chrisvoncsefalvay/vaers-outcomes huggingface dataset:
issues from the head down to the ankle on the left side; getting red and then it was red as a beat; swollen/swollen all the way down to the heel; hot; it hurt and is swollen all the way down to the heel; couldn't hardly walk; didn't even hurt for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (issues from the head down to the ankle on the left side), ERYTHEMA (getting red and then it was red as a beat), SWELLING (swollen/swollen all the way down to the heel), FEELING HOT (hot) and PAIN (it hurt and is swollen all the way down to the heel) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bee sting (Bees). Concomitant products included METOPROLOL, ALLOPURINOL (ALOPURINOL), CLOPIDOGREL BISULFATE (CLAVIXIN), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), VITAMIN B NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (issues from the head down to the ankle on the left side), ERYTHEMA (getting red and then it was red as a beat), SWELLING (swollen/swollen all the way down to the heel), FEELING HOT (hot), PAIN (it hurt and is swollen all the way down to the heel), GAIT DISTURBANCE (couldn't hardly walk) and PAIN IN EXTREMITY (didn't even hurt for 2 days). At the time of the report, DISCOMFORT (issues from the head down to the ankle on the left side), ERYTHEMA (getting red and then it was red as a beat), SWELLING (swollen/swollen all the way down to the heel), FEELING HOT (hot), PAIN (it hurt and is swollen all the way down to the heel), GAIT DISTURBANCE (couldn't hardly walk) and PAIN IN EXTREMITY (didn't even hurt for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
After receiving vaccination, patient proceeded to observation area.  He passed out briefly, then regained consciousness, but was sweaty, disoriented, dizzy and drowsy.  EMS was called, he asked to lie down and was helped to ground into a recovery position.  EMS arrived and took him for further evaluation.
Patient received HAV 1 day prior to 6 months interval/non-countable dose.
The Proquad (MMR and Varicella) combo vaccine was only given in error.  This vaccine was #3 when only should have been #2 in the series.  No treatment was given. Patient had no adverse effects of the vaccine.  Outcome, patient will be fine, more protection.
Inappropriate schedule of vaccine administered; I received a positive COVID test on 23Aug; I received a positive COVID test on 23Aug; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female consumer reported for herself that she received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 02Mar2021 (at the age of 57 years) as dose 2, single and first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 02Mar2021 at 15:00 (at the age of 57 years) as dose 1, single for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that patient received Dose 1 and Dose 2 on 02Mar2021. The patient experienced Covid on 21Aug2021. No treatment received for AE. The patient underwent lab tests and procedures which included Nasal Swab (COVID-19 Antigen rapid test): positive on 23Aug2021. The outcome of event was recovering.  Device Date: 27Aug2021.  No follow-up attempts are possible. No further information is expected.
Patient reported to me at pharmacy 11/16/23 that he had a fever the night of his RSV vaccination. He said he called his doctor's office, and they told him to take tylenlol or ibuprofen. patient said he took a few doses of tylenol and was better the next day.
About 12 hours later, fever, shakes. 2 weeks later was diagnosed chronic Shingles. Participant went to the doctor was in severe pain. Rash spread over whole left side. Was put on Gabapentin for pain also given cream. To seven weeks to recover. Booster was even worse, developed UTI, shakes and very sick.
I got my shot and ended up with the shingles/suspected vaccination failure; shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and ended up with the shingles. The patient said that, the shot did not keep you from getting the shingles and it keeps them from being so bad, but shingles were horrible and if you get them at all. 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, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Infant received Moderna Bivalent booster dose given as shot #1 in Primary Series for Moderna Bivalent vaccine in error rather than new bivalent vaccine designed for primary series.
CHILD PRESENTED TO CLINIC ON 4/10/03 WITH LEFT UPPER ARM ERYTHEMA MEASURING 15CM X 8CM, MILDLY INDURATED, NO PUS
sharp pain down the back of my left leg, the next day it was gone; I was limping around, the next day it was gone; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sharp pain down the back of my left leg, the next day it was gone) and GAIT DISTURBANCE (I was limping around, the next day it was gone) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) and OMEPRAZOLE for an unknown indication.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (sharp pain down the back of my left leg, the next day it was gone) and GAIT DISTURBANCE (I was limping around, the next day it was gone). At the time of the report, PAIN IN EXTREMITY (sharp pain down the back of my left leg, the next day it was gone) and GAIT DISTURBANCE (I was limping around, the next day it was gone) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Redness about 2 inches below injection site - irregular redness, warm to touch. Slightly sore.
This spontaneous report as received from a immunization coordinator via a company representative refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On an unknown date, the patient was vaccinated with a improperly stored dose of PROQUAD injection (lot # reported as M025690, dose, route of administration and expiration date were not reported). No adverse reaction was reported. The administered vaccine had been stored in the refrigerator for over a week before patient's vaccination. It was unknown by the reporter if data logger was involved. The reporter did not have information about the previous temperature excursion. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004601: US-009507513-1701USA004601.
Patient had 2 seizures on this day, had been seizure free for sometime.  11/09/09 Medical records received for DOS 9/16-11/02. ER and PMD office notes. Patient had been seizure free for 1.5 yrs. 9/16 had seizure and then several others between that date and 11/02. No other s&sx of illness except minor cold prior to one seizure.  Severe HA after 11/02 sz. Was able to speak during.   Seizure. 10 min long.  Slept next day.  Observe. Plan for b/w and EEG.
Pt recvd 1st & 2nd dose of MMR; One day p/vax w/2nd dose, pt devel pharyngitis, asthenia, & flu-like illness; Reporter attributed pt's exp to exposure to an unk virus prior to vax w/MMR;
Chills, 2 degrees of fever, sore arm, whole body ache, disoriented when walking & (collapsing  pain in left leg when trying to stand the next morning),  slept for 30 hours except for necessaries, didn't eat for 1 1/2 days, all in all body felt like a bad case of the flu.
No additional AE/PQC; Caller reported AE for improperly stored administered VARIVAX.; This spontaneous report has been received from a Healthcare Professional and refers to a 14-year-old patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions an concomitant therapies were not reported.  On 03-JUL-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (product storage error), at a dose of 0.5 milliliter (lot number W017551 has been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), with an expiration date established as 01-JUN-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). Temperature excursion lasted for 6 hours and 15 minutes at -10 degrees Celsius up to 8 degrees Celsius.
Pt states she noticed swelling/redness of injection site later in the evening of the day vaccine was administered which lasted 5-6 days. She states the area of injection was very "firm". Later that same night she felt very fatigued and weak. She states that she has been "tired" and "not regained all her strength back" yet, ever since the evening of the vaccination. Patient never called office to tell us this and never reported event to anyone until 05/05/15.
Rash on legs that spread to face, back and arms. Started on 2/26/2022, low grade fever with temperature reaching a max of 100.9 and restless at night on 2/26/22 and 2/27/22
Approximately 7 hours after Pfizer booster, I awoke with pain (chest region moving back and forth along lower rib line and upper chest mid to right-side), shaking, feeling unwell, headache and fever up to 100.5. No sharp pain. Maybe gas pain, not sure. This persisted for 6 hours. Then it stopped. Never experienced this before. My palpitations increased since this experience. I have them several times per week (in the early morning hours between midnight and 6:00 am). I haven't started new medication Diltiazem (Cardizem) as yet.
first dose lot #ER2613 received on 3/23/2021 nerve sensitivity, pain, tingling, crawling sensation in  shot arm. Lasted 3 days. Mentioned it to nurse prior to second dose. Second shot nerve sensitivity, pain, tingling, crawling sensation, pins and needles started in shot arm that evening of shot next day moved between arms, hands, face, legs and feet. severity has lessened but has not gone away and there is always some low level sensation of it somewhere all of the time.
8.5 cm x 7.5 cm diameter circular erythematous, warm to touch small blister noted inside circular >Dx: Right ARM Cellulitis   Treatment - Keflex & bactroban ointment
PATIENT CAME BACK TO PHARMACY WINDOW A FEW MINUTES AFTER ADMINISTRATION STATING FEELING VERY DIZZY AND FEELING LIKE SHE WAS GOING TO PASS OUT. PATIENT WAS ON KNEES WITH HEAD DOWN ON THE GROUND AND VERY PALE. PATIENT WAS GIVEN BOTTLE OF WATER AND COLD TOWEL.
Patient received the 2nd dose of the Covid-19 vaccine at 16:26 today (2/25/21). She reported symptoms of difficulty breathing, tight throat and tight and numb lips at 16:34 today and alerted staff. At 16:35 epinephrine was given for suspected anaphylactic reaction. Vitals at 16:35 before administration of epinephrine were pulse ox 100% and pulse 67. Vitals at 16:37 were pulse ox 100%, pulse 170, and BP 162/102. First response called at 16:35. Patient felt immediate improvement in symptoms with epinephrine administration. First response team took patient to ED for further evaluation at roughly 16:40 by wheelchair.
This case was reported by a consumer via call center representative and described the occurrence of neck pain in a female patient who received Meningococcal ACWY vaccine (potential MENVEO). Co-suspect products included Meningococcal B vaccine. Previously administered products included Meningitis vaccine (received a shot few years ago). On an unknown date, the patient received Meningococcal ACWY Vaccine (potential MENVEO) at an unknown dose and Meningococcal B vaccine at an unknown dose. On an unknown date, less than a month after receiving Meningococcal ACWY vaccine (potential MENVEO) and Meningococcal B vaccine, the patient experienced neck pain, jaw pain and headache. On an unknown date, the outcome of the neck pain, jaw pain and headache were unknown. It was unknown if the reporter considered the neck pain, jaw pain and headache to be related to Meningococcal ACWY Vaccine (potential MENVEO) and Meningococcal B vaccine. Additional details were provided as follows: The patient received meningitis shot a few years ago and was told that she needed to get her another one before she graduates. She just went to the doctors and she got a shot, plus the Meningitis B shot and had pain in her neck, jaw all day today and headache. The reporter was asking if the patient supposed to get both of them. She thought they set up another appointment in a month for another meningitis shot. The office was closed.
Hive rash the evening the day the vaccines were given; unsure of exact time; tx Benadryl; lasted 3 days.
Vaccine exposure during pregnancy; This is a spontaneous case initially received from agency (case ID: SEQ19-03793) by pharmacist on 03-Oct-2019, concerning a pregnant female patient of unknown age.  The patient's current medical conditions, concomitant medications and pregnancy information were not provided.   On 03-Oct-2019, the patient was administered Flu vaccine (influenza vaccine, dose, anatomical location, route of administration, batch number and expiration date: not provided) (explicitly coded as 'Vaccine exposure during pregnancy) for influenza prophylaxis.  At the time of the report, there was no adverse event described.  Event's causality was assessed as not related to the suspect product per company.; Sender's Comments: Event's causality was assessed as not related to the suspect product per company.
Circular rash, redness, swelling, hives itchiness, bruising, pain, difficulty with moving limbs, difficulty sleeping.
Severe body aches; Headache; Queasiness; Fever, lasting through three days after the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 20-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 arm right on 23Apr2021 at 09:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included inflammatory arthritis, COVID-19 ( Prior to vaccination, the patient was diagnosed with COVID-19) and sulfonamide allergy(sulfa).Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 02Apr2021 at 16:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 the patient experienced severe body aches, headache, queasiness, fever, lasting through three days after the vaccine. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe body aches, headache, queasiness, fever, lasting through three days after the vaccine was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
UrticariaPruritus  pinching in arm, hard/red at injection site  Narrative:
almost exactly 12 hrs p/injected, had the flu symtoms; symtoms were extreme: vomiting, diarrhea, h/a, backaches, bodyaches; unable to eat for 12-20 hrs, just liquids & crackers; also had a rash on lower back;
COVID ARM RED SWOLLEN SUGGESTED TOPICAL STEROID COOL COMPRESS APAP
Afib, rvr, irregular pulse, admitted to hospital 11/30  Narrative:
16 year old received the Moderna vaccine; 16 year old received the Moderna vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of the second episode of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna vaccine) and the first episode of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Obesity and Seasonal allergy. Concomitant products included IBUPROFEN (MOTRIN IB) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced the first episode of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna vaccine). On 15-Apr-2021, the patient experienced the second episode of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna vaccine). On 15-Apr-2021, last episode of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment of events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: ADR form was received and the following information was added: Two reporters, patient race/ethnicity, medical history and Dose 2 and same event as from Dose 1. The following information was corrected from  ADR form: Patient DOB and  Dose 1 date.; Reporter's Comments: This report refers to a case of  Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with no associated AEs.
hurting stomach; diarrhea; Vomiting; Chills; muscles and both shouldery the injection site) were aching; shoulder aches; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (hurting stomach), DIARRHOEA (diarrhea), VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (muscles and both shouldery the injection site) were aching) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L81A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PRAVASTATIN 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 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced DIARRHOEA (diarrhea), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (muscles and both shouldery the injection site) were aching), ARTHRALGIA (shoulder aches) and FATIGUE (FATIGUE). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (hurting stomach). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency; DICLOFENAC at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (hurting stomach), DIARRHOEA (diarrhea), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (muscles and both shouldery the injection site) were aching), ARTHRALGIA (shoulder aches) and FATIGUE (FATIGUE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: abnormal (Inconclusive) Last night her temperature was 99.8F, it went down to 99.5F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Client presented at the vaccination site on 01/27/22. The client reported he received a first dose of Pfizer COVID vaccine on 01/06/22 (lot #: FL3029). Client reported after 48 hours receiving his first dose of Pfizer COVID vaccine, he reported he had weakness and lightheadedness for two days without taking any medications and developed swelling and purple color of his left eye for four days with no medication applied to his eye. He reported he didn?t follow-up with his PCP. Client denied any chronic illnesses or taking any medications. He stated he had no known allergy. Today, client has a slight bump on his left eye with an unknown cause. PHN texted a picture of his left eye bump with his permission along with his request for a second dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the second dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the second dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. Client received second dose of Pfizer COVID vaccine, LOT #: FK9896 on 01/27/22 at 1414 by LVN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1444 unassisted and with a steady gait.
10 mins p/vax started vomiting, rested 45 mins, began vomiting again, became incoherent, turned pale, lips turned blue; took to MD also had hives;
patient received a second prevnar 13 instead of pneumovax 23. First prevnar 13 was given in February, 2019.