chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle aches; unable to get out of bed; stomach issues; This case was reported by a consumer and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced muscle pain, bedridden and stomach discomfort. On an unknown date, the outcome of the muscle pain, bedridden and stomach discomfort were recovered/resolved.   It was unknown if the reporter considered the muscle pain, bedridden and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and in early February. Three or four days later was unable to get out of bed. Muscle aches like I had never felt before paralyzed me. The side effect of the shingrix vaccination, it was like no side effect I had ever experienced from a vaccination. However, two days after the onset of the side effects were completely free of the aches and stomach issues.  This case linked with US2020AMR070663, reported by same reporter.
Complaint: Patient's other complaint today is that she developed bruising to both legs in the past few weeks.  Contributing medical hx/Additional Narrative: Patient reports she has been doing some work outside but doesn't remember hurting her legs. She denies bleeding disorders in the family. Patient reports that she did have a blood clot in the left thigh after being hit by a softball. Otherwise has not had any other blots or bleeding issues. Patient does report that she has tended to bruise easily in the past.    Patient also reports she thinks the bruising started AFTER her first covid vaccine was on 4/1/21 and she had her last dose last Friday on 4/23/21. Patient had Pfizer vaccine.
Whole upper arm was red with hives; Warm to touch but not itching; Sore for a few days; Arm more tender, very itchy and developing a rash; Rash, swelling and itching on the injection site; Rash, swelling and itching on the injection site; Rash, swelling and itching on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore for a few days), PRURITUS (Arm more tender, very itchy and developing a rash), VACCINATION SITE RASH (Rash, swelling and itching on the injection site), VACCINATION SITE SWELLING (Rash, swelling and itching on the injection site) and VACCINATION SITE PRURITUS (Rash, swelling and itching on the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore for a few days) and PRURITUS (Arm more tender, very itchy and developing a rash). 11-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash, swelling and itching on the injection site), VACCINATION SITE SWELLING (Rash, swelling and itching on the injection site) and VACCINATION SITE PRURITUS (Rash, swelling and itching on the injection site). On 19-Feb-2021, the patient experienced ERYTHEMA (Whole upper arm was red with hives) and FEELING HOT (Warm to touch but not itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site swelling, Vaccination site pruritus and Vaccination site rash, at an unspecified dose and frequency. On 14-Feb-2021, VACCINATION SITE SWELLING (Rash, swelling and itching on the injection site) and VACCINATION SITE PRURITUS (Rash, swelling and itching on the injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore for a few days) had resolved, PRURITUS (Arm more tender, very itchy and developing a rash), ERYTHEMA (Whole upper arm was red with hives) and FEELING HOT (Warm to touch but not itching) outcome was unknown and VACCINATION SITE RASH (Rash, swelling and itching on the injection site) was resolving.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: No specific follow-up information recorded.
Red rash that was hot to touch and slightly itchy. The rash grew from approx. 2 1/2 inches in diameter to 4in x 6in in diameter to 12in x 6in. Treated with ibuprofen and ice, no effect. Treated with one antibiotic, no effect. Treated with another antibiotic, began clearing up within 36 hours.
Flare of back pain for one month following Enbrel dose, when previously arthritis was stable. Then back to baseline.
Information has been received from a nurse, via a company representative, concerning herself, a 61-year-old female, who on an unspecified date received a dose of ZOSTAVAX (Merck) (lot number, route and injection site not reported) for shingles prevention from her primary care physician (information not provided).  Subsequently, she developed itching at the injection site for 3 weeks.  The patient sought unspecified medical attention and recovered on an unknown date.  Additional information has been requested.
Dizzy two hours after shot, general fogginess, headache, red, swollen arm at injection site for 4 days. Red, swollen arm went away completely then returned much worse on day 8 and got worse for 4 days then started to go away. During the 16 days since the vaccine I have had swollen joints, general malaise, fogginess, extreme dizziness and headaches everyday where working and driving is not possible.
sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was more diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: May2021), via intramuscular route of administration on 26Jan2021 at 11:30 at 0.3 mL, single on the left arm for COVID-19 immunization. Medical history included ongoing migraine and vomiting. Concomitant medications included ongoing sumatriptan succinate (IMITREX) for migraine, ongoing nadolol for migraine, ongoing sertraline for migraine, and ongoing ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). On 26Jan2021 at 13:00, the patient experienced really bad migraine. The patient always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea. The husband does not know if it was because of the shot or if it was because of the warm front that they are receiving because sometimes that can trigger her migraines. The husband reported that it was pretty typical for her and she will sleep with a fan on, but today she is actually covered up (for clarification) and does not want the fan on. Patient also started sweating and got nauseated on an unspecified date. The husband wanted to know if he needs to take her to the doctor. The outcome of the events really bad migraine and diarrhea was not recovered while the other events was unknown.
This spontaneous report was received from a health professional (nurse) refers to multiple unspecified patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were unspecified. On an unspecified date, the patients were vaccinated with improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Fever started at 2:30 am fever of 103.4 headachea and chills. Muscle aces and soreness.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (Lot # L024268, 01-JUL-2017, dose, route and dose number were unspecified). No adverse effect was reported. This is one of two reports received from the same source. Additional information is not expected because there was no consent for contact.
About 12 hours after vaccine, I experienced severe, intense, terrible diarrhea, lasting for several hours. I had red rash across my arms, legs and belly. My blood sugar crashed.  I had "brain fog" and was very confused.
Arm  Sore; A spontaneous report was received from a consumer concerning a 23- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in arm.  The patient's medical history was not provided.concomitant medications included,Larin for birth control.   On 16-jan-2021,prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 16-jan-2021,the patient experienced arm sore until today. No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the event pain in extremity was considered as unknown at the time of the report.
Patient was administered Pfizer Monovalent Booster (FP7150) instead of Pfizer Bivalent Booster (GH9702). Vial was covered with sticker and incorrect medication was administered to the patient. The patient was called and made aware of the situation. Patient did not require treatment.
high injection,  was given a covid vaccine superior deltoid area and developed shoulder pain 2hrs later . Was seen in ED and advised use NSAIDS and ice. Has bruise at the injection site, and states cannot abduct arm; seen by ortho, now gettng PT,  has f/u ortho 2/17/21
25MAY96 elevated temp;26MAY96 t103, restless;APAP given nap in PM;awake from nap around 5PM;sz hosp ER 520PM
Patient admitted to hospital for Elective Induction of pregnancy, diagnosed with shingles by care provider
Beginning the day following the injection, I started having significant bursitis-like shoulder pain. This has been relatively constant for the five months subsequent to the inoculation.  The pain is significant but tolerable. I cannot raise that arm over my head. Also, direct pressure on the site where I presume the injection was made causes a slight dull ache.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 11:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 11:18 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 50.51 for dose administered on 28-Apr-2021.  Concomitant medication information was not provided by the reporter.  Vial was moved to fridge on 19-Apr-2021. Batch number 007C21A underwent temperature excursion on 28-Apr-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. Product moved to clinic on 28-Apr-2021. Beyond use date for the vial was reported as 19-May-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
I did not have an adverse event after receiving the vaccine. I tested positive for COVID-19 in November 2022. I contacted my doctor to give an update. I was offered PAXLOVID but declined because I felt my symptoms were mild. I rested a lot and isolated. In December 2022, I noticed an ache and stiffness in my right knee. The pain progressed in January 2023. A few weeks later, the pain was so paid I was waking up in the middle of the night. I had tried ibuprofen to help with the pain, but it wasn't helping. I got a prescription for a higher dose of ibuprofen. At this point, it is determined that I have osteoarthritis in my right knee.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe
This spontaneous report as received from a pharmacist refers to herself. The pharmacist was reporting she inadvertently stuck the syringe needle into one of her fingers after withdrawing reconstituted ZOSTAVAX into a syringe on 23-OCT-2014. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Sore arm at injection site; Vaccine cleared his sinuses; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore arm at injection site) and THERAPEUTIC RESPONSE UNEXPECTED (Vaccine cleared his sinuses) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Sore arm at injection site) and THERAPEUTIC RESPONSE UNEXPECTED (Vaccine cleared his sinuses). At the time of the report, INJECTION SITE PAIN (Sore arm at injection site) and THERAPEUTIC RESPONSE UNEXPECTED (Vaccine cleared his sinuses) 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 24-Apr-2021: No new information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            No treatment drugs provided.  No concomitant drugs provided.  Action taken with respect to product mRNA-1273 was  not applicable.
This spontaneous report was received from a physician via an online article, referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated by her mother who was a nurse, with GARDASIL (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The article reported that the girl on an unspecified date developed leukemia and died. I was unknown if an autopsy was done to the patient. The reported did not mention the causality assessment between the events of leukemia and death with GARDASIL.  Upon internal review, leukemia  and death were determined to be medically significant.; Sender's Comments:  US-009507513-1710USA004070:
administration of only the adjuvant portion of the vaccine; administration of only the adjuvant portion of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 16th July 2021, the patient received Menveo. On 16th July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional case details were reported as follows: Age at vaccination was not reported. Pharmacist reported the administration of only the adjuvant portion of the Menveo vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The diluent was administrated on the same day of reporting.  The reporter had no details about the patient nor the expiration or lot number of the vial.  No further events were reported.  Health care professional (HCP) agreed to be contacted for follow-up.
Red area about the size of golf ball on injection site; Itching on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red area about the size of golf ball on injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red area about the size of golf ball on injection site) (seriousness criterion medically significant) and VACCINATION SITE PRURITUS (Itching on the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red area about the size of golf ball on injection site) and VACCINATION SITE PRURITUS (Itching on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided. Treatment medication information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication listed.   No treatment information provided.
Enlarged bilateral neck lymph nodes within 45 min after receiving the Moderna vaccination. Right neck lymph node decreased to a smaller size approximately 4 days after vaccination however Left neck lymph node had remained visibly enlarged since vaccination (10/22/21) and remains enlarged to current date (11/08/21). Flu-like symptoms for 3 days following vaccination and then fever and flu-like symptoms again on 11/01/21 with the addition of left armpit node swelling and right inguinal nodes swelling, low blood pressure, fatigue, fever and chest tightness for 36 hours on 11/01/2021.  Current date (11/08/21)  fatigue and swollen left neck lymph node still remains with slight difficulty swallowing due to left node and intermittent chest tightness.
Shoulder pain, unable to move the arm without pain in shoulder. Trouble sleeping without pills. Tx anti-inflammatories, pain relievers and physical therapy. This have persisted during a 8 months. The pain is worst but at least I can sleep.
Redness, heat, pain, excess swelling, hard lump, chronic itch, small amount of blistering.
Information has been received from a consumer concerning his son who in approximately 04/00 was vaccinated with one dose of varicella vaccine. Subsequently, the pt experienced a severe case of chickenpox, It was noted that the pt was home from school for a week.
Localized pruritic rash and mild headache occurred 1 day after injection. OTC remedies for symptomatic relief and instructed to keep rash covered. Instructed to return to clinic or ER if symptoms worsen acutely or don't resolve within 10 days.