chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, DYSPNEA, CHEST PAIN, TREMOR and DYSTASIA in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included LEVOTHYROXINE and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA, DYSPNEA, CHEST PAIN, TREMOR and DYSTASIA. At the time of the report, ASTHENIA, DYSPNEA, CHEST PAIN, TREMOR and DYSTASIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment reported as none.
4 hours post vax, the pt experienced 1-2 hours of screaming and then 3 days of fussiness and low grade fever.
I had a fever the day after having the vaccine, after the fever on 05/18/21 I started experiencing heart palpitations and what felt like an elevated heart rate. I felt heart palpitations (a heavy heartbeat sometimes followed by a racing heart) every 1-5 minutes for the first week. My heart rate was in the normal range, but it still felt fast. I was not able to sleep well the week after getting the vaccine.  The heart palpitations decreased over the next weeks, and appeared to go away completely at approximately 1 month (06/18/21).
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe
Swelling and redness to left upper arm left upper arm also warm to touch. Pt. given ROCEPHIN IM and oral clindamycin. Pt went to urgent care on 01/24/13 and followed up with PCP on 1/25/13. Left arm better on 1/25/13. During administration of vaccines pt struggled and fought. Pt had to be restrained. That is the reason all 4 vaccines were placed in one arm.
A non-serious, spontaneous report of administration of expired product was received from a health professional concerning a 13-year-old female. On 20-Aug-2010, the patient received FLUMIST which expired in March 2010. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
HAD + COVID PCR TEST ON 7-25-22, DECEASED 8-16-22:  HAD ACUTE RESP FAILURE, CIRRHOSIS, COPD, COMMUNITY ACQ PNEUMONIA ALSO PER RECORDS, SMOKING HISTORY, HTN
itchy palm and foot, painful sores/blisters on palm and foot, abdominal pain, nausea, loss of appetite.  ultrasound, blood and urine test, dermatology and pediatric follow up.
Initial dose of COVID-19 vaccine received was Pfizer (LOT # ER2613) at Hospital on 3/20/21 at 10:04am.  Second dose of COVID-19 vaccine received was Janssen (LOT # 201A21A, Exp 08/07/2021) on 06/16/2021.   No known adverse reaction.
pt recv vax 14APR97 & 30APR97 pt exp a fever of 102 to 103;
Quadracel that was given to the wrong age group/no AE; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 10 months old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] that was given to the wrong age group/no ae (Product administered to patient of inappropriate age)  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation.  On 09-Jan-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5500CA via intramuscular route in the right thigh.  On 09-Jan-2020, the patient received non-serious Quadracel that was given to the wrong age group/no AE (product administered to patient of inappropriate age) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  This is a case of actual medication error due to product administered to patient of inappropriate age.  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.
pt presented to ED with 3 days of increasing SOB; positive for COVID in ED; treated with dexamethasone, remdisivir, tocilizumab; on 15 L O2 via NC; oxygenation worsened requiring ICU and intubation; bronchopleural fistula secondary to heavy hx of vaping and cigarette use; was eventually made a DNR;  comfort measures; extubated and patient expired in the hosp
the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician and refers to a 4-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 24-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355, expiration date 14-OCT-2021, subcutaneously (exact dose, dose number and vaccination site were not provided) as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (lot # S032591, expiration date 16-AUG-2022).  Administered dose of vaccine was exposed to the temperature excursion of 13.6 degrees Fahrenheit for 12 hours (reported as multiple excursions) and 16 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved.
Sore arm for first 3 days, then extreme and anxiety pain in cervical spine. Nausea, dizziness and burning sensation in all four limbs (especially in hands and feet). Four months later, I developed chronic back pain in thoracic spine and shoulder blades.
Emotional lability; weepy; anxious; unfocused; This is a spontaneous report received from a non-contactable consumer (patient). A 37-year-old-female patient received dose 1 of BNT162B2 (PFIZER-NIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 08Apr2021 at 17:15 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included nebivolol (BYSTOLIC; 10 mg) and amfetamine aspartate, amfestamine sulfate, dexamfetamine saccarate, dexamfetamine sulfate (ADDERALL; 10 mg) from unspecified dates for unspecified indications. The patient did not have any allergies to medications, food, or other products. On 09Apr2021 at 20:00 the patient experienced emotional lability the day following the vaccine. It was similar to the feeling of no sleep and too much coffee- weepy, anxious, and unfocused. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of emotional lability, weepy, anxious, and unfocused were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
initially had aches, low grade fever, chills for 3 days; then in june i had severe abdominal pain and liquid stool x 4 days so went to the ER; was discharged without medication, only received iv hydration; i continued with mild to moderate abdominal pain on and off, and somewhat loose stool, for about 3weeks; then exactly one month after the ER visit i again experienced severe abdominal pain and frequent and watery stool x 24hrs; no ER visit; continued with mild abdominal pain x 5days; not sure if any of this is related to the vaccine but i'm a little concerned and thought it best you got this feedback
Information has been received from a physician assistant via a company representative referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown. On unknown date in 2018 (reported as a couple weeks ago), the patient was vaccine with ZOSTAVAX and PNEUMOVAX 23 (strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis. Other suspect therapy was sterile diluent (strength, dose, frequency, route, lot #, expiration date and indication were not provided). The physician assistant reported that the patient received the ZOSTAVAX and PNEUMOVAX 23 on the same day. The patient was immuno-compromised at the time of receiving both vaccines and then developed "unspecified issues. The outcome of the event was reported as recovered. The reporter's causality assessment was not reported.
The night of January 31, 2023, I began feeling nasal congested with a sore throat. The next morning, I woke up with the same symptoms. I tested positive for COVID-19 on February 1, 2023. I called my doctor and asked for prescription for PAXLOVID. I began taking this on February 2, 2023. The sore throat went away after 3 days. I had a low-grade fever off and on for about 6 days. The congestion lasted for two weeks. I tested negative on the 7th and 9th.
Information has been received fro a consumer concerning her 6 year old female daughter who on 13-APR-2001 was vaccinated with a dose of Varivax (lot # 635192/1133K). About eleven days ago, on approximately 27-AUG-2006 the patient developed chickenpox. About 9 days after the first lesions developed, all of the lesions seemed to clear. Eleven days from when the rash first started, more lesions seemed to form. The lesions were found on her face, back and stomach. No other symptoms were noted. Medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 2, single (Lot number: ER8727) at the age of 71 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 29Nov2022 to 03Dec2022.   Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot ER8727 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8727, fill lot EP8679, and the formulated drug product lot EP8566. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Reddened blotchy rash under arm Wed evening & spread to abd & gotten larger; Temp 100 (R). Rash bright red raised wheals.
Sore arm, lethargic, losing balance, headache, swollen lymph nodes, poor circulation, body aches
Patient received Moderna COVID-19 vaccine IM in the Administration clinic. During the observation period, patient reported feeling flushed, warm, sweaty, with lip tingling. Vital signs 138/95, HR98, 02 Sat 98%. Proceed out call. Patient transported via wheelchair to ED for further monitoring.   In ED, monitored with resolution of tingling of the lips, cheeks still with slight flushing to them. No sob or abd pain or tongue/lip swelling, no worsening rash. Encouraged followup with working well clinic. Patient was discharged home 4 hours later.
2-4 minutes after administration, began feeling very hot, with sweating. Vision blurred, hearing started to fade, and eventually fainted. Was fine nearly 10 minutes later. Was unconscious for about 10 seconds.
The pt received Pneumovax 23 and ended up having adverse reaction to the vaccine. Her upper arm is swollen and red and she has radiating pain in the shoulder on her left arm as well. The pt was informed that the Dr will call her if it is necessary to visit them. She was happy with the fact that we would be reporting this event to VEARS. She was adviced to go to the dr's office if she doesn't feel better in a couple of days.
patient initial request pfizer covid -19 vaccine on consent form, however patient has last minute change due to side effect concern and requested Moderna covid-19 vaccine instead. We missed the age requirement for Moderna covid vaccine and gave the patient Moderna covid 19 vaccine.
This spontaneous report as received from a nurse refers to an unspecified number of patients. On an unknown dates, the patient were vaccinated with an unspecified number of doses of MMR II (lot#, albumin status, dose, route and site of administration were not reported) that were reconstituted with sterile diluent (manufacturer unknown). The doses were reconstituted with 0.6 ml of sterile diluent (manufacturer unknown) and were not reconstituted with the entire volume of the supplied sterile diluent (manufacturer unknown) as recommended in the prescribing information 0.5 ml of vaccine was drawn up for administration after reconstitution. No adverse events were reported. Product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA That evening started with headache, muscle aches, nausea. About 4:30 am next morning I got up to use bathroom and passed out for unknown length of time.  I tried to go back to bed and passed out two more times. The 3rd time my wife says my eyes rolled back in my head and she could not arouse me for 3 to 5 minutes. I went back to bed to sleep. Several hours later I was still to dizzy to stand and had a knot on the back of my head from the falls.  We called 911 and I went to ER at Hospital  for further evaluation.
''after 2nd dose had pain in arm, chills, and tiredness for about 30-40 hours''.; ''after 2nd dose had pain in arm, chills, and tiredness for about 30-40 hours''.; ''after 2nd dose had pain in arm, chills, and tiredness for about 30-40 hours''.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Mar2021 10:45 (Lot number: EN6208) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Haital Hernia" (ongoing); "osteoporosis" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, Time: 01:00 AM, Anatomical site of injection: arm left, Route of administration: Intramuscular, Batch/Lot number: EN6200), administration date: 27Feb2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "Euphoria", "high pitched buzz in right ear", "Nausea", "very mild pain in vaccine spot". The following information was reported: PAIN IN EXTREMITY (non-serious), CHILLS (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "''after 2nd dose had pain in arm, chills, and tiredness for about 30-40 hours''.". Therapeutic measures were taken as a result of pain in extremity. Therapeutic measures were not taken as a result of chills, fatigue.  Additional information: Vaccine facility type was reported as other facility. After 1st dose she had euphoria for 1-2 hours, then high pitched buzz in right ear for several minutes, then nausea for cca half hour. Next day had very mild pain in vaccine spot. Took 2X 1/2 Tylenol and pain ointment with magnesium for achy pain. Nothing really serious. Prior Vaccinations (within 4 weeks) was reported as None. The reporter assessed the events as non-serious.  No follow-up attempts are possible. No further information is expected.
A red rash is appearing near the spot where I got my vaccine. It is itchy. I believe it is called ?Covid arm.? It feels a little warm. I noticed that it started itching and then I looked at it and it was red.  It happened aroung 8:50-9:00 while I was working out.
Headache started at 11:00 a.m on the same day. Nausea started around 3 p.m the same day. The next day, 4/3/2021 I experienced fatigue and nausea all day. 4/4/2021- fatigue, nausea, diarrhea
Human Resource representative called me 2/11/15 at 3:30P to tell me that patient passed out at work. They thought it was due to vaccines patient received for credentialing on 2/10/2015 - I called him and he said he had felt faint and had fallen to his knees. He was assisted into a chair - he said he was "out" - lost consciousness for a few seconds - he states he had a cold 1 week before but was not sick at time of vaccines - he said he had felt chilled and had right earache before he fainted - states he feels fine now - resting at home at 4:PM 2/11/15. Follow up 2/13/15 - no further complaints.
Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00771, 2012-00773, 2012-00774, 2012-00775 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, date, route and site of administration not reported) and an unspecified amount of time later experienced "headache, blood shot eyes, itchy eyes, swollen eyelids, then for next 2 days weak, nausea, fatigue, temperature 99.9, then eyes improved but for 2-3 more days continued to have nausea, fatigue and swollen injection site." It was unknown if the patient had any illness at the time of vaccination, had any pre-existing medical conditions, took any concomitant medications or had any other vaccinations within 4 weeks of FLUZONE. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Patient was sitting on the exam table and received the 3 vaccines (HPV, Tdap, meningitis), she tolerated the vaccines very well and was laughing and talking to her mom.  The CMA turned round to place the tray on the table to wash her hands and the patient passed out and fell to the ground.  She was on her stomach and the left side of her face was on the ground.  Found to have a permanent tooth that was hanging out of her mouth and bleeding. Intact tooth was retained.  It was noted that adjacent teeth also seemed to be loosened with the fall.
quite a bit of muscular; joint pain in the area where she received the shot; feels like her muscle is going to tear; This is a spontaneous report from a contactable consumer or other non health care professional. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization at Clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first ad-ministration date of the suspect vaccine. It was reported that reporter states he did want to say that he thinks is very relevant, his employee had the Pfizer shot and she has quite a bit of muscular or joint pain in the area where she received the shot and its ongoing, if she goes to reach for something, she feels like her muscle is going to tear. Patient verifies she received the Pfizer Covid vaccine. Patient unsure of LOT, , Expiry date. Patient unsure of which arm she received it in. Patient unsure of date received the vaccine. Patient states she received the shot because she works in a hair salon and mostly for the compliance aspect and to resolve COVID but also to think about the community and stuff too. Reporter verifies he is unsure of dosage and it was given by injection. The adverse events did not result in emergency room and physician office. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
1 week post vaccine last evening approx 1130 pm while putting steroid cream (treatment for eczema) noticed right shoulder area red, warm and itchy.
I first got a headache, and then I got cold symptoms. My nose was running and I developed a dry cough. Then we tested and I tested positive for COVID19. I took Mucinex severe cough medicine and Tylenol for the headache. After I tested positive I called the doctor's office and we had a video conference. She thought I was doing alright and had no trouble breathing so I didn't need Paxlovid, and she said to call back if I had trouble breathing or if symptoms got worse, which they never did. I think we didn't do so bad because we had all our vaccinations.
This spontaneous report was received from a nurse refers to a 45 year old female patient. The concurrent condition included allergy to sulfa and DEMEROL. No medical history was reported. On an unknown dates in 2003, the patient was vaccinated with 2 doses of VARIVAX (Merck), one month apart. No concomitant therapy was reported. On an unknown date, after vaccination the patient had an unspecified blood test performed to determine the patient's varicella immunity. The test determined the patient was seronegative for varicella immunity. The patient sought medical attention. No treatment was given for the events. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Pt came for well visit on 10/13/08. At that time reported to me that when pt got her Gardasil #1 on 9-22-07 about 1 week later pt began to fall her legs were weak, she had decreased sensation. She also had experienced numbness and tingling. She has seen ortho and neuro. MRI of spin and brain normal. Better  now some improvement, occas has symptoms 11/20/08-records received-office visit 10/10/07-At age 7 diagnosed with OCD is stable-repeats selft serveral times when worried. Rarely smiles or laughs. DC: Obsessive-Compulsive Disorder. Office visit 1/29/08-increasing ruminating thoughts and checking rituals have improved still some OCD thoughts. Anxious at times. Office visit 6/3/08-Doing well. 11/17/08-continues to do well overall.