chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a 74 year old female patient reporting on herself. The patient's concurrent conditions included penicillin allergy, none pertinent medical history were reported. In April 2011 (reported as "5 years ago"), the patient was vaccinated with ZOSTAVAX 19400 (plaque forming units), (lot #, expiry date, strength and route of administration were not provided), 0.65 ml "one shot in her left arm" for shingles prevention. None concomitant medication were reported. on 25-APR-2016 (reported as yesterday), the patient noticed that there was a sore tender area developing on her left breast and on 26-APR-2016 (reported as today), there was an area that appeared "red, bumpy and it was blister looking", which run from the side of the patient's left breast up to under her arm. Additionally, the patient also mentioned she was experiencing pain around the same area and she though it might was shingles. Subsequently, she purchased from her local pharmacy an Aloe spray mist called "cool blue" and a topical ointment called "burn gel" to treat her affected area. The patient sought medical attention and stated that the nurse practitioner prescribed her Acyclovir 800mg to take as well to help treat her shingles. None lab diagnostics studies were performed. At the reporting time, the patient did not recover from shingles. The causal assessment between shingles to ZOSTAVAX was not reported. Additional information has been requested.
Per patient description: "At 04:30 am I woke up and couldn't open my eyes and face and my eyes were swollen.  Applied cold compress.  At 6:30am the swelling was going down, eyes were still puffy and I was congested. Presently at 10:00 am I am still fatigued, my eyes are glassy but not swollen, my throat is sore and I'm congested".
06/18/21 Felt very tiered. 06/19/21 Got chills and nauseous, laid down on sofa w thick blanket for 2 hours. After chills my body started developing small itchy hives. Drank allergy pill at 12am cuz the hives were getting worst. 6/20/21 Still with itchy hives all over body, placed baking soda were the itch was to calm it down but no success. 6/23/21 Went to doctor and was prescribed Methylprednisolone 4mg #21, today was my last pill and the itch and hives are uncontrolable. On 6/27/21 started spraying SkinSmart Antimicrobial Eczema Therapy Skin Cleanser Spray which help a little to control the itch but not totally.  My body looks like I had a bad burn on all my body folds and some scatter spots with hives and others with vesicles.
I developed scratchy throat, fatigue, flu-like symptoms w/ diarrhea on 10/25 and later worsened to 102° Fever and moderate wheezing with headache. PCR CoVid test was done the day of on the 25th and found I had CoVid on the 26th. Telehealth on 10/28 and went to visit to get antibodies and took until 10/30 for the infusion. Diarrhea and fever completely gone in 24hrs and much less severe and often shortness of breath. Remaking symptoms only 3 more weeks and was recovered. Lingering mild headaches and slight fatigue was all that I experienced. No other tests done and sickness course lasted until late November.
HEART PALPITATIONS LASTING 1 TO 2 SECONDS WHICH OCCURRED AS MUCH AS 10 TO 20 TIMES A DAY OR MORE FREQUENT OR NOT AT ALL IN SOME DAYS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient never had consistent heart palpitations in the past. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-APR-2021, the subject experienced heart palpitations lasting 1 to 2 seconds which occurred as much as 10 to 20 times a day or more frequent or not at all in some days. Laboratory data (dates unspecified) included: Oxygenation index (NR: not provided) oxygenation normal via pulse oximeter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitations lasting 1 to 2 seconds which occurred as much as 10 to 20 times a day or more frequent or not at all in some days. This report was non-serious.
This spontaneous report as received from a medical assistant who refers to a 8 month old female patient. On an unknown date, the patient was vaccinated with ROTATEQ (dose 3, frequency: two months intervals, orally). On an unknown date also reported as one week post vaccination after her third dose of ROTATEQ, the patient experienced one week of yellow stool. The patient did not experienced any vomiting, or fever. No treatment was given for adverse event. The patient did not seek medical attention. The outcome of yellow stool was reported as recovered/resolved. Relatedness between yellow stool and ROTATEQ was not reported. Additional information is not expected, as the reporter refused additional contact.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 19-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment information was provided.
On Wed Dec 5, 2012 I took my daughter to pharmacy to get a flu vaccine at 3:30 pm. The next morning at school her chest started hurting & it got worse throughout the day. The same thing happened the next day. The pain was worse with activity especially at dance class. We went to several Drs. The cardiologist diagnosed pericarditis. Treatment is rest, no activity and taking anti-inflammatory medicines (NAPROSYN & MOTRIN).
After Shingrix vaccination developed a low grade fever (100.4 degree Fahrenheit). Had chills the evening after the injection.
Pfizer Covid 5-11yr vial was not diluted prior to staff member withdrawing dose and administering to patient.
This spontaneous report as received from an office manager (medical assistant) refers to unknown number of patients. On unknown dates the patient might have received improperly stored RECOMBIVAX HB. The vaccine was exposed to temperature of 32F for 32 minutes on 02-DEC-2013, then 32F for 24 minutes on 03-DEC-2013, then on the same day 03-DEC-2013 at 31F for 8 minutes, then 33F for 19 minutes on 04-DEC-2013, then 33F for 34 minutes on 17-DEC-2013. No adverse effects reported. This is one of four reports received from the same reporter. Additional information has been requested.
2nd dose not yet received/The pharmacist stated that since it is past 42 days period; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not yet received/The pharmacist stated that since it is past 42 days period) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-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 PRODUCT DOSE OMISSION ISSUE (2nd dose not yet received/The pharmacist stated that since it is past 42 days period). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not yet received/The pharmacist stated that since it is past 42 days period) 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.   Reporter stated that the patient was going to receive 2nd dose on 30 JUL 2021.  No relevant concomitant medications were reported. No treatment information was provided.
Sore throat, facial pain, clogged sinus, coughing phylem yellow and nose, teeth hurt, sneezing, lower back pain.
Fever - 101.75 - 102 for 3 Days, Chills, Loss Of Appetite, Chronic Cough, Joint Pain, Muscle Aches, Loss of Sleep, Lethargic.
9/12/21 G2P1001 at 41w1d by 9wks ultrasound.  Presents for Induction of Labor - Late Term
got the vaccine; I have had it twice/ it's a virus at the nerve endings; horrible pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the vaccine) (serious criteria GSK medically significant), shingles (Verbatim: I have had it twice/ it's a virus at the nerve endings) and pain (Verbatim: horrible pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-Mar-2023 The patient had it twice and got the vaccine. It was most horrible pain and it was a virus at the nerve endings.  The follow-up would not possible as no contact details were available This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. It was unknown whether patient was experienced shingles before vaccination or after vaccination. Therefore, shingles event captured conservatively.
Patient complained of ringing in both of her ears within a minute or two of receiving the vaccine. It lasted several hours.
Injection site slightly swollen, red, itchy.  Redness in a circle about 3" diameter.
Had 5th dose later in evening told mom that knee & foot of one leg hurt & also had a stomach ache; did not mention anything p/other doses;
9hr p/vax pt devel twitching & soreness in throat, h/a & gen malaise;w/in 2 days extreme congestion, fever, body aches & disoriented 'mortality dream images' occurred;congestion in lungs cont until 1DEC97;
Pt. began to see red bumps on his chest in a V-shape about 10 days after vaccination.  Member reported to clinic on day 11 with bumps on his back and arms as well.  No discharge, fever, or itching.  Reaction prevented member from deploying the next day.
cold; sniffing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "cold"; RHINORRHOEA (non-serious), outcome "not recovered", described as "sniffing".  Additional information: It was reported that the patient was still sniffing due to the cold that she got over the weekend. The patient was querying on until when she can take the vaccine since there was a scheduled snow for tomorrow and she might not get it tomorrow.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Facial numbness and lump felt in throat , severe selling/ knot at injection site ( right deltoid)
Headache, Sedation, Myalgia, NauseaVomiting, Chills Narrative:
Father reported fever of 101.1 which responded to TYLENOL, swelling of tongue & face a few hours after injections, pt is also on apnea monitor at home and stated had 2 episodes of >20 seconds, parents took to ER, observed for 1 hour with no treatments.
2 month old patient incorrectly given influenza vaccine.  Patient should not have received this vaccine until 6 months old.
Patient returned to clinic on 10/27/11 c/o redness et hot to touch - has applied cold compress - redden area continued to get larger.
Woke up with sore throat and pain and stiffness in back of neck in which she could not turn head to side positions or extend backwards. She developed an enlarged lymph node on lateral-posterior region of right neck that was painful to touch. Severe headaches not relieved by Tylenol, chills, fever peaking at 102.8 and only brought down with Tylenol which within 2 hours fever went back up. Seen by doctor 2 times within 3 days.
BUD of Moderna vial was 11/5/2022, used on 11/7/22
Non-indurated erythema eruption with some rippling of the surface with true classic dew drops on a rose petal in somewhat of an irregular area about 2 x 2 1/2cm on right lateral thigh.  Patient afebrile, LSC (Rash on injection site or varicella injection).
5-10 min after administration pt. passed out in waiting room, became unresponsive, then began shaking (almost seizure like) by time I got to him he began to regain consciousness and was talking to us. His BP was 138/78 and P 72. 911 was called. He was complaining about being hot and nauseated. He vomited while EMT was here. Pt. transported to hospital.
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Later that day on the 4th, R leg started to swell at injection site and by the 7th it was 4cm and sticking up 0.5-1cm in height. On the 13th the swelling in leg was down to the size of a mosquito bite. Then on the 11th she developed a rash on L thigh measuring 1.5cm. Mom states she is always cranky and needy after immunizations, for about 5 days. This is the first time that she has had reactions at the injection sites.
Patient called hospital call center. Pt stated pt got 2nd covid vaccine Pfizer yesterday at her local pharmacy. Pt said pt feels left throat swelling, left eye and left collar bone swelling and pain(socre 7/10) when pt touches on left collar bone swelling area, body aches and sinus headache.  Pt advised by to go to ED
not feeling good; Can't sleep; A little achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 24Mar2021 10:30 (Lot number: EP6955) at the age of 73 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Left arm, Administration time: approximately 10:30), administration date: 03Mar2021, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset 25Mar2021, outcome "recovering", described as "not feeling good"; INSOMNIA (non-serious) with onset 25Mar2021, outcome "recovering", described as "Can't sleep"; PAIN (non-serious) with onset 25Mar2021, outcome "recovering", described as "A little achy".  No follow-up attempts are possible. No further information is expected.
Patient received MCV4 vaccine and PPD, while checking out of the office patient had a syncope event. 911 was called and patient was taken to the hospital by ambulance.
woke up disorientated and confused on 01/25 at 3 am and she is still in the ER in ICU and does not recognize anyone, she is very strong an d trying to leave hospital and pulling out IV's and catheters
pt felt uncleared phlegm and funny feeling swallowing after vaccine. denied difficulty breathing. Given Benadryl, recovered, sent home
Pt. awoke at 2am on 4/24/14 secondary (L) deltoid pain - had area of redness and swelling x 3-4" at site of PNEUMOVAX injection. Pt. reported local reaction only. Used ice packs and ALEVE x 2d. sx resolved completely by day 4-5.
Red rash grew at injection site and very itchy. Did not experience at dose 1or2.
within 10 minutes of receiving  2nd COVID vaccination patient and a metallic taste in mouth and lips and the tip of tongue began to tingle.  Gave a 50mg dose of benadryl  and patient was observed for 30 minutes and called for a person to pick her up and symptoms were subsiding. Called patient later and she relayed that she was better and symptoms took about 1 hour to 2 hours to go away.. and her arm was sore at the time of our contact.
Baby stopped making eye contact soon after receiving the shot and was unable to make eye contact for a full three days after the vaccination.
Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Additional Details: Pt states that has been itching on entire right side ever since getting the vaccine.  She has been to md and gotten creams but nothing has worked.  Wants to what kind of poison we gave her and wants to know all the ingredients.  Wants to know why this is happening to her and just wants to stop itching
stroke; dermatitis; eczema; This spontaneous report as received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 23-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).         On an unknown date, the patient experienced dermatitis, eczema and cerebrovascular accident.  The patient's symptoms had resulted in physical limitations, also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries, he or she also suffered serious, progressive, permanent and incurable injuries.   The outcome of cerebrovascular accident, eczema and dermatitis was unknown.     The reporter considered cerebrovascular accident, eczema and dermatitis to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of stroke was considered medically significant.
Red rash around the area of the site starting the morning of Feb. 14, 2021. Still continuing today on the 15th.                                                                Area is approximately 4 inches by 1 & 1/2 and itches.
None. Gave expired covid 19 vaccines. expired 10/25/2022. given 1/12/2023
Information has been received from a medical assistant who reported that on unknown dates, multiple unspecified patients were administered the following improperly stored vaccines: VAQTA (lot #N005605,  expiration date 08-APR-2018); ROTATEQ (lot #M041184, expiration date 31-MAY-2018 and lot #M042171, expiration date 07-JUN-2018); RECOMBIVAX HB, (lot #M041384, expiration date 07-JUL-2019; lot #L045117, expiration date 06-OCT-2018; and lot #M010212, expiration date 21-JAN-2019); GARDASIL 9 (lot #L043213, expiration date 28-AUG-2017; lot #M009378, expiration date 23-APR-2018; lot #M024261, expiration date 30-JUL-2018; lot #M032650, expiration date 31-MAR-2019; lot #M042853, expiration date 17-JUL-2019; and lot #M043731, expiration date 22-JUN-2019); M-M-R II (lot #M016234, expiration date 31-MAR-2018; lot #M034387, expiration date 19-JUL-2018; lot #M036543, expiration date 15-AUG-2018; lot #M039913, expiration date 26-SEP-2018; and lot #M042846, expiration date 21-OCT-2018); PNEUMOVAX23 syringe (lot #M032635, expiration date 05-MAY-2018); PROQUAD (lot # N000336, expiration date 03-JUL-2018); VARIVAX (lot #M033211, expiration date 13-JUL-2018; lot #M045205, expiration date 11-NOV-2018; lot #M049126, expiration date 15-DEC-2018; and lot #N014366, expiration date 09-MAY-2019); ZOSTAVAX (lot #M041511, expiration date 08-JAN-2018); and PEDVAXHIB (lot #M034189, expiration date 23-MAY-2019; and lot #M046140, expiration date 27-SEP-2019) (dosages and routes of administration not provided), which had been reconstituted with properly stored sterile diluent. No adverse effects were reported. Temperature and time frame: 47°F to 77°F, 21 minutes; 6°F to 14°F, 42 minutes. Previous temperature excursion: No. Data logger involved: Yes. No additional information provided. Additional information has been requested.
Patient had already been observed for 15 minutes and left the facility. Patient stated while on her way home her and her husband were discussing side effects when she started to feel SOB, dizziness, and slight chest pain so they returned to the clinic. Full set of vitals was taken. Doctor evaluated patient. Patient started feeling better after drinking some water. Second set of vitals taken and patient discharged to go home with husband 1215pm.
Received Pediarix, HIb, Prevnar at 12:00 on 02/15/2005. Cried from 12:oo noon to 10:00 pm on that date, only napped for 10 minutes and refused to eat.
Myalgia, Fever, Malaise, No appetite. Narrative:  Other Relevant History:
Patient developed vomiting in the morning.  Had one episode and was sent to daycare where she developed a fever and had a second episode of vomiting.