chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient called the pharmacy the morning of November 2nd to report an adverse reaction to the first dose of the SHINGRIX shot that she had received on October 29th. The reaction began on the morning on October 30th. Her pointer finger on her left hand was swollen and felt tingly and stiff. The pain has not changed since October 30th; the patient states that it is persistent but not getting worse. She also reports that the injection site of the vaccine is tender, hard, and hot when touched. The patient had already contacted her doctor that had performed her hand surgery 5 weeks prior. The doctor informed the patient that it was a side effect of the vaccine and not from the surgery. The patient had not done anything to relieve her pain or discomfort. The patient was advised to use an over the counter pain medication and/or ice to help relieve her symptoms. She will be following up with her doctor on November 8th at her already scheduled doctor's appointment.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A patient of unspecified age and gender started to receive TRUMENBA, via an unspecified route of administration from an unspecified date to an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced a nosebleed on an unspecified date. The doctor stated the nosebleed was not related to receiving meningococcal group b rlp2086. Outcome of the event was unknown. Information about the lot number has been requested. Sender's Comments: The Company acknowledges that the reporter has come to the conclusion that meningococcal group b rlp2086 was not responsible for the event nosebleed.
This spontaneous report as received from a nurse refers to a 17 year old patient of an unknown gender. On 26-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # H012643 and expiry date: 30-MAR-2015). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Day after vaccination, 10PM  developed episode of seizure like activity (generalized tonic-clonic like movements of upper and lower bilateral extremities, eyes rolling back and drooling), brought to ED, CT head showed b/l symmetric calcification within basal ganglia and along cortical medullary junction of both anterior loves and parietotemporal lobes. Ionized calcium 0.58, PTH 630, total Calcium 4.5, EKG with QTc 545, also found to be COVID positive. Symptoms resolved with 1gm calcium gluconate. Suspected to have pseudohypoparathyroidism. Admitted to the PICU.
Pt received GARDASIL above recommended age 9-26 y/o. No adverse event.
The symptoms were similar to a head cold.  Slight fever, stuffy and runny nose, with some coughing.
the patient says the area of injection is very hot to the touch, somewhat itchy, red, and some small pustules. The redness started on the evening of 4/14/21 and has gotten bigger since. She had a less severe reaction to the first show which she received in the left arm one month prior.
pt recv vax 10OCT96 & 11OCT96 pt felt pain in head & on rt side, blacked out, had a sz;11OCT96 dx w/strep throat;fever was a little over 100;MD observed vaccinee over 12OCT96 weekend;an appointment w/neuro has been scheduled;
Pt recvd vax & exp herpes p/each dose; No further details were provided;
Day 1-slightly swollen tender lump, two small red patches, warm to touch, sleepy. Day 2-same as above. Headache for entire day, and sleepy. Day 3- Arm still tender (frogged feeling)  Day 4-6 Feeling ok Day 7 Itchy, icy feeling on arm. Feeling uncomfortable. I am considering taking an antihistamine Claritin, as I don?t want to scratch it. I have a faint large circle around shot. It isn?t red, as I have resisted scratching it.
Covid symptoms started on 05/12/22, tested positive on 05/13/22. Symptoms started with sore throat, upper respiratory congestion, coughing,  a little bit of fever around 100, and nausea, and that's what caused me to call my Doctor and get tested. I called the Doctor and had a telemed visit with the NP and she described me Paxlovid and I took 5 days of that and she also prescribed me Benzonatate for the cough and Phenergan for the  nausea and I took all of those and am still taking the benzonatate for the cough. I got better for 3 days and felt 50% of normal energy level because I've had a lot of fatigue. Then, on Sunday night I felt like I completely relapsed and my throat got super sore, I couldn't breathe out of both nostrils, my ears had fluid, and I was super congested. Monday 05/23/22 I had fever again of 99.7 give or take and all throughout the day. I treated that with Tylenol. I still tested positive on Saturday when I took another test. I will do another test tomorrow.
Immediately I got nauseas and headache. Next day my whole lower back was spasm and had horrible body pain/back pain. I almost passed out putting pants on.  A friend took me to an Urgent care they  gave me Shot of tramadol and given Tylenol 3. They also did a test on my kidney. About 50 hours after the shot I was feeling better.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received KINRIX (batch number AC20B256AA, expiry date 16th April 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication reported.  Date of administration of vaccine was reported as 02 Feb 2022 and 02 Mar 2022. The Nurse says that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as October 14, 2022.  The nurse was sending a picture of the screenshot
After the 1st shot I noticed sporadic heart pains throughout the 2week period between shots; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14May2021 11:30 (Lot Number: EW0167) at age of 53-year-old as single dose for covid-19 immunisation.  Medical history included allergies (Pollen, Mt Ceder) not 100% sure on what causes them.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. After the 1st shot, the patient noticed sporadic heart pains throughout the 2 week period between shots on 14May2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment received. The outcome of event was unknown. Since the vaccination, it was unknown if the patient tested for COVID-19.
A few months after receiving the second dose, I got shingles. Diagnosed by a physician.
Within 5 hrs. started with body aches, then chills. Within 8hrs earlier symptoms continued with additional symptoms of headache, dry cough, worsening of aching/pain, fever 103°.  Symptoms lasted 4 days and stated to slowly resolve.  Took motrin 800 MG and alternated with Tylenol 1000 MG, cool compresses, Benadryl 50 MG throughout course of symptoms.
Patient requested HPV vaccine. Patient was outside of ACIP guidelines to receive vaccine. Patient has not reported any adverse events or outcomes related to administration of the vaccine.
On Monday, 9/16/19, she had an ear ache, put some drops in it, resolved after a couple of days, but then couldn't wink w/her right eye, and right side of face was numb, felt like she had been to the dentist & she couldn't put her lips together to whistle & can't drink well from a glass.  Went to see provider on 9/19/19 and patient was diagnosed w/Bell's Palsy.  Her left eye is super sensitive to light.
Moderna  COVID-19 Vaccine EUA Itchy arm arm rash at injection site
permanent rash around my waistline; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got the vaccine and had a permanent rash around his/her waistline. The follow up would not be possible as no contact details were available.
BACK PAIN Narrative: BACK PAIN IS IMPROVED AND ABLE TO WORK TODAY
The day of the injection, approx. 3-4 minutes after getting the injection, I almost passed out.  I became hot, sweaty, dizzy and my head starting to buzz.  The nurse on-site provided me a couple cold packs and after about 30 minutes, I felt better. The nurse described my response as a "vascular" reaction.  Later that night, I got a headache and night sweats and bouts of nausea.  They only lasted a day.    Approx. 10 days after the injection,  the injection site became red, swollen, itchy and uncomfortable to the touch. Then it traveled down my arm and created a large red, swollen, itchy area on my entire upper arm.   I advised my doctor and she provided me a Rx for a topical steroid and oral steroid.    After 5 days of treatment, it is 90% better.   The injection site still hurts.
PT REPORTED OF MUSCLE PAIN THAT RADIATED FROM LEFT ARM (WHERE HE WAS GIVEN THE SHOT), TRAVELLING TO LEFT SHOULDER, THEN TO LEFT CHEST MUSCLE.  INJECTION OCCURED AT AROUND 1140AM, PT REPORTED PAIN TO PHARMACIST AT 1151AM. WHEN I EXAMINED THE INJECTION SITE, THE AREA DIDN'T LOOK RED OR SWOLLEN. I CHECKED BP AT 1153AM AND IT WAS 152/81. I CHECKED BP AGAIN AT 12:10PM AND IT WAS 155/85. AT 12:10PM, PT WAS STILL REPORTING CHEST MUSCLE PAIN ON THE LEFT SIDE OF HIS TORSO. PT WAS ALERT AND WAS ABLE TO TALK TO ME.AND TELL ME HIS SYMPTOMS.  EMT WAS CALLED AT 1214PM.  911 OPERATOR INSTRUCTED ME TO GIVE HIM 4 TABS OF 81MG CHEWABLE ASPIRIN (NDC 00904-4040-73) AT 1231PM. EMT ARRIVED SOON AFTER. PT WAS TAKEN TO HOSPITAL AT AROUND 1245PM.
0950: Pale, lethargic, cool and clammy; respond to command. Transferred from chair to wheelchair. Vital signs : BP 77/50, repeat BP158/91, SPO2 95%. Individual transferred to stretcher, O2 @ 2L via face mask; continue to respond to command -orientation x2 place and day. 10:02 BP 186/98, SPO2-100%, Pulse 80, Temp- 97.5. Patient alert and having conversation. 10:04 Rescuer (Fire Dept.) arrived - report of patient given. Lead rescuer assessed patient . Request to be transported to ER declined by patient.
pt experienced moderate sinus congestion/ drainage/ congestion/ flu like symptoms etc - required antibiotics
Once day after receiving 2nd COVID Vaccine developed diffuse abdominal pain and Intractable nausea with vomiting.
5/28 88y.o. female who presents for the above issues. Has known history of CAD, non-ischemic cardiomyopathy, and hypertension. She is not compliant with meds and has not been taking at home.
This spontaneous report was received from a healthcare worker refers to female patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 09-JUL-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K007107 with an expiry date of 16-MAY-2016, stored at improper temperature (<46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
patient had fainted a couple minutes after receiving vaccine due to a panic attack from getting a vaccine and fell the floor.  patient was observed and emergency squad was called to make sure patient was ok and was subsequently discharged from their services after observation.
A few hours after the shot I felt heat on my right side, face, hands and leg.  It progressed and became numb and tingling the next day.  I thought these were normal side effects from the second shot, but when I had trouble moving my right foot by two days later, I went the emergency room.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: patient
This patient was given a second dose of the Moderna Covid vaccine on 4/3/21 with the vaccine administrator unknowingly unaware that the first dose had already been administered the day before on 4/2/21. The patient did not have any significant immediate side effect but the patient will be checked by the yard physician today 4/4/21 to reevaluate the patient.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 10:30 as dose 5 (booster), single (Lot number: GJ6655) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 at 14:00 as dose 1, single (Lot number: EL8982), in left arm, on 25Feb2021 at 14:30 as dose 2, single (Lot number: EL9265), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jun2018, stop date: 11Feb2023. The patient has no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures, Paxlovid from 11Feb2023 to 15Feb2023, were taken as a result of vaccination failure, covid-19.
Shoulder and neck aches for 2 days, chills for 2 days, shaking for 4 days, fatigue for 6 days
Td vaccine administered 4/12/2010. Next day developed pain in site of injection/headache mild fever (T max 100 degrees F). This morning noted erythematous area 7 cm x 4.5 cm with high local temp Lt deltoid area (area of injection).
PATIENT WAS GIVEN 4TH DOSE OF HIB ON 7/7/2023.  IT WAS BROUGHT TO OUR ATTENTION TODAY ON 11/1/2023 THAT HE DID NOT IN FACT NEED THE 4TH DOSE OF HIB DUE TO HIS AGE.
sudden, generalize, red, raised, itchy, splotchy rash from head to toe; This is a spontaneous report from a contactable nurse (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 30Sep2021 13:15 at the age of 51-years-old (Lot Number: 30130BA) as single dose for COVID-19 immunization. Medical history included Kidney stones, COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Right arm on 09Sep2021 08:00 PM at the age of 51-years-old (Lot Number: FL3182) for COVID-19 immunization. Concomitant medications included indapamide; potassium; influenza vaccine taken for immunization on 09Sep2021; tetanus vaccine taken for immunization on 09Sep2021. It was reported "Two hours following the shot, I developed a sudden, generalize, red, raised, itchy, splotchy rash from head to toe - most concentrated at wrists and hands, armpits, chest, lower back, waist, groin, knees, and ankles but scattered in between." Adverse event start date was 30Sep2021 14:00. No treatment was for AE. No Covid tested post vaccination. The outcome of event was not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event rash and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a 6 month old patient who was vaccinated with a third dose of ROTATEQ. Subsequently the patient experienced diarrhea. It was reported that the patient recovered and was not hospitalized. No other information was provided. Additional information is not expected.
Experienced severe side effects from Covid-19 Moderna Booster received on Thursday 9/23/21 at 4:50pm. Symptoms lasted all day Friday to midday Saturday: 1. Lost ability to complete a sentence; unable to respond to wife's direction or questions 2. Difficulty walking; had to hold onto walls or be assisted by my wife 3. Difficulty turning into bathroom from hallway and raising foot over threshold; had to hold onto door jamb and walls 4. Could not eat for 24 hours; difficulty sipping water from bottle 5. Hands were shaking; could not hold fork without shaking 6. Finally went to bed; sweating all night. Slept from Friday noon to Saturday noon, 24 hours. On Saturday, walking and communication issues started to improve. On Sunday able to walk without assistance, food intake OK. Note: On September 2, 2021, during an Annual Wellness visit with MD I advised him that I was rejected by the system for Covid 3. He said that I had to "lie a little and to return to the system and indicate that I was immuno-compromised." I was given an opportunity to set the date of September 23, 2021 at 5:10pm. My appointment was then confirmed via a system message.
Patient received Pfizer 5-11 years old. Was supposed to get Pfizer 12 years and older. Prior to vaccination, the vaccinator and verifying staff member asked the child's age. Her mother responded 11. When in fact she was 13 years old according to date of birth. This was found after the fact. I spoke to the child's consenting parent and explained what happened.
For 2 weeks after last covid vaccine he was very fatigued, fuzzy headed and appetite was decreased.  After the first dose he has only a day or 2 of symptoms.
1505: Pt walked to AR monitoring area after reporting that following 1st Pfizer (33025BD) pt started experiencing "symptoms like my allergy to shellfish, I am itching all over, theres tingling to my lips, my mouth feels funny and my throat is scratchy". Pt ambulated with very steady gait to gurney and placed on monitors. He is AxO x4, speaking in full and very clear sentences, RR even and unlabored. Pt denies any difficulty swallowing his own saliva. He also denies any chest pain, palpitations, dizziness, headache or SOB. LSCTA, -wheezing/stridor. Pt reports that in October 2021, pt developed a shellfish allergy where he experienced anaphylaxis which required him to seek medical care in the ER in which he experienced "my throat closed up" and he was treated and recovered. Pt denies any more episodes of those symptoms up until today. He denies having any throat closing and is very calm and cooperative. Call out to on call ER MD and verbal orders obtained for Cetirizine ODT now and pt tolerated very well. Will continue to monitor very closely.   T 96.8 BP 139/87 HR 88 RR 20 SPO2 100 on Room Air  1512: Pt tolerated po Cetirizine odt and drinking water without incident. Continue to monitor.   1520: Pt reports that he feels his tongue becoming "thicker" and rated it 2/10 however he is still speaking in full and clear sentences. He continues to deny any respiratory symptoms or drooling and he is drinking the water at bedside without incident. Pt's tongue has no rash, lips do not feel swollen as per pt and he also denies any throat closing. Pt also indicates that he feels "very relaxed" and monitoring his HR. Pt continues to deny any chest pain or palpitations. States his overall symptoms he believes is not worsening but the itching is "getting better". Will continue to monitor closely for any worsening.   152/91 55 20 100 on RA  1528: Repeat VS as charted below. Pt states his "thick" tongue is now a "1.5/10" and the generalized itching has "gotten better". Pt reports that he remains with no new other symptoms. Still calm and cooperative, no acute respiratory distress.   153/94 61 20 100 on RA  1542: Pt reports that his overall symptoms are "back to normal" and the generalized itching is "minimal". Pt continues to deny any respiratory or cardiovascular symptoms. Remains free of any rash/hives or swelling and continues to speak in full and clear sentences. -stridor or wheeze. Call out to ER MD and report given. Advised pt to seek medical attention in the ED should his symptoms return, changes, worsens or becomes life threatening. EUA, VIS and educational tools reviewed with pt who verbalizes understanding. Pt road tested and ambulated with very steady gait. He remains in no acute respiratory distress, VSS. Pt released from vaccine clinic to drive himself back to work. Ambulated with very steady gait and in no acute distress.   149/97 63 18 100 on RA
vomiting; high pulse 112; upset stomach; chills; shaking; Weakness; headache; This is a spontaneous report from a non- contactable consumer, the patient. This report received from a 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:  Unknown) administered in right arm on 15Mar2021 at 08:45, as a single dose of COVID-19 immunisation. The patient had medical history of GERD and glaucoma. Patient is not known to allergies. The concomitant medications include esomeprazole magnesium (NEXIUM) for an unknown indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.   The patient experienced chills, shaking at 8:00 PM, stomach upset and high pulse 112 (normal pulse for me is 83) at 10:00 PM, which continued until about 10:00 AM, vomiting at 11:00 PM continued to about 2:00 AM, and also experienced weakness and headache on 15Mar2021. The clinical outcome of chills, shakes, stomach upset, high pulse, vomiting, weakness, headache were resolved on an unknown date.  Information about lot/batch number cannot be obtained. No further information is expected.