chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergy to adacel; Initial information regarding an unsolicited valid non-serious case received from the nurse and other healthcare professional. This case involves a patient of unknown demography who had allergy to adacel (Allergy to vaccine), when the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ACETYLSALICYLIC ACID (ACETYLSALICYLIC ACID); and CODEINE (CODEINE) (reported as patient has allergy to these products as well).  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiration date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had allergy to adacel (allergy to vaccine) (latency unknown) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  At the time of report, event outcome was Unknown for allergy to vaccine.  There will be no information regarding batch number for the case.
KNOT IN ARM; ARM SWELLING; ARM WARM TO TOUCH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and the patient had no known allergies.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced knot in arm. On 10-MAY-2021, the subject experienced arm swelling. On 10-MAY-2021, the subject experienced arm warm to touch. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from knot in arm, arm swelling, and arm warm to touch. This report was non-serious.
Severe fatigue,  headache in back of head, sore arm, extremely cold and loss of appetite first 2 days.  Ongoing symptoms: waves of being hot/sweating, blurred visions, intermittent loss of taste and false sense of feeling of drowning or suffocating and/or breathing in heavy smoke, which last for a few seconds to a few minutes. diminished appetite, more easily fatigued, loss of energy.  On February 8th,  these symptoms began: feeling anxious, fatigued,sleepy, head feels spacey, slight headache, somewhat dizzy,  intermittent buzzing sound in head, body aches, severe ache and muscle tenderness in left shoulder blade area down left arm, and muscle spasms in left shoulder and arm.  Loss of taste again.
Patient developed mid to low back pain, followed by shooting pains down his legs that were 8/10 level of discomfort. generalized faitgue, low grade temp. But the shooting pain down the legs persisted for 3 days. This was accompanied by some numbness and tingling of the legs.  Felt unsteady on his feet.  Back pain resolved within 12 hours but the shooting pains persisted.  Ibuprofen did help
Swelling of eyes, slowly progresive, mother gave Benadryl and improved eye lid swelling, having no anaphylactic symptoms.
can't walk right anymore!; This case was reported by a consumer via interactive digital media and described the occurrence of walking difficulty 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 walking difficulty. On an unknown date, the outcome of the walking difficulty was unknown.   It was unknown if the reporter considered the walking difficulty to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles shot and the patient could not walk right anymore. The follow-up would not possible as no contact details were available.
On February 2nd, 2023, I went to the doctor, I was coughing four days before that. I thought it would subside, but it was getting worse. I had COVID-19 test at the doctors and I was negative. I caught a cold. I had a severe cough no fever and very little congestion. I had no energy and it lasted for about two and half weeks. It felt like an infection. I was prescribed medication benzonatate. This relieved the severe cough I had. The cough was so bad it would double me over, and nothing will come up. It was just real had. They also gave me an inhaler; I didn't use it very much. After 200 puffs there are still 196 left on it. Even still now on occasion I will still cough.
MOTHER STATES THAT RASH APPEARED APPROX. 2 HRS. AFTER HE RECEIVED VACCINES. RASH APPEARS ASYMMTRICAL, PINK IN COLOR, AND RAISED. RASH COVERS NECK, TORSO, ARMS, LEGS, FEET AND HANDS. DENIES ANY RESP. OR SWALLOWNIG DIFFICULTY.
Swelling around the nose and eyes to the point of my eye swelling shut. Pain in that area with a palpable lump. The swelling has lasted for the last 2 days, but it is starting to go down.
A mother reported that her 17 month old son received vaccines on 01/17/00. He immediately developed an injection site reaction characterized by a 5 inch area of redness and swelling at the site of Hib-Titer administration. As of 07/19/00, the reaction had not resolved.
Local injection site reaction - redness, swelling, rash on left arm, lasted 5 days
burning pain at night; stabbing pain at night/ like a hot poker; rash on left arm; rash across chest; ongoing left arm pain/nonstop left arm pain/24/7 left arm pain/underside of the arm to elbow and around arm pit/left arm soreness; medical issue/side effects (booster dose); sick to stomach; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (medical issue/side effects (booster dose)), BURNING SENSATION (burning pain at night), PAIN (stabbing pain at night/ like a hot poker), ILLNESS (sick to stomach) and LETHARGY (lethargy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004FHA, 025A21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCITRIOL (ROCALTROL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION COMPLICATION (medical issue/side effects (booster dose)), ILLNESS (sick to stomach) and LETHARGY (lethargy). On an unknown date, the patient experienced BURNING SENSATION (burning pain at night), PAIN (stabbing pain at night/ like a hot poker), VACCINATION SITE RASH (rash on left arm), RASH (rash across chest) and VACCINATION SITE PAIN (ongoing left arm pain/nonstop left arm pain/24/7 left arm pain/underside of the arm to elbow and around arm pit/left arm soreness). On 07-Nov-2021, ILLNESS (sick to stomach) and LETHARGY (lethargy) had resolved. At the time of the report, VACCINATION COMPLICATION (medical issue/side effects (booster dose)), BURNING SENSATION (burning pain at night), PAIN (stabbing pain at night/ like a hot poker), VACCINATION SITE RASH (rash on left arm) and RASH (rash across chest) outcome was unknown and VACCINATION SITE PAIN (ongoing left arm pain/nonstop left arm pain/24/7 left arm pain/underside of the arm to elbow and around arm pit/left arm soreness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-435238 (Patient Link).
Moderate joint pain in his knees, neck and spine.  The pain was intermittent, occurred most days, and lasted for the next 3 1/2 weeks before resolving.
low grade fever for 6-7 days at 100 something-102 degrees; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an 18 years old female patient who experienced low grade fever for 6-7 days at 100 something-102 degrees, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-May-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  The patient developed a non-serious low grade fever for 6-7 days at 100 something-102 degrees (pyrexia) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  (Other relevant tests included No lab data.)  Final diagnosis was low grade fever for 6-7 days at 100 something-102 degrees.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for low grade fever for 6-7 days at 100 something-102 degrees.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
606 doses were given after expiration date; vaccine was kept in refrigrtor on 18/10/2021 and administered/expired 13/10/2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine was kept in refrigrtor on 18/10/2021 and administered/expired 13/10/2021) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine was kept in refrigrtor on 18/10/2021 and administered/expired 13/10/2021). On 22-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) and PRODUCT STORAGE ERROR (vaccine was kept in refrigrtor on 18/10/2021 and administered/expired 13/10/2021) 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 concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  The vial was placed in the refrigerator on 18-OCT-2021.Vial did not undergo any temperature excursion. No adverse event was reported.
Arm sore after 2nd dose; Arm swollen after 2nd dose; Face flushed after 2nd dose; Face red after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face flushed after 2nd dose), ERYTHEMA (Face red after 2nd dose), PAIN IN EXTREMITY (Arm sore after 2nd dose) and PERIPHERAL SWELLING (Arm swollen after 2nd dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046b21a) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ACETAMINOPHEN (The patient  takes acetaminophen for pain regularly.) since an unknown date.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced FLUSHING (Face flushed after 2nd dose) and ERYTHEMA (Face red after 2nd dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore after 2nd dose) and PERIPHERAL SWELLING (Arm swollen after 2nd dose). At the time of the report, FLUSHING (Face flushed after 2nd dose), ERYTHEMA (Face red after 2nd dose), PAIN IN EXTREMITY (Arm sore after 2nd dose) and PERIPHERAL SWELLING (Arm swollen after 2nd dose) outcome was unknown.            No concomitant medications reported. Treatment taken involved Acetaminophen for pain and Benadryl gel with camphor. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Had 2 swollen lump area. One lump to left deltoid 8.5x5.5mm. One lump to left arm sub-q 5 x 5mm. Lumps occurred one day after injection.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-MAR-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # J006245, expiration date 03-FEB-2016). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 408 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 248 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
1. Rash, pain, nausea, chills. 2. Rx Valacyclovir HCL.
felt like she was going to faint/collapse; felt hot; sweating really bad; This is a spontaneous report from a contactable consumer (patient-dental assistant).  A 57-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: FE3592) as DOSE 2, SINGLE for COVID-19 immunization.  Medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) on unknown date (lot# 3180 -there are no letters before the numbers) for COVID-19 immunization and had no reaction. Then, the 2nd dose on unknown date. Within 2 minutes after receiving the second dose, she had a bad feeling go through her body as she felt hot, sweating really bad, and felt like she was going to faint/ collapse. She sat there 45 minutes to ride it out and it eased up in a few minutes.  She didn't want to drive until she knew she was good. She was wondering if Pfizer recommends, she go forward with the booster in 8 months. Outcome of the events was recovering.    Follow-up attempts are completed. No further information is expected.
Patient got shot 12-21-15. Developed rash on back and by armpit 12-23-15 was seen and given Rx for VALTREX. No fever or other symptoms.
break through bleeding; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "menopause" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "break through bleeding".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 as dose 4 (booster), single (Lot number: GJ3274) at the age of 34 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 18Mar2023 to 23Mar2023 as Treatment of COVID-19.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and COvid-19 are  related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded.  This case will be reassessed should additional information become available.
Extreme shivers, fever, bad Headache. Shivers lasted around 2 hours. Headache was longer but was relieved with TYLENOL. Still feel poorly today.
Patient had rash all over body 2 days after receiving influenza injection. Went ER 2 days later (4 days post-injection) - Received hydrocortisone cr and BENADRYL at ER.
Numbness  in neck began within 5 minutes of injection.  10 minutes later she started have difficulty with exhalation, tightness in the chest, and sensation of neck swelling.  Patient was given 0.5 mL of epinephrine and EMS was called.  Patient began to improve within 5 minutes of epinephrine injection.  She refused to go to the ER.  She was given 25 mg of Benadryl and was monitored for 20 minutes before going home with a friend picked her up.  Patient signed an AMA for both the EMS and clinic.
HYPOTENSION 4/3/2023 ATRIAL FLUTTER, UNSPECIFIED HYPOTENSION 4/3/2023 ATRIAL FLUTTER, UNSPECIFIED
Maternal  exposure during pregnancy; arm hurts worse than the first time, a whole different level of pain; chills; nausea; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts worse than the first time, a whole different level of pain), CHILLS (chills), NAUSEA (nausea) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 02-Aug-2021. On 23-Mar-2021, the patient experienced CHILLS (chills) and NAUSEA (nausea). On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurts worse than the first time, a whole different level of pain). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Pain and Chills, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (arm hurts worse than the first time, a whole different level of pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) had resolved.            Concomitant product use was not provided by the reporter. Patient took some  unknown medication for nausea.   This case was linked to MOD-2021-056014, MOD-2021-056014 (Patient Link).
Rash the size of a golf ball at the injection site; swelling the size of a golf ball at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash the size of a golf ball at the injection site) and VACCINATION SITE SWELLING (swelling the size of a golf ball at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included METHOTREXATE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), FAMOTIDINE, FOLIC ACID, HYDROCHLOROTHIAZIDE and GLUCOSAMINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash the size of a golf ball at the injection site) and VACCINATION SITE SWELLING (swelling the size of a golf ball at the injection site). At the time of the report, VACCINATION SITE RASH (Rash the size of a golf ball at the injection site) and VACCINATION SITE SWELLING (swelling the size of a golf ball at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient felt rash an swelling in the size of golf ball at injection site.   No Treatment medication was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
No 2nd dose due to COVID pandemics, 1st dose 2020; This case was reported by a other health professional via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received first dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's comments: A health care professional had reported that several patients did not receive the second dose at the time of reporting, due to the COVID pandemics. The reporter did not consent to follow up. The case was linked with case US2022168178, reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2022168178:Same reporter. 2019 case.
Pt arrived at ED, DOA; was previously seen on 12/17/21 at the ED after a MVA and found to be positive for COVID; per death certificate pt died in the ED with the cause of death being COVID 19
Arm pain near injection site that started 3hrs after and increased until pain was almost unbearable in the evening and through the night. I also had headaches the next day, lots of fatigue, strong body aches around neck and upper back, lightheadedness, and chills. I made sure to sleep as much as possible, drink plenty of fluids, eat well, and took vitamins.