chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BONES HURT FOR 5 DAYS AFTER RECEIVING THE BOOSTER DOSE; HARD TO GET UP AND DO THINGS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: neuropathy (he was disabled with neuropathy in his feet and cannot feel his feet, since 1997) he had gradually taught himself to walk with crutches and cane and with wheel chair, diabetes, smoker (Cigarettes (half a pack) but he does not let most of the smoke in) and abstains from alcohol, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug use. Patient had lyrica allergy (slept for 24 hours and his toes were feet) for drug used for unknown indication.  The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on 01-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 28-NOV-2021 on right arm for prophylactic vaccination. Concomitant drug included fentanyl. On 28-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2), the patient's bones hurt for 5 days after receiving the booster dose and he did not know whether that was the vaccine that did it and it was hard to get up and do things but it would go away when he started doing things but would come back when he sat down (dose number in series 2). They all resolved after 5 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bones hurt for 5 days after receiving the booster dose, and hard to get up and do things on 03-DEC-2021. This report was non-serious.
6/15/06 received the TD on Thursday am. She started having SX on Friday night, Flu-like aching in upper body. Vaccine site turned red on Thursday PM. Presented to the Emergency Sat am with bones aching all over. Stayed about 2 hours, had an INT inserted and Demerol was administered. Pt left the ER. Stated she felt better the next day.
Right after vaccination patient felt warm, rash started to appear and had intense itching about 10 minutes in to the event. She had premedicated with Benadryl 12.5mg along with Zyrtec. After itching started she was given an additional 12.5 mg of Benadryl. She was monitored for >30 minutes with improvement of symptoms. Rash still present but she said no longer has itching and that she knew her body well and that she was fine to leave. She stated that her mother was in the car waiting for her since she knew that she might have this type of reaction. We had a long discussion about going to the ER but she said she has Benadryl on her if needed and knew when she needed to get to an ER in terms of symptomatology. We also discussed option of having next dose with an allergist. She would like to call her allergist to discuss options but feels comfortable getting 2nd dose knowing how she reacted this time.
Her mom stated that the site of injection was warm, not bumpy and the size of a baseball.  There are no nodules and the center is blotchy and flesh colored.  No other symptoms reported.
This is a spontaneous report from a contactable physician's assistant communicated to a Pfizer sales representative. A 17-year-old female patient of an unspecified race received TRUMENBA, intramuscular on an unspecified date at 0.5ml single dose for immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient experienced redness, swelling, tenderness at a location, muscle aches in back and nausea in Dec2016 with outcome of unknown.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant Follow-up appended: Patient details (age group) was added.
On 08/20/99, this 5 year old child received first vax in the DTaP series. The following day, 08/21, he experienced the injected arm becoming swollen to 3.5 inches, tender to the touch and discolored. The most recent information received on 08/24, reports the symptoms have improved.
pt recvd vax; apap given; called MD; T up to 104 ax; MD gave apap, alcohol & ice water bath; T down to 99 ax;
DIED; This spontaneous report received from a media via a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy before. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered 1 in total for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). Reported that "my ex MIL died after getting her booster. She was healthy before." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0- 20221132412-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
The day after the vaccine could feel thumping in my chest that didn't feel right. Moved around and it got worse. Have a monitor and it showed that my BP was normal but my heartbeat was irregular. Continued to monitor BP for a couple of hours and it continued to show irregular heart beat. Now I sporadically continue to have irregular heartbeats. Already had appt with my PCP for an unrelated situation, so I told my Dr. then. Dr. said that it may be an effect of the vaccine he wasn't sure. Said if it continues to come back and I'll be placed on a heart monitor. Dr. didn't perform any testing.
I finally did get vaccinated but only out of stupidity; vaccine is only 40% effective; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient  get vaccinated but only out of stupidity; vaccine is only 40% effective (drug ineffective) on an unspecified date. The outcome of the event was unknown.  Description of Product Complaint: Consumer stated, "Well here is what to do. I have called here before they took my address yesterday. They were interested in what I had to say unless you people just say you are interested and you, really not. You know I got forensic work for Pfizer because I went to (withheld) grad school for chemistry so, some of the guys in my lab had worked for your company. Anyhow here is the problem I am having now with this vaccine stuff. I finally got, I did get vaccinated but only out of stupidity ok cause I got a question here and here is the question. I took the COVID vaccine (Suspect not clarified hence captured as unspecified vaccine in tab) in Biochemistry the withheld you know with the organic chemistry.  I want to know with the rise in this supposedly delta variant virus. It appears to be rising with the degree of vaccination. Consumer stated, "No I want to inform you and that is the reason I am talking to you that, that Medical Technology Department goes like this 'all lines are busy goodbye' they won't talk. Do not delude yourself that, that department is honest it is not. It is not talking. I will tell you why it is not talking, it is not talking because these really prove that your vaccine is only 40% effective (Further clarification was unknown) but I am not calling about that. What I am asking a general question of drug vaccine safety. Okay, just listen a minute if you have a wrong vaccine, when I used the word wrong that it produces neutralizing antibodies that are not killing the virus. Not the worth is it is not directing the virus to the T- cells and the B- cells. That all it is doing is taking our (Incomplete Sentence). Product Details(LOT#, NDC, UPC, Expiration Date) cannot be probed hence checked unknown in tab.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.
Pt recvd vax 1JUL92 & lab eval approx 29OCT92 revealed that liver enzymes were elevated to 1 1/2 times nl & thyroid results required an inc dose of sodium levothroxine; No further detials were provided;
Information has been received from a certified medical assistant concerning a male patient who on unspecified date was vaccinated with a dose of PNEUMOVAX and had injection site reactions from PNEUMOVAX.  It is unknown if the patient sought medical attention.  At the time of reporting, it is unknown if the patient had recovered.  This is one of several cases received from the same source.  Additional information has been requested.
Very tired 3hrs after vaccine shot on 6/1/21. Fever 100.5 approx 16hrs after vaccine on 6/2/21. Fever 101.9 approx 18hrs after vaccine 6/2/21. Took ibuprofen. Fever hovered at 100+ to 101+ & occasionally spiking to 102+ 6/2/21. Fever broke approx 4am (approx 41hrs after vaccine shot) 6/3/21.   6/2/21 - fever, headache, L arm, shoulder, neck & shoulder blade pain, full body muscle pain & weakness. Pain was barely relieved by ibuprofen. Weakness , pain & feeling miserable don?t even begin to describe how badly I felt!! 6/3/21 - very painful arm, shoulder, neck, shoulder blade. Weak. 99,9 temp with ibuprofen.
CHILD RECEIVED VARICELLA VACCINE AND WITHIN 10 MINUTES 2 INCH CIRCUMFERANCE, PINK, RAISED WELT DEVELOPED AT SITE OF INJECTION. Child WAS NOT IN DISTRESS AND SHE SAID IT DID NOT HURT. SKIN AT SITE WAS NOT WARM TO TOUCH. CALLED MOM ON 8/22/2017 AND MOM STATES THAT CHILDS RIGHT ARM WELT WENT AWAY AND WAS NO LONGER PINK AND THAT CHILD WAS NOT IN ANY DISTRESS AND HAD NO FEVER AND SHE WAS PLAYING .
Child stopped interacting with the parents verbally as she had been doing. She slept more often. No fever or any other symptoms were noticed. Mother reports that after a two week period it was like a switch was turned on and the baby began to interact verbally just as she had before the immunizations. Parents did not report these concerns until today in our office 04/26/2016.
Dark maroonish purple color on her Q-tip when cleaning ears; A little fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 (Lot number: EN6206) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: In 2007, caller had to have a craniotomy and her blood pressure was real high then.; "craniotomy", start date: 2007, stop date: 2007, notes: In 2007, caller had to have a craniotomy and her blood pressure was real high then.; "cold" (unspecified if ongoing), notes: Prior to getting the vaccine: Caller reported that they had had severe weather in (city name) and she came down with a cold.; "Depression" (unspecified if ongoing); "Cough" (unspecified if ongoing); "antibiotics" (unspecified if ongoing); "Sleep/needs more sleep" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension, start date: 2007 (ongoing); CITALOPRAM taken for depression, sleep disorder (ongoing); AMLODIPINE taken for hypertension, start date: 2007 (ongoing); AMBIEN taken for sleep disorder (ongoing); Z-PAK taken for antibiotic therapy; BENZONATATE taken for cough, start date: 25Feb2021. The following information was reported: EAR DISORDER (non-serious) with onset 14Mar2021, outcome "recovering", described as "Dark maroonish purple color on her Q-tip when cleaning ears"; FATIGUE (non-serious) with onset 13Mar2021, outcome "recovered", described as "A little fatigued". Relevant laboratory tests and procedures are available in the appropriate section.  ADDITIONAL INFORMATION: No Vaccinations Prior within 4 weeks, patient had the flu shot in Nov2020, no adverse events prior vaccinations, patient states that went to the ENT last year and she had no issues. Caller reported that she had the Covid shot over the weekend, clarified to be the Pfizer Covid-19 vaccine. Caller stated that her right arm is where the vaccine was administered. She asked if there are side effects of anything in the ear? Caller reported that she cleans her ears on a daily basis and that there was a dark maroonish or purple something color when she cleaned her right ear. She stated it was a lot of it and that the color just continues to come out.   No follow-up attempts are possible. No further information is expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned two patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter stated that the patients tested positive for covid-19 infection, few weeks after the vaccination.  Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210452384-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This time I took a NSAID when I got home (Ketorolac 10 mg) which blunted the arm pain and hives like I had after the first dose. But by bedtime, I developed extreme chills and have never been so cold in my life. I developed chest wall pains that were moderately severe, some shortness of breath and rapid heart rate. I felt ill but did sleep after midnight. I did not have fever or nausea. I was not dizzy. The next day, I felt much better, though very fatigued and not yet back to normal. I told my friend that this time was shorter and was pretty much over. But by evening of the second day, I developed fever of 101. No additional symptoms returned. By the third day, I was fine.
6 mo shots given 6-12-12 - Developed 103 temp at home & fussy. Seen by MD 6-13-12. Not fussy. Temp 103.2.
Patient reported having difficulty breathing and face numbness after giving a pneumovax-23 vaccine.  An adult epinephrine 0.3 mg was given in left thigh and 911 was called. Patient felt better after the injection.  Patient delivered to hospital for further monitoring
A 5-year-old was given a Pfizer booster shot (0.3 mL) from one of the 12-years-old and up Pfizer vaccine vials. As a result, the incorrect pediatric dose was given to the patient.
I had a miscarriage on 3/23/2021 at 6.4 weeks pregnant. I received the vaccine when I was about 4 weeks pregnant. My estimated due date was Nov. 13, 2021. I went to the doctor to get blood drawn to test progesterone and HGC levels. That evening, I miscarried.   We are doing testing to see what may have caused the miscarriage but I have not had a miscarriage in the past. On Sept 9, 2020 I experienced a chromosomal stillbirth of a baby boy. His death was due to triploidy which is a fatal chromosomal abnormality.
Narrative: 9/6/2022 - Pt presented at ED via ambulance. Pt c/o chest pain, weakness, and SOB. HPI: Patient presents to the emergency department stating that he has had approximately 10 days with chest pain that he states is in the center of his chest and that is difficult to describe. He feels like at times it is like someone punching outward from the inside of his chest. He cannot describe it any differently. When asked about associated symptoms he states that this morning he started vomiting and has vomited several times. He states that there is nothing that makes his pain better or worse. When asked if it is like his heart attack he states that he thinks it is. He does also endorse shortness of breath. Patient is somewhat of a vague and difficult historian as he states that his head hurts and is hurt this way for the last 20 to 30 years after a traumatic brain injury. Patient denied diaphoresis, fever and chills, cough, peripheral edema. Cardiology Assessment: 1. Coronary disease. His last cardiac catheterization in 2018 showed some small vessel disease in the septal perforator, but no other significant disease. He has a nondominant right coronary artery. 2. Ongoing chest pain. I do not believe that this pain is cardiac in origin, but the patient is convinced that something is wrong with this heart 3. Possible hypokalemia Would recommend admitting the patient to complete the rule out protocol and to obtain a cardiac catheterization when safe to do so. *Pt will be admitted to Medicine with Primary Diagnosis: Chest pain, hypokalemia, COVID-19 from 9/6 to 9/9/2022. PRINICIPAL DIAGNOSIS (Reason for admission after study): 1. Acute Chest pain, Reccurrent 2. COVID Viral syndrome ADDITIONAL DIAGNOSES: 3. Dehydration 4. Hypomagnesemia 5. Incidental Finding of Right Thyroid Lobe nodule No meds given for COVID treatment.
Mother reports pain, redness, swelling, hard lump the day after shots. Doesn't know when she couldn't move her arm or when pain started to spread to head, neck, and back.
Headache, Myalgia, NauseaVomiting,  Chills, Body aches, lethargic Narrative:
2/10 vaccination Later that evening low grade fever by 5pm. I was getting fatigued and little bit of dizziness on and off. Tingling started in my shoulder and arm where it was after the first vaccine. Fever, fatigue, lasted 24 hours. Symptoms for back lasted, intermittingly, 2 weeks.
Information has been received from an approximately 78 year old female patient with allergy to Anesthesia and a history of mastectomy who on 22-OCT-2009, was vaccinated with a dose of 0.65 ml of ZOSTAVAX (Merck) (Lot#Unknown), SQ. Concomitant therapy included gabapentin and capsaicin. It was reported that on approximately 17-SEP-2010, she had symptoms of "back itching, and had welts on the right side of her body, front and back after receiving ZOSTAVAX (Merck)". The patient also experienced "brief burning" (onset unknown); while on therapy with capsaicin. At the time of the report the patient was recovering. The patient sought unspecified medical attention. Follow-up information was received from a physician who stated that they did not have documentation were indicates that the patient received ZOSTAVAX (Merck) and it was not listed in her allergies. No further information is available.
Exactly 11 days after mmrv he developed high fever of 106f. He had a blank stare for about a week that was associated with a neck twitch and eyes rolled around here and there. Had a full rash from head to toe and it started on the scalp/hairline. Screamed alot.
runny nose; chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and CHEST DISCOMFORT (chest tightness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (runny nose) and CHEST DISCOMFORT (chest tightness). At the time of the report, RHINORRHOEA (runny nose) and CHEST DISCOMFORT (chest tightness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Patient reported red spot approximately 2 inches in diameter, pain, itching. Right arm tingling - body full of electrical impulses, random itching that hurts when scratched. Patient went to see physician 10/19 and told her reflexes and strength were fine and prescribed MEDROL DOSEPAK. Followed up with patient 10/21 and patient reports improvement, tingling is better and itching gone.
Patient complaints of dizziness. Per pt, last meal was 6 am ( over 9 hours ago) Patient noted to be pale and diaphoretic. Legs elevated. EMS evaluated. Vital signs obtained. HR noted to be in 40-50s. Patient provided powerade. Patient drank powerade. After drinking powerade, patient stated that she is feeling better.  Vitals signs within normal limits.
Small stroke. I can't 100% say the stroke was caused by vaccine. But I was told I need to report it anyway.
Pt experienced local erythema and edema that was 9-10cm wide and long. Pt experienced a fever of 102 and myalgias, ears, feet, nose freezing cold. Symptoms began 24 hours post vax.