chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 20-Oct-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA for influenza vaccination from 20-OCT-2016 to 20-OCT-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54707. No additional suspect drugs. Adverse event description: On 20-Oct-2016, a partial dose was administered to the patient as the needle was not fully attached to the syringe (special circumstances: underdose without adverse event, wrong technique in drug usage process without adverse event). No product complaint, they did not attach the needle fully. Reporter comments: The healthcare professional classified the event as a medication error. Additional information received on 24-Jan-2017: QA investigations results: WT54707 Final assessment: Risk has been excluded. The review and investigation of the manufacturing, dispensing, shipping and product testing of Influenza Vaccine lot: WT54707 found no evidence of a product quality issue to prompt the potential 'vaccine reaction'.
12 hours following vacation started with fever , chills fatigue. 24-48 hours was froth with facial swelling on lips eyes and face which then turned into hives and raging rash from head to the bottom of my feet. Excruciating itching and hives.  This was all accompanied by vomiting and raging diarrhea and heart palpitations. Day  3 symptoms subsided , however rash and welts still were present. Days 4/5 rash still preseny
No additional AEs; Caller reported vaccine administered after temperature excursion.  No other information provided.  No additional AEs or PQC reported.          ?    Names of vaccines involved (including lot/exp) VARIVAX X010534  4/11/2025        ?    Temperature; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.    On 30-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml intramuscularly, lot # X010534, expiration date 11-APR-2025 (anatomical location was not provided), for prophylaxis. The vaccine was incorrectly stored for 1 hour 2 minutes (-1.1 degrees Celsius). There was also a previous excursion (no details reported). No additional adverse events were reported.
Day of injection, arm sore to touch.  Following day (10/27) developed 102 degree fever, nausea, extreme chills that felt like convulsions.  2 to 3 blotches of red at injections site appeared later on day of injection.  Thursday (10/28) fever decreased to 99 degrees.  Patient overall felt exhausted, and flu-like symptoms.
SINUSITIS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no history of allergies or sinuses infections.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced sinusitis. On 03-APR-2021, Laboratory data included: Pain scale (NR: not provided) 12 to 9. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) indicated sinusitis. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from sinusitis. This report was non-serious.
heavy vaginal bleeding that lasted 10 days; heavy vaginal bleeding that lasted 10 days; I was spotting again; booster (3rd dose); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 09:15 (Lot number: FA7218) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 02:45 PM), administration date: 20Apr2021, when the patient was 27 years old, for Covid-19 immunization, reaction(s): "Vaginal spotting"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 02:45 PM), administration date: 23Mar2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 09:15, outcome "unknown", described as "booster (3rd dose)"; HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset 16Dec2021, outcome "unknown" and all described as "heavy vaginal bleeding that lasted 10 days"; INTERMENSTRUAL BLEEDING (non-serious) with onset 16Dec2021, outcome "unknown", described as "I was spotting again". The events "heavy vaginal bleeding that lasted 10 days", "heavy vaginal bleeding that lasted 10 days" and "i was spotting again" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heavy menstrual bleeding, menstruation irregular, intermenstrual bleeding. The patient had vaginal spotting for 3-4 days after her 2nd dose and less than 48 hours after her booster (3rd dose) the patient experienced heavy vaginal bleeding that lasted 10 days with no change in volume of blood or color (still heavy, bright red, no clotting on the 10th day) the patient went to the hospital and was prescribed a 10 day prescription of Provera to stop the bleeding. When the patient took this her bleeding was lighter and fully stopped on the 9th day of the prescription, however the patient was spotting again within 48 hours after finishing the prescription. Spotting lasted an additional 2 days, then stopped. The last day of her menstrual cycle in December was 10Dec2021. The patient got her booster on 15Dec. The patient normally had a very regular cycle which was light and lasts no longer than 4 days, and no spotting between periods so this was definitely not normal.  No follow-up attempts are possible. No further information is expected.
Left arm w/swelling and redness - approx 5 1/2" x 3 1/2", additional sx's include: N, lightheadedness, area warm to touch, pt states "just don't feel good"; Denies any respiratory difficulty, fever, numbness or tingling at site.  Pt seen at urgent care facility 2 days after vaccine 10/28/07. TX - ABX (Cephalexin 500mg PO qid x7 d) along w/Benadryl for itching at site.  Pt advised to f/u w/urgent care facility after ABX complete.  HD received TC from pt 10/30. Pt states redness has decreased, however, swelling remains at site.  Advised pt to f/u w/HD if any additional changes.
Patient received dose 1 of moderna on 2/10/22 at outside facility.  pt came in for dose 2 on 3/3/22 . Vaccinator discovered after dose is administered that dose was given too early.
Sore arm for approximately 30 hours - peak soreness at about 12-14 hours after injection; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 15:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 01Mar2021 at 20:00, the patient experienced sore arm for approximately 30 hours - peak soreness at about 12-14 hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was resolved on 03Mar2021 at 02:00.   No follow-up attempts are needed. No further information is expected.
sore arm/sore injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm/sore injection site arm.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 005C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm/sore injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore arm/sore injection site arm.) outcome was unknown. No concomitant medications were reported. Patient does not remember which arm patient received the vaccine after first and second dose. Patient had sore arm after first dose. Patient had sore injection site arm after second dose and third dose (first booster dose). No treatment medications were reported. This case was linked to MOD-2022-646794 (Patient Link).
muscle aches in shoulders and body 1 month after receiving series.  C/O Pain in both soles of feet.  TX w/ NSAID but no relief.  Elevated rheumatoid factor.  As of 16JUN93, C\O pain in shoulders and both knees;can't sleep at night.
Rash on injection upper arm, extending 8 inches down on bicep.  Commonly called COVID Arm.
Itchiness started  3-25 with slight swelling. Redness increased swelling with redness 28 hours later on 3-26
Full body aches starting the day after i received the vaccine. The next day the body soreness was severe enough to where it was painful to clench my fist or walk even a small distance. I also experienced nausea, loss of appetite, migraines and light sensitivity, and was unable to do normal tasks around the house for about 3-4 days. The full body soreness was the most debilitating symptom and certain aresa like elbows, knees, wrists and hips were painful to the touch. I think my joints were most affected. The soreness and pain can be compared to a flu but it was more intense than anything i have experienced before.
a sore deltoid at and surrounding the injection point (pain level 2 out of 10); This is a spontaneous report received from a contactable consumer (patient) in response to the mail trail sent regarding the confirmation of below mentioned query sent in cross referenced case. The response included that:    A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection) via an unspecified route of administration on 19Feb2021 11:30 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection) via an unspecified route of administration, on 28Jan2021 at 08:15 as dose 1, single for covid-19 immunization and experienced sore leg at approx. 18:00 that evening (pain level 3 out of 10 similar to growing pains, more of a nuisance). On 19Feb2021, the patient experienced a sore deltoid at and surrounding the injection point (pain level 2 out of 10) which lasted approx. 24 hrs. Upon follow up 08Mar2021 response include when patient was aware of second dose AE "a sore deltoid at and surrounding the injection point". When it happened and is it on 19Feb2021. First dose AE "sore leg" awareness date was 28Jan2021, but patient reported on 11Feb2021 which is delay and second dose's AE ""a sore deltoid at and surrounding the injection point", if the onset date was 19Feb2021, but patient reported it on 23Feb2021, which will also mean delay. Patients need to report within 24 hours please help for delay comment. Patient stated, I received the 2nd COVID-19 vaccine on 19Feb2021 at 11:30 and I only experienced a sore deltoid at and surrounding the injection point (pain level 2 out of 10), which lasted approx. 24 hrs.  and to be clear my deltoid was sore on 19Feb2021 and was not sore the next day. I no longer have a sore deltoid. The patient underwent lab tests and procedures which included pain assessment: 2 out of 10 on 19Feb2021. The outcome of the event was recovered on 20Feb2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Pt requested Janssen  COVID shot but Flu shot was entered into our system instead. Vaccine was given to patient and that was when we discovered the error. Patient then got the correct Vaccine.
Pt recvd Engerix-B 1OCT91  @ 1230PM as part of hosp's immun program infect/prevent policy; w/in 3 hrs 330PM p/recvd vax pt exp periodic itching of arms; upper legs, back & abdomen w/rash appearing; pts recvd itching off & on through 9OCT91;
The member had possible myocarditis in March - a few weeks after having the Covid vaccine. He had chest pain and elevated troponin, with a negative cath. Symptoms resolved with medications.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: patient felt lightheaded after around 10-15 min of the vaccination , blood pressure checked was 150/90 then 148/87 after 10 min , offered water , lifted legs , offered to call 911 or the doctor
Low lying placenta; Vaccine exposure during pregnancy; This is an observational study case from, initially received from other health professional on 16-Oct-2019, concerning a 35-year-old female, pregnant subject of body weight 200 lbs, height 68 in and body mass index (BMI) 30,4, enrolled in, a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine, during pregnancy.  The subject's current condition included anxiety, history of deep vein thrombosis (DVT) and allergies. The subject's concomitant medications included DHA Prenatal (docosahexaenoic acid) and Vitamin C (ascorbic acid) both as supplement; Singular (montelukast sodium) and nasal spray both for allergies and heparin porcine for DVT prophylaxis.  The subject's obstetrical history included one previous pregnancy with one full term live birth. The subject had no history of offspring with major congenital malformation (MCM). Also, the subject had no maternal or paternal history with MCMs. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period was on 08-Jan-2019 and estimated delivery date (EDD) was reported as 15-Oct-2019 and corrected estimated delivery date (CEDD) was reported as 28-Oct-2019. The type of pregnancy was singleton with risk factor reported as advanced maternal age.  Paternal age was 36-years old.  On 19-Mar-2019, the subject underwent ultrasound scan and no MCM was noted.  On 22-May-2019, the subject underwent ultrasound scan and it was established that the right kidney was located in pelvis.  On 27-Jun-2019, the subject underwent fetal echo and it was established that the right kidney was located in pelvis.  On 27-Sep-2019, at 37 weeks of gestation, the subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: P100118566, dose, expiration date, route of administration, anatomical location: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunization.  On the same day, the subject underwent ultrasound scan and no MCM was noted.  On an unspecified date, the subject developed low laying placenta.   The outcome of the event low laying placenta was not reported, at the time of initial reporting.  The case was assessed as serious and the reporter did not provide causality assessment.  Company Comment: The subject experienced placenta praevia associated with the suspect product Flu Vaccine Egg Split QIV CSL. Reportedly, vaccination occurred during pregnancy at gestational age of approximately 37 weeks of gestation. Temporal relationship is implausible because the placenta is fully formed by 18 to 20 weeks. Causality was confounded by use of concomitant drugs, Singular (montelukast sodium) and heparin. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related per company conventions. Causal relationship between the suspect product and the event placenta praevia is assessed as not related.
Redness and swelling at site of injection. Unknown if Hib or PCV13 reaction. Child in no distress.
Anaphylactic reaction; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction.  The patient's medical history was not provided. Concomitant product use was not reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, after vaccine administration, the patient had an anaphylactic reaction. The patient reported he was "all smooth" now, and would not be receiving the second dose. Treatment for the event included epinephrine.  The second dose of mRNA-1273 was discontinued in response to the event.  The event, anaphylactic reaction, was considered resolved.; Reporter's Comments: This case concerns a male patient who experienced a serious unexpected event of anaphylaxis. The event occurred on an unspecified date after first dose mRNA-1273 (Lot# unknown) administration. The subject's concomitant medication was not provided. The event was treated with epinephrine. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
the vaccine was put in fridge on January 10th 2022, and given on 05/31/2022 which was over the 10 weeks in the fridge. given after use date
I thought I had a bad cold. I had coughing, sneezing, teary eyes, congestion. I tested using my home COVID-19 Test, it came back positive. I called the doctor he prescribed some cough syrup and told me to take some over the counter medicine. I am feeling better now.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD subcutaneously, lot # R001541, 15-JUL-2019 (dose was not reported). It was unknown, if sterile diluent (strength, dose, lot# and expiration date were not reported) used to reconstitute was stored properly. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 43 minutes. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA013035.
Patient received Janssen COVID-19 Vaccine on 04/02/2021 as per immunization Records Patient received first dose Pfizer COVID-19 vaccine on 8/31/2021 at the vaccine station by registered nurse patient denied and attested never receive any Covid-19 vaccine in the past  No adverse reaction reported by the patient
Two hours after second dose, 1/12/2021, nausea, mild headache. In evening fatigue, aching all over. Next day 1/13/2021, flu like symtoms, felt feverish, sluggish, ache all over, felt better after 3PM in afternoon, but not 100% normal.
took longer to feel alright after this dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (took longer to feel alright after this dose) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ILLNESS (took longer to feel alright after this dose). At the time of the report, ILLNESS (took longer to feel alright after this dose) had resolved.            Treatment medications include blood thinners. No concomitant medications was reported by the reporter. Action taken with mRNA-1273 in response to the events was not applicable   This case was linked to MOD-2021-042834 (Patient Link).
This spontaneous report was received from a health professional refers to a patient of unknown demographics. Pertinent medical history and drug reactions were not provided. On 07-APR-2015 the patient was inadvertently administered with an expired dose of VARIVAX (Merck) (lot # J003223, expiry date: 15-MAR-2015). Concomitant medications were unspecified. No adverse effects were reported. Outcome of the event, expired product administered was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
painful chest pains, that awakened me; went to the ER.  Tested for heart attack; none found.  However, was given a heart scan and my cardiologist found it revealed some narrowing of the arteries.  Outcome - increase cholesterol medication
12/25/2020 08:00AM patient awoke with left eye twitching, mouth drawn to left side. Neck severely aching from right earlobe to the back of neck, severe headache. Unable to close left eye.   ER visit  12/26/2020 in the morning - discharge diagnosis, Bell's palsy. Prescription Valacyclovir hcl 1 gram tablet,  Butalbital, Acetaminophen, Caffeine Oral tablet 50-325-40mg , solution eye drops , Azithromycin cream
NO adverse effect reported; a patient was administered a dose of improperly stored VARIV AX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 20-AUG-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), lot # S004554, expiration date 14-FEB-2021 (strength, route of administration and exact dose were not reported), for prophylaxis. No adverse effect was reported. Administered dose of vaccine experienced the temperature excursion of -14 Celsius degrees to -10 Celsius degress (also reported as -14.4 Celsius degrees) for 18 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous temperature excursions reported.