chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen dry itchy lips; swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip; swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip; swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip; yellow tiny pimples on the upper lip. The yellow raised bumps are wet to touch; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen dry itchy lips), LIP DRY (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), LIP PRURITUS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), CHEILITIS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip) and ACNE (yellow tiny pimples on the upper lip. The yellow raised bumps are wet to touch) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021H21A, 016B21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Swollen dry itchy lips), LIP DRY (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), LIP PRURITUS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), CHEILITIS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip) and ACNE (yellow tiny pimples on the upper lip. The yellow raised bumps are wet to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swollen dry itchy lips) was resolving and LIP DRY (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), LIP PRURITUS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip), CHEILITIS (swollen dry Itchy lip with rash and yellow tiny pimples on the upper lip) and ACNE (yellow tiny pimples on the upper lip. The yellow raised bumps are wet to touch) had not resolved.            Concomitant medication was not provided. Treatment also included oral steroid.  The patient called her health care provider and prescribed treatment. Patient was not sure what  caused the side effects and was not sure if it was staph infection. The swelling has gone down a bit.   This case was linked to MOD-2021-421613 (Patient Link).
hot flashes; rashes all over the body; soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), PAIN IN EXTREMITY (soreness of the arm) and RASH (rashes all over the body) 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 26-Jun-2021, the patient experienced PAIN IN EXTREMITY (soreness of the arm). On an unknown date, the patient experienced HOT FLUSH (hot flashes) and RASH (rashes all over the body). At the time of the report, HOT FLUSH (hot flashes), PAIN IN EXTREMITY (soreness of the arm) and RASH (rashes all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment medication was not provided.   Reporter did not allow further contact
Patient developed dizziness and coldness in extremities. She tried walking and fell down, but did not lose consciousness. She then alternated between feeling hot and cold and seeing "blurry spots". I noticed her lips turning white and she said she needed to lie down. I got her water and ice packs since she was sweating. We sat on the floor for about 10 minutes, then she was able to move to a chair for another 5-10minutes and then left the facility. Mom reports that she has been lethargic and napping most of the day. Patient ate a few cheez-its for breakfast and reports that she did not get a good nights sleep last night.
One day after receiving the injection, the baby developed a large red lump on her lt leg. The 3rd day the lump was baseball sized. Went to ER. Antibiotic prescribed.
11MO OLD GIVEN PEDS 5YR-11YR. MA UNSURE IF CORRECT DOSE WAS GIVEN AND WRONG LABEL WAS SCANNED AS APPROPRIATE DOCUMENTATION/ ORDER IS THERE.,
pt recv vax;constant crying p/ vax;cried as if in pain,very irritable;felt hot 2 hr p/vax;apap given; no hardness/redness at site;T 101; seen by MD;
This spontaneous report as received from a female patient of an unknown age concerning herself. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 20-SEP-2016, the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not reported) for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On 01-OCT-2016, 12 days after onset of therapy, the patient experienced tinnitus. The outcome of tinnitus was not recovered. The causal relationship between the event and ZOSTAVAX was not reported.
Aunt states pt woke early this am w/ a full body rash, excluding arms; c/o itching.
Increased angina and shortness of breath began approx 1 week following 2nd Pfizer COVID dose.  This persisted for about 3 weeks, then spontaneously subsided to pre COVID status.  Symptom were increased enough to see appt. with cardiologist.  By time of appointment, symptoms had subsided.  This was discussed with cardiology at the appointment..
RA deltoid area site DTaP. soft tissue swelling 7cm x 6.5cm non fluctuant, erythema, increased local temperature.
(R) arm red area 4 1/4 in x 3 in, swollen area. Hot to touch, painful to touch. Arm sore to use, pain into neck causing headache, unable lay on (R) side.
Pt called the local County Health Department  requesting to report adverse effects from Pfizer Covid 19.  Pt reports she been experiencing the following s/s:   Joint pain, Popping and cracking in joints, muscle pain, bilateral hands swelling,  pain in elbows with movement.
8 days following the first Covid vaccine administration, patient started with vaginal bleeding that persists until today unless maintained on high dose oral contraceptives.  She is currently under the care of a gynecologist who is trying to manage her symptoms.
Right arm swollen, warm to touch, painful from top of shoulder to mid-deltoid, started May 10/06 AM, day after vaccine given.
On April 1st through April 4th, it first started with extreme fatigue. On April 5th, my entire left side of my neck, shoulder, upper back, and arm became tight and racked with pain. My whole left arm had felt like pins and needles, which progressed to my fingertips. I went to the chiropractor on April 6th, 8th, and 10th. On April 12th, I went to Dr.  and he prescribed me steroids and muscle relaxers.  It took a month to feel like I was at 99% again, I still have tingling in my left hand.
I get urinary tract infections, & I feel like I'm getting one; Injection site is little red, where you can tell that a needle went in; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (I get urinary tract infections, & I feel like I'm getting one), VACCINATION SITE ERYTHEMA (Injection site is little red, where you can tell that a needle went in) and FATIGUE (A little tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included UTI.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced URINARY TRACT INFECTION (I get urinary tract infections, & I feel like I'm getting one), VACCINATION SITE ERYTHEMA (Injection site is little red, where you can tell that a needle went in) and FATIGUE (A little tired). At the time of the report, URINARY TRACT INFECTION (I get urinary tract infections, & I feel like I'm getting one), VACCINATION SITE ERYTHEMA (Injection site is little red, where you can tell that a needle went in) and FATIGUE (A little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
The baby had no heartbeat, and we did D&C and genetic tests, The outcome was no reason.
Blacking out; seeing spots; pounding headaches; memory loss; This is a spontaneous report from a contactable consumer (patient).  A 21-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 17Sep2021 at 09:00 (Batch/Lot number was not reported) (at the age of 21-year-old) as single dose for COVID-19 immunisation.  Medical history was none. The patient did not experienced COVID-19 before vaccination. No known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. On 17Sep2021 at 09:15, the patient experienced blacking out, seeing spots, pounding headaches, memory loss. The events resulted in emergency room/department or urgent care. The patient outcome of the events was recovered without treatment (the event memory loss lasted for 2 weeks).  The patient underwent lab tests and procedures which included COVID-19 virus test (Nasal Swab): negative on 21Sep2021.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Approximately 2-3 days after the first dose of the Covid-19 Vaccination on 30 Jan 21 I felt soreness on both breasts. After about another week, I noticed that the right breast also had a lump just behind the nipple. It feels round and approximately 1.5 to 2.0 CM in size. Soreness and lump continues to the date of this submission.  On 17 Mar 21, the soreness and lump was confirmed by a Physician's Assistant at Family Doctor's office. He placed an order for an Ultra Sound and a referral to a Breast Surgeon, both Pending. Note:  2nd Dose of COVID19 (Pfizer-BioNTech) Vaccine was given on 20 Feb 21, at same location as 1st dose. Lot Number EN6201, Intramuscular, Right Arm.
Patient started spiking high fever on the day vaccine was given and fever continued for 4 days. No cough no cold no vomit no diarrhea. Mom gave TYLENOL.
Tongue swelling, face felt funny, and throat  pain. See above in report for times. Dexamethasone 10mg IM in clinic. Benadryl OTC as directed. Pepcid 20mg daily po x 7 days
Received DTaP#5, IPV#4 in Left deltoid (IM) 5/28/04 reported some swelling of arm beginning 5/29/04. 5/30/04 seen by on call MD- +swelling, redness-heat down to elbow (no Fever) full REM swelling to mid lower arm. Destal pulges +. Adverse rxn?/vs cellulitis? Presc. Augmentin CS
pt recvd vax & 5-6 hrs later pt became pale, diaphoretic, listless assoc w/vomiting; lasting approx 1 1/2-2hrs w/complete recovery to nl;
Pt. reported a "lump" in her throat after the 1st Covid vaccine 4 weeks ago.  5minutes after second dose pt. reported pressure  in throat, 10 minutes later had minor hoarseness and cough, 25 mg of Benadryl given.  VS stable.  Monitored for an additional 30 minutes, reported pressure in throat minimal and cough gone.
Pt recvd 1st dose of vax w/no adverse reaction; Pt recvd 2nd dose of vax & the next day devel generalized hives; seen by MD prescribed med;
Aside from general achiness, I developed the inability to form sentences and while I understood what I wanted to say, I could not form the words.  It lasted approximately 36 hours
Initial symptoms were swelling of the right eye and fever to 102.  She started applying cool packs, oral Tylenol and Benadryl for symptom management.  The next day (3/7/21) she noted improvement to the fevers with Tylenol and progression of the swelling to involve the lips and the area under the tongue.  She increased use of Benadryl from initially 25 mg every 4 hours up to 50 mg per dose.
weakness & atrophy & loss of muscle mass in lt arm & hand;weakness in lt deltoid;fasiculations in lt rt upper extremities;polyphasic fasiculations of mid thoracic paraspinous bulbar palsy;knot lt arm, tenderness & aching, loss of muscle mas
Uncomplicated febrile sz, T 103.9; 24 hrs p/vax;
Sore arm/sholder at first.  Gradually affecting mobility - unable to lift my arm above my head or put in certain angles/positions.  To the point where I'm now struggling to hook/unhook my bra as it's painful reaching back.
The night after receiving the second dose of the Pfizer Covid , the patient developed severe headache, who body myalgias, severe fatigue, and fevers. The next day he also developed pleuritic chest pain and shortness of breath. He described the chest pain as like a heart burning sensation, worse lying down and better sitting up. He documented a fever to 100.8 deg F. By the thord day the fever had resolved but the chest pain persisted, leading him to present to the emergency department.   On exam he had BP 113/84, HR 95, RR 18, O2Sat 95% on RA, Temp 97.5 F. His lungs were clear to auscultation. Heart was RRR, S1, S2 WNL without MGR. ABD was soft, without tenderness, masses or HSM.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient' concurrent conditions, medical histories and concomitant medications were not reported. On 22-FEB-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degree Fahrenheit for 1 hour. There was no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
I had nausea stomach pains and cramps,  This has lasted since vaccination, intermittingly with different levels of severity.
1SEP95 few large red spots, 5mm, over face & body including limbs; t100; applied caladryl & gone;APAP; rash resolved in 4 days; temp was nl in 24hrs;
IT WAS NOT AN ADVERSE EVENT , BUT A MEDICATION ERROR. THE COVID-19 BIVALENT ( 6MONTHS-4YEARS)  MISTAKENLY DILUTED INSTEAD OF THE MONOVALENT ( 6MONTHS - 4 YEARS) AND WAS ADMINISTERED TO PATIENT.  DR MADE PARENT AWARE , THE CHILD IS FINE. THE DR ALSO CALLED CDC , SHE WAS TOLD THAT THE CHILD DO NO NEED ANY MORE DOSES OF COVID-19 VACCINE.
This spontaneous report as received from a healthcare worker refers to a 6 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 13-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2015, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
After immunizing the patient, I was trying to put the cap back on the syringe before putting it on the red bin then the needle slid and poke me in the left middle finger.  I told the Pharmacist on duty right away.
No adverse reaction. She was give Pfizer 5-11 in error. Mother was notified and has no questions or concerns
covid-19; covid-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), on 21Dec2021 at 14:00 as dose 1, single (lot number: 33030BD) at the age of 61 years, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) with onset 27May2022, outcome "not recovered" and described as "covid-19". The patient underwent the following laboratory tests and procedures: covid-19 test: (27May2022) positive (first day of covid); (01Jun2022) negative; (06Jun2022) positive (woke up with symptoms, tested positive again). Therapeutic measures were taken as a result of drug ineffective and covid-19 which included Paxlovid. Clinical course: The patient started Paxlovid on first day of covid 27May2022. Took for 5 days. Tested negative on 01Jun2022. Woke up with symptoms on 06Jun2022 and tested positive again. No fever; head cold, cough and fatigue as of 09Jun2022.
Left thigh cellulitis s/p comvax vaccine. Patient given ABX, Keflex for cellulitis.
CELLULITIS IN VACCINE ARM AFTER RECEIVEING SHINGRIX VACCINE WHICH WAS TREATED AND RESOLVED WITH ANTIBIOTICS
Vaccine given 4/24/2021. Reaction was within 1 minute after exiting clinic room enroute to observation room. Immediaty asked ems for water, said I was e experiencing sudden issues with swallowing.  Drank some water, issue persisted, another 5 minutes later I could not breathe through my nose and I was still having issues swallowing. Was held an additional 15 minutes, was given benydril by ems on site. Felt like the oil got caught. Was given pudding to push down which also required a hard push. . I was not wheezing but it was suggested I go to thr hospital if my symptoms worsen or do not resolve. Went home (I live 7 miles away), immediately took another benadryl. Swallowing issues persisted for 6 hrs after 2nd dose. Stuffy nose did not resolve till the following day.  Reported incident to my primary on Monday 4/26/2021 via our health insurance portal. Was told I would need to pretreat with benydril 1hr prior to my second vaccine,  was prescribed an eppi pen and will need benydril again 6 hrs post vaccine.
Abnormal bleeding. My menstrual cycle was not consistent. I had a month of 3 days of bleed (June) and now 28 days of bleeding (July-current). I am not pregnant or experiencing pain of any kinds. Just bleeding (light/regular). I have never had issues like this before the vaccine in my history.
Information has been received from a health professional concerning a 12 year old female who on 19-APR-2007 was vaccinated with 0.5mL varicella virus vaccine live (Oka/Merck) (Lot# 656287/1508F). On 20-APR-2007, the patient developed swelling, heat and redness in the arm in which she was vaccinated. The area affected was 2 to 3 inches in diameter. At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No other details were provided. No product quality complaint was involved. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Continual, Daily Severe Headaches.  Rarely Ever Had Headaches Before Covid Vaccinations
Deltoid muscle weakness.  Pain in deltoid muscle 7/10=best.  Swelling and joint stiffness in  right hand, wrist, fingers.  Muscle spasm in neck and shoulder.  Severe headache.
Swollen arm, red rash, hot to touch, dizzy, nausea & running a fever for 3 days following-sore throat & pharyngitis. Rx'd Atarax for arm.
Hematoma at injection site; Redness at injection site; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site hematoma in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th August 2019, 1 days after receiving Shingrix, the patient experienced injection site hematoma, injection site erythema and injection site pain. On 17th August 2019, the outcome of the injection site hematoma, injection site erythema and injection site pain were resolved with sequelae.   It was unknown if the reporter considered the injection site hematoma, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site hematoma, injection site erythema and injection site pain after vaccination. The patient consented to follow up. This case has been linked with case US2019185226, reported by the same reporter.
This case was reported by a consumer and described the occurrence of injection site soreness in a 58-year-old female subject who was vaccinated with Havrix, for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. Concurrent medications included Imitrex, Valium, Fiorinal, Lescol, Folgard, Evista, Effexor, Levoxyl, Armour Thyroid, Metrogel, Dhea, Multivitamins, CoQ10, Garlic, Omega 3 and Melatonin. On 06 March 2006 at 4:30 p.m., the subject received 1st dose of Havrix "in the gluteal region." The recommended site of administration of Havrix is the deltoid region. On 06 March 2006, less than one day after vaccination with Havrix, the subject experienced injection site soreness. The subject was seen at a physician's office. At the time of initial reporting, 08 March 2006, the outcome of the injection site soreness  was not reported.
generalized twitching of the face & extremities, weakness; pt was given Hep B yesterday 21MAY94; few hrs later felt fatigued & went to sleep; this AM 22JUN94 pt cont to feel weak;