chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. The physician reported that on an unknown date, if the GARDASIL series had been interrupted, he had restarted the GARDASIL series, (Lot #, exp. date, strength, dose and frequency were not reported) for the unspecified patients. No adverse effects were reported. Additional information is not expected as the reporter did not want to be contacted.
Pt reports her arm turned pink from injection site to her elbow. As well as swelling & itching. Advised pt to use BENADRYL & not to get the High Dose Flu vaccine again.
11/1/2017-Mom called stated after infant woke from nap he had redness to right thigh, back & stomach. She was worried this could be allergic reaction to shots received earlier today. Spoke with Associate from PCPs office and stated grandmother was on the other line regarding this as well. Associate instructed them to rotate MOTRIN and TYLENOL with BENADRYL every 6 hours. If redness or rash increases or any signs of SOB is noted that she should got to ER for evaluation. Also was concerned due to recent exposure to shingles. I viewed photos that mom sent and had CDNS to evaluate them, she suggested they follow instructions from PCP. Mom verbalized understanding, LPN. Spoke with mom on 4/10/2018 via phone to verify any further treatment needed and she stated that infant was seen by APN as documented above infant was given BENADRYL and sent home with instructions as noted above.. LPN.
This spontaneous report as received from a pharmacist refers to a 67 year old male patient. On 11-DEC-2014 the patient was vaccinated with one dose of ZOSTAVAX (lot # K010732, exp 10-OCT-2015, 0.65 ml, subcutaneous). The patient had no drug reactions/allergies. On 12-DEC-2014, the patient experienced a red, warm, hard area at the site of injection. The patient sought medical attention via coming to pharmacy. The outcome of the events was reported as not recovered/not resolved. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Body rejecting different (tried 4) medications, fatigue, immune function appears impaired. Raised blood pressure, unable to tolerate BP medication. Waiting on labs and appointment with rheumatologist.
Side effects that have been reported in clinical trials with the vaccine include: -Injection site reaction: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness AND  fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever,
Issue 1- 06/21/2022 Reddness and swelling (large knot the size of a half dollar under the skin.)   The virtual doctor with his pediatrician's medical group, diagnosed him as an vaccination reaction.  He was diagnosed clindamycin 20mg/2x day for 5 days and Mupirocin 2% ointment.  Today is the last day of the medication. The swelling and knot under the skin went down and was completly gone by Sunday, 06/26/2022.  On Friday, 06/24/2022 he has had severe nasal drainage and sneezing.  It has been very consistent and is still a present sympton.
PATIENT REPORTED "A HARD LUMP" AND SWELLING AT INJECTION SITE WHICH PRESENTED ABOUT 24 HOURS AFTER INJECTION. INJECTION SITE SWELLING WAS PAINFUL AND LASTED SEVERAL DAYS BEFORE RESOLVING COMPLETELY. APPROXIMATELY 3 DAYS AFTER INJECTION, THE PATIENT NOTICED BRUISING IN THE AXILLA AREA OF THE INJECTION ARM WHICH PROGRESSIVELY SPREAD FROM UNDER HER ARM TO AXILLA AND ONTO UPPER TORSO. THE BRUISING WAS NOT PAINFUL. TWO WEEKS POST-INJECTION, THE BRUISING IS STILL VISIBLE ON THE LOWER AXILLA/UPPER TORSO OF THE RIGHT SIDE BUT THE PATIENT REPORTS IT HAS IMPROVED SINCE ONSET.
After my first shot, my throat felt a little bit tighter and a little itchy. They think it might have been an anxiety attack. They had me laid down and they kept checking my pulse and stuff. About 45 mins later they let me go home. I was feeling better. In the middle of July, I felt pressure in my chest. They thought it was my asthma. They did some heart test, and they found a coronary artery disease, it was mild. I had a hard time. I still feel pressure in my chest. I cannot walk as far because I end up winded. I get tired very easily. It is not asthma, because my breathing is clear. They put me on hard medications and high cholesterol medications after that. I was at the hospital for 3 days. They did a lot of medical tests. I also had issues with my thyroid. It was ginormous so I had that removed. They gave me thyroid medications. I am still winded and tired. One of my heart doctors said his wife was feeling the same way and he is thinking it might be because of the vaccine. I cannot take my booster shot yet, because right now I have a sinus infection that I cannot seem to get rid of. They also found I have sleep apnea.
My BP went extremely high. The reason I went to the  hospital initially, because I had some spotting and I was pregnant. I called the doctor and I was advised to go to the ER room. I had no more bleeding, but my BP was way too high.  I was a 28 weeks pregnant at the time I went to the ER room.  I delivered my baby on 03-29-2021 via emergency C-section.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 61-year-old female patient who received SHINGRIX (batch number LL552, expiry date 20th June 2021) for prophylaxis. Previously administered products included SHINGRIX (on an unknown date received the 1st dose and had no adverse events). On 19th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 22nd February 2019, 3 days after receiving SHINGRIX, the patient experienced injection site itching, generalized pruritus and pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching, generalized pruritus and pruritus were unknown.  It was unknown if the reporter considered the injection site itching, generalized pruritus and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced itching at the injection site of the left arm, the entire arm itself, the back of the neck, and on the head. The patient received Benadryl, that helped her slightly. The reporter consented to follow up.
(R) upper arm injection site with approx 12CM diameter of erythema, edema, warmth and a few fluid filled (serous) blisters. Treated with cephalexin x 1 wk.
HIVES ON EXTREMETIES AND BURING/POSSIBLE HIVES IN EAR CANAL ABOUT 60 MINUTES POST VACCINATION. PATIENT RESPONDED TO ORAL DIPHENHYDRAMINE AND WAS FEELING SYMPTOMATIC RELIEF 12 HOURS POST VACCINATION. WILL MONITOR FOR COMPLETE SYMPTOM RESOLUTION.
Patient discribed mild headache immediately after. Patient experienced sore arm for about 10 days. Patient started experiencing pain all over a week after the injection. she describes it as a burning sensation though her nervous system and joint pain. Patient also experienced a brain fog a week after her injection. She states that she has trouble putting her thoughts to words. She still feel this reactions on your 17th day.
Information has been received from a legal firm regarding a case in litigation concerning a female child who was exposed to vaccine containing thimerosal beginning in or about 10/99 and thereafter up through and including 5/01 and each and every time she received a multidose vaccine. It is alleged that as a result of the vaccines containing thimerosal, the pt sustained severe and permanent personal injuries, including being dx'd with severe autism and other neurological disorders. It is also alleged that the pt sustained further neurological insult from other vaccines, including the MMRII which does not contain thimerosal but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, severe autism, other neurological disorders, severe and permanent personal injuries and exacerbation of neurological disorders were considered to be "Other Important Medical Events". Additional information has been requested.
By 11/18, also had a diffuse, splotchy rash, and fever to 102; she also had some emesis. Initially presented to ED, where (per our EMR notes), she had a WBC of 20, without substantial left shift, and received Motrin and ceftriaxone. She was sent home, but with first feed, had emesis, and thus family came to hospital. Had Temp up to 39.2, imaging showed L lung basilar opacity - patient given dose of oral Amoxicillin, but threw up, and thus given another dose of ceftriaxone. Monitored for 2 days treated for dehydration (no additional antibiotics given). Subsequently diagnosed with Kawasaki Disease. Treated with IVIG and ASA, improved quickly and discharged home. Notably has had a previous event after 2 month vaccination (7 days after vaccination) with clinically "viral sepsis" presented with Edema and rash. Pan cultured (negative) and treated with abx. Clinically improved after 2 days and discharged home.
A mother reported that her daughter, now 5 years of age, received series of Hib-Titer, Acel-Imune, and IPV from 6/4/97 through 3/9/00. She also received a dose of Infanrix on an unspecified date. The mother reported that following receipt of "any vaccine" her daughter would not eat, slept all the time, and developed fever of 103-104 deg F. Three and one-half years ago, she was diagnosed with having speech problems. At that time, she was talking at the level of a 1.5 year old. In December 2002, she was diagnosed with autism. Autism was considered medically important (OMIC). Copies of this report has been forwarded to manufacturers of other reportedly administered vaccines.  A 15-day follow report received 03/20/2003 adds: Follow-up info received from the physician on 03/13/2003 provided clarificatin of Hib-Titer lot number and an additional concomitant vaccine.
Information has been received from a licensed practical nurse concerning her daughter with no medical history of allergies, who in October 2008, was vaccinated with first and only dose of GARDASIL, intramuscularly. There was no concomitant medication. The patient had been experiencing hair loss after receiving the GARDASIL vaccine dose. The reporter even noted a bald spot on patients head. No laboratories studies performed. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Additional information has been requested. 11/9/2009 PCP records for 2 visits 9/2009. Patient with c/o's hair loss, fungus on toenails, sore on foot. Impression: onychomycosis
Client received Tdap vaccine at 10:00 AM. At approximately 12:30 AM, 3-20-08 client began vomiting and had increased temp of 102 F (PO). Vomited several times until 4 AM when mother noticed injection site was swollen with deep red rash approximately 6"x3". Clients primary care physician examined child on 3-20-08 and said child was "allergic" to the vaccine and should never receive it again. Child was prescribed Claritin, Benadryl, and Motrin. Temp 3-20-08 later in day was 101.4 (PO). Today child is subdued, not eating, but retaining all fluids.
Had an adverse effect from the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had an adverse effect from the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had an adverse effect from the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Had an adverse effect from the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
noticed elevated temp w/in 30mins of inj;was given APAP but low grade temp cont for 4 days;lethargic, not eating well, became shaky;was taken to ER on 4th day of illness;given an ATB p/ dx ear infect;primary MD was not notified;
Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue areas.  Affects similar to receiving a Novocain shot. No treatment, went away on its own Lasted four hours-was closely monitored
Immediately after injection of vaccine, I experienced a strange aftertaste in my mouth that went up through my sinuses. This sensation lasted for about six hours. I also felt very fatigued the day after.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 16-DEC-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # J004311 and expiration date on 12-JUN-2014, (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
I have a spot on my face on the left side that is slightly swollen and itchy as of yesterday morning.  I also just had the spot where the injection was given become itchy and raised last night.  It has been a week since my  1st injection. Lastly, I have had a persistent headache/neck ache for the last week.
Pain, swelling and purple discoloration of right leg. Diagnosed with Nicolau's Syndrome.
Was seen at ER on 8/17/2021 16:39. Patient is 11-year-old who presents with an allergic reaction. He just received his HPV, TDAP, MENINGITIS vaccine and he broke out in a rash primarily on his face. Denies any throat, tongue, or mouth swelling. No difficulty breathing, no wheezing, no nausea, or vomiting.
Vial was not diluted. Entire vial was drawn and administered to patient. Two days later, medical assistant realized error and informed staff Called patient's parent, no obvious side effects noted since error. Pfizer called, advised not to repeat dose, continue schedule for subsequent doses
This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, female patient of unspecified age. This refers to 43 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (not adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Arm very sore chills for one night fever for one night loss of appetite general feeling of not feeling well general feeling of fatigue second day/ feeling slightly  better but not back to normal
Patient arrived to receive the Pfizer 12+ bivalent booster vaccine. Patient instead received the Pfizer monovalent vaccine. No noted adverse reactions. Patient's Primary Care Provider is in the process of being notified, and outreach to the patient will take place soon thereafter.
Red, raised, painful hives- they are warm to the touch and on the arm beneath the injection site. They do not itch. These showed up 2 days post injection.
ache all over body; tiredness; arm pain; she is getting sick; her lips and tongue are a little numb and tingly; her lips and tongue are a little numb and tingly; her lips and tongue are a little numb and tingly; her lips and tongue are a little numb and tingly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Comments: Blood pressure high; "Panic attacks" (unspecified if ongoing), notes: Comments: Panic attacks. The patient took concomitant medications. Vaccination history included: Moderna covid-19 vaccine (Primary immunization series completed), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 13Sep2022, outcome "unknown", described as "ache all over body"; PAIN IN EXTREMITY (non-serious) with onset 13Sep2022, outcome "unknown", described as "arm pain"; PARAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 13Sep2022, outcome "unknown" and all described as "her lips and tongue are a little numb and tingly"; ILLNESS (non-serious) with onset 13Sep2022, outcome "unknown", described as "she is getting sick"; FATIGUE (non-serious) with onset 13Sep2022, outcome "unknown", described as "tiredness". Therapeutic measures were taken as a result of pain, fatigue, pain in extremity, illness, paraesthesia oral, hypoaesthesia oral, hypoaesthesia oral, paraesthesia oral.  Additional information: She states she received the Pfizer Covid-19 Bivalent booster vaccine yesterday and she has had body ache, arm pain, overall achy feeling like she is getting sick, her lips and tongue are a little numb and tingly. She states that her son also got the vaccine yesterday and he came home and went to sleep and has a headache. So, she is calling today give her experiences and her son's experiences were normal with the vaccines. She did also state that she had recieved the primary Covid series with Moderna vaccine'. Treatment, consumer stated, He didn't took no medicine. I took some Advil today. Reporter stated, I do take high blood pressure pills and also for panic attack, that's it'.  No follow-up attempts are possible. No further information is expected.
Three different types of Rash all over body began 1 1/2 weeks after vaccination with continuous breakouts from onset until now---current date (2 weeks timeframe) and new breakouts are still occurring. Very itchy and uncomfortable and continuing to spread. Appt with personal physician on 4-15-2021.
At 3:36 pm- while sitting in the observation area client was approach by observation nurse when client complained of shortness of breath, and stated heart racing.?  Intervention included extremities elevated, cold compresses, and water offered, vital signs initiated, and emotional support provided; client remained  alert ,calm and responsive. No changed in mental status noted. Observation extended to 30 minutes. Last set of vital signs within normal limits. client was observed walking and talking on steady gait before leaving site, client was made aware to self-monitor for non-resolving, recurring or worsening symptoms. Client left on stable condition on steady gait at 4:08 pm.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Stomach flu. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and POLYCARBOPHIL CALCIUM (FIBER) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Dec-2020 and the estimated date of delivery was 02-Oct-2021. On 19-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 18-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: unknown (Positive) Positive pregnancy..         Treatment information was not provided.
NAUSEA; HEADACHE; SHORTNESS OF BREATH; NOT HUNGRY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced not hungry. On 10-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced nausea, and headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, shortness of breath, not hungry and headache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious..
This spontaneous report was received from a pharmacist via company representative and refers to  a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-MAY-2017, the patient was vaccinated with a dose ZOSTAVAX lot # M037016 with an expiration date 22-NOV-2017, subcutaneously the right arm for prophylaxis. Administered dose of ZOSTAVAX was reconstituted in a sterile diluent (STERILE DILUENT) for 45 minutes, withdrawn into a plastic syringe and stored for one hour outside prescribing storage, reported also as "in either the refrigerator or at room temperature'. No side effects were reported. Additional information has been requested.
psoriasis on the hands basically cleared up, legs stopped itching and looked 70 percent better; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriasis", start date: 1981 (ongoing), notes: for over 40 years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "psoriasis on the hands basically cleared up, legs stopped itching and looked 70 percent better". Additional information: The patient was not on any immune suppression drugs. The vaccine stopped the scales on the patient's skin and rerouted the immune system. The patient has never seen anything like this in the past (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client was needed a second dose of pfizer, but was accidentally given moderna and she is 14 .