chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot at the injection site; Itchy at site of injection; Arm is sore - left arm / sore to touch at the injection site; Arm is swollen - left arm; Rash at site of injection; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE PAIN (Arm is sore - left arm / sore to touch at the injection site), VACCINATION SITE SWELLING (Arm is swollen - left arm) and VACCINATION SITE RASH (Rash at site of injection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE PAIN (Arm is sore - left arm / sore to touch at the injection site), VACCINATION SITE SWELLING (Arm is swollen - left arm) and VACCINATION SITE RASH (Rash at site of injection). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (topical) for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE PAIN (Arm is sore - left arm / sore to touch at the injection site), VACCINATION SITE SWELLING (Arm is swollen - left arm) and VACCINATION SITE RASH (Rash at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-Jun-2021 , contains non significant information. Reporter contact number, patient information on race and ethnic group was updated .
I need to talk about my pfizer experience. I'm 56. January 15 I received my first dose. I had zero side effects. The night after that initial dose. I began having what I'd term as cognitive issues. Trouble focusing. Blurred vision. Confusion. My synapsis weren't synapping. My brain and mouth didn't work. I felt like inside my body was shaking. But visibly, outside, was nothing. At that time, I was managing diabetes and I figured it was related to victoza being stopped since I'm not a diabetic now. And it continued about 7 days. Then, dwindled for a few, but it returned. I then began getting panicked about it and having panic attacks. I'm afraid of dementia, and remembering was an issue.  It continued 4 days off 4 days on. Oddly enough. The 3rd week, it went away about 3 days in. I had about 7 days of bliss, but on the 4th day I got vaccination number 2. At this point, troubleshooting, I quit all my medications. I thought the issue was meditation related. I got shot number two and 3 days later, it hit and stayed again. 4 days on. 4 days off. By this time, I figured it is not my medications. So I went to my Dr. We did an MRI. Carotid workup. We did every test known to man, inluding heavy metals and found no anomalies except I was dehydrated. So I increased water and raised kidney functions. Weeks went by like this. Off and on. Dr finally told me I had toxic metabolic encephalopathy and I could have died. All testing rules out everything except vaccination reactions. He said my body didn't recognize the vaccine and that my brain attacked the toxins and swellee and caused the TME because of that. I want others to know. TMEs can be deadly. Your brain can swell, and you can die. Fortunately I'm on the upswing. But I still worry about memory. I forget appointments.  I still am for the vaccinations. But we never know how our own bodies will react. My physicians diagnosis is a TME caused by Pfizer vaccine. He has ruled everything else out.  I advocate this vaccinaction. Do it. I think what I went through is rare. But interestingly enough, online, it states 23 percent of covid victims get TME.  I didn't have Covid. I've tested negative. This is also not dementia or anything of that nature. I've been thoroughly examined.
PNEUMOVAX given at 11:30 AM and sx started at 4 pm same day. Severe pain in (L) shoulder extending superiorly to neck and inferior to wrist. C/o inability to move arm. Denies SOB, wheezing, rash or angioedema. No neurovascular compromise, tenderness w/palpation to (L) shoulder and elbow. Decreased ROM d/t pain in (L) upper ext., 2+/4 radial bruises. Cap. refill w/in 2-3 sec. bil. no rash no angioedema lungs WNL. PERCOCET and MEDROL Dose Pak given. Sling given and advised ice and heat.
Patient felt tachycardia, was hypertensive, HR 200, O2 wnl, skin with red blotches throughout shoulders, face and chest and had cold hands and more blotches on shoulder area, transported to ED urgently for further evaluation
Parent contacted clinic within 24 hrs of vaccine administration, stating that injection site had an area of redness approximately 3-4 inches across. Mild low grade fever for 12 hours only. Negative arthralgia, negative myalgia
Swelling/Redness of 4 cm x 5 cms, diameter, at site of injection
1 wk /p MMR, pt developed dark red mac pap rash, concentrated on buttocks & lower extremeties /w surrounding pale halo, few lesions on arms. Rare lesions on trunk & scalp. Pt refused to walk X 3 days.+ Diarrhea DX:HSP, anaphylactiod purpura
Woke up sore all over, had extreme fatigue and went in and out of sleep all day, had the chills an a low grade fever of 100. Towards end of night around 9 pm I was still tired but no longer feeling ill
Experienced chills/fever, painful muscle spasms afterwards and during the night (they have improved the next day), emesis occurred at 3 am, headache
CHILLS; FEVER; BODY ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, and body aches. This report was non-serious.
This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On 12-JAN-2018 (reported as today), the patient was vaccinated with M-M-R II lot # N013296 and expiration date 28-APR-2019 for prophylaxis (dose, frequency and route were not provided). The reporter stated that the vaccine was clearer than it was yellow in appearance. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1802USA001719.
Lymph node swollen in your arm pit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swollen in your arm pit) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph node swollen in your arm pit). At the time of the report, LYMPHADENOPATHY (Lymph node swollen in your arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Around 9pm woke up from sleep crying and screaming, disoriented. Had wakening after 10-30 minutes with screaming and crying until 1 AM. Following morning child didn't recall what happened. Also developed local redness around DTAP site, indurated approximately 4 inches. Seen 6/10-rash sl. red, flat approximately 3 x 2 in. not tender, not warm, not indurated.
No adverse event; patient received improperly stored dose of varivax; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/ allergies were not reported.   On 14-MAR-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (product storage error) with lot # S025609 and expiry date 18-AUG-2021, 1 dosage form for prophylaxis (strength, route, anatomical location not reported) which was reconstituted with properly stored sterile diluent. No additional adverse events reported. Doses of suspect vaccines experienced temperature excursion from 15 degrees Fahrenheit (°F) to 46 °F (also reported as -9 °C to 8 °C (-5.48C)) for 7 hours. It was reported that no previous temperature excursion was done. Digital data logger was involved. No product quality complaint was involved in this report. No further information was provided.
I had the normal flu like symptoms with fever and body aches for about 2.5 days after the injection. Five days after injection, I developed a huge rash/hives all over my body - arms, legs, stomach, back, buttocks, face out of nowhere.
This spontaneous report as received from a registered nurse concerning to multiple unspecified patients who on an unknown date were vaccinated with an improperly stored dose of PROQUAD (Lot No. N012491, 17-OCT-2017) (rHA). Concomitant therapies included sterile diluent. No adverse effects reported. Temperature: -9° C to 8°C. Time frame: 2 hours 13 minutes. Previous temperature excursion: No. Call made because of a "data logger". This is one of two reports from the same source. Sender's Comments: US-009507513-1708USA011112.
12/28 Vaccine 6:30 AM. 2 hours later rash appeared @ injection site and 3" around in diameter. Around 8 hours after, I felt SOB and rash spread to all extremities.  I took hydrosteroids; prednisode and benadryl. The rash started to get better about 4 hours later.  12/29 Body aches, fatigue. Swollen lymphnodes for at least 5-6 days.  History of Severe allergies; eggs, shellfish, sulfa, etc. (listed on first page). Carry epi pen 24/7.  Have not had Anaphylaxis reaction for 4 years.  *premedicated with benadryl before 2nd vaccine. No rash. but still had body aches.
No adverse effects reported; 3 Patient were administered improperly stored; This spontaneous report was received from  a registered nurse, concerning to a 8 week old patient of unknown gender. The patient's historical conditions, concurrent condition, and drug reactions/ allergies were not reported.  On 07-MAY-2019, the patient was vaccinated with improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, route of administration were not provided); the nurse was unsure which lots had been administered if lot number R021650 with expiration date 27-MAY-2020 or lot number R021216 with expiration date 25-APR-2020. On the same date, the patient was also vaccinated with improperly stored of hib conj vaccine (ompc)(PEDVAXHIB) (strength, anatomical location or route of administration were not provided); the nurse was unsure which lots had been administered if lot number R021085 and expiration date  07-JUN-2021 or lot number R027321 and expiration date 09-JUL-2021. Both vaccines were administrated as prophylaxis. No adverse effects reported.          The storage temperature of the vaccine was reported as total time and highest temperature above 9 degrees Celsius (°C) (9.3 C, multiple excursions) for 1 hour and 45 minutes. There were no previous temperature excursions. The digital data logger was involved.  This is one of several reports received from the same reporter.  Lot number and expiration date were reported in the source document. But, when entering the lot number in MARRS the system automatically auto-populated the correct expiration date, which sometimes  may differs from the expiration date reported by the source.; Sender's Comments:  US-009507513-1906USA000495: US-009507513-1906USA000487: US-009507513-1906USA000497:
About 12 hours after vaccination developed allergic reaction. Hives, itching and swelling. Went away after an hour
Extremely cold, achy on first day, achy and vomiting on second day, third day sore to touch anywhere on body
dizziness, blurred vision, ear ringing, ear pressure, fatigue/malaise, mild headache, sluggishness, brain fog, difficulty speaking, joint pain, symptoms from 8 hours after vaccination until 48 hours after vaccination
Female patient received Td in early December, 2014 due to stepping on a nail. On the same day as vaccination, the patient felt throat swelling, inner ear itching, asthma, woozy, and fainting. Patient took prednisone for about one week. When she stopped taking prednisone, she felt that the same symptoms worsened, and she also experienced high blood pressure, diarrhea, vomiting, high heart rate, fever, and chills. Patient was transported to the hospital, by an ambulance. She was hospitalized for 2 days, 12/11/14 - 12/12/14. The hospital performed unknown blood tests and a CT scan showing an enlarged spleen. Patient has not recovered; she has abdominal pain and an abscess tooth.
PFIZER COVID VACCINE #3 GIVEN 8/27/21, LOT #C-EW0176; pt to hospital with SOB; placed on BiPAP and later NRB and 15L high-flow via NC; positive for COVID; family made pt a DNR with comfort measures and hospice consult; pt waiting on hospice bed when she passed away in the hospital
I did not have an adverse reaction to the vaccine. On 03/11/2023, I had to go to the emergency room and was diagnosed with kidney stones. I was given medicine for the pain and one to help pass the stones. I was able to pass the stones within two days. As of today, I have no lingering symptoms.
Patient received the vaccine and sat down for 15 minutes.  After the 15 minute wait patient got up to schedule their second dose appointment.  While waiting in line, patient fainted and fell to the floor.  Patient stated had blurred vision, was not showing signs of difficulty breathing , denied a soar itchy throat.  Had patient lay down, feet were elevated.  ambulance removed patient from pharmacy area via stretcher.
Patient complaints of inside of cheeks and lips and tongue felt almost heavy and swollen, stated having trouble swelling. Went to ED on Jan. 7 around 2000. PA stated thought it was an adverse reaction and not an allergic reaction since it was 2 days post vaccination. instructed to take Benadryl and given prednisone and to return to ED if symptoms became worse. Felt tired and started to feel better Saturday January 9th. . PA assessment- no obvious signs of swelling noted.
Site reaction with possible palpations.  Palpations lasted a couple hours, resolved this am when seen.  Right deltoid is hard and warm to touch with erythema.  This area measures 12 cm x 8 cm. --Do not recommend she receive any further Moderna COVID shots. -To apply ice to the area x24 hours and then may rotate heat and ice.  2 ice packs given in clinic. -Naproxen 500 mg tablet.  Take 1 tablet twice a day for pain.  Take with food in stomach to prevent GI upset.  Encouraged to take for at least 3 days routinely.  After 3 days she can change taking naproxen to as needed. -Benadryl 25 mg capsule.  1 capsule every 4-6 hours as needed.  May cause drowsiness.  Explained that I do not think it is necessary that she take Benadryl at this point.  But will provide it to her to use at her discretion.  It will cause drowsiness.
Pt recvd 2 doses of Hep B vax on 2APR91 & 17APR91; On the evening of 2nd dose pts arm became sore; The following morning pts arm was hot, swollen, red, painful up to neck, & unable to be moved; pt missed 4 days of work; MD gave APAP;
Patient reported redness that began to spread down arm towards elbow. Patient consulted w/ PCP and was prescribed oral antibiotics.
Numerous large itchy aching red bumps over most of my body. Skin was biopsied  on 12/09/2021 by local Medical Group, . The report was reviewed by MD with a concluding diagnosis of "drug eruption" related to the Moderna Vaccine. Symptoms have mostly concluded as of this date. Only one outbreak during the past 3 weeks.
I had a delayed reaction with a red and itchy rash at site of injection about 7 days later. It was also warm to the touch. It  resolved 2 days later. I also had a very low grade fever that was also delayed (I believe it was 4 days later which was momentary and resolved after an hour). No other side effects.
Cyanosis, lethargy, unarousability, hypotonia, disorientation; lasted 20 minutes; no fever; occurred hrs p/shot;
from 130-9PM pt screamed uncontrollably rt thigh mottled & edematous from knee to hip;
Swelling, purple legs, twitching and rash on body. Admit to observation; neuro, pulse checks, labs drawn, IV.
After 3rd vaccine, the next day because extremely exhausted and weak.  It was very difficult to perform basic daily tasks.  Short of breath - especially when climbing stairs.  Nausated.  Lack of appetite.    This continued for several days. 1st MD consult via telehealth.   I was told my condition was too complicated and needed to be physically seen. The following day, I was seen by my MD.   EKG showed sinus brady 40's.  Cardiologist referral was made.    Also, my endocrinologist was consulted.  He recommend my hydrocortisone dose to be tripled for a few days while I am experiencing these symptoms.
Bump and redness the size of a dime at the injection site on the Left thigh. Patient was also fussy.
I had extremely high blood pressure; my heart was throbbing. I was told to go to ER at work but I didn't and went home and rested. That went on for days. I called my doctor and she put me on Metrozal to help with heart rate and BP and that brought that back down again. I'm taking this every day now in addition to my other blood pressure medicine. It has helped.  I had headaches; I had terrible dreams and couldn't sleep. My eyes turned all dark - like when you need to drink water (underneath eyes). Had a terrible thirst. I drink water constantly.  I had bruising on various parts of my body - legs; arms etc. It's calmed down with all these symptoms within a couple of weeks.
chills, muscle aches, headache, temperature, pain at injection site, redness at injection site
Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EL9265) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, SINGLE , Lot no#: EL1283), administration date: 12Jan2021, for COVID-19 Immunization, reaction(s): "Tired"; and "Little soreness". The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "Tired". Clinical course: After the 2nd shot went home and slept. Have been tired ever since  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021139683 Same patient, different vaccine dose
Shortness of breath and chest pain began three days after receiving the first Moderna shot. Symptoms have worsened in the 3 weeks that followed. Heart palpitations and exercise intolerance made things worse. All symptoms are still present over 3 weeks later.
Dose given to a patient  was expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix) (batch number 57E3G, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th May 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 25th May 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-May-2022 Reporter's comment: The pharmacist reported that an expired dose of Twinrix was given to a patient. The reporter had no more details about patient at the time of call. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
I thought I had a cold because I was in a hotel and felt it was drafty. In the morning I had a cough and congestion. I traveled out of state and felt an oncoming head cold while driving. On the 7th I got home and it was a little worse but not real bad so I started taking cold medication. I took the test on the 16th and by then it was mostly past but like a mild cold and tested positive that day. I had a tele med appointment on the 17th and was already past the day since I think I got it on the 8th.
At around 1 am 07/29/16 patient awakened with a cough went downstairs in into his living room fell on the floor rolling around coughing uncontrollably. He rolled into a table on top hit the side of his head. He then went back upstairs to bed and slept the rest of the night. The episode lasted a "few seconds" according to him.
High fever 101.9 began the evening when I got my shot and as of an hour ago just came under the 100 mark. I?ve been taking Tylenol every 4-6 hours to combat high fever but it wasn?t going down. I had chills with the fever, so bad that my body was shaking. Fever stayed in the 101 range from Monday evening until Wednesday morning. Extreme shoulder pain radiating from left to right on Monday evening - lasted into the early morning on Tuesday. Chest tightness with R shoulder pain Tuesday afternoon from roughly 130p-315p. It subsided and so I did not seek medical attention. I?ve also had a severe migraine the entire time since getting my shot, but haven?t taken my Ubrelvy as I wasn?t sure how my body would react.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 76-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient tested positive in Covid-19 test on an unspecified date and received oral PAXLOVID as COVID 19 treatment from 13Sep2022 to 18Sep2022. The patient was initially treated on 13Sep2022 x 5 days and then tested negative on 18Sep2022. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events.