chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left underarm swelled with mild sensitivity; Left underarm swelled with mild sensitivity; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; Pain and stiffness from front of left shoulder to bicep; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 09:00 (Lot number: FJ8757) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Bee sting" (unspecified if ongoing), notes: known allergies: Bee sting. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 22Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 03Feb2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "booster"; PERIPHERAL SWELLING (non-serious), SENSITISATION (non-serious) all with onset 16Dec2021 08:00, outcome "recovering" and all described as "Left underarm swelled with mild sensitivity"; ARTHRALGIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), MYALGIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 16Dec2021 08:00, outcome "recovering" and all described as "Pain and stiffness from front of left shoulder to bicep". Therapeutic measures were not taken as a result of peripheral swelling, sensitisation, arthralgia, musculoskeletal stiffness, myalgia, musculoskeletal stiffness.  Additional information: The patient did not covid prior to vaccination and covid was not tested post vaccination. The patient did not take other vaccine in four weeks and other medication in two weeks.  No follow-up attempts are needed. No further information is expected.
Pain, swelling, rash, black & blue, very hot. Started to go away on 9/16/2013. Have not had problems in the past, this was a double shot.
Elevated HTN that was no longer controlled be betablockers as it had been for 20 years, resulting in elevation of care. Elevation in care, adding ACE and ARB, had no effect and ultimately had development of AVNRT that required cardioversion. No previous cardiac conditions prior to vaccination.
p/flu shot given pt exp persistent nausea @ 12hr p/shot lasting about 10 days;also had bodyaches/lack of energy-fatigu for 20 dasy;did not see MD;
Approximately 11:00pm on 12/29/20:  Hives/itching on bilateral hands/wrists/forearms/lower legs/ankes, red face/swelling on face, rapid pulse, headache, nausea, extreme fatigue.
One hour after injection c/o severe pain Lt arm-fever that afternoon - temp not checked -Fever with chills - Left school next day because of temp.
PATIENT RECEIVED PROQUAD ALONG WITH HER VARICELLA INSTEAD OF A DOSE OF MMR. THIS RESULTED IN HER RECEIVING 2 DOSES OF VARICELLA IN THE SAME DAY. PARENT WAS NOTIFIED. THERE HAVE NOT BEEN ADVERSE REACTIONS REPORTED TO US FOLLOWING THIS OCCURRENCE.
Administration error - 0.1mL administered. Patient returned to the POD and was administered additional 0.4mL on the same day.
p/vax pt devel T104 which resolved p/24hr; oct 1,1998 had cough productive for white sputum & had chest congestion
On June 1, 2017 I was given TWINRIX first dose I also had blood drawn the same day in a adult clinic in the same building. I had a sore arm leaving the medical provider that day. I had this sore arm for about one week. I called the medical provider to ensure this was common the nurse that give me the shot just read me the facts on the vaccine information sheet over the phone. On the 5th I started having severe pain in my arm I waited it out until on the 13th I could not grip the steering wheel of my car, so I went to urgent care where I was diagnosed with Carpel tunnel in my right arm. I had no other symptoms at this time. Appox. two days later I began have pain in many of my joints and feeling weak. I again went to the doctor on the 27th the doctor completed allergy testing and treated me with muscle relaxers, pain medication and Nerve medication to treat my pain and carpel tunnel. I am currently have symptoms in my left hand as well. I will soon see a specialist. Arm is still sore at injection site July 5, 2017.
Lt arm deltoid area-by 5:30pm was swollen around injection site to the size of orange, raised from surface of arm about 1/2"-3/4". Heavily aching and painful. Next day area more severe in pain and heavy-could not hold up arm. That night left ankle extremity started swelling to bilateral sides of foot and down into toes of foot. Swelling extended around foot to sac-like swelling right above heel. No injury to that left foot or leg or body side. No swelling in rt extremity concurrent to this time.
CHILD DEVELOPED HIGH FEVER DURING THE NIGHT FOLLOWING IMMUNIZATIONS AND VOMITED TIMES ONE AND HAD SHAKING OF ARMS AND LEGS, EYES LOOKED FUNNY AND DID NOT RESPOND TO PARENTS AND THEN IMMEDIATELY FELL ASLEEP. CHILD TAKEN TO EMERGENCY ROOM AND DOCUMENTED FEVER OF 104 (DAD REPORTED A FEVER OF 105. TYLENOL AND IBUPROFEN WERE GIVEN WITH RESOLUTION OF THE FEVER. CHILD SEEN THE FOLLOWING DAY IN CLINIC AND WAS REPORTED TO PROVIDER AND EXAM WAS NORMAL. NO FEVER. PARENTS WERE ALTERNATING TYLENOL AND IBUPROFEN EVERY 3 HOURS.
ADMINISTRATION OF EXPIRED VACCINE; TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 44 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: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the patient experienced administration of expired vaccine. On 07-JUN-2021, the patient experienced temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915623, 20210915646, 20210915661, 20210915719, 20210915731, 20210915852, 20210916498, 20210916520, 20210916465, 20210916312, 20210916228, 20210916300, 20210916415, 20210916401, 20210913164, 20210916129, 20210915748, 20210916697, 20210916910, 20210916965, 20210916959, 20210917160, 20210917163, 20210916907, 20210916455, 20210916584, 20210916658, 20210916768, 20210916808, 20210916811, 20210916849, 20210917074, 20210917226, 20210917500, 20210917515, 20210917603 and 20210916715.
Chills and swollen throat starting 01/21 @ 2030, went to doctor on 01/27 with no answers. Difficulty swallowing, labored breathing, heart racing, neck pain and right ear plugged up on 01/27 around 2200. Went to ER at 0500 on 01/28. Received steroid shot, ibuprofen, lidocaine gargle. CT scan inconclusive, blood test normal, vitals normal. Prescription for amoxicillin and adavant. Lymph nodes in neck remain swollen to date.
10/22/21 PATIENT PRESENTED TO ER WITH SOB,  NAUSEA, VOMITING, DIZZY, LIGHTHEADED. HAD BEEN RECENTLY HOSPITALIZED FOR TOTAL SHOULDER REPLACEMENT ON 10/18/21.SHE NOTED TO BE HYPOTENSIVE. LAB WORK INDICATES ACUTE RENAL FAILURE, ISHCEMIC HEPATITIS, ELVATED TROPONIN AND proBNP, ULTRASOUND INDICATED LIKELY EARLY CHOLESYTITIS. SHE WAS ADMITTED TOHOSPITAL.  FOR SHOCK, SUSUPECT SEPTIC SHOCK.POSSIBLE NSTEMI. ON 11/1/2021 PATIENT DISCHARGED TO REHAB FACILITY BEFORE RETURNING HOME. DISCHARGE DX: BILATERAL PULMONARY EMPBOLISM, ANEMIA, SOB, NSTEMI, ACUTE RENAL FAILURE, SEVERE SEPSIS AND SEPTIC SHOCK, ENLARGED RV. COVID +
Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around the injection site) 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 09-Feb-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In February 2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication details were not reported by the reporter. No treatment details were provided.
FULL BODY RASH WHICH WAS DESCRIBED AS ALLERGIC REACTION; This spontaneous report received from a patient via a company representative concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no preexisting condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the subject experienced full body rash which was described as allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full body rash which was described as allergic reaction on 16-MAR-2021. This report was non-serious.
Nurse states vaccine leaked out of patient's right arm after the ID administration; a large amount was noted leaking out of patient's arm by clinic staff. Staff alerted clinic assist who noted patient had a keloid scar on his left arm from Jynneos dose #1.  Another nurse administered patient's second dose subcutaneously in the left arm due to the keloid scar. No patient complications. Patient education provided.
Pt recvd vax on 13NOV92 & later that evening pt devel t102-104 & exp a h/a & nausea; w/in 12 hrs, sx subsided; No further details were provided;
Tenderness and aches of arm where injection was given; Tenderness and aches of arm where injection was given; Headache; Drowsiness; Light headedness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 at 11:45 as dose 4 (booster), single (Lot number: FH8028) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Whey from milk" (unspecified if ongoing), notes: Known allergies: Whey from milk; "Known allergies: Unknown fragrance" (unspecified if ongoing), notes: Known allergies: Unknown fragrance. The patient took concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose lot number: FF8839, Prev dose dose number: 3,, Prev dose vaccine location: Left arm), administration date: 20Oct2021, when the patient was 50-year-old, for COVID-19 Immunization; BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose lot number: EL3247,, Prev dose dose number: 2,, Prev dose vaccine location: Left arm), administration date: 08Feb2021, when the patient was 49-year-old, for COVID-19 Immunization; BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer,, Prev dose lot number: EL3247, Prev dose dose number: 1), administration date: 20Jan2021, when the patient was 49-year-old, for COVID-19 Immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 01Jun2022 at 01:00, outcome "recovering", described as "Drowsiness"; HEADACHE (non-serious) with onset 01Jun2022 at 01:00, outcome "recovering"; DIZZINESS (non-serious) with onset 01Jun2022 at 01:00, outcome "recovering", described as "Light headedness"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 01Jun2022 at 01:00, outcome "recovering" and all described as "Tenderness and aches of arm where injection was given". Therapeutic measures were taken as a result of vaccination site pain, vaccination site pain, headache, somnolence, dizziness. Additional information: Patient had not received other vaccine in four weeks. Patient had received other medications in two weeks. Patient had not COVID prior vaccination. Patient had not COVID tested post vaccination. Patient had took acetaminophen treatment for AE.
Patient was given vaccine that was pasted its "use by" date of 8/16/22
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 31-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 31, on Apr 6, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a  headache and dizziness, onset Apr 2021, with outcome of unknown. Additional information: Patient stated she felt ok, but two weeks later felt dizziness and had a headache. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Pt stating she was having some itching.  She received Benadryl 25mg p.o. x 1 dose, vitals taken, stable per patient. Patient stated she's having some chest pressure, patient taken to the ER for evaluation
Information has been received from a nurse concerning a female (age not reported) who in August 2007 (exact date not reported), was vaccinated (site and route not reported) with the 1st dose of Gardasil vaccine (lot# not reported). On 11-OCT-2007, the patient was vaccinated (site and route not reported) with the 2nd dose of Gardasil vaccine (lot# not reported). The patient reported that post the 2nd vaccination, she developed back pain. It was not reported if the patient received medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Approx 5 min post Injection, mouth become tingly and throat felt thicker. No difficulty breathing. Received Benadryl 25mg, no further exacerbation of symptoms.
Mild fever and some fatigue; Mild fever and some fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3248), via an unspecified route of administration on 02Mar2021 at 11:00 (at the age of 28-years-old) at dose 1, single in the left arm for COVID-19 immunization. Medical history included asthma. Concomitant medications included sertraline hydrochloride (ZOLOFT) film-coated tablet and budesonide, formoterol fumarate (SYMBICORT) for asthma. The patient previously took cefaclor (CECLORE) and experienced drug allergy. The patient was not pregnant at the time of vaccination. 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, and since the vaccination, the patient has not been tested for COVID-19. The patient was vaccinated in a workplace clinic. On 02Mar2021, the patient experienced mild fever and some fatigue. No treatment was received for the events. Outcome of the events was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
potentially receive a 3rd dose of Shingrix on that day; would potentially receive a 3rd dose of Shingrix on that day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 30th August 2019) and Shingrix (received 2nd dose of Shingrix on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: potentially receive a 3rd dose of Shingrix on that day) and circumstance or information capable of leading to medication error (Verbatim: would potentially receive a 3rd dose of Shingrix on that day). The outcome of the extra dose administered and circumstance or information capable of leading to medication error were unknown.   Additional Information: GSK Receipt Date- 09-NOV-2023 The pharmacist reported that the patient would potentially receive the 3rd dose of Shingrix vaccine on that day which led to extra dose administered and circumstance or information capable of leading to medication error. The reporter denied to follow up.
Unspecified acute conjunctivitis, bilateral: -Patient is a 25-year-old male primary vaccinee who received smallpox vaccine on 5 Mar 2018, which resulted in an appropriate take, and later developed conjunctival hyperemia burning, discharge, light sensitivity, and injection to his right eye and light sensitivity and hyperemia to his left eye. He has been seen by ophthalmology and was instructed it is most consistent with viral conjunctivitis, however due to his history they treated him for possible ocular vaccinia with ZIRGAN and VALTREX. His presentation is consistent with conjunctivitis. Possible etiologies are viral, bacterial or allergic. He has no history of atopy. Given his recent SPV ocular vaccinia needs to be considered and he would meet case the CDC case definition for a suspected ocular vaccinia based on presentation and temporal relationship. There are no specific lesions to collect samples for PCR. Patient has done well since initial visit. Eye symptoms have mostly resolved but still some symptoms of eyes 'feeling tired'. On exam, conjunctival injection and mucopurulent discharge has resolved. Continue current eye medications as prescribed by Ophtho. Continue to avoid contact lenses until vaccination site scab has fallen off. Follow-up with Ophtho on Thursday as scheduled. Follow-up with IHB as needed. He was instructed to contact us should he experience any worsening of symptoms, and number provided and reinforced. Patient voiced understanidng and agrees with plan, all questions answered. Adverse effect of other vaccines and biological substances, subsequent encounter: -plan as above. Patient meets CDC case definition of suspected ocular vaccinia.
5 mins after shots turn white and bumped self on door and fell slowly to floor. BP and VS normal. Reportedly now with pain and paresthesia of L arm.
Pt recvd 1st dose of Hep B vax on 28APR92 & on 30APR92 devel nausea followed by vomiting & diarrhea which lasted approx 24 hrs;
c/o weakness & tiredness starting 4NOV; site of inject sl sore; states also has sl cough, congestion & nasal discharge, lightheadedness h/a;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing), notes: Other medical history: Chronic lymphocytic leukemia. Concomitant medication(s) included: PAXIL [PIROXICAM]. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 3:58 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 3:58 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions was reported.  No treatment medications were provided.  Total 280 patients received Moderna  COVID-19 stored at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
Patient was given half dose of Moderna Bivalent Booster 0.25mcg, patient was to receive 0.5mcg. Wrong dose given to patient.
Local symptoms- pain-discomfort, redness, swelling, itching. General symptoms- headaches, muscle pains, joint pains, fatigue, nausea, diarrhea. Narrative: