chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started about 15 hours after dose # 2 on 18Feb2021.I had flu like  symptoms.; achy legs; achy back; chills; fatigue; Headache; runny nose; mild cough; This is a spontaneous report from a contactable consumer. This 73-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (Lot number: EN6200) at single dose for covid-19 immunization on 18Feb2021 (08:15 AM, at left arm). Relevant history included allergies with Sulfa drugs. Relevant concomitant drug was unknown. The patient received the first dose of BNT162B2 (Lot number: EN9625) for covid-19 immunization on 28Jan2021 (08:15 AM, at left arm). The patient did not receive other vaccine in four weeks. No other medications received in two weeks. The patient stated about 15 hours after dose # 2 on 18Feb2021, at 11:30 PM, she started to have flu like symptoms (achy legs and back, chills, and headache which recovered by 7:00 am the following day. Started about 7 am the day following, very runny nose(used 2 boxes of tissue in 24 hours) and had intermittent headache and fatigue. At the reporting time (day 3) and she was still having very runny nose and mild cough. No treatment was received.  Outcome of event was resolving. The patient was not infected COVID prior vaccination. The patient did not  have COVID test post vaccination.
Patient had no prior history of any autoimmune disorders.  Patient experienced joint pain and swelling. Saw primary care doctor on 4/20/21 with inflammation in left ankle.  Inflammation reduced with prednisone 20mg BID x 5 days.  Approximately 1 week later, patient experiences pain and inflammation in both hands, to include wrist and fingers.   Patient requested a lab panel for inflammatory markers.  Results with rheumatoid factor > 2 times upper limit of normal and referred to rheumatologist.  Patients first appointment is 7/12/21
Mom stated, 'my child had a head to toe rash, and high fever after receiving MMR and VZV, on 6-22-15.' This child was vaccinated at another facility.
Nausea, chills, fatigue & syncopal episode requiring emergency care, sutures, X-rays, CT scan, secondary wound infection.
Called health system call center on 5/5/21. Reports sore throat and fatigue after dose 2 of vaccine. PT has visit with PCP (external)
pt recvd vax 6OCT95 & devel aplastic anemia 3DEC95;
I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia R56.9 - Unspecified convulsions
administered by error a Havrix pediatric formulation to a 24 year-old female; administered by error a Havrix pediatric formulation to a 24 year-old female; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 23-year-old female patient who received HAV (Havrix pediatric) (batch number 3397T, expiry date 30-NOV-2023) for prophylaxis.   On 24-MAY-2023, the patient received the 2nd dose of Havrix pediatric. On 24-MAY-2023, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: administered by error a Havrix pediatric formulation to a 24 year-old female) and adult use of a child product (Verbatim: administered by error a Havrix pediatric formulation to a 24 year-old female). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 30-MAY-2023 The reporter consented to follow up via email. The adult patient received Havrix pediatric by error, which led to accidental underdose and adult use of a child product.
JULY 19 SHOT GIVEN. JULY 20-24 FLU LIKE S/SX. JULY 25 URGENT CARE - GIVEN CIPRO.  JULY 26 DC CIPRO WENT TO LOCAL ER AND GIVEN IV FLUIDS. JULY 27-31 SICKNESS CONT (NAUSEA FEVER HEADACHE BACK PAIN). AUG 1 WENT TO PCP. WAS SENT TO ER. ADMITTED KEPT OVERNIGHT.  AUG 2 TO AUG 5 NAUSEA HEADACHES FEVER SEVERE BACK PAIN.  ** PT STATES HE HAD BLOOD WORK AT BOTH HOSPITALS. PCP WILL BE REFERING TO UROLOGIST NEUROLOGIST AND RHEUMOTOLOGIST.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a day after receiving SHINGRIX, the patient experienced fever, poor sleep, influenza-like symptoms, injection site pain, chills and pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever and influenza-like symptoms were recovering/resolving and the outcome of the poor sleep and chills were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the fever, poor sleep, influenza-like symptoms, injection site pain, chills and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced a 101 fever, soreness at the injections site, a few chills during the night, and mild flu like symptoms with an achy feeling. The patient took some Tylenol and the fever and flu like symptoms were resolving. The patient explained that she did not feel like herself after getting the vaccine. The patient could not sleep last night, however, she was able to nap on the day of reporting. She claimed that the side effects started in the middle of the night. The patient had denied permission to contact their physician.
Client presented at vaccination site on 12.09.21. Client reported he received first dose Moderna  COVID vaccine on 02/09/21 (lot #: 062620A) and received second dose Moderna  COVID vaccine on 03/09/21 (lot #: 003A21A). He reported with both doses of Moderna, he had headache with his ?eyes burning? 12 hours later after each vaccination after waking up from sleep the next morning lasted one day only. He reported he didn?t seek care or take any medications for both doses. He stated he didn?t follow-up with PCP. He declined any chronic illnesses. He reported he is allergic to PCN (?cannot hear?) two years ago. At 1058, PHN took his vitals: BP 148/90, HR 65, O2 Sat. 97%. Client is requesting for booster dose of Moderna  COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the booster dose of Moderna  COVID vaccine. The approval to proceed with the booster dose of Moderna  COVID vaccine was obtained from medical consult team via text message from clinical project coordinator per CDC guidelines. Client received the booster dose of  Moderna  COVID vaccine, LOT#:  035C21A on 12/09/21 at 1207 by a vaccinating nurse. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1237 unassisted and with a steady gait.
left arm cellulitis tx'd with ABX. Indicated she is much better via phone call 8/24/2016.
very swollen 4.5cm by RN;very red, hot to touch, swollen knot 5 days;
The pt experienced pain in the left arm, achiness all over, fever, chills, nausea and headache. Used analgesics and ice to the affected area. Had allot of pain for 3 days and then it lessened. The pt also experienced a hard lump at the site and a few red blotches on the left arm.
red ring at injection site site; hot and painful at injection site; tender to touch at vaccine site; hot and painful at injection site; weakness; dizziness; headache; nausea; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VACCINATION SITE WARMTH (hot and painful at injection site), ASTHENIA (weakness), VACCINATION SITE ERYTHEMA (red ring at injection site site) and VACCINATION SITE PAIN (hot and painful at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever). On 21-Mar-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot and painful at injection site), VACCINATION SITE ERYTHEMA (red ring at injection site site), VACCINATION SITE PAIN (hot and painful at injection site) and VACCINATION SITE PAIN (tender to touch at vaccine site). The patient was treated with IBUPROFEN at a dose of UNK dosage form; MULTIVITAMIN [VITAMINS NOS] at a dose of UNK dosage form and VITAMIN D NOS at a dose of UNK dosage form. At the time of the report, DIZZINESS (dizziness), VACCINATION SITE WARMTH (hot and painful at injection site), ASTHENIA (weakness), VACCINATION SITE ERYTHEMA (red ring at injection site site), VACCINATION SITE PAIN (hot and painful at injection site), VACCINATION SITE PAIN (tender to touch at vaccine site), HEADACHE (headache), NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-155661.
No adverse effects were reported; HCP called to report a TE with PNEUMOVAX 23 PFS. The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F).  The excursion was discovered upon looking at the data logs.  Data logger recorded a 46.7F temp on Marc; This spontaneous report has been received from a health care professional (also reported as consumer, conflicting information), concerning a 72-year-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.  On 03-MAR-2023, the data logger identified that pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #W027449, experienced a temperature excursion of 46.7 Fahrenheit degrees (F), and since that date did not record again until logging a 43F temperature on 06-MAR-2023 (product storage error).   Consequently, on the date of the excursion, the patient, per HCP direction, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection syringe, at a dose of 0.5 milliliters (mL) administered for prophylaxis (lot# confirmed W027449 to be valid, expiration date reported and established as 25-SEP-2024; strength, frequency and route of administration were not provided). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002667:MSD US-009507513-2304USA002675:MSD US-009507513-2304USA002694:MSD US-009507513-2304USA002759:MSD US-009507513-2304USA002776:MSD US-009507513-2304USA002650:MSD US-009507513-2304USA002932:MSD US-009507513-2304USA002750:MSD US-009507513-2304USA002696:MSD US-009507513-2304USA002840:MSD US-009507513-2304USA002746:MSD
Increased temperature, generalized rash covering arms and back. ER visit. Pt stated med prescribed but cannot relay RX information.
No adverse reaction to patient noted  Vaccine administered over 12 hrs after vial was punctured.
My mother was lethargic and showing signs of altered mental status the night before and was taken to the hospital the next day where she was diagnosed as having had a hemorrhagic stroke, a month after this shot on August 18.  It was a bleed in the right side of her brain causing an 11mm shift, left sided weakness and mouth drooping.
severe chills; weakness; temperature was about 38C.; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6204) via unspecified route of administration in the arm left on 21Mar2021 at 11:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 02:00, the patient experienced severe chills on the night after the vaccination, she woke up at about 02:00 with severe chills. The next day she was sleepy and weak and the temperature was about 38C. She felt some weakness even the day after. The treatment for the reported events included TYLENOL and ibuprophen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe chills, weakness and high temperature was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Arm Swollen for several days, Sudden Hearing Loss/Deafness (ongoing), tinnitus, hypercusis.
weakness; headache; chest pain; rapid heart beat; Chills; fever; swollen throat; body ache; This is a spontaneous report from a contactable other hcp.     A 28-years-old female Non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:45 as dose 2, single dose for covid-19 immunisation.The patient medical history was not reported. Concomitant medication(s) included phentermine (PHENTERMINE).The patient was not pregnant at the time of vaccination. The patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration,(Batch/Lot Number was Not Reported) as single dose for covid-19 immunisationIt was Reported that, the patient experienced chills, fever, swollen throat, body ache, weakness, headache, chest pain on 24Feb2021, rapid heartbeat on 24Feb2021 23:00 with outcome of recovered with sequelae.The patient underwent lab tests and procedures which included heart rate: rapid on 24Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccine given 10/23/01. On 10/25/01 F.A noted painful sensations of heat/cold numbness tingling in the left anterior/medial deltoid area. Has had past flu vaccines with reactions. NO local tenderness, erythema, heat or nodularity.
pt recv vax & w/in 24 hr post vax exp a petechial rash & edema on chin;sx resolved in 1 or 2 days;
Client noted on (R) arm (where the injection was given) hot, swollen, painful (localized) and mild weakness started yesterday 3/6/14. Nurse noted on the injection site - mild soreness and swelling. No open area, warm to touch.
Incoherent dry mouth nausea headaches speech impaired could not walk chills hothead hyperventilating and chest pressure
approx 6 hrs after vax,pt exp abdominal pain; "resting pain and pain on palpation of abdominal inject site" tx w/ pcn; T was 38.3 C "with aggravation o sx"; hosp w/ dx of lymphangitis and placed on IV therapy; discharged from hosp;
Client developed severe rash on upper body on 4/1/2021 with sunburn appearance, lasted 48 hours, faded gradually.  Rash then developed on upper arms 4/3/2021, lasted 48 hours, faded gradually.  Client's pulmonologist advised client not to receive Moderna COVID-19 vaccine dose #2.
Fever of 103 degrees Fahrenheit the next day following vaccine immunizations resulting in visit to ED. Developed Rash on torso and legs 03/22 which spread to face and back the next day. (03/23)
Patient came to the ED with shortness of breath, cough, weakness, and fatigue.  Patient admitted to the hospital with Covid and treated with remdesivir.
This spontaneous report as received from a pharmacist refers to a 53 years old female patient with reactions/allergies to opioids and insomnia. The patient was vaccinated with ZOSTAVAX, which was administered subcutaneously on 29-SEP-2012. The reported lot number was 0564AE (expiration date was not specified). Concomitant therapies included zolpidem tartrate. On 02-OCT-2012 the patient experienced a rash that looks like welts in all the areas of the body where there are sweaty creases. The patient sought medical attention for the event and was treated for the event with CALADRYL. The outcome of rash that looks like welts in all the areas of the body where there are sweaty creases was reported as recovering/resolving. No lab diagnostic studies were performed. The relatedness for the adverse event is unknown for ZOSTAVAX. Additional information has been requested.
Received positive covid test. Symptoms were mild - headache, 102 fever, sore throat; Received positive covid test. Symptoms were mild - headache, 102 fever, sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 15:10 as dose 1, single (Lot number: EJ1685) intramuscular, in left arm, on 25Mar2021 at 13:45 as dose 2, single (Lot number: EK5730) intramuscular, in left arm and on 27Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Ciprofloxin, reaction(s): "ciprofloxin: Drug Allergy", notes: known allergies: ciprofloxin; Tessalon perles, reaction(s): "tessalon perles: Drug allergy", notes: known allergies: tessalon perles; Gluten, reaction(s): "Gluten: Drug allergy", notes: known allergies: gluten; Differin, reaction(s): "differin: Drug allergy", notes: known allergies: differin; Yellow, reaction(s): "yellow: Drug allergy", notes: known allergies: yellow. The following information was reported: VACCINATION FAILURE (medically significant) with onset 13May2022, outcome "unknown", COVID-19 (medically significant) with onset 13May2022, outcome "recovering" and all described as "Received positive covid test. Symptoms were mild - headache, 102 fever, sore throat". The patient underwent the following laboratory tests and procedures: Body temperature: (13May2022) 102; SARS-CoV-2 test: (14May2022) Positive. Therapeutic measures were not taken as a result of covid-19.Clinical Course: Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no.
Redness, warmth, pain, and fever. Non- steroidal resolving.   Date seen by dr.  2/17/23
Sx began Wednesday night with crying, pulling up of legs, late Wednesday night pt. Began to vomit.  From 8:30am-1pm on Thursday pt. Screamed, not eating and then fell asleep from 1pm-6pm.  Mom woke child up at 6pm and reports that child was limp, took to ER.  Reports that child was dehydrated.
Pregnant patient had first dose of vaccine administered; really sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient had first dose of vaccine administered) and PAIN IN EXTREMITY (really sore arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-Mar-2021. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient had first dose of vaccine administered) and PAIN IN EXTREMITY (really sore arm). On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient had first dose of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (really sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   At the time of this report, patient was 35 weeks pregnant.   Treatment information was not provided
received Covid-19 vaccine on March 18 following temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported. No treatment related information has been reported.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe
29 YO patient received Kinrix; Patient received Kinrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 16-SEP-2022 Reporter's comment: The reporter stated that the 29 years old patient received Kinrix instead of Boostrix (booster dose).  The reporter consented to follow-up. Additional Supportive Information: The 29 years old patient received Kinrix instead of Boostrix (booster dose), which led to Inappropriate age at vaccine administration and Wrong vaccine administered.