5:48PM at 04/09/2021 patient during 15 minute observation patient started to develop urticaria to the left arm around the injection site. Pt at assessment has no other complaint, and was AA&Ox4, airway patent, breathing normal and non-labored with clear lung sounds. Pulse strong and regular with adequate perfusion. Pt administered IM Diphenhydramine in LA 50mg at 5:49PM. Pt urticaria and itchiness resolved. Pt offered transport for assessment to ED, and denied multiple offers, after being described risks of not furthering care. Pt wife transported patient home via personal vehicle.  Vital signs 5:54PM(118/82, 70P, 20R, 97%)
SORE, REDNESS AND SWELLING TO LEFT ARM. STARTED 3 DAYS AFTER ANTHRAX SHOT. TX APPLY COLD COMPRESS TO AREA, NAPROSYN 500MG, BENADRYL 25MG,RETURN TO CLINIC IF WORSENS.
pain, tenderness, left arm, swollen lymph nodes in axilla to primary provider if symptoms worsen
Narrative: Patient reported to ER triage on 8/22/2021 with c/o cough and general malaise x 7 days. Pt denied CP, SOB, NVD, Fever, loss of taste/smell. Patient tested positive for COVID-19 and was diagnosed with COVID-19 Pneumonia. Patient admitted to hospital.
Preschool teacher called reporting that patient's left arem was swollen and warm to touch at the sight of injection.  The swelling measured 4 inches down and 3 inches across.  He was not running a fever and was not really complaining about his arm. The grandmother called to see if this was a normal reaction.
This case was reported by an other health professional via call center representative and described the occurrence of Bell's palsy in an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter mentioned that in a very casual conversation with her sister, her sister mentioned to her that one of her friend was going through the same identical situation experiencing Facial Bell's Palsy. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided. This case was linked with US2018082822 and US2018082823, reported by the same reporter.
Left posterior deltoid + wheal + erythema + swelling 10mm x15mm.
Vaccine was expired on 01-Apr-2022, stored in the refrigerator on 04-Apr-2022 and administered on 18-Apr-2022; Vaccine was expired on 01-Apr-2022 and administered on 18-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 18-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in the refrigerator on 04-Apr-2022 and administered on 18-Apr-2022) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 18-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in the refrigerator on 04-Apr-2022 and administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 18-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in the refrigerator on 04-Apr-2022 and administered on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the pharmacy received the vaccine on 23-Feb-2022. The reporter stated that, they thought vaccines will expire in Jun-2022 however vaccines were expired on 01-Apr-2022. The vial did not undergo any temperature excursion.  No treatment medications were reported.
Abnormal, large thigh hematoma/bruise that was excruciatingly painful and ended up decaying from my body
Patient received vaccine on 2/27/18. He returned to office 03/08/18 complaining that his upper arm and upper left pectoral region felt tight and uncomfortable. He had a little swelling in the first 2 days but this had resolved when seen. He had no redness or swelling, normal range of motion.
Extreme shortness of breath-feels like I am gasping for air; Elevated Heart rate; body aches; stiff arm; Severe fatigue; This spontaneous case was reported by an other and describes the occurrence of DYSPNOEA (Extreme shortness of breath-feels like I am gasping for air), HEART RATE INCREASED (Elevated Heart rate), PAIN (body aches), MUSCULOSKELETAL STIFFNESS (stiff arm) and FATIGUE (Severe fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced DYSPNOEA (Extreme shortness of breath-feels like I am gasping for air), HEART RATE INCREASED (Elevated Heart rate), PAIN (body aches), MUSCULOSKELETAL STIFFNESS (stiff arm) and FATIGUE (Severe fatigue). At the time of the report, DYSPNOEA (Extreme shortness of breath-feels like I am gasping for air), HEART RATE INCREASED (Elevated Heart rate), PAIN (body aches), MUSCULOSKELETAL STIFFNESS (stiff arm) and FATIGUE (Severe fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 95-105 (High) 95-105 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant and treatment medications were unknown.