chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    Concomitant product use was not provided by the reporter. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
Information has been received from an office manager in a physician's office concerning a 13 month old male who on 12 Dec 2006 was vaccinated inadvertently with a dose of Rotateq vaccine live (human-bovine) when Rocephin was ordered. After the inadvertent administration the patient was given Rocephin, 250 mg as well as a dose of influenza virus vaccine (unspecified). At the time of the report the patient had diarrhea and was throwing up. No other information was provided. Additional information has been requested.
A few minutes after vaccination, pt made loud moaning noise and started to lean to right and lost consciousness briefly.  Pt lowered to floor and ice was applied to back of neck. Pt was diaphoretic and awoke within a minute. vitals taken, BP 98/58 @5:38pm, 100/60 @5:42pm, 98/56 @5:50pm, pulse ox 98%.  Pt was given water and was no longer diaphoretic. he was feeling better and was able to walk on his own. He left with parents to go home. Spoke with mom, he has had no further adverse reactions following this.
Patient became diaphoretic and dizzy 2 minutes post vaccine. Patient's legs were immediately elevated,  ice pack to back of neck, 2 bottles of water were given and graham crackers.  10 minutes later patient feeling better and stated this happens when she gets her blood drawn.  Patient's vitals were T 87.5, P 64 BP 100/70 R 15.  Patient stayed an additional 20 minutes post vaccine.
Patient was screened for adverse reaction prior to flu administration at the mass flu shot and had indicated he had a adverse reaction as a child of age 5 with vomiting and hives.  Pt was screened by provider and was recommended to give shot. Pt was given Afluria LOT #T59406 EXP: 30Jun15 in L arm using a 25G needle in the L arm and observed for symptoms.  Approx 10 min later pt developed several small hives localized in area of injection.  50 mg of Benadryl was administered and soldier was placed on monitor. Vital signs remained stable and pt was released without further reaction.
diagnosed by PCR with Covid 19 /sore throat, nasal congestion, fever, myalgias, fatigue and cough; diagnosed by PCR with Covid 19 /sore throat, nasal congestion, fever, myalgias, fatigue and cough; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 13Jan2021 as dose 2, single (Lot number: EL3249), in right arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 01Jun2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "menopause syndrome" (unspecified if ongoing); "seasonal affective disorder" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; DIVIGEL; DULOXETINE; VITAMIN D [VITAMIN D NOS]; DOCUSATE SODIUM. Past drug history included: Voltaren, reaction(s): "Voltaren causes rash", notes: Voltaren causes rash; other NSAIDS are fine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "not recovered" and all described as "diagnosed by PCR with Covid 19 /sore throat, nasal congestion, fever, myalgias, fatigue and cough". Clinical course: Patient was diagnosed by PCR with Covid 19 on 28Jun2022 after one day of sore throat, nasal congestion, fever, myalgias, fatigue and cough. Her covid symptoms improved noticeably after 5 days of PAXLOVID treatment with no further symptom beyond mild fatigue, but starting on 08Jul2022, patient had a recurrence of sore throat, nasal congestion, dry cough, myalgias and fatigue. Patient was still symptomatic on 11Jul2022, but slowly improving again without further treatment. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) positive, notes: A home Covid antigen test was positive on day 11; (28Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included PAXLOVID.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
Headaches from 12/22/20-12/24/20 Nausea from 12/22/20- currently
No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 7-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 05-DEC-2022, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, lot #U039549, expiration date: 14-DEC-2023, administered subcutaneously for prophylaxis (dose and strength were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W018825, expiration date: 14-JUN-2024, administered subcutaneously for prophylaxis (dose and strength were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838:
Patient explained had redness and swelling from her shoulder to her elbow. Also experienced itching, pain, headache, gastrointestinal discomfort and warm to the touch. Patient explained has gone done since the initial occurrence but is still having discomfort.
No adverse events have been reported. Patient's vaccine was past the beyond-use-date by approximately 10 hours due to being refrigerated for over 30 days. The beyond-use-date was not noted until 2-3 hours after vaccination. Pharmacy left a message with the patient, but has not spoken with him yet.
After I receive the vaccine I had really bad inflations in the joints, my hands, and my feet. I took prednisone for the swelling. I saw the doctor on the 24th and he gave me a stereo shot to help with the pain. I started taking Actemra but am still not better.
blisters in my mouth; aches; flu like symptoms; This case was reported by a consumer via social media interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, blistering of mouth and pain. On an unknown date, the outcome of the influenza-like symptoms, blistering of mouth and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, blistering of mouth and pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and was sick with flu like symptoms for 4 days, blisters in mouth and on the day 1 had aches. The above events were recovered. The patient was scared to get 2nd one. The follow-up would not possible as no contact details were available.
Information has been received from a 66 year old female with no known drug allergies and abnormal cholesterol and blood pressure who in February 2008, was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included CRESTOR, MSD, LEVAQUIN, doxazosin mesylate and hydrochlorothiazide (manufacturer not specified).  The patient reported getting shingles after receiving ZOSTAVAX (Merck).  Two weeks ago, on approximately 20-AUG-2008, it started as a blister on her forehead and moved to her hairline and down to her left eye.  Then she had a scab on her left eyelid.  She noted that "I looked like a gargoyle".  She was given "generic VALTREX" and she went to her ophthalmologist every 2 days to make sure it did not advance to her cornea.  No labs/diagnostics were performed.  The patient reported she was not warned of the efficacy rate.  She was told ZOSTAVAX (Merck) would prevent shingles entirely, or she might only develop a mild case.  At that time of the report the patient had not recovered.  Additional information has been requested.
3 1/2 x 5 cm redness and induration, painful and warm to the touch.
severe vertigo; dizziness; inflammation causing vertigo and dizziness; nausea; tingling in right foot; tingling in the left side of face; pain on left side of head; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), PARAESTHESIA (tingling in the left side of face), PARAESTHESIA (tingling in right foot), VERTIGO (severe vertigo) and DIZZINESS (dizziness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease and BPPV (Experienced nausea and vertigo). Concomitant products included CARVEDILOL, PRAVASTATIN, ESTRADIOL (VAGIFEM), L-ARGININE HCL, UBIDECARENONE (COQ10 [UBIDECARENONE]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021 at 1:30 PM, the patient experienced TINNITUS (tinnitus). On 18-Jan-2021, the patient experienced PARAESTHESIA (tingling in the left side of face) and HEADACHE (pain on left side of head). On 19-Jan-2021, the patient experienced PARAESTHESIA (tingling in right foot). On an unknown date, the patient experienced VERTIGO (severe vertigo), DIZZINESS (dizziness), INFLAMMATION (inflammation causing vertigo and dizziness) and NAUSEA (nausea). The patient was treated with PROMETHAZINE for Vertigo and Dizziness, at a dose of 1 dosage form at bedtime; PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, PHENYLPROPANOLAMINE HYDROCHLORIDE (DIMETAPP (PPA)) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, TINNITUS (tinnitus), PARAESTHESIA (tingling in the left side of face), PARAESTHESIA (tingling in right foot), VERTIGO (severe vertigo), DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (pain on left side of head) had resolved and INFLAMMATION (inflammation causing vertigo and dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: Additional information added. On 09-Jun-2021: Outcome of events updated, additional events added.
vomited; vomit blood; nausea; body was very painful; headache; chills; fever; felt ill; weak; The initial case was missing the following minimum criteria: unspecified AE). Upon receipt of follow-up information on 17May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer.  A 53 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 29Jan2021 at 14:30 at single dose via an unspecified route of administration on left shoulder for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number: EL3248) on 08Jan2021 at 16:00. On 30Jan2021 the patient woke around 3.00am, she slightly moved, nausea and vomited so violently occurred. Patient reported she vomited blood. Body was very painful, patient had a splitting headache, chills, fever and all slight movement brought on nausea and vomiting. She also informed  ate no meals on 30Jan2021. On the same day (30Jan2021) patient also felt ill and weak for fear and vomiting. Provided pulse oxygen was 129. It took two weeks to completely void of symptoms (as reported). Patient reported body pain made her cry. The patient was not treated for pain and nausea. Treatment for headache was not reported, while treatment was received for other reported events. The patient recovered from the events on an unspecified date in 2021.   Information about batch/lot number has been requested.
None Pt received J & J on 3/16/2021. Pt received monovalent Pfizer COVID instead of bivalent Pfizer COVID
HEADACHE, WEAKNESS IN LEGS, FATIGUE, TINGLING ACROSS BODY WITHIN 11 HRS OF GETTING SHOT.
pt states on 10th day injection spot is itching, swelling, and warm.  11th day injection is slightly swollen and pink but no pain or itching.
Hypokalemia, Altered mental status, nausea and vomiting, unable to walk, migraines,
Information has been received from a registered nurse concerning a patient who on 17-JUL-2007 was erroneously vaccinated with varicella virus vaccine live (Oka/Merck) in place of zoster vaccine live (Oka/Merck). The nurse reports the event was a result of human error and not a case of product confusion. No symptoms have been reported. There was no product quality complaint. Additional information is not expected.
This patient received an expired vaccination. It had been taken out of the fridge on 4/28/21 so it should've been used by 5/28/21. The expiration on the bottle was 11/09/21. This patient experienced sore arm, body aches, fatigue, and chills.
Immunizations given 6/20/05. Fever reported that evening 102.8, rectal mode-Thermascan. Child also listless at 16:00 PM 6/20/05. Mom called on 6/21/05 and said fever is gone and child is fine.
bruising at the site of the GARDASIL 9 injection; Pharmacist reported that she administered the third dose of GARDASIL 9 to the patient in the patients right deltoid / patient stated her concern to the pharmacist that the GARDASIL 9 was not administered in the deltoid region.; Patient Age: 33 year old; This spontaneous report has been received from a pharmacist concerning a 33 year old female patient. The patient had no pertinent medical history nor drug reactions or allergies. Her concomitant therapies included unspecified birth control medication. Her concurrent conditions were not reported.  On 18-AUG-2020, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis, intramuscularly in her right deltoid (product administered to patient of inappropriate age) along with an unspecified flu shot; and a dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) in her left arm. Dose, lot number and expiration date were not reported for both suspect vaccines.  On 22-AUG-2020, the patient complained of bruising at the site of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (injection site bruising). It was reported that no treatment was given for the event. Moreover, the patient stated her concern to the pharmacist that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not administered in the deltoid region (wrong technique in product usage process).  At the time of reporting, the patient had not recovered from injection site bruising (reported as Present Status: Ongoing).  The causal relationship between injection site bruising and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
site of injection is swelling; site of injection has red mark; site of injection has pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (site of injection is swelling), VACCINATION SITE ERYTHEMA (site of injection has red mark) and VACCINATION SITE PAIN (site of injection has pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (site of injection is swelling), VACCINATION SITE ERYTHEMA (site of injection has red mark) and VACCINATION SITE PAIN (site of injection has pain). At the time of the report, VACCINATION SITE SWELLING (site of injection is swelling), VACCINATION SITE ERYTHEMA (site of injection has red mark) and VACCINATION SITE PAIN (site of injection has pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extremely dizzy), DEHYDRATION (Found to be dehydrated), PALPITATIONS (Heart was racing/heart was pounding), BLOOD PRESSURE FLUCTUATION (Blood pressure went up and down) and FEELING ABNORMAL (Feeling of fogginess for 2 days/fogginess cleared up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation and Heart rate increased.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced PALPITATIONS (Heart was racing/heart was pounding). 03-Dec-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure went up and down) and FEELING ABNORMAL (Feeling of fogginess for 2 days/fogginess cleared up). 03-Dec-2021, the patient experienced CHILLS (Experienced chills). On 04-Dec-2021, the patient experienced MALAISE (Feeling sick). On 05-Dec-2021, the patient experienced DIZZINESS (Extremely dizzy). 05-Dec-2021, the patient experienced DEHYDRATION (Found to be dehydrated). On 05-Dec-2021, DIZZINESS (Extremely dizzy), DEHYDRATION (Found to be dehydrated), PALPITATIONS (Heart was racing/heart was pounding), BLOOD PRESSURE FLUCTUATION (Blood pressure went up and down), FEELING ABNORMAL (Feeling of fogginess for 2 days/fogginess cleared up), MALAISE (Feeling sick) and CHILLS (Experienced chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2021, Electrocardiogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported feeling sick after the booster dose. The patient received her Moderna Booster Dose on 2DEC2021 lot number 027H21B expiration date was not provided. The patient received the booster dose in her left arm shoulder deltoid muscle. 24 hours after the booster dose the patient experienced chills, heart was racing and pounding, blood pressure went up and down. The patient was blood pressure went up and down. The patient went to the emergency room on 5DEC2021 for because she got extremely dizzy. Upon presentation to the Emergency Room the patient was found to be dehydrated. The patient reports a feeling of fogginess for 2 days. The fogginess cleared up around 5DEC2021. The patient was found to be dehydrated and received IV Fluids.    This case was linked to MOD-2022-447895, MOD-2022-447964 (Patient Link).
Hands started getting very painful in joints.  As the days went on, my left hand got much worse.  It was hurting so bad that I could not use my left hand at all and in great pain. ( Left arm is where i received the booster shot. )  My right hand was hurting but not nearly as much as my left hand.  Went to Dr. and he prescribed some prednisone.  The prednisone relieved the pain and I could use my left hand again.  Its been a few days since I took my last prednisone and my left hand is starting to get bad again.  Right now, I can not move my 2 fingers next to my thumb and is in quite a bit of pain.  I just e-mailed Dr. asking him what I should do.
BODY ACHES; CHILLS; FEVER; WOKE UP THE NEXT MORNING WITH EXTREME HEADACHE; This spontaneous report received from a patient via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced body aches. On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced woke up the next morning with extreme headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and woke up the next morning with extreme headache on 2021. This report was non-serious. This case, from the same reporter is linked to 20210541124.
Symptoms are swelling of right arm and enlarged lymph node in neck right side and under right arm. Swelling of entire right arm to leg. Clinic told me to take Benadryl and Advil which helped.  Swelling still on day3 today after shot. Also shot site still sore . Haven?t recovered as of today which is 3rd day after shot
Pt vax /w DTP/OPV 2 hrs after DTP/OPV parents noticed that child became limp & pale. Although limp she was responsive child vomited 1 time. Seen in ER. No treatment.
Full body hives, severe asthma attacks, anaphylactic reaction causing use of epi pen.