chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination adverse reaction; Weakness; chest pain; chest inflammation; agitation; legs pain; sometimes weak; Muscle aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation) and AGITATION (agitation) in a  patient of an unknown age and gender 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 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), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation), AGITATION (agitation), PAIN IN EXTREMITY (legs pain), ASTHENIA (sometimes weak), MYALGIA (Muscle aches) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), ASTHENIA (Weakness), CHEST PAIN (chest pain), INFLAMMATION (chest inflammation), AGITATION (agitation), PAIN IN EXTREMITY (legs pain), ASTHENIA (sometimes weak), MYALGIA (Muscle aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication listed.   No treatment information provided.
Patient received an extra dose. Patient came by pharmacy on 7/25/22 with his vaccination card showing only 3 doses of Pfizer i.e., 2 intial and 1st booster. He asked to get his 2nd booster so we gave it to him and filled out his vaccination card for the 2nd booster. On 7/27/22, patient called the pharmacy and informed us that his daughter told him that he already had received his 2nd booster months ago so this makes the vaccination given to him on 7/25/22 as 5th dose.  There was no notation on his vaccination card that they gave him his 2nd booster.
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 09-JUL-2014, the patient was vaccinated with an expired dose of ROTATEQ oral fluid, 2 ml orally (lot# J003464, expiry dose: 08-JUL-2014; indication unspecified). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
dose of PNEUMOVAX 23 was administered intradermally by a medical assistant; red raised area "the size of her pinky"; red line running down her arm, to her; This spontaneous report has been received from a nurse referring to a 66-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 21-MAR-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 ml, (lot #U039721 had been verified to be a valid number; expiration date 10-AUG-2023, and upon internal validation established as the same date) administered intradermally for prophylaxis (strength was not provided) (Incorrect route of product administration).  On an unspecified date in March 2023, the patient experienced a red raised area "the size of her pinky" (vaccination site erythema) and a faint red line running down her arm, to her deltoid (erythema). The outcome of the events was not provided.  The causal relationship between the events of vaccination site erythema and erythema, with the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
(Temp 98.3) Persisted crying for 3 1/2 hrs. Slight redness and swelling in leg with vaccine. Mom gave no TYLENOL at home. In office ice packs applied to thighs and TYLENOL given. Infant calmed in 20min. Able to breastfeed.
approx 10min p/vax pt felt a rush, heart racing, sweating;VS checked in ER;sl pale & diaphoretic;
Patient developed lip swelling (angioedema) 16 hours after the vaccine.  It was not itchy but felt some pressure. Symptoms resolved after 2 doses of Benadryl. She had taken one dose of OTC Ibuprofen 1 1/2 - 2 hours prior to developing lip swelling but has no history of allergies to NSAID?s or any other medications.  She also had headache, bodyaches and fatigue .
Patient was achy and had nausea and vomiting, felt real bad, had diarrhea and dry heaves, had a low grade fever. Informed patient to keep fluids going.
This spontaneous report was received from a physician refers to a male patient of unknown age. There was no pertinent medical history and there were no drug reactions or allergies reported. On unknown dates the patient was vaccinated with dose 1 and 2 of RECOMBIVAX HB 1 ml, intramuscular (lot number reported as J008227 and expiration date unspecified, for dose number 1 and 2 in the series). The patient received the third dose on an unknown date (lot # J008505, expiration date 07-FEB-2016) 1 ml, intramuscular. Thimerosal status of the vaccine was not reported. There were not concomitant medications reported. On an unknown date the patient experienced negative hepatitis B titers. The physician reported that the patient had the titers measured 31 or 32 days after the third dose, and they measured less than 5 which was determined to be negative. No additional symptoms were reported. it was reported that there was no treatment given for the patient. There was no product quality complaint (PQC) involved. The outcome of the event was reported as not recovered. The causality of the event was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Extreme soreness. Tiredness for half an hour. Strep like symptoms 2 weeks later. Strep test done but negative. Pain in lympth nodes. No fever and mild soreness in muscles. Pressure on forehead and headache that lasted 3 days possible 4 days.
Injection was given low on upper arm, below deltoid. Became red, swollen, and painful in 12 hours, worsening over  3 days, resolved in 5 days.
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 1:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 1:45 AM, 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 32.41 for dose administered on 28-Feb-2021.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 and 26 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-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 degrees Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No concomitant and treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Within a minute of receiving the vaccine, patient slumped back in the chair, head back, eyes open. He was unresponsive and shaking in the chair. After about 20 seconds he came to and leaned forward but wasn't oriented to time and place. As I was talking to him, trying to assess his breathing, he slumped back in the chair and began shaking much more violently.  I asked the store director to call EMS at that point, I took his mask off at that point to better assess his breathing. After about 15 seconds, he came to again. At that point, I had him lean forward with his elbows on his knees, and he didn't lose conciousness after that. I took his blood pressure (70/22) and pulse (52, light and hard to find). EMS arrived soon after and at that point patient felt much better. EMS decided not to transport the patient to the ER. They instructed patient to follow up with his provider. Patient left the vaccine area under his own power about half an hour later.
Sore arm at the time of injection. 24 hours later developed chills, fatigue, headache and itchy, red, hot rash at injection site.
JOINT PAIN IN WRIST AND SHOULDER; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 02-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced joint pain in wrist and shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain in wrist and shoulder. This report was non-serious.
Patient given the vaccine in her L) arm, she was very nervous and anxious about getting the vaccination. She felt well and took a seat afterwards. About 10 minutes after, she began itching on her chest and back. PHN assessed for respiratory distress. She was not experiencing any breathing difficulties, no swelling in the face or mouth, lips or tongue. No other symptoms other than itching and what appeared to be a small little "prickly heat" like bumps on her chest, where observed. Approximately 15 minutes after the vaccine was given, she took 50mg of Diphenhydramine with a glass of water. She was under observation for about 20 more minutes without increase in symptoms. She called her daughter for a ride home.   Upon follow up on 3/11/21 at 1:00pm: Patient said she went home on 3/10/21 after her daughter picked her up and changed clothes, did not observe any rash, crawled into bed and "slept hard until morning". She woke up with a headache (not a migraine) slight fever, no itching. She was sleeping at the time of the call, woke to answer the phone .
Fever 100.3 w use of ibuprofen, hard chills, very swollen arm at injection site preventing movement, pain in arm. All symptoms abated in 48 hours.
pt recv vax & exp noc sweats & dizziness;pt has hx of MS;
Patient complained of localized itching and swelling at subcutaneous site of immunization.  Patient denied any generalized symptoms or dyspnea.
09/08/2021 that night she began to run a fever and very quickly had severe nausea, she could not keep solids down. Could keep fluids down though. That lasted for a week. 09/13/2021 took her to ER.
pt admitted to hosp with difficulty breathing; pt was positive for COVID; placed on BIPAP; DNR; pt's condition worsened and O2 saturations declined; pt was pulling mask off and stating she was ready to quit wearing the mask and die; pt's family was called in to be with pt; pt died in the hosp with family around her
Heart was racing; fever of 101.4; nausea; Body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart was racing), PYREXIA (fever of 101.4), NAUSEA (nausea), MYALGIA (Body aches) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ0A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020. Concomitant products included ANASTROZOLE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced TACHYCARDIA (Heart was racing), PYREXIA (fever of 101.4), NAUSEA (nausea), MYALGIA (Body aches) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Heart was racing), PYREXIA (fever of 101.4), NAUSEA (nausea), MYALGIA (Body aches) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 101.4 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: No specific follow-up information recorded.
Received phone call at 4:30pm. Stated child was seen in office today for reaction to vaccine received in Right Deltoid (Pneumovax). Stated red, swollen area around injection site, no fever, warm erythema with mild edema on right upper arm, no infection noted. Stated was a local reaction and mom was advised to watch area for cellulitis and to return to office in 2-3 days if no better.
Having a stabbing pain in the center of her chest, went on for a few days. Was taken to the dr whom advised them to  take her to the ER.
Felt like the flu.  Then a few days later ears started to ring and has been ringing ever since
Unable to life sore arm for about 48 hrs , headache , and a sore scald, light nausea when done eating  and fatigue
Pediatric dose administered to an adult; Pediatric dose administered to an adult; Pediatric dose administered to an adult (27th October 2022); Pediatric dose administered to an adult (27th October 2022); This case was reported by a nurse via call center representative and described the occurrence of underdose in a 71-year-old male patient who received HBV (Engerix B pediatric) (batch number ZP72S, expiry date 15th December 2024) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number ZP72S, expiry date 15th December 2024) for prophylaxis.   On 23rd November 2022, the patient received the 2nd dose of Engerix B pediatric. On 27th October 2022, the patient received the 1st dose of Engerix B pediatric. On 27th October 2022, not applicable after receiving Engerix B pediatric and unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On 23rd November 2022, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose, adult use of a child product, underdose and adult use of a child product were unknown.     Additional Information: GSK receipt date :27 Jan 2023 Reporters comment: The nurse reported that the patient received 2 pediatric dose a month apart. Consent to follow up via email.  Additional supportive information. As an adult patient received 2 pediatric dose which led to adult use of child product and underdose.
Initial misuse case was received from a healthcare professional on 29 OCT 2013. Cases were received on 21 March 2014 at agency. A 4 month old patient whose demographic details, medical history and concomitant medication were not reported received a dose of FLUZONE QIV vaccine on an unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received a vaccine of incorrect product. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
Information has been received from a physician concerning a "happy and healthy" 17-week-old female who on 25-JUN-2007 and 29-AUG-2007 was vaccinated with a first and second dose, respectively, of ROTATEQ (lot# 656390/0236U, 657459/0509U). Within 24 hours of the second vaccination, on approximately 29-AUG-2007, the patient experienced dark tarry stools. Medical attention was sought, the patient's parents phoned the office. Subsequently, the patient recovered from dark tarry stools within 5 days onset. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a pharmacy student refers to a female patient of unknown age. On 27-SEP-2014 the patient was vaccinated with a first dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) at her unspecified physician's office and then the patient received the second dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) at an unspecified pharmacy on 29-SEP-2014. No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
On the 8th day following the vaccine, I noticed in the morning that my arm was red in the area of the vaccine site.  Later in the day, it became quite itchy, and then a bit swollen.  The itching went away overnight, and then eventually the redness and swelling went away, probably by the end of the 2nd day.  I hadn't signed up with V-safe, yet, but decided to do that a couple of days after this happened.  I intended to report this symptom on V-safe, but I couldn't figure out how to enter anything after the fact.  I understand now that this has happened to some people, Moderna Arm?!  And the photos I've seen look much like what I had, and the description, in terms of when it started and the how it manifested, was right on target.  I'm not especially concerned about this, but it was odd at the time, and it was good to learn that this has happened to others.  My intent in reporting it is just to help contribute to your understanding of numbers, how many people have experienced this, how often it happens.  If there is a better way to do that, please don't hesitate to let me know!
swelling of arm p/vax & subcutaneous nodule still present p/3wk;
- Chills: started same day as second dose, after 10-11 hours of receiving the shot. Lasted for 24 hours intermittently  - Nausea, dizziness, tiredness , hot flashes, muscle pain: started the day after receiving the second dose, around 19 hours of receiving the shot. Lasted for 14 hours approx. - Sudden blood pressure drop, cold sweats: started 3 days after second dose (today). Blood pressure in 9/6. Recovered after laying down for a while.
Tested positive for COVID-19 after taking booster; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19 after taking booster) and DRUG INEFFECTIVE (Lack of drug effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032120A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Spinach.), Hyperprolactinemia, Hashimoto's thyroiditis (hyperthyroidism), Palpitations and Vitamin D deficiency. Concomitant products included ALBUTEROL SULFATE, DICLOFENAC, ESOMEPRAZOLE, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 03-Feb-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 9:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after taking booster) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for COVID-19 after taking booster) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported. The patient received a 0.25 ml booster dose on 21-Dec-2021.  Company Comment: This spontaneous case concerns a female patient of unknown age with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test). Drug ineffective was also considered (COVID-19 occurred approximately 9 months post-completion of primary vaccination of mRNA-1273 within recommended interval). The event of COVID-19 occurred 6 days after the booster dose of mRNA-1273 vaccine. Patient did not have any signs and symptoms associated with the event. She did not seek medical care nor received any treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-503460 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test). Drug ineffective was also considered (COVID-19 occurred approximately 9 months post-completion of primary vaccination of mRNA-1273 within recommended interval). The event of COVID-19 occurred 6 days after the booster dose of mRNA-1273 vaccine. Patient did not have any signs and symptoms associated with the event. She did not seek medical care nor received any treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Palpitations and shortness of breath occurred within 10 minutes of receiving injection. These synonyms lasted for 8+ hours. Also extreme fatigue, lightheadedness, "brain fog", lethargy began 3-4 hours after injection and continue into the second day.