chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered Punctured Vial Beyond 6 hours; A spontaneous report was received from a pharmacist concerning a 60 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced administration from a punctured vial beyond 6 hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 31 Dec 2020 for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient received the Moderna COVID-19 vaccine in the unknown arm on 31 Dec 2020 from a vial that was used beyond the 6 hour limit. The vial was first punctured on 30 Dec 2020.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, experienced administered punctured vial beyond 6 hours, was considered resolved on 31 Dec 2020.  The reporter did not provide an assessment of the event, out of specification product use.; Reporter's Comments: This case concerns a 60 year old female subject who experienced a nonserious unexpected event of out of specification product use.  There were no reported AEs associated with this case of out of specification product use.
Patient states the night of the first vaccine she noticed hives on bilateral forearms. She also mentioned she takes medication for her blood pressure and was unsure if the combination of the medication and the vaccine caused the reaction. She took Benadryl and the hives subsided and she has not had an issue since.
I (patient) experienced mild to moderate vertigo starting around 9pm that did not resolve after food and water intake. The vertigo was not exacerbated or improved by a particular movement or position. The vertigo continued for 3h, and resolved 1h after I took meclizine 25mg p.o . The vertigo resolved with meclizine but my balance was altered,  but without impairment, until around noon the following day.
HPI    This is a 19-year-old male that presents for complaint of witnessed seizure-like activity. He arrives by EMS. Patient is currently awake alert and oriented ×3. Today, he was out on the golf course with friends. It was a normal day and he returned home. When he got home, he was complaining of a headache to his mother. She gave him Motrin. Mother then heard a noise from the other room and found the patient on the floor unresponsive, displaying tonic-clonic activity, and eye rolling into the back of the head. This lasted for 4-5 minutes per mother. EMS arrived on scene he was postictal. Patient is never had this happen before. He denies any illicit substance, alcohol or medication use.     Review of Systems  Constitutional: Negative for chills, fatigue and fever.  HENT: Negative for facial swelling and trouble swallowing.   Respiratory: Negative for cough, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria and frequency.  Musculoskeletal: Negative for back pain and neck pain.  Skin: Negative for rash and wound.  Neurological: Positive for seizures and syncope. Negative for weakness, light-headedness and headaches.  Psychiatric/Behavioral: Negative for confusion. The patient is not nervous/anxious.
rash; Hives with bumps fill with fluids in his chest; sore arm (Covid arm); This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm left on 12Feb2021 10:00 (at the age of 43-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient's medical history and concomitant medications were not reported. On 22Feb2021, the patient experienced rash, hives with bumps fill with fluids in his chest, and sore arm (Covid arm). No treatment was received for the reported events. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained
Swollen neck and tender; swollen neck and tender; Llittle bump in between collar bone around throat area(about an inch long); Feels like shes trying to catch her breath; Rash on the shoulder and underneath the right breast and lower back (about10 inches long); Swollen around lymph nodes; muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen neck and tender), TENDERNESS (swollen neck and tender), NODULE (Llittle bump in between collar bone around throat area(about an inch long)), DYSPNOEA (Feels like shes trying to catch her breath) and RASH (Rash on the shoulder and underneath the right breast and lower back (about10 inches long)) in a 54-year-old female patient 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swollen neck and tender), TENDERNESS (swollen neck and tender), NODULE (Llittle bump in between collar bone around throat area(about an inch long)), DYSPNOEA (Feels like shes trying to catch her breath), RASH (Rash on the shoulder and underneath the right breast and lower back (about10 inches long)), LYMPHADENOPATHY (Swollen around lymph nodes), MYALGIA (muscle pain) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (Swollen neck and tender), TENDERNESS (swollen neck and tender), NODULE (Llittle bump in between collar bone around throat area(about an inch long)), DYSPNOEA (Feels like shes trying to catch her breath), RASH (Rash on the shoulder and underneath the right breast and lower back (about10 inches long)), LYMPHADENOPATHY (Swollen around lymph nodes), MYALGIA (muscle pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-176365 (Patient Link).
redness on the injection site; pain on the injection site; This is a spontaneous report from a contactable consumer (patient). An 84-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on 24Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of the Pfizer Covid vaccine last Sunday (24Jan2021) and started to experience pain and redness on the injection site on 25Jan2021. On the day of the report (26Jan2021), the pain was completely gone but the redness is still there. The patient wanted to know if this is normal or if he should be concerned about this. The event redness at the injection site had not resolved while the pain on the injection site resolved on 26Jan2021.   Information on the batch/lot number has been requested.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unspecified demographics. Approximately on an unknown date in 2013 (reported as between 18-FEB-2013 and 11-JUN-2013), an unknown number of patients might have received dose of GARDASIL (dose, lot number and expiry date was unspecified) that had been improperly stored. Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of patients might have received improperly stored GARDASIL was unknown. No further information was provided. This is one of the several reports from the same source. Additional information has been requested.
WORSENING MULTIPLE SCLEROSIS; MIGRAINE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis, interstitial cystitis, and prior migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 15-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, the patient started to experience migraine every day except for two days since the day of vaccination. It was reported that the patient used to have migraines before vaccination but the ones after vaccination were different and they would hurt a lot more than before and the patient had experienced vision going funny with migraines and had sickness to stomach from migraine. The patient was treated with steroids (unspecified) by the neurologist which did not help. On 16-JUN-2021, the patient experienced worsening multiple sclerosis and loss of strength in arms. The patient had planned to have MRI on 05-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, and worsening multiple sclerosis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210800516-covid-19 vaccine ad26.cov2.s-Worsening of multiple sclerosis. 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: MEDICAL HISTORY, UNDERLYING DISEASE
dizziness; slight stomach pain/stomach pain under her breast that moved to her abdomen and belly button; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that she is a recipient of the Pfizer vaccine and got her last dose on Saturday. Stated that yesterday she noticed stomach pain under her breast that moved to her abdomen and belly button. Stated that she drank tea and rubbed with rubbing alcohol each time and it went away. Stated that it started up again this morning but is not as severe as yesterday. Stated that she thinks that it is gas pain because it moved. Wanted to know if this is a side effect because she had the vaccine or if she should go to the emergency room or doctor. Clarified that it is for the Pfizer Covid vaccine. tHe outcome of the event was unknown.
Patient reported mild flu like symptoms from vaccination later that evening.  Next morning LTCF staff found pt deceased
Case number PHEH2014US001298 is an initial spontaneous report received from a pharmacist on 14 JAN 2014. This report refers to a 15-year-old male patient. His medical history and concomitant medications was not reported. Erroneously he received only Men A  lyophilized conjugate component of MENVEO (batch number A11081), reconstituted with a sterile water instead of MenCYW-135 liquid component intramuscularly on 07 JAN 2014. No adverse reaction reported following this administration error.
36 y/o female, spouse of retired SM presents to FBVHC with report of developing a rash "hives" on both arms and legs within 24 hrs of receipt of Tdap (left deltoid) received on 05-19-08.  In addition, PPD was placed in her left forearm on same date and read as 0mm on 5-23-08.  She has had annual PPDs as a WAMC IT civilian employee, but never has developed any rash or local reaction to PPD in the past.   Symptoms:  Rash, pruritic.
Large bump; Large bump hot to touch; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 11:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and for unspecified indication and experienced drug allergy. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Mar2021 at 12:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, the patient underwent for COVID-19 virus test (nasal swab) and the results were found to be negative. On 17Apr2021 the patient experienced the event large bump hot to touch. Since the vaccination, the patient had been tested for COVID-19. No therapeutic measures were taken as the result of the reported events. The clinical outcome of the event large bump hot to touch was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness, swelling, itching, & warmth at the injection site, starting day after injection.
Around 30 minutes after receiving vaccines, pt and mother returned to office because pt with hives on face, trunk.
4/1/21 Started with nerve pain around my neck and back.  On 4/4/21 symptom of trigeminal neuralgia, felt as if I were having a stroke and went directly to the ED.  Stroke was ruled out and a small rash appeared on my shoulder blade.  ED suspected shingles as a reaction to the Covid Pfizer Vaccine.  On 4/7/21 rash appeared on upper back, neck and front shoulder.  Pain became very severe.  Started on acyclovor.  Rash and pain became worse, back to the ED on 4/20/21, was direct admit into the hospital until 4/24/21.
Hives, treated with Benadryl pills and ointments, but hives continue to come back daily after one week. Saw primary dr today. Starting new course of treatment with Zertec & Pepicid. If that does not work, she prescribed Prednisone.
R deltoid-Tdap injection, then MENACTRA after 2nd injection, within 30-60 seconds child looked blank, MA told to lay down-he blacked out seconds. Layed down x 15-20 mins on 3x2m table. PN at side and MA's.
face flushed; really fast heart rate; bad headaches; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (face flushed), HEART RATE INCREASED (really fast heart rate), HEADACHE (bad headaches) and PYREXIA (Temperature) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 04120A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FLUSHING (face flushed), HEART RATE INCREASED (really fast heart rate), HEADACHE (bad headaches) and PYREXIA (Temperature). On 18-Feb-2021, FLUSHING (face flushed) and HEART RATE INCREASED (really fast heart rate) had resolved. At the time of the report, HEADACHE (bad headaches) and PYREXIA (Temperature) outcome was unknown.            No treatment medication was provided.  Concomitant medications reported were Heart pills   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up report received included no new information.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On an unspecified date around 01-JUN-2013 (also reported as "last week" by the reporter by the time of the call), the patient was vaccinated subcutaneously with an expired dose of PROQUAD (lot # 666078/0192Z), 0.5 ml. The nurse did not have any patient or physician demographics available at the time of the call. No adverse effect reported. The outcome of a patient is unknown. Additional information has been requested.
Patient asked for a Covid Booster.  I gave her the booster used as a primary dose instead of the Bivalent booster.
experienced a shingles outbreak under nose above lip that lasted 4 weeks in duration. Claims to have never had a shingles outbreak before. Patient contacted their PCP and who denied a valcyclovir prescription and instead directed patient to purchase Abreeva OTC. Outbreak resolved in 4 weeks.
Within 24 hours, right eye swelling and tenderness at the site of dermal fillers. Treatment with Benadryl and oral steroids have been started.
Systemic: Chills-Mild, Systemic: Dizziness /Lightheadedness-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild. Additional Details: Patient vomited. Face white; pulse low; SP02 okay; dizziness; sweating; gave patient water; laid him down on mat; elevated feet;  sat with him for 20 minutes; monitored SP02 and pulse several times. Patient felt better after 20 minutes. Known history per patient of having this reaction from shots.
The patient describes a fever which began a day or two after the vaccination, this gradually improved and as it was disappearing on about 1/4/2019 she began getting intermittent abdominal pain, localized to the RLQ. Overnight on 1/8/2019-1/9/2019 the pain became steady, and then worsened. I am an Emergency Physician, she presented to me in the E.R.  in the afternoon of 1/9/2019 with acute appendicitis.
10 cm by 8 cm area of erythema and edema over injection site of left deltoid muscle.
Right arm is red, swollen, and hot to touch. The redness starts from the deltoid muscle to the elbow and the width of the arm.
Information has been received from a nurse concerning a 12 year old female who on an unknown date, was vaccinated with the second dose of VARIVAX (Merck) (lot# 663942/0340Y) 0.5mL. On 11-MAY-2009, the patient experienced warmth, redness and severe swelling at the injection site. Subsequently, the patient recovered from warmth, redness and severe swelling at the injection site. Unspecified medical attention was sought. This is one of several reports from the same source. Additional information has been requested.
Severe abdominal and upper torso muscle spasms. With dose #2 same with 6 weeks of ocular migraines
PATIENT IS PAST THE 14 DAY MARK OF GETTING THE SECOND PFIZER COVID VACCINE AND TESTED POSITIVE FOR COVID ON PREADMISSION TESTING LABS.
shot was given in left arm. right arm went numb immediately. tingly, like sleeping. has been two weeks and right arm is still numb -- from shoulder to wrist. (SHOT WAS DEFINITELY IN LEFT ARM... not sure why right arm is affected.)
DPT/OPV/HIB vax given AM of 8JAN92 pt mom called 1PM 8JAN92 to report vomiting, pallor, cold skin, & extreme sleepiness; referred to urgent care facility for eval; pt later devel fever 8JAN92;
Teusday, 11:20am shot received Wednesday, 03:00am woke up with left arm soreness. Also severe fatigue, muscle aches, nausea 09:00am fever 101.5 10:00am fever 103 noon nausea from 10:00-5:00pm fever was 103-104. Pt alternated tylenol and advil and used ice packs with little to no effect. Thursday am, fever 102.7. At noon, fever 101 Friday, fever 100-101 all day. Injection site swelled to size of lime. No redness at site. Saturday, Pt felt fairly normal. Injection site still moderately sore
Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was transferred to behavioral health unit at an outside nursing home on 2/15/21 after hospitalization for psychiatric evaluation on 1/29/21 w/subsequent Law for erratic behavior w/ delusions/hallucinations. Patient passed away on 4/12/21 at an outside facility with details surrounding death unknown. PMH significant for CKD, AAA, PVD, anemia, CAD, Dm, HTN, COPD, advanced age.
Body aches; Headache; Fever of 100.6; Nauseated; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), HEADACHE (Headache), PYREXIA (Fever of 100.6), NAUSEA (Nauseated) and INJECTION SITE RASH (Rash at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MYALGIA (Body aches), HEADACHE (Headache), PYREXIA (Fever of 100.6), NAUSEA (Nauseated) and INJECTION SITE RASH (Rash at injection site). On 05-Mar-2021, MYALGIA (Body aches), HEADACHE (Headache), PYREXIA (Fever of 100.6), NAUSEA (Nauseated) and INJECTION SITE RASH (Rash at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: 100.6 (abnormal) fever of 100.6.         No concomitant medications or treatment details reported.   Reporter did not allow further contact
Received PPV23 on 11-6-06.  Next morning generalized body aches.  The next day developed hot and sore spot on Left upper arm ~3-4 inches below shot site.  Body aches lasted 24 hours.  Arm remains hot and sore 3 days later 3-4 inches below injection site.
Myalgia, NauseaVomiting Hot flashes, redness, stomach pain Narrative:
No adverse event occurred per guardian. Patient is under age to receive Covid vaccination until 08/25/2021.
Redness, swelling, warmth, and pain commenced w/in hours of vax admin.