chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed mild breakthrough with less than 50 lesions. It was noted that the patient was part of 7 children reported, 4 male and 3 female, some of which were siblings who were vaccinated with varicella virus vaccine live. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned six other patients who were vaccinated with varicella virus vaccine live and experienced similar reactions. Additional information has been requested.
At approximately 1328, patient reported feeling dizzy. Patient denied itchiness, rashes, hives, difficulty swallowing and difficulty breathing. Patient assisted into anti-gravity chair. Patient reported she felt "hot". Patient given ice pack. RN placed ice pack on back of patient's neck. Patient given juice. Patient able to drink juice. At 1333, RN assessed patient vital signs: blood pressure 98/62 mmHg, pulse 81 beats/minute and SpO2 97%. Patient reported no known allergies and history of similar reactions with needles. Patient has gastritis and currently takes omeprazole. At 1343, RN reassessed patient vital signs: blood pressure 100/70 mmHg, pulse 80 beats/minute and SpO2 98%. Patient reported feeling "better". Patient's mother reported family history of low blood pressure. At 1353, RN reassessed patient vital signs: blood pressure 110/70 mmHg, pulse 78 beats/minute and SpO2 98%. Patient denied dizziness and reported feeling "good". RN educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider, and to sign up on v-safe. At approximately 1357, patient left facility with mother. Patient left facility with unlabored respirations and steady gait.
I was fine for the first 3+ hours. Throat began to tighten, started producing lots of mucus in the back of my throat. voice became hoarse and nose was streaming watery fluid. became difficult to speak.  seemed to be an allergic type of reaction. Went to the ER, Was given IV benedryl, famotidin and a steroid - dexamethazone. Was released after treatment and went home. took the benedryl another day and have not experienced any additional effects.
TONGUE AND THROAT ITCHING : BENADRYL 25 MG PO X 1
Urticaria all over the body, site of vaccines, no swelling or redness, but hives came on 1 hr after vaccine. No respiratory problems.
Emp. called on 6/16/03 at 1:30 PM stating that on Saturday PM, she developed itching on her upper trunk, nasal cavity, developed myalgias and joint pains. States she had large localized reaction of erythema and swelling (about 2 50cent piece size). Emp. spoke of her PMD and her Atarax dosage was doubled and all resolved on Sunday.
See HPI: n/v fever, headaches 12-24 hours after every AVA vaccine, but had 2 episodes cp/sob after AVA #3/SMPX vac, wt loss, hungry, insomnia...dx graves disease Aug 2004 and septal MI. Symptoms: Tremors, Palpitations, Weight loss, unexpected, Chest Pain, Dyspnea (shortness of breath), Joint Pain, multiple joints, Fever, Headache, general, Fatigue.   5/8/09 medical records recieved DOS 10/2003-2006. FINAL DIAGNOSIS: Grave's disease with exophthalmos, septal MI, PTSD Post vaccine dose #1: chills, vomiting, fever, headache behind eyes. Post vaccine dose #2: headache pain behind eyes, vomiting, eyes sensitive to light, unspecified sleep disturbance. Post vaccine dose 3#: no adverse events remembered, went to bed early. 2004 MI/septal infarct. Eye sight decreasing, hand tremors. Chest pain, shortness of breath. Heart fluttered. Constantly eating difficulty sleeping. Later episode consisting of grayed out vision with loss of consciousness.  Weight loss. Septal MI confirmed. Graves disease confirmed. Multiple joint pains. Infected lymph node behind right ear. Nervous, agitated. 2005 sinus problems. Buzzing in ears, early hearing loss. Medical records have been requested. Follow-up: No known changes.
NONE MEDICATION ERROR PATIENT IS 16 YEARS OF AGE. MASS VACCINATION EVENT AND FAMILY REQUESTED JANSSEN FOR BOTH PEOPLE BEING VACCINATED. VOLUNTEER HEALTH PROVIDER ADMINISTERED JANSSEN TO BOTH INDIVIDUALS AND ONE WAS 16 YO
On 12/31/2020 (day 7) arm started to itchy, no redness.   1/1/2021 (day 8) woke up with rash, inflammation, itching. Took Benadryl and applied Cortisone Cream several times that day.  Rash continued to spread.   On 1/2/2021, has now spread to 3/4 of upper arm.  Now taking Zyrtec and Cortisone cream.  Still red rash, inflammation, itching.   Less itching on 1/3/2021, red rash still spreading 1/4/2021 rash stopped spreading, less area covered with rash, decrease in itching.  Continuing with Zyrtec and appling Cortisone cream
Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at injection site and has not gone away, gets worse with some motions, has not been red or swollen Makes dressing, reaching, dishes, laundry, putting on a backpack, working with patients all painful (I am a physical therapist in the hospital) I have an old injury to the long head tendon of my biceps in the L arm and originally thought it just flared that up for some reason, but the pain is also more lateral by the injection site I have been resting it, trying not to aggravate it, using some tylenol as needed for sleeping as positioning is hard lately, and it's been hurting more towards the end of the day It is not getting better, and I feel like may be getting a little worse. I am going to start icing it this weekend too.  It is starting to affect how I do my daily activities and my job - I am considering going to the doctor
Pt was given diluent only: the vaccine was not added to the syringe. Then patient was given the vaccine correctly after the error was discovered.
patient come in on 6/26/2019 at around 11am and stated she had the rash again, but even milder and is taking allerga 180mg once a day. patient also reported body chills that lasted one day after 2nd dose vaccination that where also self resolving.
pt recvd vax & 48 hrs later exp a severe h/a, rash, nausea & malaise; developed sinus infect;
Developed hives underneath left and right armpit, down to my stomach as well about 3 hours after vaccination. Thought it was a mosquito bite until the itching got worse and felt like there were welts on my skin, when I checked I realized it was  hives that had developed late at night. I proceeded to go to the ER where I was treated immediately.
Information has been received from a Registered Nurse (RN) concerning a 72 year old male patient with "lot of different disease states" who on 16-APR-2008 was vaccinated IM into the left arm with a dose of pneumococcal 23v polysaccharide vaccine ("it was not known if this was the first or second dose of pneumococcal 23v polysaccharide injection"). Concomitant therapy included (therapy unspecified). It was reported that "patient had a lot of different disease states". The nurse reported that on 16-APR-2006 the patient developed pain at the injection site. The patient recovered on an unspecified day. No additional information was available. Additional information is not expected.
Spouse woke at 3am got up for a drink of water and fainted - fell on a tile floor damaging lips and teeth.  I got up to help, cleaning up blood and checking injury.  After a while I got dizzy and fainted, got up too soon and fainted again.  I fainted a third time, had convulsions and lost bladder control.    Visited my PCP a week later.  Now have a neurologist appt scheduled, a month out.  Currently, I have no apparent issues.
Patient developed  ear ringing , nerve pain (fire-ant sting like) on hands, neck and back, skin sensation (worm crawling like) and heart pounding.  Pt will see doctor on Monday 8/9/2021. She took OTC vit D3 and some homeotherapy meds she believed benefitting her nerves and she felt better.
pt recv vax; devel itching & spots w/in 3-4 days progressing to full blown case of chicken pox; pt had exposure prior to vax;
Caller went 1 whole year without receiving 2nd primary dose; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Caller went 1 whole year without receiving 2nd primary dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Caller went 1 whole year without receiving 2nd primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Caller went 1 whole year without receiving 2nd primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Caller went 1 whole year without receiving 2nd primary dose).    No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Dizziness and muscle weakness within minutes of receiving H1N1 vaccine. Was given cookies and water; rested lying down, was advised not to drive home and parents picked her up.
2nd dose - mild joint pain, body aches, fever and sore arm for a few days (arm better this time as I kept it moving right after shot). Headache, fatigue, lethargy and general malaise lasted for a week. Headache was different than my "normal" ones and didn't respond to just acetaminophen, and barely to the aspirin/caffeine/acetaminophen combo of excedrin.   Appetite was good for the day of and day after the shot but then I had constant nausea and loss of appetite from Monday until Friday afternoon - no vomiting, thanks goodness, but I couldn't read, look at screens or function for 4+ days.   The headache and nausea combo were awful - makes me sick thinking of it.  1st dose resulted in headache, mild joint pain, body aches, fever and very sore arm for a few days.
Patient called pharmacy when we were closed and left a voicemail on 7/23/22 at 919 pm reporting the adverse event from the vaccine she received on 7/22/22 around 4 pm. I listened/received her voicemail on the next business day 7/24/22 around 835am. She said 4-5 hours after receiving Pneumovax 23 her deltoid muscle became red, painful, itchy, hard, and swollen about the size of a softball. She put ice on it and took Ibuprofen and benadryl. She says it seems a little better today (7/23/22 when she called) but it is still sore and the redness extends under her arm.  She is going to let her doctor know about it.
started yawning 5 minutes, yawning multiple times a minute, could not even speak without yawning.  Stopped yawning at 2pm then broke out in rash on trunk, neck, arms, face, flushed.  Took 2 benadrdyl, monitored x 1 hr, rash subsiding, then started itching at 5pm all over, at 8pm left arm got blood red, throbbed x 30 min, took more benadryl. She has itched all over since day of vaccination and cannot get a deep breath.
Information has been received from a physician concerning a 6 month old preterm infant who on 28-SEP-2010 was vaccinated with the first dose of ROTATEQ. No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 07-DEC-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L014458 and an expiration date of 11-FEB-2017 (route and anatomical location of administration were not reported). The sum of hours in excursion was 8 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient had a vasovagal response shortly after vaccination, while in the observation area. Reported dizziness and nausea. Patient was given water and asked to lay in supine position in exam room. After 20 minutes, patient felt better and was able to leave the clinic.
On 05/20/2021, two weeks after the vaccination, my left leg in my thighs are feeling sharp pain, especially when I walk a lot. On 07/16/2021- the doctor did x-rays and ultrasound. They didn't see a clear pic. but they think its a nerve that is pinched. He diagnosed it as Meralgia paraesthetica.  I still have the AEs I still have to go to the doctor to get more tests for my leg.  On 08/12/2021- I went to pharmacy and was tested for COVID-19 and the results were positive. I was having normal flu symptoms. I lost my smell and taste, for the 1st time in my life, I had fever, runny nose, headache, muscle ache, bone ache, all that stuff, the usual flu symptoms. I had the symptoms for a week and they resolved on their own.
PLEURITIC CHEST PAIN, MACULAR CHEST RASH 45 MIN. TO ONE HOUR AFTER ADM. OF Tdap (ADACEL). TREATED IN ED WITH NEBULIZED LEVALBUTEROL AND DIPHENHYDRAMINE WITH RESOLUTION OF SYMPTOMS; PREDNISONE TABLETS Records received 4/24/07-Admitted with 3 day history of fever and chest pain. Chest pain localized, central and stabbing began shortly after receiving DTaP. 06/05/07-DC summary received from facility for DOS 4/4-4/6/07-DC DX: Idiopathic myocarditis temporally related to TDaP administration. No associated pericardial effusion, cardiac dysfunction or arrhythmia.
Narrative:  09/20/21 Shingles vaccine administered 09/22/21 Pt came as a walk in c/o allergic reaction to shingles vaccine that was given on 09/20 in left deltoid; he has redness and tenderness to the injection site with a red rash on his neck and  chest area; he also has an area that is swollen and appears to be fluid filled on his  lower left neck/collar bone area; diphenhydramine administered
Fever, chills, neck pain, diffuse joint pain and myalgia, fatigue, and left axillary lymph node swelling and pain,.  Symptoms lasted approximately 1.5 days. Treated with Tylenol, rest, fluids.
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 27-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction. No treatment medications were reported.
chills; headache; fever 103 F; red, swollen arm; tiredness and fatigue; unsure" if patient developed a cough; red swollen arm; This case was reported by a other health professional via call center representative and described the occurrence of chills in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   On 24th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th July 2020, 1 days after receiving Shingrix, the patient experienced chills, headache, fever, swelling arm, fatigue, cough and erythema of extremities. On 28th July 2020, the outcome of the chills, headache, fever, swelling arm, fatigue and cough were recovered/resolved and the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the chills, headache, fever, swelling arm, fatigue, cough and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: The patient experienced chills, headache, fever of 103 degrees F, red swollen arm, tiredness and fatigue. She stated that the patient might have developed a cough at this time, but not documented in their chart.  She states that all these symptoms resolved on 28th July 2020. The reporter consent to follow up.
pt suddenly loss consciousness briefly about 5-10 mins p/receiving immun & fell backwards, striking head on the floor;
soreness around the injection site (started around 2pm) Muscle aches (around 4pm) Headache (around 5pm) fever 100.3 F (around 5pm) Extreme fatigue (around 5pm)
This report described the occurrence of knee and leg pain and swelling in a male patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient received injections of Lymerix on 7/3/01, 8/6/01, and 1/22/02 according to the client. This represents a schedule of 0, 1, and 6 months rather than the recommended schedule of 0, 1, and 12 months. On 9/3/03, the patient's attorney alleged that the patient suffered right knee and leg swelling and pain. The onset of his symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported.
About  24 hours after receiving the vaccine, I heard an unfamiliar low, breathy, wisking sound in the left side of  my head.  It occurred on and off for 8 or so hours , while alarming me somewhat until it finally stopped but not really distracting me much.  From what I learned, it appeared to be tinnitus.
chest pain; shortness of breath; tiredness/extreme fatigue; acid reflux; This is a spontaneous report from a contactable consumer. This consumer (patient's Mother) reported for a 28-year-old male patient (reporter's son) that: A patient received bnt162b2 (PFIZER-BIONTECH COVID VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing Asthma he had asthma as a child, he really does not have many problems with asthma as an adult, maybe an occasional seasonal flare up, he hasn't had to use an inhaler in a long time. The patient's concomitant medications were not reported. The patient experienced Chest pain, Shortness of breath and Tiredness/Extreme fatigue on May2021, Acid reflux in 2021. The patient underwent lab tests and procedures which included blood test: normal on May2021, Echocardiogram: negative on an unspecified date an echo of his heart was done, which also came back negative, echocardiogram: normal on Jun2021, Electrocardiogram: normal on May2021, Electrocardiogram: normal on Jun2021. Therapeutic measures were taken acid reflux as heartburn medicine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Caller asking if Pfizer has heard of anyone developing acid reflux after the Covid vaccine. He didnot have that before. Is there any information about the safety of him getting a second shot if they had a strong reaction to the first one. The outcome of all the events was recovering except for the event acid reflux it was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Left arm: 5x5cm red circle with whelp 2 cm x 4cm center.  Right arm 2x2cm red circle area with 1cm knot middle.
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Between 20-MAY-2016 and 31-MAY-2016 the patients were vaccinated with improperly stored ROTATEQ (lot # L023870, expiration date 20-APR-2017; lot # L035508 expiration date 12-MAY-2017; lot# L039141, expiration date 16-AUG-2017, dose was not reported). The vaccines were exposed to 8.9 Celsius degree for 44 minutes without previous excursion. The issue was due to data logger. No adverse effects were reported. This is on of the several reports from the same reporter. Additional information has been requested.
pt had syncopal event following tdap and varivax administration. she was okay during tdap shot and immediately after safety mechanism activated with varivax, she experienced her event. she pasted out for no more than 5 seconds. She slumped back into her chair without sustaining injury. i was able to lift her upright and she immediately regained consciousness. she was pale and confused at first and i was able to orientate her to person place and time. i administered cold compress and cold water. code was called to pharmacy. in discussion following event, she told me she did not eat much for lunch and had just started her new job. I had a tech grab her gatorade to give hydration, sucrose and electrolytes. she regained her pre-vaccine color. we all suggested she remain in pharmacy for at least 30 minutes, walk around the store for 5 minutes to ensure no repeat events and instructed her to have a family member come support her leaving. her aunt lives close and she called her to tell her she is coming to expect her arrival. she left on her own
Patient received Zostavax on 6/9/08 and called on 6/13/08 and had outbreak of shingles.
Initially under nose. R side facial swelling with pain and extreme fatigue. Within 4-5 hours of receiving vaccine swelling has gone as of 12/9/09.
Had a stroke 36 hours after getting second vaccine. Lost ability to speak and see clearly, had word salad. Was identified quickly by my wife and was taken by ambulance to hospital where they gave me TPA clot buster infusion after identifying a clot in my left back side of brain and luckily I responded well and have all speech function back we believe so far.