chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINATION ADMINISTERED FROM A VIAL AFTER POST PUNCTURE TIME PERIOD; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned an elderly male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced vaccination administered from a vial after post puncture time period. On 04-JUN-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination administered from a vial after post puncture time period and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210613154.
130PM pt was awakened w/itching & had a rash over body; had a temp 103 & a h/a;
pt recv vax & exp severe soreness @ the inj site;pt still has pain 4wk post inj;
Approx 10 days after bivalent moderna vaccine I began getting smells of "burning cigarettes". I don't smoke and am not around any known smokers. I smell at home, at work, driving in the car. It has been approx a week since it began and has not stopped. Doesn't affect taste. Just smell of cigarette smoke, not necessarily constant but happens multiple times an hour. Usually just smell for a single inhale then not the next but it can happen again as soon as a few inhales later. Sometimes 100 times an hour sometimes just a few an hour. Very displeasing and hoping goes away.
vomited; diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Dec2021 15:00 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VOMITING (non-serious) with onset 12Dec2021 07:30, outcome "recovering", described as "vomited"; DIARRHOEA (non-serious) with onset 12Dec2021 07:30, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of vomiting, diarrhoea.  Additional information- It was reported that patient did not have any known allergies except seasonal allergies. The patient did not suffer from Covid prior  to vaccination and did not undergo COVID tested post vaccination. It was reported that 15 hours after the vaccine she vomited. She vomited 5-6 times over the next 6 or 7 hours. She also had diarrhea.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Case previously recorded as MA2009-3901. Initial case report received via Med Com from a health care professional on 09 NOV 2009: A 3-year-old male patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 06 NOV 2009. No adverse event was reported. MedCom ref. no.: NA09-007793.
Anaphylactic like reaction after DPT leading to 2 urgent care visits and I continue to have disfiguring uncomfortable rash sequelae on hands and face.
Pt. c/o increased pain, redness, swelling, warm to touch (L) arm after PNEUMOVAX given.
PATIENT STATES THAT ABOUT 20 DAYS AFTER GETTING HIS FIRST COVID VACCINE HE WAS DIAGNOSED WITH AND TREATED FOR BELLS PALSY
1hr p/vax pt rt thigh reddened & swollen sl;Dad instructed to give APAP put warm clothes on site;
Baby received vaccines approx 11 AM, after getting home became very fussy, inconsolable crying, high pitched crying, refusal to feed, fever 100.8, seen in ER, received LP, bld cx, urine cx, Ceftriaxone given, patient d/c'd home after work up.
Moderna COVID-19 Vaccine EUA  started as a series of small bumps, 5 days after vaccination, then grew into a 2? raised rash by the 7th day. Red, itchy, painful. No outcome yet. Not treatment yet but I will be taking an antihistamine soon.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine placed in refrigerator after the expire date) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine placed in refrigerator after the expire date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine placed in refrigerator after the expire date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. There was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Date place in refrigerator was 18Oct21. Patient did not experience temperature excursion and any adverse event. No treatment medication was provided by reporter.
She got her vaccine, son relates that she did not feel well, does not know what that meant.  She postponed her plans to have Holiday as she felt so bad.  She complained to her son on 1/1/22 that her leg hurt like somebody had hit her with a bat, and her son found her on the floor deceased.   The autopsy report showed pulmonary embolism.    She did not have any health issues, and was fine up until the booster.  The other two vaccines she received she only had  a sore arm, no other issues.
Approximately 8-10 hours after vaccination, patient developed erythema that enlarged to approximately 5 cm in diameter over the next 24 hours.  Area was approximately 4-5 cm lower than injection site and on the anterior portion of the arm.
I had very bad pain in my left side in my back like where my lungs would be; I am starting to get burn on my skin, on my fingers and I am getting some kind of strange thing; I had a severe pain in my left leg that, it was like to the bone; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP7534) via an unspecified route of administration on 18Mar2021 at 1st dose, single dose and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0153) via an unspecified route of administration on an unspecified date in Apr2021 at a 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced i had very bad pain in my left side in my back like where my lungs would be, i am starting to get burn on my skin, on my fingers and i am getting some kind of strange thing, on an unspecified date in May2021 i had a severe pain in my left leg that, it was like to the bone. Additional Context: Concern: patient stated, patient have some questions may be six days ago patient was in a store and patient had to leave it because patient had a severe pain in my left leg that, it was like to the bone and patient couldn't do anything with the food that patient had, since then patient had very bad pain in my left side in my back like where my lungs would be and patient had got a COVID shot in 18Apr and then because patient started to get burn on my skin, on my fingers and patient am getting some kind of strange thing happening automatically and patient don't know its something from the vaccine and there is something to worry about patient do wanna check with self. LOT: Consumer stated, Ok, EP7534 (First dose) and that shot was given on 18Mar and the next shot the number is EW0153 (Second dose captured in tab) and that was given on 8Apr and that is in (city name). Date of first shot: 18Mar2021, Date of second shot: 08Apr2021. Outcome of the events was unknown.  Further probing could not be done as the consumer hung up abruptly. Hence limited information available over the call.; Sender's Comments: :
I never had a reaction of any kind to vaccines. I have a  psoriasis flare up.  I've never had one  before. It's very itchy, flaky, sore and there are red spots.  its on my hands, alittle bit on my legs. I go back to see my dermatologist in 3 months. I am taking a prescribed cream.
Initial unsolicited report received from a healthcare professional on 08 January 2015. An 11-month-old male patient, whose concomitant medication was not reported, had received intramuscularly a dose of IPOL, (batch number: J1561) (number of dose not reported) in left thigh on 04-Feb-2014. Medical history was reported as allergy to formaldehyde and polymixin B. On 04-Feb-2014, patient experienced flushing of his facial cheeks and fever of 101.8 degree C. Illness at the time of vaccination and Pre-existing physician diagnosed allergies were denied by the reporter. Corrective treatment was reported as ibuprofen. Laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as recovered. Documents held by sender: none.
Chills; Low grade fever; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (Chills) and PYREXIA (Low grade fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Low grade fever). At the time of the report, CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
pt devel generalized urticaria 24hr p/vax;hives resolved over next 3 days w/DPH;pt did devel URI sx shortly p/developing hives;pt currently hive free;no other systemic sx x/URI;no other meds;
Scaling type pruritic papular rash; Scaling type pruritic papular rash; Scaling type pruritic papular rash; Rash all over her body; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXFOLIATIVE RASH (Scaling type pruritic papular rash), RASH PRURITIC (Scaling type pruritic papular rash), RASH PAPULAR (Scaling type pruritic papular rash) and RASH (Rash all over her body) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced EXFOLIATIVE RASH (Scaling type pruritic papular rash), RASH PRURITIC (Scaling type pruritic papular rash), RASH PAPULAR (Scaling type pruritic papular rash) and RASH (Rash all over her body). The patient was treated with DIPHENHYDRAMINE HCL for Rash, at an unspecified dose and frequency. At the time of the report, EXFOLIATIVE RASH (Scaling type pruritic papular rash), RASH PRURITIC (Scaling type pruritic papular rash), RASH PAPULAR (Scaling type pruritic papular rash) and RASH (Rash all over her body) 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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: No specific follow-up information recorded.
This spontaneous report as received from a healthcare worker via company representative refers to a 69 year old male patient. In 2008, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose, lot number and expiry date not reported) and then received ZOSTAVAX subcutaneous (dose, lot number and expiry date not reported) on 30-MAY-2014. No adverse effect was reported. Additional information has been requested.
Temp in the refrigerator was 19 for approx 2hrs. Action recalled client.
On September 1, 2005, the day after the patient's third rabies pre-exposure vaccine administration, he complained of swelling, redness, and itching in his penis and general groin area.  On September 2, 2005, the patient woke with the same above symptoms plus swelling redness and itching on the eyelids and a rash on his right arm (not at the area of the injection according to the patient). He was examined by the doctor and put on prednisone and Zithromax.
Headache; Sore arm at injection site; Fatigue; Irregular Period/vaginal bleeding; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737), via an unspecified route of administration in the left arm on 01Apr2021 at 19:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Concomitant medication included birth control pills unspecified (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced headache, sore arm at injection site, fatigue and irregular period or vaginal bleeding. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the headache, sore arm at injection site, fatigue and irregular period or vaginal bleeding. The clinical outcome of the events headache, sore arm at injection site, fatigue and irregular period or vaginal bleeding were unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Pt left arm, from injection sit to elbow, large area of bruising and pooled blood. Looks like  a giant blood blister/ hematoma
congestion, throat; I'm feeling really bad, you know, like fluey kind of thing; low grade fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First Booster but Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: UPPER RESPIRATORY TRACT CONGESTION (non-serious), outcome "unknown", described as "congestion, throat"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "I'm feeling really crappy, you know, like fluey kind of thing"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: During the phone call received, the patient stated, "On Thursday I got my second booster shot for Pfizer and um, I (inaudible) more than 6 months. I didn't realize it's been 9 months since I've gotten the last booster and, um, I don't know if its coincidence or not but I'm feeling really bad, you know, like fluey kind of thing. I've got a low grade fever too. Its 98.4, um, you know, congestion, throat and all that kind of stuff."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had shots on Friday, right leg not hot to touch but hard with big red circle, 4" X 4" area of erythema around injection site. Not indurated. Treat with Benadryl cream, soaks and monitor for further erythema. Pt had IZ reaction. We pulled the chart and it was from the DTAP. This is the 3rd one we've seen recently. We didn't pull the previous charts, thinking they were isolated events. Those pt's were told to follow-up with their PCP and let them know they'd had a reaction. Now, it may be wise to look them up and see if we have been using a bad batch. I didn't know if you have a way to track them.
Exposed to COVID 19; Soreness in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID 19) and VACCINATION SITE PAIN (Soreness in her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID 19) and VACCINATION SITE PAIN (Soreness in her left arm). On 08-Apr-2021, EXPOSURE TO SARS-COV-2 (Exposed to COVID 19) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness in her left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: TCR attached contains no new information.
Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that the vial was initially stored in refrigerator on 22-Oct-2021 and didn't undergone any temperature excursions.  Treatment information was not provided.
COVID positive; COVID positive; a little tenseness in his arm; This is a spontaneous report from a contactable consumer (patient) and from same contactable consumer (patient) via Pfizer-sponsored program.   A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 01Feb2021 about noon for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 01Feb2021 maybe 11pm that night as he raised his arm, he could feel a little tenseness in his arm. On 23Feb2021, he was diagnosed COVID positive, he tested positive for COVID but has no symptoms. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive. The outcome of events was unknown. The patient was due to have his 2nd dose on 03Mar2021. The patient asked if he should still take the 2nd dose. A product complaint was filed.  Information about lot/batch number has been requested.
I experienced my heart beating at a fast pace, dizziness, chest pains, fatigue, and weakness.
Headache, Myalgia, Fever, NauseaVomiting, Localized pain, chills, fatigue Narrative:
Information has been received from a physician concerning a 5 year old patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed a rash which was reported as questionable chickenpox, the physician also described it as breakthrough chickenpox. Unspecified medical attention was sought and it was reported as a mild case, if it was chickenpox. At the time of this report the child was recovered. No product quality complaint was involved. Additional information has been requested.
10-10 Blisters on trunk x 1 day before seen in office Tx'd with Zovirax 200/s 3 1/2 tsp QID x 5 days.
Within a few hours of receiving PNEUMOVAX injection pt reported itching and slight temp (99 deg F). Reports itching persists this morning, fever resolved. BENADRYL given. Fever and Urticaria, Pruritus. Diphenhydramine 50 mg once.
Fever up to 104, (temp over 102 for about 48 hours), chills, sweats, malaise, better now, down to 99 now.
Headaches beginning Apr 21-25 Pain through right thigh Apr 24 Headache Bursts on right side of head began Apr 26- now Drowsy beginning Apr 26-now 1 sec blackout while sitting up on Apr 26 Side pain in upper right abdominal area beginning May 13 General malaise continues everyday Shooting leg pain continues through right thigh
SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 76 year old male. The patient's weight was 194 pounds, and height was 72 inch. The patient's concurrent conditions included blood pressure, alcohol user drinks wine 2 per day, cholesterol, and non-smoker, patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number:043A21A expiry: UNKNOWN) dose was not reported,1 total administered on 01-APR-2021 around 17:00 on left arm for prophylactic vaccination. Concomitant medications included simvastatin for cholesterol. On 05-MAY-2021 at 10:00 and 02-JUN-2021 between 9:00 to 10:00 the patient went through blood test and found out vaccine was not taken based on test(Suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182753 The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210630345-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
pt to ED with chest tightness, SOB, nausea, diaphoresis; scheduled for heart catherization; positive for COVID; placed on BiPAP; transported to ICU; pt's condition worsened and she experienced cardiac arrest and died in the hosp