chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ear hurts; back ache; sore throat; lethargic; poor appetite; not talking much; arm ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm ache), BACK PAIN (back ache), OROPHARYNGEAL PAIN (sore throat), LETHARGY (lethargic) and DECREASED APPETITE (poor appetite) in a 25-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.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL for an unknown indication.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm ache). On 25-Mar-2021, the patient experienced BACK PAIN (back ache), OROPHARYNGEAL PAIN (sore throat), LETHARGY (lethargic), DECREASED APPETITE (poor appetite) and TACITURNITY (not talking much). On 26-Mar-2021, the patient experienced EAR PAIN (Ear hurts). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE (COUGH & COLD [CHLORPHENAMINE MALEATE;DEXTROMETHORPHAN HYDROBROMIDE]) at an unspecified dose and frequency. On 26-Mar-2021, BACK PAIN (back ache) had resolved. At the time of the report, PAIN IN EXTREMITY (arm ache), OROPHARYNGEAL PAIN (sore throat), LETHARGY (lethargic), DECREASED APPETITE (poor appetite), TACITURNITY (not talking much) and EAR PAIN (Ear hurts) outcome was unknown. Not Provided
I might have been a little sore at injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE PAIN (I might have been a little sore at injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced INJECTION SITE PAIN (I might have been a little sore at injection site). At the time of the report, INJECTION SITE PAIN (I might have been a little sore at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-406730 (Patient Link).
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The vial was placed in the refrigerator on 19-Sep-2021. Dose was not undergone any temperature excursion. No adverse events were reported.
I had cognitive problems, felt sick body aches pain in joints, shoulder, have an unexplained rash on buttocks and back since May 2021 still have rash can't get rid of steroid cream was prescribed antibiotics prescribed sinus  infections several of them! Coughing in mornings throwing up in morning after coughing And can't smell still haven't been able to since vaccine
VEIN ISSUE; VEIN SWELL; HAD REACTION; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 155 pounds, and height was 63 inches. The patient's past medical history included: lack of effect, pain, and hallucination, and concurrent conditions included: shrimp allergy, certain grass allergy, dust allergy, dog dander allergy, non alcoholic, non smoker, psoriatic arthritis, and histamine allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient was previously treated with golimumab; and experienced drug allergy when treated with clarithromycin, prochlorperazine edisylate, and risankizumab. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A ZOZA21A or Z0ZA21A, expiry: UNKNOWN) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. Non-company suspect drugs included: tofacitinib citrate ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Concomitant medications included guselkumab for psoriatic arthritis. On SEP-2021, the patient experienced vein issue. On SEP-2021, the patient experienced vein swell. On SEP-2021, the patient experienced had reaction. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) inconclusive, backwash stuff, and Laboratory test (NR: not provided) inconclusive, backwash stuff. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with tofacitinib citrate was withdrawn. The patient was recovering from vein issue, vein swell, and had reaction. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Injection site redness and hardness persisting 2 days.  Fever and headache only lasted 24 hours.
Information has been received from a nurse concerning a female patient who was vaccinated with a second dose of Gardasil. The patient was vaccinated in the "glut" per the patient's request. Subsequently the patient felt dizzy and nauseous. It was noted that the patient may have not eaten all day. Subsequently, the patient recovered. Additional information has been requested.
shingles; This is a spontaneous report from a non-contactable consumer (patient daughter) received via a sales representative. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient experienced shingles after second dose of COVID vaccine on an unspecified date. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
enlarged lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The Pfizer COVID -19 vaccine been associated with enlarged lymph nodes in patients after administration. It was reported that after receiving the 2nd Pfizer COVID -19 vaccine the patient experienced enlarged lymph node. The physician ordered a biopsy and it came back normal. Patient questioned if they should get the booster and Dr recommended that the patient get the vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client received HEP A, HEP B, TDAP. Immediately after TDAP she leaned over in chair and fell on floor. Began seizure like movement for approx. 1 min and began to hyperventilate. Stopped jerking movement and began shivering after c/o being cold. Breathing returned to normal and client able to communicate normally. EMS arrived and transported to ER. Client returned approx 2 hrs later ambulatory and without any effects from earlier episode. States ER physician stated that it was not likely a reaction from vaccine, but a fainting episode.
pt recvd vax & immed c/o lightheadness 13sep, pain at inject site & shoulder w/ t 100.6 19sep ; pt c/o purulent drainage & soreness at inject site; wound cleaned to MD I & D done; atb given;
patient experienced a rash since the first dose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient experienced a rash on an unspecified date since the first dose. The patient has received both doses. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
RED RASH ALL OVER BODY; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. patient had no known medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAY-2021 17:00, the subject experienced red rash all over body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rash all over body. This report was non-serious.
Tachycardia (over 100 bpm for 48hr); Nausea; Headache; Chills; arm pain; This is a spontaneous report from a contactable Nurse reporting for herself. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm on 18Dec2020 13:00 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Reynald's, Irritable bowel syndrome (IBS), spontaneous pneumothorax. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergy to medication of Vicodin. The patient experienced tachycardia (over 100 bpm for 48hr), nausea, headache, chills, arm pain, started on 18Dec2020 13:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event Tachycardia was recovered on 20Dec2020 13:00, the outcome of the other event was recovered on an unknown date in Dec2020.
In order: injection site soreness, muscle aches in shoulders and shoulder blades, headache, dizziness, fatigue, chills, muscle aches in entire back, worsening headache, worsening fatigue, fever. All of this was within 24 hours of the vaccine, and most of it was between hours 14 and 24.  No treatment has been done yet outside of rest and sleep.
fatigue, shivering chills extremely cold, lasting several hours.  - burning  all over body all joints painful   - hands and feet felt very swollen and heavy -  headache  -  both shoulders ached  the injection site was not painful compared with  all the other  pain I experienced  - extremely tired slept next 2 days  took aspirin 3 x a day when I was able to get out of bed.
Rash. Diphenhydramine 25 mg prn, ibuprofen 300 mg prn.
Fever, muscle aches, joint aches, headache, chills, dizziness, exhaustion. Lasted approximately 24 hours.
10/21/21  Took a home COVID test and came back positive. Repeated COVID 19 test in office, positive.  Congested, coughing, no fever since Tues. 10/19/21.  took benadryl and using her albuterol several times daily since symptom onset.  Shortness of air intermittently  Prescribed Tessalon 200mg, 3x/daily for 5 days.
This was NOT an Adverse Event.  The vaccine was in freezer longer than 14 days.   The patient was advised to revaccinate per CDC.   Patient Re-Vax 11/3/2021
Patient was given 0.3 mL dose of pediatric Pfizer instead of 0.3 mL dose of adult Pfizer. Patient received 15 mcg of medication versus expected 30 mcg dose.
Other comments include: Patient presents with c/o hives, redness and itch to chest area. Denies SOB, throat discomfort, tongue swelling, chest pain. O2 sat 100% RA. Speaking in full sentences. NAD.
pt awakened w/rash; evaluated by MD on 7/28, generalized rash & temp 99.7 was tx with hydroxyzine & prednisolone
This spontaneous report was received from a pharmacist who refers to a currently 54 year old female handicapped (unspecified type of handicap) patient. The patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot# reported as H013017, exp 10/2013) on 06-DEC-2012. The pharmacist reported that pink changing to bright red injection site reaction (onset date was not provided). The patient sought medical attention by contacting with a pharmacist. She did not receive any treatment for adverse event. At the time of the report patient's state was not recovered. Additional information is not expected. This is one of several reports from the same source.
Immunization given approx. 3 pm.  Approx 15 minutes later developed diaphoresis, became pale and dizzy, BP 90/60, pulse 72-60.  Left building ambulatory 15 minutes later, no difficulty walking out of the building.  That evening patient developed fever (no temperature has been taken at any time) and confusion (didn't know where he was, stumbling around, no loss of bowel or bladder function).  Mom gave him Tylenol, and prayed, and his fever would come down, and he would act normal.  Patient has had 4-5 episodes since Tdap was given, about once or twice a week.  Mom states these episodes always occur after patient has fallen sleep, and occur sometime though the night.  She has not taken him to a private provider because she "knows he will be okay."  Patient has had no previous problem with immunizations and siblings have not had any problems either.  Mom states she is "not happy", She "doesn't know what is in that vaccine" and she will not be bringing him back for any more immunizations.  Instructed I will report adverse reaction (on VAERS) and get back with her to see how patient is doing. Mom states she "does not expect patient to be doing bad" but we can check.
Starting the evening of the shot the pt starting to feel ill the next day and until 2/20/19 the patient felt like she had the flu and could not leave the house with pain on tops of her hands and feet and pain in shoulders. Blisters also developed about 2/18 and are starting to go away now. She is feel better today.
Refrigeration excursions identified/undergone several temperature excursions; No Adverse Event; Vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No Adverse Event) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Sep-2022 at 6:14 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 6:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions).    No concomitant medication was provided. On an unknown dates, patient had received dose 1, dose 2, dose 3 of moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.  Date vial was moved from freezer to refrigerator on 7-Sep-2022.  The vial had undergone temperature excursions. It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.  Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.  It was reported that no adverse reactions were reported to their knowledge for any patients. Treatment medication was not provided by the reporter.
Received her flu and coronavirus disease (COVID) vaccines, so was having some aches and pains; This is a spontaneous report received from non-contactable reporter(s) (Other HCP and Consumer or other non HCP).  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 06Nov2023 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "secondary pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: ASPIRIN EC; PULMICORT; LIPITOR; CRANBERRY; OFEV; PROAIR DIGIHALER; IPRATROPIUM BROMIDE. The following information was reported: PAIN (non-serious) with onset Nov2023, outcome "unknown", described as "Received her flu and coronavirus disease (COVID) vaccines, so was having some aches and pains".  Additional Information: On 06Nov2023, the patient received her flu and coronavirus disease [COVID] vaccines so she was having some aches and pains (pain). Concomitant medications Multivitamins (Ascorbic acid, Ergocalciferol, Folic acid, Nicotinamide, Panthenol, Retinol, Riboflavin, Thiamine hydrochloride) Tablet, Omega-3 (Docosahexaenoic acid, Eicosapentaenoic acid) and Oxygen (Oxygen) were also taken.The reporter's causality for the event of pain with influenza vaccine and COVID-19 vaccine was considered to be possibly related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm felt burning; Left arm felt Itchy; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Left arm felt burning) and PRURITUS (Left arm felt Itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced BURNING SENSATION (Left arm felt burning) and PRURITUS (Left arm felt Itchy). The patient was treated with FLUOCINONIDE from 16-Jan-2021 to 17-Jan-2021 for Burning sensation and Itchy, at a dose of .5 % three times a day. At the time of the report, BURNING SENSATION (Left arm felt burning) and PRURITUS (Left arm felt Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up received on 13 Apr 2021, patient denied further contact
Patient reported tingling in tongue and throat approximately 15 minutes after vaccine administered. Patient was given diphenhydramine.
Took the vaccine at  3 PM. Around 6 PM had lower back and left leg pain. This increased a lot during the next 2 weeks. Then visited my physician on Apr 02. The doctor prescribed Meloxicam 15 mg. since I also had seasonal allergies for which the Dr prescribed Fluticasone 50 mcg and Azelastine 137 mcg nasal spray. The Dr also requested for lower back MRI.  I have scheduled the lower back MRI for 04/16. I did let the doctors office know today about the vaccine.
the patient experienced some swelling just above the hip bone; This is a spontaneous report from a contactable consumer.A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 18Jan2021 at SINGLE DOSE for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced some swelling just above the hip bone in Jan2021. The reporter said the swelling is kind of a nut lumpy spot under skin. The outcome of event was unknown.    Information on the lot/batch number has been requested.
Swelling, Headache, diarrhea, aches, pain. Flu like symptoms.
Patient received 3rd dose of COVID vaccine (Pfizer). However, patient stated it was his 2nd dose upon confirmation. Incident was found due to the patient's benefit plan not covering the vaccine. After contacting the patient, he stated that his physician recommended that he restart the 2 dose series due to being out of the country for several months after receiving only one dose of the vaccine.
pt recv vax 29OCT96 & pt exp inj site pain, sore neck glands, & body pains p/second dose;soreness started @ noc;no txwas given;lt arm was still sore as of 5NOV96 report;sx resolved in 1mo;