chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Call from mom 05/13/05 AM-. On 05/12/05 PM child c/o itching to right arm. Mom did not notice any redness or swelling. Now on 05/13/05 AM, child with "grapefruit" sized area of right upper arm with redness, hot, itching. No hardness,no lump, no fever. Appt given but mom cancelled. Gave Benadryl and SS are gone.
Incredibly painful arm at injection site starting four hours after injection.  Pain continued to worsen when 46-48 hours later my left armpit start to have sharp pain that also felt like burning.  The swelling is very tender with a hard, pronounced "ball" between the center of my armpit and my left breast.  It hurts to touch, making it difficult to rest my arm at my side.    The pain has continued, in my armpit, through today (5/10/2021) approximately 96 hours after second dose injection.  The swelling is improved.  There is intermittent burning and pain.  I have used iced packs as well as two doses of extra strength Tylenol.  First dose of Tylenol was on Saturday Morning 5/8/2021 at approximately 10AM CST.  Second dose of Tylenol was today, Monday 5/10/2021 at approximately 1:30 PM CST
patient wanted Moderna BiValent Booster, was given regular moderna  dose 0 .25. She was notified and had not complaints.  Will wait 2-3 months for booster
Severe headache; Fever; Flu symptoms; Congestion; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW1077 and Expiration Date: unknown), via an unknown route of administration, administered in left arm on 24May2021 at 14:00 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. Medical history included pcn (penicillin allergy) and covid-19 from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with covid-19. There was covid prior vaccination and it was unknown that Covid tested post vaccination. Concomitant medication included (medications the patient received within 2 weeks of vaccination) levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. On an unknown date in May2021 after the 1st shot, the patient experienced severe headache, fever, flu symptoms and congestion. The events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for covid-19. Outcome of events was not recovered.
rash, fever, irritability, cough, coryza, mild conj-10d p/vax;  had mild case of rubeola;
I went for my second shot of Pfyzer vaccine and everything was fine (including the waiting period before leaving the event). During the night  felt mild flu symptoms, but not bad.  The next day, Sunday February 28, around 8:00 pm I noticed (while putting my car seatbelt ) I felt a lump on my left side of my neck below my ear.   Before going to  bed last nine I had some mild flu symptoms  but no pain.  As of today, I still have the lump or nodule.
Pt recv vax on 12/18/97; on 12/19/97 pt exp fever, chills, vomiting
One day after vaccination, started w L leg/calf pain and was limping. That self-resolved within 2 days.  He also then developed abdominal pain, then vomiting that proceeded to bilious vomiting. Admitted to the hospital after 3-4 days of vomiting for hydration, workup.  He had fevers that started 3 days after the vaccine, low grade. Higher in the hospital 101, 102 but very sporadic, and self-resolved.
Pt. sneezing, red blotchy face and chest, cough, throat swelling  Gave pt. Benadryl PO, Gave Dexamethazone IM,  breathing treatment  Monitored -congestion resolved, rash resolved. O2 100%  HR 122  RR 22
From telephone call received at manufacturer on 08/08/2002 from pt it was reported that she received a dose of Imovax Rabies in her left deltoid on 07/25/2002. She experienced dizziness, diarrhea and parasthesia in both legs; tingling sensation that traveled up her legs, mainly in feet, pt stated it was uncomfortable to walk barefoot. She did not experience weakness or numbness. Pt experienced a slight tingling feeling in both hands. These symptoms persisted and became worse on 07/29/2002. on 07/30/2002 pt saw an infectious disease physician, he recommended stopping PEP treatment. The pt was afraid to continue with Imovax. Symptoms resolved 08/07/2002. Doses administered at hospital.
Patient received the first dose of Moderna vaccine on 2/5/21.  Patient reports waking up the following morning (2/6/21) with a rash on her chest.  The rash progressively worsened/spread over the weekend to her back, arms, stomach and legs.  patient reports calling the on call physician for her medical practice on Sunday 2/7/21 to report the rash.  Advised to schedule a visit the following day for evaluation and to go to ER if experiencing high fever, difficulty breathing, etc.  Patient reports she called to schedule a visit and was seen on Tuesday, 2/9/21.  She was advised against receiving the second dose of Moderna vaccine and prescribed Prednisone taper.  Physician's note indicates the rash covered the entire
pt recvd Cholera vax & devel a 3inch wheal @ the inject site; a pea-sized wheal persists p/1 wk;
Developed redness and induration at vaccine site which increased to whole forearm. Then developed blisters over deltoid region. No temp.
High Fever (102.8), Chills, Body Aches, Sore Arm, Big Bump on Injection site, Itchy injection site Took Tylenol & Advil. Fever broke after 24 hours Arm sore and bump still persistent
Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; headache; hypersensitivity to noise and physical contact; muscle aches; joint aches; malaise/ fatigue; malaise/ fatigue; excessive thirst; mild tinnitus; feeling cold; random shooting pains; hypersensitivity to noise and physical contact; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, in right leg on 24Feb2021 11:00 AM (at the age of 48-years-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included transient ischaemic attack, found to be heterozygous for factor V Leiden, and diagnosed PFO (repaired) from an unknown date and unknown if ongoing. Patient was allergic to azithromycin, penicillin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, in right leg on 03Feb2021 09:30 AM as dose 1, single for COVID-19 immunization and experienced First injection site was erythematous, not swollen or painful, covering ~10cm x 10cm; began to itch after 8-10 days; now appears as a large diffuse, blotchy bruise surrounded by erythema. Patient was sure as she can be that this was administered into fat (ie.not IM). The patient concomitant medication included aspirin (81 mg), one-a-day vitamin (received within two weeks of vaccination). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021, the patient had experienced Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic. On an unspecified date feb2021, the patient had experienced pronounced side effects 1 and 2 days post-injection: headache, hypersensitivity to noise and physical contact, muscle aches, joint aches, malaise/ fatigue, excessive thirst, mild tinnitus, feeling cold (no fever), random shooting pains! Stayed home from work that day. Should not have gone to work 28Feb due to recurrence of these mid-morning left work early. Reporter stated that first awareness of initial sign for 1st vaccine was 04Feb2021, and for 2nd vaccine was 25Feb2021. Patient had not received any treatment for the events reported. The outcome of the events was recovered with sequel on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Seen at Hospital ER on 9/1/18 for c/o asymmetric smile, dx with (L) idiopathic facial nerve palsy. 1 week post Hepatitis B vaccine (number 2 dose) no other symptoms noted. Empirically treated with CEFTIN for Lyme (x 14 days), referred.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211002617, 20211038507 and 20211038614.
MODERATE SYSTEMIC ITCHING.  PT GIVE 50MG OF BENADRYL STAT WHICH RELIEVED SX'S
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) 1 total dose, start date of therapy was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced suspected covid-19 infection and the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210535990-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Headache, Myalgia, Arthralgia,  hot & cold flashes, shakes Narrative:  Other Relevant History:
cold chills, hot chills; body aches; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious), outcome "unknown", described as "cold chills, hot chills"; PAIN (non-serious), outcome "unknown", described as "body aches"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PAtient woke up next morning with soreness in her ARm. The pAin is from the top of the shoulder to her elbow And is constant. It sometimes rAdiAtes to her wrist. Dr. suggested Aleve twice daily for 5 dAys. If it does not get better thAn physicAl therApy. PAtient sAw doctor 11/2/20, plus pAin with lifting ARM.
rash on injection site that was itchy and red; rash on injection site that was itchy and red; rash on injection site that was itchy and red; the infection site was warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on injection site that was itchy and red), VACCINATION SITE PRURITUS (rash on injection site that was itchy and red), VACCINATION SITE ERYTHEMA (rash on injection site that was itchy and red) and VACCINATION SITE WARMTH (the infection site was warm to touch) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L208) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on injection site that was itchy and red), VACCINATION SITE PRURITUS (rash on injection site that was itchy and red), VACCINATION SITE ERYTHEMA (rash on injection site that was itchy and red) and VACCINATION SITE WARMTH (the infection site was warm to touch). At the time of the report, VACCINATION SITE RASH (rash on injection site that was itchy and red), VACCINATION SITE PRURITUS (rash on injection site that was itchy and red), VACCINATION SITE ERYTHEMA (rash on injection site that was itchy and red) and VACCINATION SITE WARMTH (the infection site was warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment was given   This case was linked to MOD-2021-081188 (Patient Link).
Pain both arms including forearms, beginning 3 hours after injection. Arms felt as if them were constricted. She constantly had to rub them.  Felt like she had flu. Pain remains in left deltoid. Pain with ROM any direction.
Low grade headache, sore (L) deltoid next day. Both shots in (L) deltoid. Arm feels hot, slightly swollen, red blotches, went to urgent care 11-11-12. Was given KEFLEX. Told she had an infection. Advised continue KEFLEX, take BENADRYL & ZYRTEC.
Day 2 after vaccine, sore arm, body aches, fatigue.  Tylenol and Motrin helped.  Day 3- mid day started experiencing chest pains, pounding heart, very uneasy sick feeling like I was going to pass out.  This came in waves throughout the afternoon into the evening.  Went to urgent care.  Blood pressure was elevated to 148/98 (normal is 122/78 and below). Heart rate was 102.  No prior history of blood pressure issues or heart rate issues.  Urgent care recommended I go to the Emergency Department.  At ER blood pressure and heart rate were still high, with palpitations  and shortness of breath. ER took x-rays, covid 19 test (which was negative), D-Dimer, and bloodwork.  Heart monitor was placed and was released with instructions to follow up with primary care and a cardiologist.    At primary care appointment 4 days later, blood pressure was still elevated well above normal range.  It was 141/82 and resting heart rate 94.  For two weeks I continued to experience chest pains, palpitations, waves of feeling like I was going to pass out that would last for about 2 minutes then pass throughout the day.  Daily tasks like folding clothes, or getting dressed would cause shortness of breath.  Any exercise activity would make my heart pound so I was advised to cease weight lifting and running.  These sporadic symptoms lasted for two weeks and slowly began to fade.  However the blood pressure and heart rate have remained elevated.  Blood pressure has gone into the 150/100 range.
THE ZOSTAVAX SITE WAS RED, HOT, AND HARD IN AN AREA THE SIZE OF A SOFTBALL ABOVE HER RIGHT ELBOW. PATIENT WANTED TO RETURN TO WORK, SO WE GAVE HER 2-25MG DIPHENHYDRAMINE TABLETS AND INSTRUCTED HER TO TAKE 2 MORE IN 4 HOURS. I MARKED THE AREA IN RED MARKER AND INSTRUCTED PATIENT TO GO TO THE ER OR URGENT CARE IF IT GROWS AN INCH FURTHER THAN THE MARKS AFTER TAKING THE BENADRYL. UNCLEAR IF THIS IS AN ADVERSE REACTION OR ALLERGY AT THIS POINT.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received from another manufacturer (reference numbers 45202312 and 1-3083040017) on 20 August 2008.  The other manufacturer received the report from a health care professional.  A one-year-old female patient received a dose of pertussis vaccine (manufacturer, trade name, and lot number not reported) 15 years ago.  An unspecified amount of time after receiving the vaccine, the patient experienced a seizure.  According to the reporter, the event took place "about 15 years ago".  The patient has fully recovered.  No other information was provided.
Information has been received from a medical assistant (C.M.A.) concerning a female in her 60's or more, who in about the week of 04-OCT-2010 was vaccinated IM with 0.5 ml dose of PNEUMOVAX 23 (lot # 665925/0932Z, expiration date 18-JUL-2011). The next day (approximately 05-OCT-2010) the patient's arm was "blown up from the shoulder to the wrist". The patient was treated with ice and BENADRYL. Subsequently, the symptoms had completely resolved. It was unknown at that time if the patient received PNEUMOVAX 23 in the past. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. The doctor was requesting a lot check since each patient received the same lot number. The doses were administered by different staff members. The doctor had four more vials of the vaccine and was concerning about using them because of the above reactions. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
First day my arm was sore but much less than the first shot. That night at 5am I woke up very nauseous and had to throw up. I also had fever and chills and today I still have those symptoms. Drank water and Tylenol but still not feeling well.
sore arm/body aches; chills; fever; headache; swollen lymph nodes on her neck on the left side; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm/body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes on her neck on the left side) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced MYALGIA (sore arm). On 06-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (sore arm/body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes on her neck on the left side). At the time of the report, MYALGIA (sore arm/body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph nodes on her neck on the left side) and MYALGIA (sore arm) outcome was unknown.            Treatment included Ibuprofen
I developed a generalized pruritic body rash 4 days after receiving the BOOSTER dose. This same thing happened after I received the 2nd dose in February 2021 but I did not connect to vaccine because I did not know what happened to me back in February 2021.
Patient is a 28 y.o. year old G1P0 at 38w6d who presented for fevers, chills and decreased fetal movement. She received her first COVID vaccine 8 hours prior. No cough. She felt well before the shot. No bleeding or leaking fluid. Her COVID test was negative. She was tachycardic to the 140's and the baby was tachycardiac to the 180's starting at presentation. She was treated with oral tylenol and IV fluids. After about 90 minutes of monitoring a prolonged fetal heart rate deceleration was noted to the 60's for 6 minutes. This recovered with repositioning. After another hour a reactive tracing was noted with a normal heartrate for baby. In induction of labor was started.
Feeling tired, Muscle pain, Headache, Shivering, Nausea
By 6PM 30AUG pt had fever (102 via dermal strip on forehead), anorexia, c/o testicles hurting; 31AUG 1AM stomach hurt-food stuck, cramping & dry heaves; APAP given 30AUG-31AUG AM; vomit, testicles hurt, PM fever 102;
Shingles outbreak; Sore arm; Body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles outbreak), VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to codeine) and Drug allergy (Allergy to fentanyl).   On 28-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches) and FATIGUE (Fatigue). On 13-Apr-2021, the patient experienced HERPES ZOSTER (Shingles outbreak). The patient was treated with VALACYCLOVIR [VALACICLOVIR] on 14-Apr-2021 for Shingles, at a dose of 500 milligram; PARACETAMOL (TYLENOL) on 28-Mar-2021 at a dose of 325 milligram and PARACETAMOL (TYLENOL) on 29-Mar-2021 at a dose of 325 milligram. On 31-Mar-2021, VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches) and FATIGUE (Fatigue) had resolved. On 22-Apr-2021, HERPES ZOSTER (Shingles outbreak) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HERPES ZOSTER (Shingles outbreak), VACCINATION SITE PAIN (Sore arm) and MYALGIA (Body aches) to be related. No further causality assessment was provided for FATIGUE (Fatigue).    No concomitant medications were reported.  The action taken with mRNA with the events was considered as not applicable.   This case was linked to MOD-2021-031311 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up was received on 30-JULY-2021 and patient demographics updated, Added drugs Allergy. Added newevents, dose 1 information updated, and treatment medications were added. Adverse events causality updated to related with suspect products.
Beginning 2-4 weeks after vaccination patient states has sharp pain that runs between the shoulder & elbow with exertion of muscle & joint.  Per consult of regional office I suggested patient consult PCP.
Initial misuse report received from a healthcare professional on 10 June 2014. An 8-year-old patient received a dose of PENTACEL instead of  TDAP (No other information was provided regarding the patient). Thus inappropriate age at vaccine administration and wrong vaccine was administered but no adverse events reported. No adverse event was reported. List of documents held by sender: none.
Patient had large area of warm red skin about softball size. It was not raised or swollen but said arm was stiff and sore as well. She had been using ice to keep any swelling down. Went to Doctor to have it checked and was given an antibiotic (Cephalexin) to take to prevent cellulitis (according to patient).