chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health care worker refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 07-NOV-2014 the patient was vaccinated with VARIVAX (Merck) (dose, frequency and route were not reported) that underwent a supported temperature excursion. No adverse experiences reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This case is linked to case # 1501USA001936 (same reporter link). Additional information has been requested.
Pt called at 5:15 PM reported her arm hurt yesterday at injection site and now pain had settled in her spine.
started getting dizzy; like the world was going round and round and round and round; I fell face down on the concrete; Damaged the three front teeth's that have to be replaced; very upset; I could not move; knee was all swelled up; my face; it was all black and blue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 11Oct2021 (at age of 69 years old, Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthma. The patient stated she did take other medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on an unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. She had a reaction from the first shot. Patient stated she had a very bad reaction from the second COVID shot. She was on the capsules three 'solid' weeks. She got up because had to get some doggy food and food for the house and whatever, whatever and she had to go to the bank and started getting dizzy, like the world was going round and round and round and round and do not have any that kind of illness ever. It was going round and round. She fell face down on the concrete and have a 6000 Dollar dental bill right now, okay 6000 dollars. Damaged the three front teeth's that had to be replaced. She was so very upset. It was not fair. She never heard of this kind of side effect and the, Pharmacy said well that was really severe. This month has been a nightmare for her. Those events occurred on 12Oct2021 (the next day after vaccination), when she woke up, she could not move. She was on the capsule three weeks. Patient stated, she went and got, she went to an urgent care, she fell and they took X-ray to make sure that she did not break anything in her face. Her knee was all swelled up. It was horrible and her face she had it was all black and blue. Just to make sure that she did not break anything. Especially face. That is 'when she went to' an urgent care. The outcome of the events was recovered on Oct2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Severe headache, eyes hurting, nausea, vomiting, no fever, no vomiting, no diarrhea.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 02/09/2021 and 03/10/2021. They tested positive for COVID-19 on 10/25/2021. They died on 11/07/2021. COVID-19 is listed on Part II of the death certificate. I see no evidence of hospitalization related to this illness.
This spontaneous report was received from a registered nurse concerning an unspecified patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot number M011666; expiration date: 08-MAR-2018, lot number M032485; expiration date: 06-JUL-2018, lot number M035388; expiration date: 05-DEC-2018 or lot number M035389; expiration date: 02-AUG-2018 (strength, dose and route of administration were not reported) for prophylaxis. The temperature excursion with M-M-R II was 30 minutes between 9 to 25 Celsius degrees. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of three cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005140: US-009507513-1703USA009374: US-009507513-1703USA009372.
This 15 year old did not have an adverse reaction.  She was immunized with Hep A and the meningoccal vaccines and nurse did not notice the #10 screening question asking about pregnancy.
Patient is a 18 year old female who presents for evaluation of rash she has had for 1 day(s). Describes localized involvement on upper arm  and inner bilateral upper legs that are raised, maculopapular, scattered, red, well demarcated and itchy.
On 10/26/11 at 10:30 AM my daughter received the flu/H1N1 combo mist. On 10/27/11 in the AM she had a nose bleed that lasted about 5 min to stop. And again on 10/29/11 in the afternoon.
11JAN93 mom reports that pt has nodule which is increasing in size; pt c/o soreness to affected area;
This might seem benign, but shortly after getting the vaccine (and I don't know the exact dates, so the value entered is just a rough estimate) I got a cold sore, which I haven't had in 30 years; and I also got ring worm, which I've never had (and still have it today); and I'm also getting a ton of ingrown hairs - all over.
SEVERE PAIN ON LEFT LEG; SEVERE FATIGUE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol use, and non smoker, and other pre-existing medical conditions included no known allergies. no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for high blood pressure. On 10-APR-2021, the subject experienced flu like symptoms. On 10-APR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 99.0 F. On 14-APR-2021, the subject experienced severe pain on left leg. Laboratory data included: Diagnostic ultrasound (NR: not provided) negative, and Echocardiogram (NR: not provided) negative. Treatment medications (dates unspecified) included: menthol/methyl salicylate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain on left leg, severe fatigue, and flu like symptoms. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Had bowel and felt like a lousy Flu; Had bowel and felt like a lousy Flu; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 07Jun2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history included aortic valve replacement from an unspecified date in Mar2021 to an unspecified date in Mar2021. The patient's concomitant medications were not reported. It was reported that, when probed for the concern, the consumer stated that, she think she had a side effect that has been unreported so far of the Pfizer vaccine (unspecified vaccine). Stated that, the patient had her first Pfizer injection (first dose) on 07Jun2021 and had no reaction until 4 days, later on the patient three day had bowel and felt like a lousy Flu. The outcome of the events was unknown.  Information about Lot/Batch number was requested.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient with allergy to Sulfa antibiotics. The patient has no pertinent medical history. On 16-JUL-2016 the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneously on the back of her upper arm below the deltoid area. The patient was not taking concomitant medication. On 17-JUL-2016, the patient developed redness at the injection site (injection site erythema); the area of redness was described as 3 inches by 2.5 inches around the injection site. The patient also developed swelling at the injection site (injection site swelling), described as really raised, as if there is fluid underneath. Additionally, the patient developed pain (injection site pain) and itching at the injection site (injection site pruritus); the area of itching was described as originating at the injection site but had begun to "radiating down to her elbow and down her side to her left breast" (pruritus). Furthermore, the patient also had "5 very small faint flat circles" around the injection site (injection site discolouration), although she could not determine whether these "circles" may be part of the patient's normal skin appearance. The patient sought medical attention, she called the physician and visited the pharmacist and the treatment provided for the events included BENADRYL and MEDROL DOSEPACK. The outcome of the events was not recovered. The causality between the therapy with ZOSTAVAX and the events was unknown. Additional information has been requested.
Large rash like spots appearing on rib cage  Spread to stomach on 6/14  Now on 6/22 I have 3 more spots including face with swelling
Started with runny nose then later that evening went to severe congestion in head (sinus). Next day (9/16) had severe congestion in head and sore throat and body aches. That night started having a severe cough and chest hurting. Continued to get worse went to doctor on 9/17. Doctor stated had an upper respiratory infection that traveled down into right lung. Received a shot and prescription for antibiotics and steroids.
Rectal bleeding x 1 episode after both doses of Gardasil ( 2-14-2008 and 04-17-2008)
Heartburn; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced DYSPEPSIA (Heartburn). At the time of the report, DYSPEPSIA (Heartburn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
c/o blurry vision like a film on eyes;n/v, fever, pain & edema @ rt deltoid inj site;
Fever all night, up to 104.7 Axillary, decreased activity level, cranky but consolable.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA001261: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA00126.
Started with a headache then Nassau and throwing up.   Also have the shakes after throwing up.   Low grade fever.
A non-serious spontaneous report of administration of H1N1 vaccine to an over 50-year-old was received from a registered nurse concerning a patient over 50-years-old (age and gender not provided). Neither relevant medical history nor concomitant medications have been reported for this patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.
Pt has limited mobility of her right arm. She cannot move it fully forward, up, or backward. Pt has pain with movement. Can't lift things w/her right arm.
Nurse had the same symptoms but her symptoms were even worse. She had some numbness in the face and the extremities and her symptoms lasted longer and then subsided next day according to the nurse; This is a spontaneous report from a contactable physician. A patient (ICU nurse) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that the nurse had some numbness in the face and the extremities and her symptoms lasted longer and then subsided next day according to the nurse who administered the vaccine to the reporter but again, the reporter didn't know if even those guys were reporting this or not. The outcome of the event was unknown.   Information about lot/batch number has been requested.
8/16, EE called to EHS that Sx, chills, runny nose, fever and bodyache since 8/11. Son was pos last wk. The last day worked was 7/12. EE was tested. Fully vaccinated.
Local redness about 9cm x 9cm circular on injection site. Better than it was yesterday.
pt developed shingles outbreak shortly after receiving vaccine - had R shoulder/chest soreness within 1-2 days of vaccine, then developed rash on R arm.
Red patch on left arm, about 4 inches in diameter. Warm to the touch and sore. Has lasted 3 days so far since injection.
reaction started with swollen and red area around the injection, became hot to touch and then got other red welts resembling hives down right arm, right armpit, on to chest , abdomen and face. Took Benadryl immediately 50mg, which I then repeated in 4 hours. Reaction calmed and welts remained present on upper right arm, took benadryl orally and topically in the area for several days to follow.  Have had similar reactions in the past. Red welt that surrounded injection site subsided 8 days following the injection.
After my son received his 2nd Dose of the Pfizer on the scheduled date at approx.10:45 am, we went home and were just relaxing and at approx 1:54 pm.  My son in a panic yelled for me to come into the bathroom and he showed me his urine and it was bright red with clots (Gross Hematuria).  I know the time because as soon as I saw it I took a picture (of which I still have on my phone).  I proceeded to access how he was feeling and after he said he felt okay just scared-no pain or anything, I called his Pediatrician whose office instructed me to take him to the ER and that is what I did.  He was not rough housing, there was no trauma  and again no pain.  This has never happened before.
Dose was given after expiration date; Vial refrigerated on 18-Oct-2021 after expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 18-Oct-2021 after expiry) in a 29-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 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 18-Oct-2021 after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 18-Oct-2021 after expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No temperature excursion happened after vial was placed in refrigerator on 18-Oct-2021.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter. No adverse event was reported.
The person in charge of completing the demographic information of the patient before the administration of the vaccine forgot to record the age of the patient and the nurse administered the dose and when she went to complete the vaccination card she realized that the age was not set and when she verifies the The patient is 15 years old and the third dose was administered, which is not authorized in children under 18 years of age. Mother and patient were instructed to wait 30 minutes to observe and identify reactions, at the moment there were no reactions or adverse effects
Patient received the Pfizer Vaccine around 4:00 PM.  Patient  proceeded to sit at the observation area for monitoring then patient flagged down staff with c/o dizziness, blurred vision, hearing loss, slight pallor noted.  Patient was noted sitting at the observation area with LVN next to her side. Patient was offered to lay down. Ice pack was placed on the back of patients neck,  patient ate a candy bar, Nurse encouraged fluids. VS were taken and noted to be stable. Patient was monitored for 30 mins before departure. Patient stated having needle anxiety in the past.   Nurse instructed patient and patient mother on  signs, Symptoms of Severe Adverse Reactions to report to health care provider or to go to the emergency room. Patient/Family verbalized understanding.
This is a spontaneous report from a contactable consumer. A female patient of unknown age received PREVNAR 13, single dose intramuscular on unknown date. Relevant medical history included a slight episode of pneumonia 2 weeks before this report and received a 5 days course of antibiotics, unspecified, and the pneumonia resolved. The patient reported that she experienced a slight headache when she woke up in the morning after the vaccine. Follow-up (03Mar2015): New information received from a contactable consumer includes: patient's and physician details.
August 8, 2021 I had a single sting by a yellow jacket on my right lateral calf. I only had some localized itching and irritation at this sting site. I have no past allergies to insect envenomation.  Within about and hour of the insect sting my left upper arm along the biceps region became hot, tender and developed a very focal petechial  (not vesicular) rash. My arm ached as it did after getting my first and second vaccines and then for about 48 hours I had systemic aches, chills and moderate to severe generalized joint pain. I did not run a fever nor did I have any airway issues or GI symptoms. The petechial rash on my left upper arm has taken several days to subside--it is still present but far less pronounced than it was for the first 48 hours.  I cannot recall if I got one or both doses of the Moderna in my left arm--I know I had at least one of the series in the left biceps because my arm was incredibly sore afterwards. I listed Lot number for the first vaccine above (I had it on December 30, 2020). The Lot number for the second vaccine was 030L20A and I had it on February 1, 2021.
early administration of MENQUADFI booster dose with no reported AE; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 years old male patient who had early administration of menquadfi booster dose with no reported adverse event , while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 09-Aug-2022, the patient received a 2nd dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE( lot U7299AA and expiration date: 01-Aug-2024) at an unknown dose (total) via intramuscular route in the deltoid nos for immunization.  On 09-Aug-2022 (latency: same day), the patient developed a non-serious event of early administration of menquadfi booster dose with no reported adverse event (inappropriate schedule of product administration) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was reported "the patient first received their dose of MENACTRA at 8 years old due to high risk travel and is now 14 years old and was asking if they were to give the second dose (MENQUADFI) today would that complete the series or will the patient receive a booster shot when the child turns 16 years old. They were informed that the primary dose was valid and that the 2nd dose given was actually considered as too early as per agency."  Action taken :not applicable  It was not reported if the patient received a corrective treatment for the event .  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01228446: