chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the patient's husband referring to his wife, a 75 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 (batch # reported as MJ1356, expiration date 15-OCT-2017, dose not reported) intramuscularly in left arm near the shoulder. On 29-JUL-2016 (reported as "the next morning"), the patient could not move her left arm, had chills, fever and was shaking. Therefore, the husband took the patient to an unspecified emergency room. The patient vomited violently on the way to the emergency room. The patient was given unspecified intravenous (IV) fluids in the emergency room and kept for several hours. The patient still had soreness in the left arm and the left hand was swollen. The outcome of the events was reported as not resolved. The causality between PNEUMOVAX 23 and the events was not provided. Lot number MJ1356 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Face tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Face tingling) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (Face tingling). At the time of the report, PARAESTHESIA (Face tingling) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was provided.  The patient also had other symptom which she could not explain.
BODY ACHES; CHILLS; MENSTRUAL SPOTTING; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any drug abuse, illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A,expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 22:00, the subject experienced menstrual spotting. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from menstrual spotting, chills, and body aches. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Fever 103; pain at injection site on day of admin. Fever 100-102, mild pain and swelling at injec site on day 2. Treated with ibuprofen and ice pack.
Patient came to Pharmacy today for his J&J vaccine along with his wife who also received her vaccine as well. After I administered the vaccine, the patient got light headed and I asked him if he would like to lay down. Before he could respond, the patient collapsed off his chair hitting the side of the plastic trash bin in our patient care room. I caught him before he hit the ground. I asked if he could hear me after saying his name a few times, no response. I assessed his subjective vitals and could tell he stopped breathing. Called for Pharmacy resident to grab and administer an epi pen. Patient responded within 30 seconds of epi pen administration and started breathing again. Proceeded to call emergency services, first responders arrived within 5 minutes and administered IV fluids and oral ondansetron. Patient left with the ambulance and will follow up tomorrow to make sure everything is ok.
Redness; Injection site warmth; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   On 9th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient had a injection site reaction to Shingrix. The reporter stated that just underneath the injection site was warm and red, no swelling nor breathing problems.
Upon receiving vaccine pt immediately stated she felt lightheaded, then stated it was becoming worse and passed out in chair in vaccine booth. Assistance called pt lowered to floor and then assisted to w/c when fully awake a few moments later. Pt stated she immediately felt better. Pt escorted to back recovery area and vitals taken by staff and monitored. VS were as follows HR 88, Resp 20 and BP 92/70. No injuries or abnormailities noted
Nausea vomiting diarrhea for 1 day. No medication treatment was given just clear liquid diet. All s/s resolved in 24 hours.
immed p/vax pt fine got up from chair as walking towards door slowly collapsed & fainted;pt caught a/hit the floor;opened eyes immed p/no injuries noted VS BP 84/60, P80, R18;monitored for 15 min pt had no complaints;
Dose number: 3; I am age 50 and have an IUD/I began having periods again.; I am age 50 and have an IUD/I began having periods again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 09:00 (Lot number: 320030BD) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; BUSPAR; VITAMIN D [COLECALCIFEROL]; CALCIUM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 17Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 07Apr2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "I am age 50 and have an IUD /  I began having periods again.", "I am age 50 and have an IUD /  I began having periods again.". The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 09:00, outcome "unknown", described as "Dose number: 3"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I am age 50 and have an IUD/I began having periods again."; MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "I am age 50 and have an IUD/I began having periods again". Therapeutic measures were taken as a result of menstrual disorder, menstruation irregular.  Additional information: It was reported that, the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient had not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
15mins post vaccination pt c/o numbness to L cheek which self resolved w/ 30mins of observation. Vitals: 170/92 -- > 160/82 -- > 152/88
Patient developed shingles (Herpes Zoster) in distribution of supraclavicular nerve on left.
Mild headache starting about 18 hours after vaccination & lasting throughout the day worsening around 24 hours after vaccination. Acetaminophen was then given resulting in reduction of headache pain prior to bedtime.
Hives, swelling, trouble breathing, an accelerated heartbeat, changes in behavior, dizziness, and weakness.
I got my shot and started feeling lightheaded. I also had a metal taste in my mouth. As I was speaking, I fainted. I was given Benadryl and was sent home. The next few days, I had chills, headaches, body aches, stomach pain and tingling in my fingers. A few days later, I felt disconnected from myself. It was not a normal feeling for me. I was sitting with friends and family laughing when all of a sudden, my left side body went heavy and stopped working. I went to the ER had a CT scan, brain scan, heart scan and was tested for a stroke. I went home and went to a PCP who suggested I was having a panic attack. We did tests that were not conclusive. Currently, I experience the heaviness 3-4 times a day. Sometimes it's short and sometimes it will last for 20 minutes. My thyroid was also tested but I don't think it came back with concerns. I had none of these symptoms prior to the moderna vaccine. I was prescribed a medication for panic attacks, but I was experiencing suicidal thoughts, so I was immediately taken off.
lt arm red raised area size of baseball 9JUN98 c/o sore arm, vomited x 1, T100;
9/1/04 DTaP, IPV, MMR given; 9/2/04 red swollen left deltoid; 9/3/04 worsening of symptoms and itching.
pt recv vax & devel hives;pt went to ER & was given epi;f/u correspondence 14MAY98 pt had wheezing on arrival to ER:pt was reported to have recovered from this exp;
This spontaneous report as received from a licensed practical nurse refers to a 9 weeks old male patient. The patient was inadvertently vaccinated with lot # (671517/1068AA expiration date 09-MAY-2012) VAQTA intramuscularly in the right thigh on 25-APR-2012, instead of RECOMBIVAX HB. No adverse effects were reported. Additional information has been requested.
Patient states that he was feeling dizzy after he waited in observation for 15 minutes. Patient became unsteady, pale, and started to fall and was lowered to the ground by staff. Patient was talking and then became unresponsive for 15-30 seconds. Patient had a pulse and was breathing and 911 was called. Patient became responsive and states that he fell asleep and was dreaming.  Blood pressure was 86/49. States blood pressure is usually low. Patient drank 2 apple juices and 2 waters. EMS arrived took blood pressure and patient's pressure returned to his baseline and was responding appropraitely.
Swelling of Lymphnode in chest/shoulder near injection site.  Within 2 days it was visible swelling (large).  Within 30 days the enlarged lymphnode caused 2 fractures in shoulder/arm at swelling site (also near injection site).  Diagnosed with diffuse large B-cell lymphomas (DLBCL).  PET Scan showed majority of cancer was at injection site but did spread into other lymphnodes as well.
65 by 45 millimeter pink rash in area of DTaP with firmness beneath the skin. Began after immunization then got better in a few days but then came back.
Pt with swelling from shoulder to just above elbow, area was inflamed. Treated with SEPTRA due to PHx of MRSA.
Mom notes that shortly after vaccines were administered she developed swelling and redness at the injection site. Warm to the touch.
2 Varicella given in one day from two different healthcare facilities.  At Public Health, parent circled on the Vaccine questionnaire that the patient has had a vaccine in the past four weeks. I, RN, saw that question was circled and I specifically asked which vaccines that this patient had in the last four weeks. The mother stated Covid. I repeated to her that the patient only received a Covid in the last four weeks and the mother stated, yes.    Also, I reviewed database for this patient and confirmed that this patient needed a MMRV. At that point, I went to draw and administer the MMRV.  Once the MMRV was administered I noticed that a Varicella was given this morning on the same day from peds, which was not there earlier in database.   Immediately, I informed the mother, my boss, and the patient's provider, FNP's office staff from peds.    I educated mother to look for symptoms of a possible reaction and if there are any reactions to call the patients provider, FNP.    Patient stayed in office 15 mins after injection, no sign or symptoms of a reaction in office.
Arm pain and rash at injection site, tremors, very cold, fever, joint and body aches, no appetite, diarrhea sleep, extra strength Tylenol, fluids , rice 4 days before all symptoms subsided
Developed macular-papular itchy rash of trunk and extremities 3 days after.
Note from provider: woke up 3/28 with fevers and body aches, temp 3/28 102 degrees F, 3/29 103 degrees F in office, legs felt weak, no neuro changes, no pain at injection site, labs drawn were negative. Patient called back 3/31 and stated symptoms were worse and going to ER.
Can´t stand; Does not want to eat; Is vomiting; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Can´t stand), DECREASED APPETITE (Does not want to eat), VOMITING (Is vomiting), PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Can´t stand), DECREASED APPETITE (Does not want to eat), VOMITING (Is vomiting), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ASTHENIA (Can´t stand), DECREASED APPETITE (Does not want to eat), VOMITING (Is vomiting), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
This is not an adverse event. CDC information line recommended that a VAERS report be submitted for this situation. Reporting a partial dose administration. Patient reported that after injection, there was clear fluid running down his arm. Nurse administering vaccine reported that amount was minimal, but patient reported that it was a large amount. Most likely cause was that the needle was not seated well on the hub of the syringe which could have cause a leak. However, this cannot be verified. Unable to quantify how much vaccine that patient received. Called Moderna's medical line after received that is report on 1/25/21, and reached medical information  on 1/27/21 Moderna-EUA Medical Information Inquiry Response. Received guidance that if there is a deviation from the recommended dose or schedule that additional doses should not be given. If there is a partial dose administration, do not repeat that dose. Proceed with 2nd dose at 4 week interval. This guidance was shared with the patient.
This spontaneous report received from a patient concerned a male of unspecified age. 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUL-2021, the patient experienced loss of bladder control. On 15-JUL-2021, the patient experienced slurred speech. On 15-JUL-2021, the patient experienced occasional loss of balance. On 15-JUL-2021, the patient experienced sharp pain sensation in feet. On 15-JUL-2021, the patient experienced tingling sensation in feet. On 19-NOV-2021, the patient experienced boils on lower extremities. On 19-NOV-2021, the patient experienced red splotches on torso. Treatment medications (dates unspecified) included: syzygium aromaticum oil.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient had not recovered from loss of bladder control, slurred speech, tingling sensation in feet, occasional loss of balance, red splotches on torso, boils on lower extremities, and sharp pain sensation in feet.This report was non-serious. Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
patient initiated a series with a Hepatitis B vaccine and then received 3 doses of VAXELIS which is also counts as Hepatitis B immunization; No additional AE reported; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not reported.  On an unknown date (reported as "0 months"), the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (manufacturer unknown) for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported). Then, on unspecified dates (reported as 2, 4 and 6 months), the patient was vaccinated with 3 doses of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported), which was also counted as hepatitis B immunization (interchange of vaccine products). There was no additional adverse event (AE) or product quality complaint (PQC) reported.
Narrative:  Patient complained of itching after the COVID vaccine. Pt's BP was elevated at 179/79; he has autonomic dysfunction with fluctuating BP. Pt's pulse ox was 97-100% on Room for the duration of one hour of observation. Pt did not  have any facial swelling or swelling of the mouth/tongue. His pulse was regular. Lungs were clear. No wheezing. Pt's vitals were checked every 10mins. Except for the elevated BP which started to come down, his vitals were stable. Except for pruritis he did not complain of any other symptoms. Denied sob. ***Of note, allergist phone visit at a later date states patient said he had facial swelling and redness (?); this was not noted in the original physician observation note immediately after vaccination.***
A HCP called with a question about VARIVAX and reported an AE. The HCP reported that patient came into the pharmacy yesterday and stated they had one dose of VARIVAX as a one year old. The patient is currently 26 years old and has not received a seco; No additional adverse event reported; This spontaneous report has been received from a pharmacist regarding a 26-years-old of unknown gender patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On an unknown date in 1998 (also reported as when the patient was 1-year-old), the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, frequency, lot # and expiration date were not reported) as prophylaxis.   On 05-OCT-2023 (also reported as yesterday), the patient went to the pharmacy and reported that she/he had not received a second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX). The patient requested was requesting a second dose. No additional adverse events were reported.
received vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-403046, MOD-2021-403077, MOD-2021-403096, MOD-2021-403116, MOD-2021-403134, MOD-2021-403138, MOD-2021-403147, MOD-2021-403151, MOD-2021-403166 (Patient Link).
Patient received yellow fever vaccine on Monday 8/24 just prior to departure on 8/25. He became ill with high fever (104.5) and myalgia, (more specific to back pain) on 8/29. The fever lasted approx 2 days but back pain persisted.  During this time, the patient returned home. He was contacted by the nurse on Monday 8/31 and stated that the fever had improved and he was feeling somewhat better.  He had returned to work.  On 9/5 the patient started experiencing shooting pain down his leg.  By 9/6, he was unable to walk due to numbness in the the limb.  He did not report for work on Tuesday 9/8 and make an appointment with his family physician.  At this time he has completed a five day course of steroid therapy and states that he has seen some improvement in the leg pain but it has not resolved completely. 9/24/09 PCP office note DOS 9/8/09. Assessment: lumbar disc displacement. Patient presents with low back pain of 2 weeks duration, radiates down right leg to foot.
Administration error. Patient received pediatric Pfizer formulation at age 12; she should have received the adult 12+ Pfizer formulation. No adverse reactions, signs or symptoms were noted or reported during the 15min observation period. Patient's parents will be notified of need for adult formulation of second Pfizer vaccine on 12/7/21.
At approximately 10:00am on 1/5/2020 the client received her first Moderna vaccine.  At approximately 10:15am while waiting the 15 minutes  client said to the paramedic on site she felt like her throat was swelling and had SOB. BP 211/110. A physician arrived on the seen and instructed the paramedic to start an IV. Fire Rescue call at 10:47am and she was taken to medical facility via ambulance.   She was evaluated and released home.
congestion in her chest and throat; Body aches; Vomiting; Nausea; Chills; Fever; dosn't feel good; lost her sense of taste and smell; loss of taste; A spontaneous report was received from a 56-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, chills, nausea, vomiting, body aches, not feeling good, loss of taste and congestion in her chest and throat.    The patient's medical history, as provided by the reporter, included COVID-19 infection in November 2020.  Concomitant product use was not provided.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, approximately nine and a half hours after the vaccine was administered, the patient experienced fever, chills, nausea, vomiting, body aches and loss of taste and smell. Later, she experienced some congestion in her chest and throat. Treatment for the event included paracetamol.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, fever, chills, nausea, vomiting, and body aches, were considered resolving. The outcome of the events, loss of taste and smell, were considered resolved. The outcome of the events, congestion in her throat and chest, were considered unknown.; 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.