chrisvoncsefalvay/vaers-outcomes huggingface dataset:
18days p/vax pt exp varicella like rash. pt started to exp fatigue, general malaise, headache, nausea, vomiting & low grade fever. pt broke out w/fluid-filled vesicles over body.
16 y/o was administered a 0.25 mL dose of Moderna by mistake; Patient had received Pfizer as a primary series; Did good except for her sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Did good except for her sore arm), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 y/o was administered a 0.25 mL dose of Moderna by mistake) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received Pfizer as a primary series) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Patient had received Pfizer as a primary series) and PFIZER BIONTECH COVID-19 VACCINE (Patient had received Pfizer as a primary series). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In December 2021, the patient experienced PAIN IN EXTREMITY (Did good except for her sore arm). On 16-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 y/o was administered a 0.25 mL dose of Moderna by mistake) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received Pfizer as a primary series). On 16-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 y/o was administered a 0.25 mL dose of Moderna by mistake) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received Pfizer as a primary series) had resolved. At the time of the report, PAIN IN EXTREMITY (Did good except for her sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Hives allover the body; Left eye swollen; Left upper lip tingling; Sore arm; Trouble lifting arm; A spontaneous report was received from physician, concerning a 23 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm, had trouble lifting it, left swollen eye, left upper lip tingling and hives all over her body.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot number 11220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, around 09: 00 pm, the patient experienced a sore arm and had trouble lifting it. On 02 Jan 2021, the patient experienced a left swollen eye, left upper lip tingling and hives all over her body. The patient went to the emergency room where she was treated with Benadryl intravenously. The symptoms subsided.   Action taken with mRNA-1273 vaccine was unknown.  The outcome of event, a sore arm, had trouble lifting it was unknown. The outcome of events, left swollen eye, left upper lip tingling and hives all over her body was resolving.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded.
SIDE EFFECTS; BODY RASH; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a male of unspecified age, race and ethnicity. 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, and batch number were not reported, expiry: Unknown) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was hospitalized 3 times with unspecified side effects, and body rash. The number of days of hospitalization was not reported and it was unspecified if the patient discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the side effects and body rash was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20230109707-Side effects-The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.     V0- 20230109707-Body rash-. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
slight ache around injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2021 (Lot number: EL3247) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "slight ache around injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Facility type vaccine: Workplace clinic. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not covid tested post vaccination. No known allergies. No other medical history. With first dose, the patient experienced only slight ache around injection site (<24hrs).  No follow-up attempts are possible. No further information is expected.
Pfizer Covid Booster given to 13 year old.  Patient has not experienced issues but booster has not been approved for children under 16 yet so Patient should not have received the booster at this time.
Swollen & warm to touch & tender all across upper arm. Not just spot of injection site. Approximately 7? across and 1? down.   Not severe enough to cause me to contact dr yet. Just to inform of reaction.
allergic to it; hives; difficulty breathing; sick; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on 05Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic to it, hives, difficulty breathing and sick. It was reported that the patient was wondering how long would it take before the events comes out of her arm and she was wondering if she can take Mucinex or Benadryl. No unaddressed medical questions was referred or forwarded to Medical Information. Outcome of the event was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Pt's mother c/o diahrrea, decreased urination despite adequate fluid intake, red buttocks and gluetal fold.  Also, consistant fever of 101 F .  Referred pt to family dr. Continue fluids, diaper cream for reddness and acetaminophen/ibuprophen for fever.
Went into Afib at 3:00AM on 4-21-21. 911 was called. Diltiazem was administered IV. ER performed EKG and CT. I received Eliquis, Diltiazem and Lovenox. Released from ER at 9:00am still in Afib. Referred to cardiologist.
Inj. given at 3:52 PM. Fever of 102.7, chills, achy joints at night. In AM pt. has red, raised hives all over legs and itching. Tx: BENADRYL.
Pt. called w/ redness, swelling 4-5 days out and resolved after 8-9 days.
At exactly 840 I started having Body aches, headache, fatigue, muscle pain. I felt worse every hour. I laid my head down at work barely able to move.  Once I got home I went straight to bed with my work clothes still on and slept for 15 hours straight.  I woke a bit outta sorts but feeling better.  The arm I got the shot in still tingles like it's asleep a week later.  Have had episodes of feeling if things are moving around me, even when standing still.
Pt recv vax on 4/7/99; on 4/9/99 pt exp fever, blue to red color of skin area- blood under skin
PT C/O OF PAIN AT INJECTION SITE AND GENERALIZED PAIN OF R ARM. DEVELOPED FEVER TO 103F, SITE BECAME RED AND APPROX 10CM OF INDURATION TRANSFERRED TO ED AND ADMITTED FOR TREATMENT WITH ORAL ABX, CULTURES NEGATIVE.
This spontaneous report was received from a patient's mother and refers to a 25 year old non pregnant female patient who had peanut and animal allergy and no other pertinent medical history. On an unknown date, the patient was vaccinated ("within the recommended dosing schedule for GARDASIL") with the second dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). The mother was not sure of what vaccine her daughter received. It could not be confirmed if it was GARDASIL or GARDASIL 9. Concomitant therapies included birth control pill. On an unknown date, approximately in April 2015 (reported as "late April or early May"), the patient started losing her hair, having thinning of her hair, having bald spots, losing weight, achiness and major fatigue. On an unknown date, the patient had been to see her regular physician, dermatologist and rheumatologist for her symptoms. She was given steroid shots and clobetasol propionate ointment as a treatment. She also had biopsy for her scalp performed with no results provided (date unspecified). The outcome of events was reported as not recovered. The relatedness between GARDASIL or GARDASIL 9 and events was not reported. Additional information is not expected as no contact details were provided.
I developed extreme fatigue and pulsatile tinnitus in a gradually increasing level in the months following the vaccine. It got so very bad (with near fainting and extreme weakness)  that I scheduled a physical with my PCP, She ordered routine bloodwork in advance and I had that at Clinic on Sept 10th and got an emergency call Set 11th that I was "critically anemic" with Hemoglobin at 4.9 (my annual testing "normal" is around 12+) and very low iron etc. Dr immediately put me on iron supplement 2X daily (ferrous sulfate 375/60) and sent me for CT scans of pelvis, abdomen (9/13) and chest xrays (9/14)  which all came back normal. More bloodwork at clinic 9/16 still low HB at 5.3  I saw a GI doctor on (9/20) who said cannot schedule colonoscopy till Hb levels increase, but my previous Cologuard was normal. He could feel no abnormalities. Also have been seen by Hematologist Dr, (9/29) who ran extensive blood tests - all normal except for the previous markers, including Hb which was still low at 6.8 but somewhat improved from 2 weeks of iron supp. He increased the iron supplement to 3x daily (He offered iron infusion but I asked to wait a bit for iron supp to work. Returned to him today (10/27) and thankful Hb up to 10.8 and iron in normal range. I found a discussion on Clinic where many people are reporting same as me with no previous anemia that developed after Covid vaccine so am reporting this in case related
Patient has a malignant brain tumor diagnosis on 1/30/02. He has had a craniotomy but most of the tumor still remains in brain stem and left thalamus. He had 5 doses of chemotherapy. He still is a cancer victim today.  60 Day follow up states my child has a malignant brain tumor in his brain stem and thalamus. It's for life. I do not know which vaccines did this and have no legal proof but had I known what was in them I would not have given them to he. The annual follow up received on 10/1/03 states, "I don't know which vaccines had to do with my son getting brain cancer but I know these are the cause of it. I don't think I have any further info for you."
woke up with tingling in his right hand which extended to his fingertips; intense shivering; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a day after receiving Shingrix, the patient experienced shivering. On 19th October 2022, the patient experienced tingling of extremity. On an unknown date, the outcome of the shivering was recovered/resolved and the outcome of the tingling of extremity was not recovered/not resolved.   It was unknown if the reporter considered the shivering and tingling of extremity to be related to Shingrix.     Additional Information: GSK receipt date: 19-OCT-2022 Reporters comment: The reporter was the patient. The patient received the 2nd dose of shingrix and experienced intense shivering which eventually went away and today( the day reporting )he woked up with tingling in his right hand which extended to his fingertips. tingling was still present The reporter consent to follow-up.
I was six full weeks prior to this COVID - I had a breathing exam and multiple tests. I had been sick before that, too. I have been sick for basically a year straight. I had a sore throat, a headache, an earache and congestion. I had sneezing and fatigue, loss of taste and smell. I called my doctor and she sent me to COVID test  - Monday, August 2nd and I went to drive through through Asanti - positive result. No treatment. I quarantined for a week - 7 full days. I didn't results of COVID test until Wednesday (quarantined through following Wed). So that following Wednesday, I was still very tired, and still had a tight chest/congestion - but it's very smokey here so it might have been from the smoke. My sense of taste and smell were slowly coming back that following Wednesday. I do have them back fully now.
30yo M with PMH concerning for possible allergy to PEG.  Because of this further evaluation was undergone with SPT to PEG330.  Patient was found to be reactive to 170mg/ml on testing.  Given this and his prior reaction to the bowel prep I discussed with patient that this likely represents a true allergy.  We discussed next steps moving forward such as the risks/benefits of receiving a booster dose of the COVID-19 mRNA vaccine (Pfizer).  After discussion of possible risks of anaphylaxis despite him tolerating 2 doses of the vaccine previously we decided that the benefits outweighed the risks of proceeding with the vaccine.  After receiving the vaccine he remained asymptomatic for the first 15 minutes.  After that he developed a globus sensation in his throat and some subjective itchiness of the hand/scalp.  VS were taken at that time which were normal and no objective symptoms were noted.  About 10 minutes later patient endorses some diffuse pruritus, with objective rhinorrhea and conjunctival erythema.  At that time we administered 0.3mg of epinephrine via EAI into the anterolateral left thigh.  Patient was subsequently given an OAH Zyrtec 10mg.  10 minutes after receiving the epinephrine patient endorsed resolution of the pruritus and conjunctival erythema as well as improvement in the globus sensation. 10 minutes later the globus sensation had completely resolved.  throughout this time lungs remained CTAB with no urticaria noted and stable vital signs throughout.  Patient was observed for an hour after resolution of symptoms and discharged home.
patient received a flu shot on 10-02-23. mom says the area is red. last night his arm felt hot and there was a lump at the injection.   Mother states left arm was swollen from shoulder to the elbow with area distal to injection site that was a Firm purple lump that was warm.   Gave 12.5 ml of ibuprofen. Patient states he felt like he had asthma after taking the ibuprofen.  "felt burning in my lungs" with breathing in and out.   Denies tongue or lip swelling. No vomitting.  Denies diarrrhea.   This morning the swelling and the lump much improved.
Upon returning from two weeks of traveling my ears were full, head was congested, and I was coughing up a lot of mucus from my chest. The following Monday I saw a Dr. and he prescribed me some prednisone for about a 5 day treatment. After 4 days I could finally clear my ears. I then experienced vertigo, but that cleared within about a day. I haven't had a reoccurrence of that, but I am still congested and have a cough just not as severe. I haven't experienced any other side effects since then.
TOOTH WAS NOW DEAD; PAIN ON UPPER MOLAR RIGHT SIDE; ONE VEIN WAS COMPLETELY BLOCKED AND THREE OTHER VEINS PARTIALLY BLOCKED; BLOOD CLOT; This spontaneous report received from a patient concerned a 60 year old white male of unknown ethnicity. The patient's weight was 193 pounds, and height was 73 inches. The patient's concurrent conditions included drinks alcohol, and was non smoker. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total administered at left deltoid around 12:00 in noon on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the patient noticed red marking and pain on the right leg. On 05-AUG-2021, diminished the use of right leg and walk was affected. On 06-AUG-2021, patient went to emergency room and diagnosed with blood clot and one vein was completely blocked and three other veins partially blocked. As of 06-AUG-2021, the patient was started on Eliquis 20 mg per day for 7 days. On 11-AUG-2021, the patient begins to feel pain on upper molar right side, so patient went to dentist on 18-AUG-2021. The patient was informed that the tooth was now dead, may had been micro clot blocking of circulating. At the time of this report the patient was on Eliquis 10 mg daily and regimen will last for six months. On an unspecified date, patient underwent factor 5 genetic marker test which was negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tooth was now dead, and the outcome of blood clot in vein and one vein was completely blocked and three other veins partially blocked was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210838162- covid-19 vaccine ad26.cov2.s-blood clot, one vein was completely blocked and three other veins partially blocked, tooth was now dead. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Initial unsolicited misuse report received from a Consumer on 16-FEB-2017. This case involves a 55 years old female patient who was intramuscularly vaccinated with a dose of TENIVAC (lot number: U5184CA, expiration date: 23-OCT-2017, dose, dose in series not reported) in left deltoid on 29-DEC-2015. It was reported that patient was bitten by a child, on the right arm and there is still a tender area at the site. The Illness at time of vaccination was reported as no and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as hypothyroidism, allergic to liquid iodine, Demerol, sulfa drugs. Any other vaccinations within four weeks of vaccinations were also not reported. Concomitant medications were not reported. On 12-JAN-2016, 14 days (reported as two weeks) following the vaccination patient had spasms in her arms and abdomen, difficulty in breathing, her legs swelled to 3x the regular size, severe headache. Patient had to stop her thyroid medication due to severe headache. On an unspecified date, post vaccination, patient had difficulty in concentrating, doesn't feel like herself and hasn't been able to work. It was also reported that the vaccine received by the patient was in a temperature excursion and was deemed unstable for use. This was also a case of incorrect product storage. The patient had not been seen by MD due to lack of medical insurance. Lab data was reported as none and corrective treatment was not reported. It was reported that some symptoms were resolved but was not specified. Patient continued to have a difficulty in concentrating, doesn't feel like herself, hasn't been able to work. Patient was recovered from headache as she started taking her thyroid medication again without headaches occurring. Patient was not yet recovered from other events. List of the documents held by sender: none.
No adverse effects reported; the patient was vaccinated with an improperly stored VARIVAX; This spontaneous report was received from a medical assistant, regarding a 20 month old male patient. The patient's illness at the time of vaccination were reported as none. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included pneumococcal 13v conj vaccine (CRM197) and Hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL).  On 02-OCT-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S000133, expiration date 02-JAN-2021), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 13.28 degree Celsius from 30-MAY-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012360: US-009507513-1910USA012981: US-009507513-1910USA012356: US-009507513-1910USA012355: US-009507513-1910USA012357: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012358:
Chills, headache, eye ache, fever, body aches, fatigue, feeling like I'm going to pass out, soreness of arm where injection was given, upset stomach, heavy period after vaccine followed with cramps, having to wear a pad and tampon changing every 2 hours due to heavy blood flow and lots of clots
No adverse event noted.  Pediarix (DTaP, IPV, and Hep B) was given in place of DTaP, resulting in a double dose of IPV and unnecessary dose of Hep B for the patient.  No adverse reaction, rash, illness, or event noted.