chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of fever in a infant male patient who received FLULAVAL Tetra (batch number J9PP5, expiry date unknown). On 11th October 2017, the patient received FLULAVAL Tetra. In October 2017, less than a week after receiving FLULAVAL Tetra, the patient experienced fever, irritability, injection site tenderness and emotional distress. In October 2017, the outcome of the fever, irritability, injection site tenderness and emotional distress were recovered/resolved. It was unknown if the reporter considered the fever, irritability, injection site tenderness and emotional distress to be related to FLULAVAL Tetra. Additional details were provided as follows: The health care professional stated that the mom said the patient had the following reactions after receipt of FLULAVAL QIV on Wednesday; high fever (up to 103 F) for 2 to 3 days; irritability, tenderness at the injection site, cranky and inconsolable. These reactions lasted for 2-3 days and had now subsided; the patient was back to normal. The health care professional also stated that the mom brought patient back to the doctor's office last Friday (2 days after receipt of FLULAVAL) because the patient was having the above reactions. They tested for different types of viral infections and found nothing. No further information was provided.
A non-serious spontaneous report of expired FLUMIST administered was received from a healthcare professional concerning a five year-old female.  Patient received two doses of FLUMIST, at the time of the second dose the FLUMIST had expired.  The reporter stated that they are unable to return a partial box of FLUMIST for a refund and in order to re-dose other patients they would need to purchase a new box of FLUMIST.  The reporter asked why does the FLUMIST expire in mid-seasons.  There was no adverse event associated with this event;  therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root of cause for the medication were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medications errors that occurred shortly after the product expired.  Additional information received on 09-Apr-2009 that included the results of an investigation on medication error.
Soreness at the injection site / it was minimal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site / it was minimal) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site / it was minimal). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site / it was minimal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sweating, Lethargic after 5 minutes following the administration of flu shot. Paramedics arrived 15 minutes later. Checked the BP it was 9?/6?. Was rechecked after 5 minutes. BP was 114/73. Pt still wanted to see MD. Sx resolved when pt left pharmacy.
On 9/11/2015 patient received PREVENAR 13, the next morning patient woke up with arm swollen at site of injection. The swelling progressively got worse throughout the day. On 9/16/15 patient saw Dr. where she was prescribed cetirizine and MEDROL dose pak.
I was given vaccine on 12/29/20 at 11:45 am and at 7:00 pm my right side of face/jaw was swollen. When I woke up on 12/30/20 at 6:00 am, the swelling was worse and traveled to right side of chin & lip. My mouth was a  little droopy and felt like I was drooling.
Mother of patient called at 846 am 12-10-15, stating swelling in left leg "size of tennis ball" and warm to touch. Pain in leg. No fever. No limp. Seen by physician at 250 pm 12-10-15. 14cm x 7 cm. KEFLEX and BENADRYL started.
Received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) had resolved.        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 medication was reported. No treatment was reported.
pt recv vax 13DEC95 & 14DEC95 pt devel a rash on trunk & tongue, fever of 104, sore throat, nausea, vomiting, & diarrhea;the child's mom contacted family MD who advised her to give the child DPH;
Approximately one week after the shot, I noticed some mild itching at the injection site.  On 2/11/21, I noticed a large, red rash around the injection site, 2-3 inches in diameter.  The rash was itchy and hot.  Consulted with primary care doctor who advised Benadryl, which was taken.  On 2/12, the rash has faded a bit but is still itchy and warm.
12/03/2021 vaccination. 05/16/2022 Started to experience cold-like symptoms, HA & fever, fatigue. 05/17/2022 COVID positive (@home test). 05/27/2022 COVID.
flank pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received bnt162b2 (BNT162B2), on 09Apr2021 as dose 2, 0.3 ml single (Lot number: EW0158) at the age of 34 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "typhoid", start date: 2010 (unspecified if ongoing); "two pregnancies" (unspecified if ongoing), notes: during 2011-2012 and 2015-2016. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Anatomical site of Injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: ER2613), administration date: 19Mar2021, for COVID-19 immunisation. The following information was reported: FLANK PAIN (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Many full abdominal ultrasounds and CT scans for other purposes (e.g., typhoid diagnosis in 2010, as well as two pregnancies during 2011-2012 and 2015-2016). Patient was a mother of two kids (11years and 7 years). Both the delivery was normal, and the pregnancy period was also normal. Patient did many ultrasounds during her pregnancy time. She never had any issues at that time. She had no previous kidney injury. Patient also did a complete CT scan on Abdomen in 2010 in (Withheld) due to a typhoid infection. In that report (attached) it was mentioned that both kidneys were seen clearly. No atrophy was mentioned there. Further, patient never had any flank pain before early 2022. It started after second Pfizer vaccine for COVID19 and became severe with fatigue after the third (first Booster) vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300135086 same patient/product, different dose/events;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral treatment start from Jul2022 to Jul2022. After having COVID for 6 days, patient took 5-day course of Paxlovid, patient was tested negative for 1 day, and then began testing positive again. Slightly different symptoms this second time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVIS-19 Vaccine EUA - Fever, chills and achy muscles.  Lasted about 24-36 hours.
This spontaneous report was received from a pharmacist regarding multiple patient of unknown demographics. Information on pertinent  medical history, drug reactions/allergies and concomitant medications were not reported. The pharmacist reported that multiple unspecified patients received improperly stored PNEUMOVAX 23 lot# K006681 with unspecified expiry date (dosing details not reported). No adverse events were reported. No product quality complaint (PQC) involved. Additional information has been requested.
9.5 x 6.5 erythematous, swollen & warm on (L) thigh.
Momentary headache (temple area, alternating left/right, fairly strong but lasting only fraction of a second. Repeated about 5-6 times.
Gave 0.5ml third full dose instead of half shot booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.
Tinnitus in left ear began April 2nd, 8 days after first Moderna Vaccine and has continued.
Lab test positive for detection of COVID-19 virus Pneumonia of left lower lobe due to infectious organism
02/06 bursa sac irritation, persistent pain in left arm, 3/06 muscle therapy, 6/06 MRI showed a torn rotator cuff, 6/15/06 surgery for rotator cuff injury, Prednisone x 2 wks refer to ortho.
BOOSTER; rash; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional based on information received by the company from other company (manufacturer control number: EC-2021-094942), for bnt162b2. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included COVID-19 Vaccine (solution for injection) via unspecified route of administration, administered on an unspecified date as dose 1, single and COVID-19 Vaccine (solution for injection) via unspecified route of administration, administered on an unspecified date as dose 2, single for COVID-19 immunization, Primary Immunization series completed but unknown manufacturer. Patient reported had fatigue, joint pain, hypothyroidism, and rash. She attributed the rash to the covid booster. Patient reported missing one dose due to forgetting to take it. On an unspecified date the patient experienced booster and rash. Outcome of the events were unknown.
Felt run down, running a slight fever which got higher over the next 3 days to 103.1, vertigo.
Approximately 48 hrs after my second Pfizer vaccination for covid I experienced chills, migraine, lethargy, loss of appetite, and general digestive discomfort. Treated with plenty of fluids, naproxen, and rest. Experienced mild fever but never > 100 degrees that I know of.
Symptomatic Bradycardia with fatigue and dizziness with near syncope: several echo cardiograms, several visits to cardiologist; several zip patches. Magnesium recommended. Continues to wake and wane.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2008, the patient's healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2013, the patient was treated by her healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Moderate pain and tenderness at injection site left deltoid area  in 4-5 hours, followed rapidly with pain across back of neck to pain and tenderness over right deltoid area., all lasted just short of 24 hours
Severe Cold; Fever; headache; heavy head; tiredness; weakness; This is a spontaneous report from a non-contactable consumer.   A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left Arm on 23Feb2021 11:00 (Batch/Lot number was not reported) as SINGLE DOSE ( at the age of 33 years) for covid-19 immunisation.  The patient took dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 04Feb2021 at 09:30 in the left arm. The patient was not pregnant at the time of vaccination.   Since the vaccination, the patient has not tested for COVID-19.  Medical history included COVID-19 from an unknown date. There were no Allergies to medications, food, or other products and no other medical history.  The patient's concomitant medications were not reported.  The patient experienced severe cold on 23Feb2021 21:30 with outcome of recovering, fever on 23Feb2021 21:30 with outcome of recovering, headache on 23Feb2021 21:30 with outcome of recovering, heavy head on 23Feb2021 21:30 with outcome of recovering, tiredness on 23Feb2021 21:30 with outcome of recovering, weakness on 23Feb2021 21:30 with outcome of recovering.  No treatment was given for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
large red area where injection was given appeared within 48 hours then went away and then returned about 12 days late.  It is about 3" in diameter
severe headache; fatigue; foggy thinking; poor sleep; within 6 days developed a rash on her left lower leg that was painful, burning, and itchy; within 6 days developed a rash on her left lower leg that was painful, burning, and itchy; For the next 4-5 multiple lesions erupted on her leg and then scanned over and was told she had shingles; For the next 4-5 multiple lesions erupted on her leg and then scanned over and was told she had shingles; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 08Aug2021 at 14:00 (at the age of 47-years-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 and asthma both from an unknown date. The patient previously took aspirin and experienced allergy. The patient has no concomitant medications in two weeks. The patient experienced within 24 hours of the vaccine severe headache, fatigue, foggy thinking, and poor sleep all on 09Aug2021; On an unspecified date (within 6 days, as reported) developed a rash on her left lower leg that was painful, burning, and itchy. For the next 4-5 multiple lesions erupted on her leg and then scanned over and was told she had shingles. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Returned to clinic one day after receiving vaccinations with Right upper arm reddened, swollen and warm to touch.  Patient stated tenderness; denied fever and chills.  Tylenol or Ibuprofen prescribed as needed.
Fever, chills, muscle joint aches x 2 days. Pt took ALEVE with good effect. Pt feels better today 6/27/14.
sore arm around injection area, swelling in arm and armpit, red blotchy rash around injection area, headache, flu-like body aches, tiredness
Approximately 4 day after the injection I developed a rash/hives on both arms and the tops or hands. Approximately a week later my injection site became red and very itchy and I also developed a rash/hives on the backs of my legs at the knee bend. It has now been 25 days since the injection and I stillo have the rash/hives on the back of my legs but the ones on my arms are gone.
Pt appt was 11 AM - prepped left shoulder using alcohol. Used sterile syringe with sterile needle and administered DTaP. Mom states child c/o discomfort to arm. Later Friday night arm swelled. Mom applied cold packs to (L) shoulder, returned to office on 4/22/13 due to swollen arm.
One day post vax the pt began having vomiting once per day and diarrhea of twice a day. She experienced irritability and decreased appetite with slight congestion and respiratory raspiness. She felt warm but no documented fever. She was somewhat crabby or irritable. She had one day of leg pain but no swelling.
No initial reaction. Four hours after vaccine injection I got severe hives, started on the back of my neck and then extended over my torso and face. Went to ER in city the next day, 2/13/21. We confirmed it was hives, didn't doc as reaction but simply as treated hives. Received prescription for EPI pen and dosage of five days of Prednisone. He said I was over the worst part and should not need Prednisone but fill scrip if necessary. The next day 12/14 my hives were much worse, spreading over my body, itching, fever, swollen face and ears. Started Prednisone and it took the full five days for hives to be mostly gone. Used benedryl cream topically, Motrin. ER doc said report to primary, which I did that week; was told not do anything and not to report as it was just hives, a typical non-life threatening reaction. This primary dr later told me to get the vaccine, not to worry about any further allergic reaction. I haven't to date taken a second dose per CDC site.
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Left arm started itching; Left arm had some fluid; Left arm was red; Had a line around her arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Left arm started itching), BURSAL FLUID ACCUMULATION (Left arm had some fluid), ERYTHEMA (Left arm was red), RASH (Had a line around her arm) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Rotator cuff injury. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VITAMINS NOS (DAILY VITAMINS), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PRURITUS (Left arm started itching), BURSAL FLUID ACCUMULATION (Left arm had some fluid), ERYTHEMA (Left arm was red), RASH (Had a line around her arm) and FATIGUE (Tired). At the time of the report, PRURITUS (Left arm started itching), BURSAL FLUID ACCUMULATION (Left arm had some fluid), ERYTHEMA (Left arm was red), RASH (Had a line around her arm) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient states that she has a history with her left arm.
On the evening of the day (Aug 12, 2021) I received the vaccine, I started running fever and having aches and pains throughout my body, including headaches. The fever lasted though the night of Aug 14 but the other symptoms didn't go away. The headaches had gotten worse and by Aug 24, I left work and had a severe headache with blurry vision. I went to the E.R. at that point. They did an MRI of my head and bloodwork.  I was given IV steroids, pain meds and a prescription for the headaches.
Started with a sharp pain under left rib cage, progressed to under left breast and shot up to shoulder.  Lasted 3 days. Treated with ibuprofen with relief.