chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt complain of Headache, Nausea,and chills.  TX: IV fluids, NS 1L bag#1, LR 1L bag#2.
No adverse effect; patient was administered improperly stored varivax; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on patient's medical history, concurrent condition and drug allergies/reactions were not reported. On 22-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)( product storage error) subcutaneously (dose, dose number were not reported) lot # R017642, expiration date:20-JUN-2020 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of minus 12 degree Celsius(minus 14 degree Celsius to minus 10 degree Celsius) for 51 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
nausea, headache,rash on inner thighs, pt has been applying neosporin
Headache; Chills; 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 HEADACHE (Headache) and CHILLS (Chills) 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 an unknown date, the patient experienced HEADACHE (Headache) and CHILLS (Chills). At the time of the report, HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
same day heat at site of injection followed by a bothersome "breakout" in the groin area; the patient has not sought medical help, but only wanted to report symptoms.
1st shot: extreme fatigue, congestion, severe muscle aches, pain/swelling at injection site 2nd dose: extreme fatigue, sever swelling at the injection site with heat, pain and redness, muscle aches, pain
Menstrual Period is Late Because of the Vaccine; Sore Arm After the Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual Period is Late Because of the Vaccine) and VACCINATION SITE PAIN (Sore Arm After the Second Shot) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm After the Second Shot). On 26-Apr-2021, the patient experienced MENSTRUAL DISORDER (Menstrual Period is Late Because of the Vaccine). On 08-Apr-2021, VACCINATION SITE PAIN (Sore Arm After the Second Shot) had resolved. At the time of the report, MENSTRUAL DISORDER (Menstrual Period is Late Because of the Vaccine) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090334 (E2B Linked Report). This case was linked to MOD-2021-090621 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090334:Cross linked
Evening post injection- red, swollen, warm and hard at injection site; morning post injection: fever of 101.0, chills, nausea, joint pain, muscle pain, fatigue.
Myalgias, Headache, Shaking chills and fever to 100.5
Initial unsolicited report received from a nurse on 11 March 2016. This case involves a 45-year-old male patient who was vaccinated with a dose of ADACEL (batch number U4804AA, expiry date 22 May 2016) intramuscularly in left deltoid on 09 March 2016. Patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as diabetic. Concomitant medications were not reported. On 10 March 2016, one day following the vaccination patient experienced headache. Pain is not as bad as a migraine and is located at the top of his head. On 11 March 2016, two days following the vaccination patient experienced stomach pain (intermittently). Laboratory investigation was not reported. Corrective treatment was Aleve. The outcome of event was not recovered. List of documents held by sender: none.
Patient was given Moderna Booster vaccine  4 months prematurely. The patient and provider was notified immediately (within1- 2 minutes) after the vaccine was administered. Patient was called on 11/01/2021 to check on his status. He states he has not had any complications nor problems. He states he felt a little tired that afternoon but he thought it was from being on the go all day. He thanked me for calling and informed me he would reach out to me if he had any problems.
Swelling; redness; This case was reported by a nurse via sales rep and described the occurrence of swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were recovered/resolved.   It was unknown if the reporter considered the swelling and erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-MAR-2022 Reporter's Comments: The nurse mentioned that when she received the vaccine she had swelling and redness for almost 3 weeks. The reporter did not consent to follow-up. Additional Supportive Information: This case was linked with case US2021AMR070799, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070799:Same reporter
Information has been received for a healthcare worker via a field representative referring to a 22 year old female patient. No relevant medical history or concurrent conditions were reported. On 27-APR-2015 the patient was vaccinated with a dose of (Merck) VARIVAX (dose, frequency and route not reported; lot# L000455, expiration date 06-JAN-2017) in her left deltoid region for vaccination. Concomitant therapies included meningococcal vaccine (unspecified) in her opposite arm. On an unknown date in April 2015 after receiving the vaccines, the patient developed an injection site reaction in her left deltoid (Merck) VARIVAX injection site, which was diagnosed as cellulitis at the injection site on 29-APR-2015 by a nurse practitioner. Also on 29-APR-2015, the patient was diagnosed with a yeast infection (onset date of the yeast infection unspecified), approximately in April 2015. The nurse practitioner prescribed AUGMENTIN and BENADRYL to treat the cellulitis and DIFLUCAN to treat the yeast infection. The outcome of the events was unknown. Additional information has been requested.
Information has been received from a 49 year old female registered dietician who in November 2007 was vaccinated with the first dose of GARDASIL vaccine. The second and third dose of GARADSIL vaccine were administered on unknown dates. She reported the the sternoclavicular pain started after the first dose and after the third dose, the pain went into her neck. The patient spoke to a physician. At time of report, the patient had not recovered. Additional information has been requested.
Erythema with induration  just below the injection site developed on Sunday evening, following Friday vaccination. Applied ice pack and took ibuprofen on advice of PCP.  Induration is very painful and size has only slightly decreased in 24 hours. Other side effects include fatigue, headache, muscle pain, fever, chills and nausea.
Swollen upper left arm (elbow to shoulder) red in appearance, warm to the touch.  Childrens Tylenol recommended per package instructions for age, cool compresses to affected area (wet wash cloth).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-APR-2013, the patient was inoculated with the ZOSTAVAX vaccine at a county health department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-MAY-2013, the patient was treated at a healthcare facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
On June 26, 2023, donor presented for donation and disclosed that he went to the hospital 2 days after receiving a hepatitis B vaccine from out facility. The donor received his 2nd hepatitis B vaccine on 06/16/23 and reported he went to the hospital with nausea and vomiting on 06/18/23. Donor reported no treatment or medication was given or prescribed and he was just monitored and released. Donor stated the nausea and vomiting lasted 4 days untreated. Donor stated he has been stable since 06/22/23.
pt recv vax 3MAR97 & 24MAR97 pt devel 3 lesions on arm, neck, & back;26MAR97 pt devel 3 new itchy lesions, early pharyngitis, h/a, & fatigue;pt devel addl vesicles through 31MAR97;pt also devel poison ivy rash p/exposure to weeds;
Pt recvd vax & NOV93 hospitalized-dx junvenile infant spasms; DEC93 recvd Tetramune; 26JAN94 hospitalized p/sz;
10mins p/inj pt devel acute resp distress w/diaphoresis, nausea, dizziness, abd pain & sense of doom;pt was pale & cyanotic;pulse oximeter dropped to 69% on room air;hypotension also present;dx anaphylactic rxn;tx DPH & 02;
Day 1 Sore arm in injection site. Day 2 approximately 24hrs after vaccination, extreme headache only on left side of head from mid forehead back to behind ear and extreme  exhaustion. Symptoms subsided by end of day 3. Day 8 extreme tenderness in left armpit in lymph same arm as injection and exhaustion returned. Day 11 woke with hard swelling and warm to touch of injection site and continued exhaustion and mild headaches on and off. Symptoms finally subsided by day 14. Next dose scheduled for February 1, 2021 at 12:40PM.
1/5/21 itching of left arm pit, soreness of arm 3cms below injection  1/6/21 bruise noted at the site of soreness previously (not the injection) rash on the arm below bruise 1/7/21 seen by employee health, rash slightly warmer, 1% hydrocortisone applied to rash 1/8/21 no change except rash is not warm, hydrocortisone applied  1/9/21 rash extended down the arm toward the elbow, bruise lightening, hydrocortisone applied
Just this time: cramping, nausea, fever, swollen left lymph (in the armpit area), body aches, lethargy and migraines.
Received HPV #1 2 days ago 12 hours later swelling of lips and chin.
No additional adverse event.; the patient was inadvertently administered a dose of PNEUMOVAX 23, that was expired; This spontaneous report was received from a medical assistant referring to a 43-year-old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 22-JUL-2020, the patient was inadvertently vaccinated with a dose of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R036943 with expiration date 09-APR-2020; dose detail, frequency and route were not reported) for prophylaxis (expired product administered). No additional adverse event was reported.
After the vaccine she went to have blood drawn and then her hands and face started turning purple. She had troubles with a pain in her arm through the night. When she woke up the next day at around 5 am. She had to go to the bathroom. She told her dad that her arm was hurting then she was holding on to the stove and it all "went black". She did fainted in her dad's arms. He took her to the couch and she fainted again. This was for a few seconds each. She then went to the doctor that same day. She continues to have fatigue and headaches daily since then.
The pt developed a know in his left leg 3 days post vax. The pt complains of left leg pain and the knot is the size of a quarter. He now has a yeast infection on his bottom.
Description: Service member complained of pain (3/10) in right hip 24 hours after receiving anthrax #4, Hep A #2 and Hep B#3 injections and dry, itchy rash with peeling of skin on left index, right ring fingers and right thumb within 2-3 weeks of immunizations.  Also reports local pain at site (8-9/10) and redness for first 3 days post shots, new onset arthralgias (left shoulder, left knee), change in keloid size on anterior chest, blurred vision, tinnitus, sleep problems and depression. Symptom: joint pain isolated start: 9/3/2004 Comment: Moderate pain right hip that caused limping; Symptom: Erythema Start: 9/3/2004 End: 9/6/2004 Comment: Left arm; Symptom: Pain Start:9/3/2004 End: 9/6/2004 Comment: At site; Symptom: Dermatitis, focal Start:9/16/2004 Comment: itchy, peeling rash left index finger and right thumb.
No additional adverse effects; Expired vaccine administered; This spontaneous report as received from a medical assistant concerning a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.      On 17-JUL-2020 the patient was vaccinated with an properly stored but expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # reported and validated as R018584, expiration date reported and validated as 12-JUL-2020, administered intramuscularly as prophylaxis (dose, dosage schedule and site of administration were not reported) (expired vaccine used). No adverse effects reported.
mom states pt drags leg rt;pt recv vax 15NOV96;pt exp swelling x 2-3 days;pt did OK & walked fine x 2 wk then 8DEC96 starts to drag rt leg;
Mom went to ER because daycare called mom on 11-19-08 because child c/o hives and wheezing.
Pt vaccinated with DTP developed fine papular rash skin colored, non-pruritic antero-lateral aspect of lt thigh surrounding site of DTP shot appeared next day after shot.
After my first vaccine on  March 18th, I noticed for the first time my palms starting to itch on April 4th.  This would happen when I was outside.  I thought it must be some sort of spring allergy, though I've never had the symptom before.   After my second dose (April 14th) I had a severe reaction to being outside at a spa.  My entire body areas exposed to the sun turned into a red rash and started to itch.  This has turned out to be a sun allergy and continues to be a problem.  I cannot spend time in the sun as an exposed area turns red and starts to itch.  As the summer as progressed, the areas that have already been exposed are a bit slower to cause a problem, but if an area of skin is exposed for the first time, it almost immediately turns to a red, itchy rash.  Depending on the severity, the rash and itch resolve within an hour or so once out of the sun.
Mom reported childs Rt arm had small rash after injection and continued to get a larger red rash on most of Rt arm for 2 days.
This spontaneous report as received from a nurse practitioner refers to a 6 month old patient. The nurse practitioner reported that the patient received dose 1 of ROTARIX at 2 months of age and dose 2 of ROTARIX at 4 months of age. Dosing information, route of administration and lot numbers were not provided. At 6 months of age the patient inadvertently received dose 1 of ROTATEQ. Dosing information, route of administration and lot number were not provided. No symptoms were reported. No other details. Additional information has been requested.
37 days of interval between two doses; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (37 days of interval between two doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 15-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (37 days of interval between two doses). On 15-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (37 days of interval between two doses) had resolved. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: No new information; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Fully vaccinated with Pfizer vaccine. Second dose administered 4/27/2021. Tested positive for COVID 19 on 1/3/2022. Patient was admitted to the Hospital on 01/02/2022 and expired on 01/04/2022 while still hospitalized.
This spontaneous report as received from a Licensed Practical Nurse refers to a 13 month old male patient. On 05-JUL-2018 the patient was vaccinated with VAQTA lot # N030286 dose 1, intramuscular in the left thigh for prophylaxis. On 05-JUL-2018 the patient was vaccinated with VARIVAX lot # R002051 dose 1, subcutaneous in the left thigh and pneumococcal 13v conj vaccine (CRM197) intramuscular in the right thigh from lot T78675. Concomitant therapies included sterile diluent. No adverse effects reported.; Sender's Comments: US-009507513-1807USA007589:
Left arm became itchy around vaccine site and irregular pattern of redness appeared in deltoid region, worse after scratching. There was some discomfort in the same area which was worse in the mornings. Discomfort was mild and unlike the soreness just after the vaccine. It felt like a deeper aches similar to what I've felt during an uncomfortable blood draw. This lasted 3-4 days and has now gone away.
11/10 - Began low grade fever 99.5 and fussyness - did not treat.  11/14 - Began 101.9 fever at 7am until 3am  on 11/15; gave Tylenol & Motrin every three hours alternating, fever continued.   11/16 - Fever returned 100.9 around 3pm and through the rest of the evening.  11/17 - 12pm: Developed rash on face, neck and trunk (Continued until 11/20); Black stool, suspected to be blood.  Talked to advice nurse and decided to go to Emergency Room.  ED confirmed blood in stool and ran CBC, C-Reactive Protein and LDH tests - ultimately discharged to monitor at home.   11/18 - 1st stool of the day mostly normal with small amounts of black.  Next two stools normal.  11/19 - 12pm stool - 1/2 normal 1/2 black.  2pm stool - completely black.  6pm stool - small amounts of black.   11/20 - Several normal stools followed by 1 stool with small amounts of black.  (Today is 11/20 - this is not yet resolved).
Vital Signs: BP 92/61 HR 80 Resp 18 O2Sat 98  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Initial Treatment: Brought to triage for eval, C/O burning at injection site. No swelling or discoloration present.  3:20 PM Vital Signs: BP 92/64 HR 86 Resp 18 O2Sat 98  Skin Signs: Warm and dry  Ciculation: 1  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Ice pack to injection site. Arm more comfortable.  Notes:  D/C home with mother. Will monitor and f/u if no improvement.
3/15/2021 vaccination 4/13 Noticed cyst on L wrist; came in on the middle of the night. 1" in diameter.  4/15 Appt with Dr. Gave option to drain cyst. I have been doing some heavy lifting and may have ruptured my rotator cuff. I may need to contact my PCP to follow up.
On 6/14/01, pt started with dry lips (breakdown and bloody) on 6/15/01 with periorbital swelling and redness which progressed to entire face, ears/periauricular, eye canthus/cheilosis, sparred nose and forehead, denuded area on chest. Treated with prednisolone 2mg/kg tapered over 8 days. Improved to fine peel of large areas on arms, neck and face. Dx: hypersensitivity Steven's Johnson-like reaction.
Patients guardian falsified DOB when registering for vaccination, stating the minor's DOB was a year earlier than actual DOB. Guardian consented to the vaccination. Department of Health verified with statistical records the correct DOB, which made the vaccine a contraindication.  No known adverse reactions noted.
I am having chest pains, clenching like pains, hard of breathing, most of the day i get flutters or random fast heart beats.
cold shivers/chills; fevers; headaches; eyes were red; This is a spontaneous report from a contactable consumer(patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history were not reported and concomitant medications included patient was using Rybelsus therapy. On an unspecified date the patient experienced cold shivers/chills, fevers, headaches, eyes were red. The patient had taken 1 Tylenol as treatment. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Tested positive for COVID 4/8/21. Completed COVID vaccine series 1/26/21. Onset of symptoms 4/8/21.
He was given the shot standing up. After the shot he pulled down his sleeve started walking to the doorway hit the wall and fell to the floor.  He was immediately wiped down with a wet cloth and a fan was placed beside him. I was wiping his face and stomach with the cloth.
Patient developed petechial rash around neck and on face within 15 minutes of vaccine administration. He was straining, struggling, and screaming. Mother had her hands on his shoulders and he was scratching at his neck.
Patient states she was experiencing slight mental fogginess for Wednesday 6/8/22 and Thursday 6/9/22 which has since cleared.  She stated she is normally a very calm person but since the vaccine she gets very upset at the slightest provication.  She stated that she has had nothing different in activity, food or medication  that would contribute to either event.
Dizzy, cloudy, burning sensation of right side of neck. BP is ordinarily 11/62, but was 135/85. Observed, issues resolved at 12:46 pm/
R57.0 CARDIOGENIC SHOCK 6/3/2022 AV BLOCK, COMPLETE    CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 6/3/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
pt recvd vax &  7 days later devel localized rxn at inject site w/ systemic sxs; devel fever 100-6; myalgia; fatigue & emesis;