chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine some came out of the syringe, outside the patient/no AE; cracking sound when applying the needle to the syringe/no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult patient who received partial dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (pre-filled syringes).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a partial dose of dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route.  It was of actual medication error due to Vaccine underdose and syringe issue..Reporting clinic staff complaint that Fluzone Quadrivalent pre-filled syringes crack and leak during preparation for injection.  It was unknown whether adverse event was experienced or not..  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
3 days after couldnt move talk. burning pain in chest moved down to arms  . Same thing happened 3 days after the 2nd vaccine. still having same issues but more frequently
MMR given subcutaneously right deltoid area. Within 3 minutes became flushed, chest pain, tachycardia. Taken to ER for treatment. Was hospitalized overnight, released next day with no restrictions.
Both left and right arm presented in the office to be extremely inflamed, red and warm to the touch
Headache, Myalgia, Fever, SkinRash, NauseaVomiting, swollen lymph nodes, chills Narrative:  Other Relevant History:
Patient received second dose of Janssen and Janssen vaccine on 12/4/2021.  About 12-13 minutes after the injection the patient reported lip sensitivity and palpitations.  Denied chest pain.  Lip color within normal limits.  Vitals remained stable.  Patient was monitored for an additional 15 minutes without incident.  Patient left vaccine clinic stable. Patient aware to inform PCP of incident.
Pt recvd 3 doses of Engerix-B approx 4 hrs p/3rd dose pt devel flu-like sx; gradually progressed to serum-sickness like synd w/vascular skin rash, arthritis, arthralgia, back pain, facial swelling & fever;
School did not accept Engerix-B peds 0.5 ml dose as indicated in package insert and built into EMR
patient started noticing swelling on his arm that spread down to about his elbow, starting yesterday. he woke up and it was more red, but he hadn't noticed it getting any worse since he woke up. patient states he had no other symptoms except the swelling but found it unusual since he has had shots before and no problems. he has had a flu shot last year with no problem and the prevnar13. this year he received the flu shot and pneumovax 23 when it occurred. he  just wanted to let us know and said he would keep an eye on it and let us know if it got worse or if he wanted to go get it looked at or etc.
5 YO with history of afebrile seizure x1 10/04 cm no reds, neg EEG, CT. No further seizures. 9/1/05 received Dapt, MMR, IPV 4PM less than 1 hr, later had staring, generalized seizure. EEG +. No fever, 9/3/05 reported erythema swelling at Dapt site. Discharge summary states personal distress, vomiting.
Big blue bruise; Did not receive the full second dose/warm fluid running down her arm; A spontaneous report (United States), was received from a consumer (patient), concerning herself, a 69 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced big blue bruise (contusion) and did not receive the full second dose/warm fluid running down her arm (incorrect dose administration).   The patient's medical history was not provided. Concomitant medications were ibuprofen and cefixime.  On 13 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch N0: 011M201A), intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Batch N0: 048A21A) intramuscularly in the right arm for prophylaxis of COBID-19 infection.  On 13 Mar 2021, same day, the patient noticed that warm fluid was running down her arm. The person giving the injection soaked it up with a cotton swab and told her that she was okay. The patient was concerned that she didn't receive the full second dose as her arm was not sore this time, although it did have a big blue bruise. The patient went to a pharmacy and asked someone about it and was told that maybe they didn't hit her muscle but rather hit below the muscle. Treatment information not provided.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of event, big blue bruise was not reported and that of event, did not receive the full second dose/warm fluid running down her arm was considered as resolved on 13 Mar 2021.; Reporter's Comments: This case concerns a 69 years-old female patient who was experienced did not receive the full second dose/warm fluid running down her arm (incomplete dose administration) mRNA-1273 (Batch #; 048A21A) and experienced big blue bruise.  Based on temporal association, a causal association between the event if big bruise and product use cannot be excluded.  The event of incomplete dose administered is considered not applicable.
Large area of heat + erthema to right vas lat- area covered top of thigh + inner thigh area.  Diagnosed with Cellulitis and placed on Augmentin
1st dose  Severe stomach pain,, stomach swelling, shortness of breathe and passing out. It too approximately three week for the pain in my stomach to go away
This spontaneous report was received from a female patient of unknown age referring to herself. There was no information about the patient's concurrent conditions, medical history or concomitant medication provided. On 01-MAY-2018, the patient was intramuscularly vaccinated with a dose of GARDASIL 9 (exact dose, lot# and expiry date were not reported) for prophylaxis. Later on that day she found out she was pregnant. No adverse effect were reported.
This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265].  Both vaccines gave me a reaction, and both around the same time the next morning.   My reaction to my 1st vaccine included slight fever, aches, and chills.  Both doses were administered around 3:30pm and reaction was approximately 10:30-11am the next morning.  On this 2nd dose, roughly 40 minutes after waking from sleep, I became mildly nauseas. I sensed I would vomit, so I sat down on the commode with a bucket in front. I started getting the sweats, got very cold, and my arms starting shaking. I started to feel the room spin, saw big black dots, and after banging on the wall to alert my husband something was happening, I fainted and passed out cold.  My husband saw me fall face down, and after waking me, I was in a panic, did not know where I was, or how I was on the floor. I passed out a 2nd time, at which point, my husband was able to get me to the car and he took me to the local hospital. I was incoherent on the car ride, moaning, and not knowing what was happening. My eyes remained closed until I was wheeled into the emergency area and they asked me my name.  I was taken to a private room, where they hooked up a blood pressure cuff, an oxygenator on my finger, and took several viles of blood. I was then taken to the cat scan room for a brain scan, and several hours later, was given a chest xray.  I remained in the room for approx 6 hours, where I was becoming more and more aware of where I was. I had not eaten/drank anything, except a cup of water. I had not used the lavatory.  The PA came to me hours later stating all my tests came back negative, and they could not determine what happened, xrays and blood tests were good, and cat scan was good.  He said that while they couldn't determine what happened, they would recommend a stay, so they can do more extensive testing.  I contacted my husband via cell, told him what they said, and after another 1 1/2 hours, I made the decision to release myself as I was feeling more like myself again, albeit tired.  I went home that evening, ate a small dinner, went to bed, and by 12 Noon the next day, I was fine again.
Pt called  5/6/2021 regarding of covid vaccine side effects. Noted pt has no emergency s/sx. Pt stated she got 1st covid vaccine Pfizer 5/1/2021  and pt got headache(pain score 8/10), eye pan and burning sensation on eyes, cough, runny nose, sore throat, loss of taste and smell for 3 days. Pt is taking tylenol and OTC allergy medicine Zyrtec. Noted hx of DVT, asthma, severe obesity (BMI 51.2). Pt is taking wafarin regularly. Pt scheduled urgent care visit 5/6/2021.
Caregiver received her 1st COVID vaccine on 12/28/2020 and her 2nd on 1/19/21 (EL1283) and became symptomatic on 5/8/21, testing positive on 5/11/21
breastfeeding; A spontaneous report was received from 28 year old female patient who is also a nurse. The patient is a participating in the mRNA-1273 Emergency Use Program and experienced breastfeeding with the use of mRNA-1273.    Medical history included allergy to vancomycin, sulfa, and bees. Concomitant medications included Prenatal vitamins (nos).  On 28 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Dec 2020, the patient, experienced the non-serious event of breastfeeding. The patient reports she had the vaccine and is currently breastfeeding. There was no treatment information provided.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the reported event of breastfeeding was unknown at the time of this report.  Causality was not provided for the event of breastfeeding.; Reporter's Comments: This report refers to a case of Maternal exposure during breastfeeding for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case.
PT had severe local rxn--swelling & redness over shoulder--upper arm to elbow--"like a balloon";
Within an hour after vaccine, arm was sore and I felt draggy; She was in bed that night by 6pm because she could not stay up; Felt hot at night; I felt draggy; Joint pain; Muscle pain; Fatigue; Head was killing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Within an hour after vaccine, arm was sore and I felt draggy), UNEVALUABLE EVENT (She was in bed that night by 6pm because she could not stay up), FEELING HOT (Felt hot at night), FEELING ABNORMAL (I felt draggy) and ARTHRALGIA (Joint pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Total hip replacement. Concomitant products included EZETIMIBE (ZETIA), FENOFIBRATE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Within an hour after vaccine, arm was sore and I felt draggy), UNEVALUABLE EVENT (She was in bed that night by 6pm because she could not stay up), FEELING HOT (Felt hot at night), FEELING ABNORMAL (I felt draggy), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Head was killing). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Within an hour after vaccine, arm was sore and I felt draggy), UNEVALUABLE EVENT (She was in bed that night by 6pm because she could not stay up), FEELING HOT (Felt hot at night), FEELING ABNORMAL (I felt draggy), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Head was killing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fainted, seizure event happened 2-3 minutes past injection. Appeared rigid lasted 8-12 seconds child alert past event. Stated he had not had any liquid intake since breakfast, gave Gatorade in office. Child left office alert and responding appropriately.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-FEB-2017, the patient was vaccinated with expired doses of VARIVAX lot # L002871 and expiration date: 27-JAN-2017 (strength, dose, frequency, route and site of administration were not reported) and M-M-R II, lot# L003855 and expiration date: 05-FEB-2017 (therapy type, strength, dose, frequency, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
nausea; vomited; stomach pain; experienced diarrhea; This spontaneous report was received from a consumer via a company representative referring to a 14-year-old male patient. Information of the patient's medical history, concomitant medication and concurrent condition was not reported.   On the evening of 09-JAN-2023 (also reported as 09-JAN-2022), the patient was administrated with 1st dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (strength, lot #, expiry date, anatomical location and route of administration were not reported) for prophylaxis .  In the middle of the night in January 2023, the patient woke up with stomach pain and experienced diarrhea. During the morning on 10-JAN-2023, the patient experienced nausea and vomited one time. Diarrhea resolved on 10-JAN-2023. The stomach pain continued as of 11-JAN-2023(also reported as today's date (11-JAN-2022)). The outcome of stomach pain was considered as not recovered. The outcome of nausea and vomited was not reported. The causal relationship between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
Pain and soreness at the injection site which started approx 4 hours after vaccine and lasted approx 72 hours. Malaise and fatigue that started approx 4 hours after vaccine and lasted for 48 hours. Headache that started approx 4 hours after vaccine and has lingered one week later; as of reporting headache has not resolved.
Swollen, red, itchy rash at shot site. One week later from the shot. Taking Benadryl
not feeling great; sleepy; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling great), SOMNOLENCE (sleepy), HEADACHE (headache) and FATIGUE (tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced FEELING ABNORMAL (not feeling great), SOMNOLENCE (sleepy), HEADACHE (headache) and FATIGUE (tired). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 27-Mar-2021, FEELING ABNORMAL (not feeling great), SOMNOLENCE (sleepy), HEADACHE (headache) and FATIGUE (tired) had resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  No concomitant medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
pt recv vax 20MAR97 & 17APR97 pt had transient inc liver function test results;MD visit was required in connection w/the event;
Client suffered a stroke on 02/11/21 which caused client to fall while getting into shower.  Client hit his head during fall causing a brain bleed and also broke his left shoulder.  Client was transferred to hospital via ambulance and admitted to hospital.
Office would draw up all COVID booster vaccines at the beginning of the day and discard vial. They kept a sticky note with bivalent  NDC, lot and expiration date and used that data to enter into the EMR. At some point the realized that on some days they had pulled and administered monovalent instead of the bivalent booster as intended. Office is unable to say with certainty who received monovalent or bivalent.
Welps/raised itchy patches on my face, hairline and neck when I overheat due to workout.
Symptoms presented next day with large red rash and swelling at injection site and covering side of upper arm down to the top of elbow area and hot to the touch. Patient presented at urgent care and cephalexin was prescribed and circle was drawn around the rash to see if it would get worse. Rash seems to be getting better at time of reporting .
This spontaneous report was received from a 51 year old female patient with asthma and migraines (since she was five) who was reporting on herself. The patient did not have any drug reactions or allergies. On an unknown date in approximately 2010 at 3 PM (reported as "about 5-6 years ago"), the patient was vaccinated with a dose of PNEUMOVAX 23 1 shot, once (strength, lot # and expiration date not reported). The patient's concomitant therapies included ZYRTEC and unspecified vitamins. On an unknown date in approximately 2010 (reported as "by morning of the following day, a Thursday" after vaccination), the patient could barely walk. She was also debilitated by pain which she described as "worse than excruciating back labor, on a scale of 1-10 the pain was one hundred, it went through her body like wildfire". By Friday the pain reduced to "50 on a scale of 1-10." It went down again on Saturday to about 10 on a scale of 1-10. The pain continued to lessen and by Monday, the pain was completely gone. That was the day she was scheduled to see her physician. There was nothing more to be done at that point but they did give her some pain pills. It was reported that no treatment was given to the patient and no laboratory studies were performed. The patient recovered from the events on an unspecified date. The patient did not get any pneumococcal vaccines since that time. She stated that she had all of her normal vaccinations without any issues. The patient considered the events to be related to PNEUMOVAX 23 and life threatening, she stated that PNEUMOVAX 23 "nearly killed her". Additional information has been requested.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. The reporter stated that since 16-JUN-2015, the patients were vaccinated with doses of VAQTA (Lot # K019560, expiration date 02-JUN-2017; lot # K008333, expiration date 10-MAR-2017; lot # K010579, expiration date 12-FEB-2017) (doses and route were not specified), which were exposed to temperatures outside of the recommended range. No concomitant medications were reported. No adverse experience had been observed or reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Initial unsolicited report received from a pharmacist (Director of pharmacy) on 12 Oct 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, , 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189846, 2016SA189846, 2016SA189847, 2016SA189848 (same batch number). This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number: UI669AA, expiry date: 30 June 2017, dose, dose in series, route and site of administration were not reported) intramuscularly on 04 Oct 2016 (over the past month). Illness at the time of vaccination was reported as and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not reported. On an unknown date (over the past month), following the vaccination, the patient had developed Aches, chills, pounding headache past 2 days (systemic reaction) and big red welt on left arm, warm to touch (local reaction). The patient required ER/doctor (Pharmacy department) visit. The patient's laboratory data was not reported. The patient did not take any treatment. The outcome of events was unknown. List of documents held by sender: none.
approx. 5 minutes after vaccine administration, patient reported lightheadedness, tingling in toes.   Patient complained feeling like "throat closing" but no - objective skin, respiratory or GI signs.  VS: 160/99, HR 158, POX 100% R/A at 11:42        138/113, HR 135, POX 100%, R/A at 11:45        168/100, HR 112, POX 100%, R/A at 11:47 Epinephrine 0.3mg subq given via Epi Pen at 11:43 in the right leg Patient was sent to ER for further evaluation at 11:50 am via ambulance Patient was monitored briefly in ER without further intervention, and then discharged home
8-31-09 @ 7:30 pm - lower right thigh red - dime size, upper right thigh slightly red, low grade fever, pain 9-1-09 PREVENAR @ 7 am - red, nickel size, 12:20 pm, red, raised - warm > lower (R) thigh upper (R) thigh remains red, low grade fever, pain 4:15 - in office : upper (R) thigh 3/4 in x 1 in - red, lower (R) thigh 2in x 1 in warm, raised, red - saw MD gave TYLENOL every 4 hrs since injection 99.2 degrees.
COVID19 positive; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID19 positive) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced COVID-19 (COVID19 positive). At the time of the report, COVID-19 (COVID19 positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     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. No treatment information was provided.