chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 09Jan2023 and vaccine was administered on 10Apr2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jan2023 and vaccine was administered on 10Apr2023) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jan2023 and vaccine was administered on 10Apr2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jan2023 and vaccine was administered on 10Apr2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jan2023 and vaccine was administered on 10Apr2023).    The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  The vial was initially stored in the refrigerator on 09-Jan-2023. BUD date was 09-Feb-2023. The vial did not undergone any temperature excursions. No adverse events reported from the patient.  No treatment medications was reported.
No additional adverse events reported; the patient was administered an improperly stored dose of MMR II; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 16-JAN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) 1 dose, lot # R030813, expiration date 24-OCT-2020 (dose number and route of administration were not provided) for prophylaxis. Sterile diluent used to reconstitute vaccine was properly stored.  The temperature excursion was above 47 degrees Fahrenheit (F) (74 F) for 13 hours. There were no previous excursions reported. The digital data logger was involved. No additional adverse events were reported.
Shot at 12:30 6 pm - Fast heartrate 8 pm - vomiting and felt bad (possibly fever) took 24 hours to feel normal again.
Bones hurt, fever, chills, weak, headache forming. 4/10 ~5 AM PST  Lymph node in neck swollen after 1st shot
Local reaction at injection site right thigh - warm, red & swollen Rx'd with MOTRIN & warm packs.  resolving 4/23/09
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis (Infusion for osteoporosis (1 per year)). Concomitant products included VITAMIN D NOS and CALCIUM for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VERTIGO (Vertigo). The patient was treated with Physical therapy for Vertigo. At the time of the report, VERTIGO (Vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Onset 12/13/99, body aches, headache "all over", fever 100 - 102, pains upper chest, sore throat, cough with phlegn (color?), decreased appetite.
pretty sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (On an unknown date the patient received 1st dose of shingles vaccine refer case US2022AMR142039).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR142039   Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comments:  This case was received from Consumer via interactive digital media. The reporter stated that a shot was little bit of a rough shot, but way better than getting Shingles. The patient did not get covid or flu shots of course they would vary from person to person. The patient was pretty sick after both shots, but from he/she heard, getting shingles was considerable worse and recommended getting the shots. Additional supportive information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR142039:Same reporter
Terrible stomach ache; Flu-like symptoms; He's been in bed all day; Aches; Diarrhea; Vomiting; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Terrible stomach ache), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (He's been in bed all day), PAIN (Aches) and DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Terrible stomach ache), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ASTHENIA (He's been in bed all day). 31-Mar-2021, the patient experienced PAIN (Aches), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and CHILLS (Chills). At the time of the report, ABDOMINAL PAIN UPPER (Terrible stomach ache), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (He's been in bed all day), PAIN (Aches), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
A couple of hours after getting the Booster shot, she felt sick like with a minor hangover; A couple of hours after getting the Booster shot, she felt sick like with a minor hangover; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover) and HANGOVER (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 001B21A and 016E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced MALAISE (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover) and HANGOVER (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover). On 09-Dec-2021, MALAISE (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover) and HANGOVER (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover) had resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
1 week after my 2nd dose, I had an overwhelming fatigue, body aches, it was very unusual for me that's why I decided to report. I drank lots of fluids to recover along with bed rest. After 24 hours the symptoms subsided and I was feeling normal and fine again.
initial presentation of tachycardia, sweating and feeling unwell  Took patient to monitoring room and her symptoms worsened after ~20 minutes. Progressed to shaking, throat getting tight (per patient) nauseous, swelling of face, flushed and said feeling cold   Gave 25mg of benadryl but after symptoms progressed, gave epinephrine 0.3mg IM STAT
Received DTAP on 9/26/00 in right thigh in the afternoon around 11:30-12:30. Went to daycare on 9/27/00. Came home from daycare on 9/27/00 around 15:30 and grandmother noticed a whelp on both sides of face, legs and arm. Went to ER at 18:30 and was given Benadryl. The doctor told the grandmother to notify health dept regarding vaccine. Grandmother reports increased temperature last night. Pt was given Motrin. There was still a small whelp area on right side of face. On 10/10/00, spoke with parent and pt is fine now.
75yo male developed Bell's possibly, possibly associated with administration of COVID-19 vaccine (Pfizer). Pt received dose #1 on 3/20/21 at local  clinic. On 4/7, pt developed R-sided facial droop and eye weakness, prompting visit to ED and short one-night admission (Neurology service) at hospital. Hx of subdural hematoma in Sept 2020 in the setting of COVID. Imaging with probable small vessel disease but no acute infarct. Discharged on 7-day course of prednisone. Spoke to patient on 4/12. He received does #2 on 4/10 (external location) and tolerated well without any change in sx.
20 min post vaccine, pt c/o headache; mild stom pain. C/O nausea later in evening. Vomited x 2 that night. C/O stom pain next day. Afeb. Headache gone next day. Pt seen by Dr. 9/1/11, stable condition.
Severe headaches that Tylenol did not help with the pain. Chills. Arm soreness
Patient received MMR injection left deltoid on 8/14/2009. States she developed a rash starting at the injection site which was covered by a band aid. She has an allergy to adhesive. The band aid used is latex free. She is not on any medications. No food allergies. No new cosmetics or lotions/soaps. The rash has spread to involve her arms, legs and trunk. Rash is fine grain and pruritic. Heart NSR Lungs Clear. No difficulty breathing. No facial swelling or erythema. Has a fine grain erythematous rash on her arms, legs chest, abdomen and back.
Swelling, pain, headache, nausea, hot to touch, redness, vision troubles, shaky, difficulty breathing.
See VAERS on brother completed same day as this report.  08/11/2008, fever 101 degrees F late afternoon, apparently coughing & gagging. To take to pediatrician this A.M.- with brother. Mom started this A.M. with abd cramping
This serious spontaneous case, initially received from physician on 30-Oct-2018, concerns a male patient of unspecified age. On an unspecified date, the patient received FLUCELVAX QIVc [dose, batch number, expiry date, route of administration and anatomical location: not reported]. On an unspecified date after vaccination, the patient developed flu. The patient claimed that, the vaccine gave him flu (coded as lack of drug effect). This case was considered as lost to follow up, since the reported had not given the consent to follow up.
It started within a few days, it was a severe relapse of my chronic fatigue. I barely could make it to the couch to watch TV.  This lasted for a whole month. I was not able to function, manage my food preparation.
On 4-29-2021 Patient reported to me that she has been feeling very dizzy since her COVID shot given at our pharmacy on 4-16-2021. The dizziness started 1 day after her shot and is at the point of affecting her daily life. She waited for the effects to improve, however she has remained dizzy. I urged her to contact her provider. On 4-30-2021 Patient was seen by her provider and given a prescription for meclizine 25mg. She was advised to not receive the second COVID shot.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided and concomitant drugs are provided.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 04-May-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-102237 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Several hours after the vaccine the left arm began to swell from the elbow to the shoulder. There was pain and redness in the swelling area. The swelling and redness resolved over the next few days and was completely resolved by 10/25/2017. Did not experience any nausea, vomiting, or shortness of breath.
This spontaneous report was received from a physician via a company representative and refers to a 14 year old female patient. The patient did not have any relevant medical history or drug reactions/allergy. There were no concomitant medications. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 and at the end of August 2016, the patient received the second dose of the vaccine (dose, frequency route, lot # and expiration date were not reported) for prevention of human papillomavirus (prophylaxis). Approximately in September 2016 (reported as three weeks after administration of the second dose of the vaccine), the patient had a psychotic episode and on an unknown date, some unspecified blood tests revealed possible Lupus. Therefore, the patient had been hospitalized (reported as she was in and out of the hospital) and was scheduled for another hospital visit on approximately 15-FEB-2017 (reported as next week) to confirm her diagnosis. The patient had been in contact with her pediatrician as well as with other several specialists. At the reporting time, the patient had not recovered from the events psychotic disorder and systemic lupus erythematosus. The causality between the aforementioned events and GARDASIL 9 was not provided. Additional information has been requested.
PATIENT FAINTED A FEW MINUTES AFTER RECEIVING THE SHOT AND WOKE UP AFTER A FEW SECONDS. WE LET THE PATIENT LIE DOWN AND ELEVATED HIS LEGS. WE ALSO ASKED PATIENT TO STAY FOR 30 MINUTES FOR OBSERVATION.
I got my vaccine in my left arm. Approx. 2 days later, I couldn't lift my arm and that continued for a week or so. I went to my chiropractor thinking she could adjust my arm. She could feel all my lymph nodes on my left side were inflamed. I went back to her probably 3 times for that. I also spoke to my PCP about it. I was in touch with him but never saw him. I talked to him over the phone and via email. It lasted for approximately 3 weeks, and he didn't want me to get the 2nd vaccine unless it subsided. At week 4, it subsided, and I got my 2nd vaccine. Also, during this time, my left breast was also swollen, and I was supposed to get a mammogram, but I was advised by PCP to wait on that. Couldn't lift my arm during this time and felt like my arm would fall off. Again, that lasted for maybe 3 1/2 weeks but then I was fine. I got my 2nd vaccine and that one was actually fine. On 03/11/2021 I texted my PCP: pain radiates in shoulder and down to fingers, tingling in tongue, pain in neck. On 04/06/2021 I texted my PCP: let my PCP know about my 2nd vaccine and that everything was fine. On 08/2021 I had mammogram (was fine, but still had discomfort in the left breast), told me to get an ultrasound and that came back okay as well. My left arm will still bother me every now and then.
headache; leg cramps; shivering; dry cough; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022 15:00, the patient received the 1st dose of Shingrix (intramuscular). In April 2022, 10 hrs after receiving Shingrix, the patient experienced headache, leg cramps, shivering and dry cough. On an unknown date, the outcome of the headache, leg cramps and shivering were not recovered/not resolved and the outcome of the dry cough was recovered/resolved.   It was unknown if the reporter considered the headache, leg cramps, shivering and dry cough to be related to Shingrix.  Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment: The case was reported by the patient.  The patient received Shingrix in the left arm. On 27th April 2022 at about 1 am, he started to get a headache, legs cramps, shivering and a dry cough.  The reporter reported that when he awoke, he still had all the symptoms except the dry cough, which had resolved.  The reporter believed that the dry cough might be related to the pollen in the air. The reporter did not consent to follow-up.
Patient had received Pfizer (Lot# EN6201,  )at another location on 2/20/2021. Patient did not disclose her prior dose and indicated the Moderna was her first dose.
Fever, body aches, chills, tremors, increased heart rate, nausea, wheezing, tightness in chest.
Very sore arm leading up to the shoulder,  body aches especially neck area,  chills, tiredness.
ADMINISTRATION OF VACCINE FOR MORE THAN 6 HOURS AFTER THE FIRST VIAL PUNCTURE (VIALS STORED IN THE FRIDGE AFTER PUNCTURE) (OUT OF SPECIFICATION PRODUCT USE); INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1855835 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of vaccine for more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use), and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine for more than 6 hours after the first vial puncture (vials stored in the fridge after puncture) (out of specification product use) and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220527916, 20220528196, 20220528178 and 20220528115.
Patient presented to the ED and was subsequently hospitalized for rhinovirus infection, severe aortic insufficiency, elevated troponin within 6 weeks of receiving covid vaccination.
pt recv vax 14FEB96 & 48hrs later started itching w/visible urticaria & gen swelling;took DPH;saw MD on 20FEB96 dx w/urticaria r/o allergic rxn to vax;given Periactin
26 yowm presented 7 days post SPV with ant chest pain, worse w/ each heart beat, improved leaning forward, worse leaning backward, worse with deep breathing.  Denies SOB. States started 3days prior, seen in ER w/ non-specific ST elevation.  Pt returned w/ worsening chest pain & found to have pan ST elevation with PR shortening.  CPK elevated 1461, MB>80, Troponin 23.5.  Pt transferred to 121 for admission, monitoring & cardiac echo.
Extreme itchy arm, huge red spot at injection site, hard, hot, painful to the touch
My kids have been sick for 10 days now so I got RSV from them. Its basically respiratory, lots of phlegm, loosing my voice, coughing and fevers. I was given a zpack and I've completed it.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 09:00 as dose 1, single (Lot number: EN5318), in left arm and on 25Feb2021 at 08:00 as dose 2, single (Lot number: ENG200) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 at 17:00 as dose 3 (booster), single (Lot number: 012H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 27Apr2022, stop date: 03May2022; BENZONATATE, start date: 29Apr2022, stop date: 03May2022; ESTRADIOL vaginal, start date: May2021; ESTRADIOL, start date: Aug2013; SYNTHROID, start date: Jan2012. Past drug history included: Sulfamethoxazole, reaction(s): "known allergies"; Trimethoprim, reaction(s): "known allergies: Trimethoprim". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19. Patient received other medication in 2weeks. Anti viral details: product: COVID 19 treatment, brand: Paxlovid, treatment start date: 29Apr2022, treatment stop date: 03May2022, lot number: FY5656, indication: Treatment of COVID-19.
duplicate vaccine. First dose given 3-3-22. Second dose 3-25-22 Dr office notified. Patient aware, Followed up with clinical services.