chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states she has been suffering for 9 months; Adversities have impacted her daily life; Whether she is going to die, She does not think she will survive; everyday she cannot stand or walk; everyday she cannot stand or walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EMOTIONAL DISTRESS (non-serious), outcome "not recovered", described as "Caller states she has been suffering for 9 months"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "Adversities have impacted her daily life"; FEAR OF DEATH (non-serious), outcome "not recovered", described as "Whether she is going to die, She does not think she will survive"; DYSSTASIA (non-serious), GAIT INABILITY (non-serious), outcome "not recovered" and all described as "everyday she cannot stand or walk".  Additional information: Caller stated the patient had been suffering for 9 months. It had impacted her earnings. Adversities had impacted her daily life and she was not recovered. Stated everyday she could not stand or walk. She did not think she will survive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme pain in legs for approximately 12 hours. Pain in left arm and also right arm.
No adverse affects reported; patient received an extra dose of VARN AX after receiving PROQUAD; Information has been received from a nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/ allergies was not provided.       On 07-AUG-2019, the patient an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R008394, expiration date 20-MAR-2020; frequency and route of administration were not reported) for prophylaxis after receiving measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number, expiration date, frequency and route of administration were not reported) for prophylaxis also on 07-AUG-2019 (extra dose administered). No adverse affects were reported.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001697 is a spontaneous case report initially received on 27-Jul-2022 from a health care professional via agency (reference number: USBAV22-0690) and concerns a *52-years-old female patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), intramuscularly (IM), at a dose of 0.5 mL, at the *right deltoid* for pre-exposure prophylaxis (PrEP) (explicitly coded as Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.   At the time of this report, it was known that the patient did not experience any adverse events due to Jynneos vaccination.  This case is linked with case no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from Bavarian Nordic on 29-Jul-2022 included an additional reference number. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 52-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at the right deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 52-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at the right deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Infant came in for immunizations. No illnesses. Rec DTaP #3 and hep B #3. Cried for few minutes, mother gave bottle, infant coughed, cried some, mother placed her on car seat. Nurse talking to infant, infant developed blank stare and would not focus to doll or look. Removed from car seat, stimulated took deep breth-skin warm and dry to touch, no breaking out on rash or hives. Pulse rate 200, respiration 38. 7/11/02 infant acted listless at times but would arouse. Monitored, talked with pediatrician and he felt not allergic reaction but possibly vasovagal or something. Pulse 150, R 32, no respiratory-MD felt that parents just needed to monitor her but if any change take to ER. Infant remained at clinic for approx. 1 hr and stable when left pulse rate 120, R 30, skin remained warm and dry to touch, alert when leaving. Talked with mother at 6pm and infant okay. Talked at 11am on 7/12/02, infant has had no further problems appear to be normal.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-JAN-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Ear ringing loud and consistent. Still ringing as of today. Tried antibiotics and did not correct it. Went to nurse practitioner 4/21.
Initial information received on 22-Jun-2018 regarding an unsolicited valid serious case received from a consumer/non-HCP. This case involves 18-year-old male patient who experienced vomiting, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Jun-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5848A via intramuscular route in the left deltoid. On an unspecified date, the patient developed a serious vomiting, 30 minutes following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event during 2 days. The patient was discharged on 19-Jun-2018 (hospitalization during 2 days). Laboratory investigation was not reported. Final diagnosis was vomiting. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for vomiting. Documents held by sender: None. Sender's Comments: This case involves an adult patient who experienced vomiting 30 minutes' post vaccination with MENACTRA. Time to onset is compatible with the role of vaccine. Vomiting is expected with MENACTRA vaccination. However, patient's medical history, medical condition at the time of vaccination, previous vaccination and its tolerance and lab investigation excluding other etiology were not provided. Based upon the available information, the role of vaccine cannot be assessed.
High heart rate, lack of breathing, puffy face, numb arm, beach ache , nausea , chills.
Pt. states that after receiving the 2nd dose of Shingrix 08/05/2021, started experiencing fever (100.0), body aches, chills, eye pain, arm soreness, headaches, shivering, and nausea. Continuing through present, planned Primary visit if continues.
About April I felt more ear ring apparently. I check up with my family Doctor. He referred me to Doctor. Then, E.N.T Doctor. Then, Dr referred me to do Brain MRI. Finally, no problem found.  The tinnitus symptom is stronger apparently and continue after Moderna Vaccine. Do you have any things to share me about this matter?
This spontaneous report has been received from a 65 years old female healthcare worker concerning herself. The patient's medical history and concurrent conditions were not reported. The patient reported that she was allergic to ciprofloxacin and that she experienced hives following an administration of this medicine; she was also allergic to sulfa drugs and also reported ENBREL did not work for her. On 16-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX lot number L029484 and expiration date 10-JAN-2016 (dose and route of administration were not reported). Later, eight hours after administration of ZOSTAVAX, the patient experienced itching and redness at the injection site. The reporter noted that no rash had developed. The patient did not sought medical attention. On the same date, 8 hours after the onset of the symptoms, the patient recovered from her injection site pruritus and injection site redness. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
I was a very healthy fit female, not overweight.  I received the shot due to working in dental care.  Shorty after I started having severe sciatica.  I can't sleep at night it is so painful.  I can't even sit on my couch or drive a car without having severe nerve pain.  I thought it would go away, but it is not.  It has been close to 3 months since my shot and there is no improvement.  I also developed inflammation in my eyes right after the shot and had to see an eye doctor to treat that.  It has made my nervous system flare up with inflammation and ruined my life.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a sore arm after receiving the first dose of Shingrix vaccine This resolved within a couple of days. The reporter did not provide any additional information regarding the event. For tolerance after 2nd dose, refer case US2020AMR221923. This case has been linked with US2020221335, reported by same reporter. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221335:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:2nd dose, same patient
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route not reported) lot # J011211, expiry date 31-JUL-2014. No symptoms were reported. Additional information has been requested.
Client received Fluzone '06-07' influenza vaccine at 2:20 pm. At 2:40 pm employee health notified he was cold, clammy, diaphoretic. He was transported to the Emergency  Care Center per wheel chair. Placed on chart, vitals were stable. No other treatment. Discharge from hospital 20 minutes after arrival.
Case PHEH2016US023451 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 44 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into right arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Initial stick "felt" high upon left arm. With injection of Flu Vaccine, a shooting pain was felt around shoulder and down arm. Rest and NSADIS x3 weeks with no improvement. Starting to lose ROM in shoulder. Pain continues to wake me at night - especially if I turn over on the left arm.
6x8 cm thigh induration at vaccine site. Treated with Benadryl and cool compress. Began next day
Severe pain in right arm (injection arm). Unable to extend arm in any direction. Unable to sleep due to pain. No swelling, no temp, no redness. Just awful pain and inability to use arm. Took Advil with no relief. Used warm compresses.
Patient reporting numbness in both arms and legs which began 4 days ago (4/10/2021). Numbness comes and goes and increases in intensity throughout the day. Patient also reports extreme fatigue and headaches that have not resolved since vaccination date (4/5/2021).
1.6 mL of Normal Saline diluent was used to dilute COVID 19 Pediatric vaccine instead of the recommended 1.3 mL. Parents called and notified information sheet to be sent to the parents. Per safety protocol called Pubic Health and Pfizer and their instructions for the parents were that there is no need to repeat the dose the child is to get the second dose 21 days from the first dose.
Neck ache, fever at 103F, nausea, sore throat, urinary & bowel urgency, dizziness, chills, spotting menstrual blood
MOTHER REPORTS CHILD HAD HIVES AND STOMACH ACHE. STATES SHE GAVE HIM BENADRYL AND S/S RESOLVED WITHIN 12 HRS.
Full body hives on legs, back, stomach and face. These lasted for approximately a week. I contacted my doctor on April 12th, and I believe my symptoms lasted a few days after that. The hives were not particularly itchy and they went away on their own.
I experienced prolonged symptoms of myocarditis for a period of four months that started 10 days after receiving the second dose of the Moderna vaccine.    Upon waking up one day after the second dose, I could not stand for more than 2 minutes and felt like I would collapse whenever I stood up or tried to walk anywhere.   The day after I received the vaccine, I began experiencing severe fatigue that resulted in me sleeping 10-14 hours per day and being incapacitated for exactly nine days.  I be All I could muster the energy to do was eat two meals a day and shower every few days.  I began experiencing chest pain on the tenth day that worsened when I drank even the slighest amount of caffeine, attempted to exercise, raise my left arm while sleeping on my stomach, and, scarily, at random times during the day.  The pain was akin to that of muscle soreness at the sight of my heart.  I continued taking acetomeniphen when symptoms arose. On a few occassion, I experienced a frightening,  fast-paced butterfly-like fluttering heart beats that resulted in me immediately checking my blood pressure and heart rate.  While my pulse results were always normal, my blood pressure, at times, was slightly lower than normal while within normal range for adult my age.  I experienced greater difficulty breathing while wearing masks during this period but attributed this to my Asthma. I attempted to use the internet every day to try to find out the cause of my symptoms but information regarding the vaccine-myocarditis connection was not made public until around June 12, 2021, and I did not have a doctor at the time.  While all of the  public information appeared to support that the myocarditis was a temporary,fleeting and not a cause for concern, my symtoms were neither fleeting nor tempoary.  My symptoms began to subside in earl August 2021 but returned on and off through early September 2021.  I continued experiencing pain whenever I unconsciously turned to my left side or attempted to raise my left arm to my head while sleeping.  In early September 2021, however, I felt the same pain and heart palptiations that I felt in May after attempting to drink a mild cup of coffee.  It was not until after experiencing no symptoms for a period of two weeks that I discovered that my symptoms had completely disappeared by drinking a mild cup of coffee and failing to experience any chest pain.  I have not experienced any heart-related or chest pain symptoms since September 2021 but have recently had the Moderna boster shot.
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic (HC) that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of HA / HC. The regulatory authority website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Palpitations 7:30pm; severe pain right arm, headache begins 10:00pm; chills, severe entire body pain, inability to move or touch right arm, shortness of breath, headache changes to migraine like symptoms begins 10:30am; ER visit, morphine administered, Percocet prescribed begins 12:00pm; rash from inches above elbow to inches below shoulder on right arm, swelling between elbow & shoulder, headache, exhaustion, nausea begins roughly 06:00am 04/21/2012; able to move right arm slightly begins 04/22/2012; see responsible physician 04/24/2012 for rash, continued headache, arm pain, nausea, exhaustion, low grade fever and prescribed Percocet, bacterium 800mg twice daily for 10 days; seeing physician again 04/26/2012 for continued complaint.
The flu vaccine was administered erroneously into subcutaneously tissues as evidenced by the injection site and the reaction site being low and to the right of the landmarks of the deltoid muscle.  The reaction that occurred was redness, warmth, raised area, and puritis.  No systemic symptoms were noted such as fever. The reaction began to occur about a day after the injection and the symptoms lasted for 5 days.  The peak of the reaction occurred on day 2 and 3.  At this time the doctor's office was contacted and they asked for an evaluation; however, I was not willing to pay a co-pay for a reaction caused by an erroneous flu shot administration (the office did not contact further).
pt recv vax 13SEP96 5PM & later that evening pt broke out in a rash w/hives;no elevated temp;mom gave DPH & took pt to MD next morning when problem not resolved;MD cont w/DPH - most likely rxn to vax;allergic rxn;
Right arm, warm, firm pink, itchy and burning feeling and tired, went to employee Health on 1/7/2021
Everpresent burning abdomen tissues, excruciating muscle and joint pain/aches, migrating.
Information has been received from a registered nurse (R.N) concerning a patient who in approximately February 2010, was vaccinated with a dose of PNEUMOVAX 23 (dose and route not reported, lot number 664653/1337Y). Concomitant medications not reported. Nurse reported the patient complained about severe arm pain. Patient said the pain was so bad he could not put his socks on. This may have been the patient's second vaccination with PNEUMOVAX 23. The nurse was concerned about the lot number and thought they may have received a "bad lot". The reporter did not specify if the patient sought medical attention. A lot check has been initiated. Follow up information has been received from the registered nurse regarding the male patient in his 60's who in approximately February 2010, was vaccinated with a first dose of PNEUMOVAX 23. At the time of the report, the patient had recovered. The registered nurse indicated that her office gives a lot of this vaccine and found it odd that there were three patients who had similar experiences in a short amount of time. The registered nurse contacted during telephone follow up could not supply the following information: date of birth, dates of vaccination and exact date of the event. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and released. This is one of 3 reports from the same source. Additional information is not expected.
muscle pains; Light headedness/light headed; scratchy throat; cough; sore throat; chills; Body aches; flu like symptoms/he is sick or has a virus, not Covid, but like getting the flu or something; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on 29Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced muscle pains, light headedness or light-headed, scratchy throat, cough, sore throat, chills, body aches, flu like symptoms and he was sick or had a virus, not COVID, but like getting the flu or something on an unspecified date. It was reported that the patient developed symptoms 9-10 days after he received his second dose of the Pfizer COVID-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Excruciating headache lasting 2 days, soreness at the injection site for 2 days, chills lasting 3 days, and fatigue lasting 4 days.
redness and hives on the face.  No problems with breathing, lips, trouble swallowing.  Redness to injection site.
Moderna COVID-19 Vaccine EUA First Maderna COVID vaccine No Symptoms at all  Second Maderna COVID vaccine on Monday Monday:  12 hours after:   Headache Some soreness at injection site  Could not sleep at all that night Muscle, joint soreness Chills  Tuesday Headache Fever Muscle ache Nausea, little appetite Lethargy Napped in the afternoon for a few hours Could not sleep that night.  Took 2 Advil at 10:30pm, then slept  Wednesday Felt normal on awaking.  No headache A few sweats, so probably some fever.    Thursday Normal in every way.