chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up with shot site hot; Woke up with shot site red; Woke up with shot site puffy; Woke up with shot site sore to touch; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Woke up with shot site hot), VACCINATION SITE ERYTHEMA (Woke up with shot site red), VACCINATION SITE SWELLING (Woke up with shot site puffy) and VACCINATION SITE PAIN (Woke up with shot site sore to touch) 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 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced VACCINATION SITE WARMTH (Woke up with shot site hot), VACCINATION SITE ERYTHEMA (Woke up with shot site red), VACCINATION SITE SWELLING (Woke up with shot site puffy) and VACCINATION SITE PAIN (Woke up with shot site sore to touch). At the time of the report, VACCINATION SITE WARMTH (Woke up with shot site hot), VACCINATION SITE ERYTHEMA (Woke up with shot site red), VACCINATION SITE SWELLING (Woke up with shot site puffy) and VACCINATION SITE PAIN (Woke up with shot site sore to touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Patient reports later that day (7/20/18) feeling while body pain including joint pain, high pulse rate (96 bpm) and feeling very short of breath. The symptoms continued until at least this morning when he called the pharmacy at 8:30 AM (7/21/18). I suggested that he seek the help of a medical provider via a clinic or the ER. He had not as of this morning (7/21/18).
Had a FLUZONE high dose PFS 2016-17 on October 14 at the pharmacy. In addition to the significant bruising, pain, swelling and large red mark at site of the injection where shot was given, (which were listed as likely side effects and are not at issue) I had a large spreading red welt a couple of inches below the injection mark and by the evening of October 16th also developed hives on my legs and arms. BENEDRYL relieved the symptoms of the hives on my arms and legs by morning. The large red welt continued for about a week. I do not have a known latex allergy, but I do have a history of developing hives as an allergic reaction to anti-inflammatories such as aspirin and MOTRIN. I had not taken any other medications during or before this time period nor am I aware of being exposed to any other allergens. My pharmacy has my allergy records on file. The injection site is still bruised and painful, but that is probably due to the lack of skill of the person who administered the shot rather than the drug.
Pt had hepatitis B vaccine - within 15 min got facial rash, throat and neck discomfort. Rash ad itch on chest, some nausea.
I have a lactation concern I would like to share. I received the first dose of the Pfizer COVID-19 vaccine Jan 14, 2021. At the time of my first vaccine, my daughter was exclusively breastfed and was six months old. Although, I fed her breast milk from my work pumping sessions; most of the time my daughter was feed at the breast. The next morning, Jan 15, 2021, I noticed a decrease in milk production based on her hunger cues (crying, general fussiness after nursing session). This was unusual and atypical behavior for her. During times I pumped, following my first COVID-19 vaccine dose, I noticed a marked decrease in production. We had to supplement with formula. Also to note, we began feeding my daughter solid foods at six months of age.
First it started with the arm pain, then a headache, internal fever, chills and a lot of pain throughout the body, mainly the pain in my back and my lower back. Through the area of ??the kidneys and the pelvis. The intense pain lasted about midnight, I took a pill of TYLENOL for pain and to be able to sleep, which helped me a bit but the next day the body and back pain persisted ... what hurt the most was my lower back and I could not bear to lie down in any way so I remained semi-lying or sitting in bed because when I lay down my back bothered me. I took natural teas to help me and I took water and electrolytes to feel better. gradually by the end of the second day my pain symptoms were decreasing. The dizziness in the head remained very persistent on the 2nd day. On the third day I felt a relief from my muscle pain but the discomfort or dizziness of the head was still there, it was not as strong as the last days, but when moving my head from side to side or sitting or standing up it was like a vertigo or a unstable that I felt was there. By the 4th day I felt better almost no symptoms just like body sweat ... like hot flashes.
Anaphylaxis reaction - closing throat, chest pain, dizziness, numbness in left arm.  Given Benadryl and a steroid shot. Stayed after vaccine 2 hours.
The patient stopped by pharmacy clinic today complaining of pruritis and a rash  that she states began on 6/20 after she received Zostavax on 6/16. She denies  starting any new medications around this time and cannot recall any unusual  foods she may have eaten that would cause an allergic reaction. She has been  taking Benadryl regularly for this and she states this has helped the itching.  She has had chicken-pox in the past and states this rash is similar to chicken- pox, except not as severe. She has red spots over her trunk, legs, and arms and  states they were also on her face but those have went away. She tells me the  areas are healing now and the redness and itching is subsiding.
Pt reported difficulty breathing and feeling hot, mask removed, monitored for 30 mins, Stating 98% on pulse ox, HR 77, lung sounds clear
WENT TO BED AND AT 9.30 PM LEGS STARTED HURTING TERRIBLE, REST OF BODY WAS ACHING, GOT UP TO US BATHROOM, AFTER THIS WENT TO GET A DRINK OUT OF THE FRIGE, WHEN WENT TO TAKE HOLD OF BOTTLE OF CRANBERRY WAS UNABLE TO HOLD DUE TO VIOLENT SHAKING, SOMEHOW MADE IT BACK TO BED AND BY WRAPPING UP GOOD FINALLY GOT RID OF CHILLS. BUT STILL ACHED ALL NIGHT LONG, AS OF TODAY, I STILL HAVE ACHES, RUNNING NOSE, STOPPED UP, COUGHING.
Patient awoke with chills and fever on evening following vaccine. TMAX 103.  Fever resolved within next hours. Patient well the following morning.
Pt. had a sever hemmoragic stroke the week after her 2nd vaccine dose. We did not know it at the time but she was later diagnosed with Cerebral Amyloid Angiopathy.
Emesis on 12/17/16. Standing in crib, had generalized Sz - duration 3-4 min. EMS transported to ED. Given NSS bolus and ZOFRAN and discharged.
Patient first felt pain at injection site. Then dizzy & sick in the stomach. He then passed out. He was given multiple blood pressure checks & an EKG. Five days later he is still feeling sick, he has numbness in his hands plus Headaches.
Localized redness / swelling, painful movement on upper deltoid site (where menactor was vaccinated)
Dose Error: Administered COVID-19 vaccine in person less than 12 years old in error. No adverse events reported.
My daughter has had total hair loss; psychotic episodes; rash; nausea; severe vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "My daughter has had total hair loss"; PSYCHOTIC DISORDER (non-serious), outcome "unknown", described as "psychotic episodes"; RASH (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown", described as "severe vomiting".  Additional information: It was reported that patient (reporter's daughter) has had total hair loss, rash, psychotic episodes, nausea and severe vomiting since taking the last booster Covid 19 vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
After receiving initial MMR, began declining in developmental tasks. Approximately 6 months later was finally diagnosed with Autism Spectrum Disorder. Follow up 01/26/05: Patieht has Autistic Spectrim Disorder, which is permanent neurologic damage caused by some insult to the body. This disorder cannot be cured.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/17/2021 ABNL CHEST CT SCAN J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 3/25/2021 ABNL CHEST CT SCAN R09.02 HYPOXIA 3/25/2021 ABNL CHEST CT SCAN
Student received vaccine at appox 4p. At approx 410pm she c/o light headedness. Placed in wheel chair, brought over to cot, drank 2 juice boxes and felt better. No loss of consciousness. Neuro intact, no seizure activity. Denied pain. No facial swelling, rash, difficulty breathing. All extremities with normal movement. Vitals:  4:12 -  BP: 103/58, HR 44 (she is a cross country runner), spo2: 99%. Blood glucose: 97  mg/dl. Felt completely back to normal ~425p.  Cleared by myself and EMS to go home.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA304355 (same reporter). This case involves a six- months old male patient who was vaccinated with a dose of PENTACEL (lot number: C5324AC) via intramuscular route in the left thigh on 30-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PREVNAR 13 for Immunisation; and FLULAVAL for Immunisation. It was a case of actual medication error due to incorrect product storage and poor quality product administered since vaccines were not stored in appropriate temperature ranges. It was not reported whether the patient has experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Shoulder pain and limited range of motion that has continued to worsen since administration of the flu shot.
Patient received the vaccine around 10 am and returned to her workstation without any issues initially.  Returned to where the flu clinic was being held and stated she was feeling light headed, weak, slightly clammy and had some heaviness in her chest.  One of the pharmacists on duty got a chair for her to sit down and gave the patient water to sip on while having her take deep breaths.  Patient reported her throat felt "like it was not all the way open" but denied that it was closing up.  In terms of her breathing she stated that her chest felt heavier than normal but did not indicate it was more difficult to breath.  the pharmacist observed the patient for another few minutes and the symptoms did not get any worse.  Blood pressure was taken and patient's respiratory rate was observed, both appeared to be normal.  Patient then stated she felt like she was feeling tired and was going to pass out.  She was given crackers for some calories in case she was experiencing low blood sugar.  They did not seem to change the patient's symptoms.  After another 10 minutes or so, breathing still seemed normal and patient was not having any issues with communicating, the patient then asked if there was anything we could give to her.  We offered benadryl and explained that we had epipens if needed however it did not appear she was having an anaphylactic reaction but more of a syncopial one.  The patient accepted 50 mg of benadryl and was counseled appropriately on side effects with her meds.  Her mom picked her up to take her home and rest.
Eosinophils on 2013-05-20, clinician comment: Patient has had intermittently elevated eosinophils.
swelling/rash at immunizations site, above site on shoulder radiating around entire arm.  swelling in neck and armpit
Acting "differently"- more memory issues,  cognitive issues remember vocabulary, more forgetful, difficulty with short-term memory, difficulty with basic cognition
Peeling skin, confused (mild) dizziness (mild), change in eyesight, swollen lips and tongue, tingling in legs and feet when laying down, feeling tired and weak.
Shaking uncontollably/violently like seizure attack; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking uncontollably/violently like seizure attack) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), DIGOXIN, DILTIAZEM, FOLIC ACID, METHOTREXATE, POTASSIUM CHLORIDE (KLOR CON), PROPYLTHIOURACIL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) and APIXABAN (ELIQUIS) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Shaking uncontollably/violently like seizure attack). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Tremor, at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking uncontollably/violently like seizure attack) had resolved.            The reporter was calling on behalf of one of their family members who developed adverse events after receiving both the doses of Moderna vaccine. The patient received the 2nd dose of Moderna vaccine on 09-Feb-2021 and by 7:00 pm, on the same day of vaccination, the patient started the symptom of shaking uncontrollably and violently like seizure attack. The symptom went away with in an hour and took 2 to 3 days for the patient to recover from the symptom completely. The patient took Benadryl medications as advised by the para meds for the symptoms developed.   This case was linked to MOD-2021-193645 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up was received on 08-Jun-2021 and Updated the lot number of the second dose.
Patient felt febrile with flu-like symptoms on 4/29/21.  Woke up on 4/30/21 with chest pain.  Went to the emergency department. They evaluated him and transferred him by ambulance to Medical Center where he stayed for three days for tests and evaluation. Patient was ultimately diagnosed with acute perimyocarditis.
Patient reported vaccines given in same arm. Her arm got very red and swollen hot to touch. Went to ER/Urgent care, given prednisone and Benadryl. 9/5/12 still sick, arm swollen and feverish. Will see PCP 9/6/12.
Aching day after and then swelling of lymph nodes on neck and armpits. Left armpit is the worst with swelling.
Chills, Fever of 101 degrees, muscle aches, fatigue. Lasted about 24 hours.
A pharmacist reported that a pt received Pnu-Imune 23 in 11/99 and on 11/4/99, developed cellulitis which extended from the deltoid to the wrist. The pt was seen by the physician and treated with unspecified antibiotics. The pt recovered. Additional information received 12/7/99 from the physician, included the date of immunization, the administrator of the vaccine and the pt's address. This is 1 of 3 pts from this facility who experienced an adverse event following receipt of Pnu-Imune 23 lot 461144.
FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (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. On an unspecified date, the subject experienced fever. Laboratory data (dates unspecified) included: Fever (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The outcome of fever was not reported. This report was non-serious.
24hrs p/MMR, PT suffered brain injury resulting in respiratory arrest (not shock); @ this time damage felt most likely due to trauma, but do not have definitive hx to absolutely state trauma as cause;
5 X 7 raised, edematous, inflammed area of dorsal right thigh, warm to touch, 12 hours, post vax. Treatment: ice pack, Motrin and Benadryl PRN and return if needed.
After receiving this vaccine, every time I have gotten covid or any other sickness from the common cold, to the flu it has been severely worse than ever before in my life making no sense because I am healthier in every area in my life than ever before with the only difference being the covid 19 shot.
Headache, fatigue, chills, sore throat, congestion, severe body aches
Patient states pain in entire body that started the evening of the day that she received the vaccine. States that the pain is new to her and she has never had a reaction to a flu vaccine in the past.
Adult Onset Stills disease; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Aug2021 (Lot number: EW0202) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: prior vaccination. The patient's concomitant medications were not reported. Past drug history included: Propylene glycol, reaction(s): "Known allergies: Propylene Glycol". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0198, Location of injection: Arm Left), administration date: 27Jul2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: STILL'S DISEASE (hospitalization, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Adult Onset Stills disease". The patient was hospitalized for still's disease (hospitalization duration: 19 day(s)). The event "adult onset stills disease" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Dec2021) negative. Therapeutic; Sender's Comments: The information provided is too limited to make a meaningful medical assessment of the case. However, based on the available information in the case provided, the causal association between the reported event Adult onset Still's disease and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal relationship. The case will be reassessed once new information is available. 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.
Within 7 hours from shot, I had: Headache Body aches Nauseous/ threw up Fever Hallucinating (24 hrs past shot) Weak/zero strength  Fingers tingled  Extremely achy for 36 hours even taking pain meds. Could not function or stand as I would be dizzy and weak.  Symptoms climaxed 24 hours post shot and I felt super sick.  Severe headache lasted until 54 hours post shot.   5 days past and I have still a sore and irritable arm (red, and hot to touch arm)    Would like to note that I am nursing my 10 week old baby end felt that when I was at my absolute worse, she was also very fussy as well. Cried more than often and was not happy as normal.
Tdap expired on 7/15/23 and was given on 7/18/23, 3 days past expiration date. No adverse effects. Patient will be called to repeat this vaccine.
SLIGHT HEADACHE AT THE BASE OF THE HEAD (WAS STILL LINGERING BUT VERY MILD), THEN IT GOT WORSE; FEELING TIRED; FEVER; BODY ACHES, (WAS LITTLE BIT SORE); CHILLS; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 135 pounds, and height was 64 inches. The patient's concurrent conditions included: fibroids, alcohol consumer, non smoker, and perimenopause, and other pre-existing medical conditions included: The patient had no known allergies, and no any drug abuse/illicit drug usage. Medication for fibroids and perimenopause- vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. Concomitant medications included progesterone for perimenopause, and fibroids.  On 25-SEP-2021, the patient experienced body aches, (was little bit sore). On 25-SEP-2021, the patient experienced chills. On 25-SEP-2021, the patient experienced feeling tired. On 25-SEP-2021, the patient experienced fever. On 26-SEP-2021, the patient experienced slight headache at the base of the head (was still lingering but very mild), then it got worse. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, (was little bit sore) on 27-SEP-2021, and fever on 26-SEP-2021, had not recovered from slight headache at the base of the head (was still lingering but very mild), then it got worse, and feeling tired, and the outcome of chills was not reported. This report was non-serious.
This spontaneous reports as received from an unknown type reporter refers to a 12 year old patient of unknown gender. On 01-APR-2014 the patient was vaccinated with a dose of GARDASIL (lot#batch# reported as J006350, expiry date: 31-MAR-2016) dose, frequency and indication unspecified. The reporter stated that GARDASIL was involved in temp changed. At the time of report, the outcome of the events was unknown. This is one pf several reports received from the same reporter. Additional information has been requested.
After I received the vaccine, I felt a warm sensation in my throat. Within 30 minutes of receiving the vaccine, I had a tightening in my chest, I started experiencing, chills and my body ached all over. Within 2 hours of receiving the vaccine, I was still experiencing the same symptoms but they were getting worse. Within 4 hours I felt I couldn't move and all I wanted to do was lay down.I slept for an hour. The symptoms were worse and I was short of breath and my head was swimming, I hurt all over, inside and out. I couldn't get up. I was like this for almost 16 hours. After 48 hours I was able to get to the bathroom and take a bath but symptoms were still there. After 6 more hours my fever broke. Its been 7 days and I am still experiencing a headache, body aches, chills, tightness of the chest, shortness of breath, my head is still swimming and I had no energy. I do not feel the same as I did before the vaccine and I am so tired all the time.