chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shoulder pain starting roughly 5 days after vaccination with shingrix, with decreasing range of motion. Diagnosis of bursitis by patient's dr on 9/26/2023 and treatment with meloxicam. Patient reported today, 11/18/23 of this.
Pt to Nurse office at 1:50 with hives on BL Upper arms. Pt states the hives are itching. Pt c/o back itching also. Pt given BENADRYL 50 mg PO - By 2:40 hives gone itching gone
Nausea, vomiting, nasal discharge--same day as immunization.  Taken to ER by parents.  ER doctor diagnosed "Acute vomiting", "Acute Right Otitis Media" and "Possible reaction to vaccines".  Given prescription for antibiotics.
Patient stated today she had developed a rash near injection site and some skin eruptions. She said they have since cleared. Patient just wanted to do "her part" and alert the pharmacy staff of reaction.
loses the strength on her right hand; loses the strength on her whole body; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (loses the strength on her right hand) and ASTHENIA (loses the strength on her whole body) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0391321A and 037A2113) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 16-Apr-2021, the patient experienced ASTHENIA (loses the strength on her right hand) and ASTHENIA (loses the strength on her whole body). At the time of the report, ASTHENIA (loses the strength on her right hand) and ASTHENIA (loses the strength on her whole body) outcome was unknown. Not Provided          No concomitant medications reported. No treatment information provided.   This case was linked to MOD-2021-090355, MOD-2021-090355 (Patient Link).
pt has been having a constant headache- frontal around to ocipital,  Acute nonintractible headache, unspecified headache type.    He had the vaccine in -  I'm not sure what type of facility it was either
Flu shot on 9/10/13. Caught flu and miscarried 9/23/13.
Shortly after injection, days or month, I don't recall, I woke up one morning with decreased vision in left eye. Like someone placed a piece of black cheese cloth over the top half of my left  eye.  I also lost my ability to maintain my balance.
19yo male patient who 5min after receiving the Pfizer booster had a syncope, episode lasted few seconds. He received J&J as the primary COVID vaccine. He was noted to be pale and weak but was easily arousable. Mother stated that this always happens when he gets shots, he does get anxious, nervous and faints and then self-recovers. Patient did not eat anything today. Initial VS: HR 115, RR 15, SpO2 98%, BP 107/65, Cap gluc 130. On PE AAO x 3, clear breath sounds bilaterally, RRR, Cap refill <2sec. He drank water. After a period of observation, he felt much better, was able to ambulate with no problems. Repeated set of Vital signs within normal limits. Patient was discharge home with complete resolution of symptoms.
Seen per Dr. 11-5-08 @ 1000 AM Rash on abdomen, & legs. Rx given for Medrol Pak 4mg or tabs & Benadryl 25mg tabs. Claritin 10 mg.
Runny nose, nasal congestion, scratchy throat, cough, chills, tiredness/weakness, headache, slight fever [all of these symptoms were finally present as of report date, but it took several days for them to accumulate] feels like a typical progression of a cold/flu.
Narrative:  New Patient to program reported to new primary care provider on 6/10/22 that he had received a covid vaccine (Pfizer) at facility on 1/12/2021 which caused transient right eye blindness with some residual loss. PPC reported ADE as historical ADR to vaccine. Pt is employee at facility, likely received vaccine there.
PAIN ON INJECTION SITE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced pain on injection site. On JUL-2021, the subject experienced fever. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on injection site, and fever. This report was non-serious.
PATIENT STATES HER ARM IS VERY SORE EVEN 2 DAYS AFTER VACCINATION. SHE SAYS IN THE MORNING SHE COULD BARELY LIFT HER ARM.
Information has been received from a physician and a 20 year old female consumer through a Merck pregnancy registry with no allergies and a history of 1 pregnancy and 1 live birth who on 30-APR-2007 was vaccinated with the first dose of GARDASIL (lot #0210U), 0.5 ml.  Concomitant therapy included ALDARA.  In approximately April 2007, it was determined that the patient was pregnant.  The date of last menstrual period was 10-APR-2007 and estimated delivery date was reported as 15-JAN-2008.  It was reported that the patient has had no ill effects.  On 15-JAN-2008, the patient reported that she delivered a healthy baby girl weighing 7 lbs. 13 oz. via primary cesarean due to fetal malposition (baby was transverse).  At the time of reporting, it was noted that mother and baby are both well, "without any problems."  No further information is available.
Tested positive for covid 02/07/2023, I received Paxlovid that same day, went on 5 days with Paxlovid, 5-7 days after I had a rebound case of covid went to doctor, was treated for pneumonia because of high risk due to lung cancer.
I did not have an adverse reaction to the booster. I felt COVID symptoms on 01/07/2022 and tested positive on 01/10/2022. I was sick for 7 days (upper respiratory symptoms), intense fatigue for 3 weeks. Mild cough for a month after other symptoms got better. I took Tylenol and Mucinex for my respiratory symptoms.
Myalgia, Arthralgia, Fever, injection site pain, chills, swelling left arm pit Narrative:  Other Relevant History:
Pt devel a fever of 104 on 2AUG91, had convuls @ 10PM that evening & was taken to ER; released & convuls again @ 2AM 3AUG was then admitted; ER MD felt convuls was due to fever & OM; given Amoxicillin;
Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022; First dose on 22-Feb-2022 and second dose on 17-May-2022; Patient received Moderna vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks), PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Feb-2022 and second dose on 17-May-2022) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 22-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Feb-2022 and second dose on 17-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks), PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Feb-2022 and second dose on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  It was found out that the vaccine had been expired for 2 weeks  It was reported that since the expiration date was not written on the vial they did not noticed it had already expired.  On an unknown date the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  The vaccine stored in fridge on 17-May-2022.  No treatment drugs were reported
On the evening on May 1st 2021 patient began having a racing  and fluttering heart around 200bpm, unable to get it below 180 for approximately 30 minutes. Proceeded to hospital. Patient was light headed and chest was pounding and painful.  Patient was release with no answer.   She was seen by primary care and cardiologist. Cardiologist placed a heart monitor to track symptoms when she felt her heart pounding or light headed. The times it was reported did match with an elevated heart rate.  Echocardiogram presented normal.   These symptoms continued happening daily then weekly and has slowed to about two times in the last month.  She is a normal healthy now 34 year old aside from these racing heart, fluttering instances.
PATIENT GOT HER SHOT AT 10:55 AM . SHE HAS HX OF PANIC ATTACK ASTHMA AND DEPRESSION. PT SHOWED AT PHARMACY COUNTER AFTER SITTING FOR 20 MINS . CHECKED BP 11:25 151/111, GAVE HER BENADRYL 25MG (10 MLS PO ONCE ). PT WAS ASKED TO SIT ANOTHER 15MINS AND RECHECKED HER BP IT WAS STILL HIGH, OFFERED EMS SERVICE PT INITIALLY DECLINED BUT THEN SHE STILL WAS NOT FEELING ANY DIFFERENT SHE TOOK EMS. PT WAS TRANSPORTED TO THE HOSPITAL
Received 1st dose at mass clinic. After a few minutes while sitting in observation area, pat observed by Dr and med student to be very pale, dyspneic, lightheaded and complaining of nausea. BP 148/94 O2 applied at 1.5 LPN N/C. Pt able to sit in chair without problems, remained responsive. States he was fine until he saw others getting their vaccine and that made him anxious. Observed for 30  minutes, pulse ox 95%. Oxygen removed and pt was able to walk out without difficulty and go home after condition much improved. Local EMS on site with pulse and O2.
only the adjuvant portion of Shingrix without reconstitution; only adjuvant portion administered/ Shingrix only adjuvant administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 2JA2N, expiry date 6th October 2023) for prophylaxis.   On 19th January 2023, the patient received the 1st dose of Shingrix. On 19th January 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comments: The nurse reported that the patient received only the adjuvant portion of Shingrix without reconstitution. The reporter did not consent to follow up. Additional supportive information: The patient received only the adjuvant portion of Shingrix without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Fainted within 15 mins of administration; This case was reported by a nurse via sales rep and described the occurrence of faint in a 15-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA58BA, expiry date 30th September 2021) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Bexsero. On 2nd September 2020, less than an hour after receiving Bexsero, the patient experienced faint (serious criteria GSK medically significant). On 2nd September 2020, the outcome of the faint was recovered/resolved.   It was unknown if the reporter considered the faint to be related to Bexsero.  Additional information was provided as follows: The patient fainted within 15 minutes of administration,in less than 10 seconds was aroused right away. The reporter consented to follow up.
Client presented to clinic for second dose of  Pfizer (12yrs+) COVID-19 vaccine. Client received first dose on 1/13/22. Administered 0.3ml of Pfizer (12yrs+) on 1/24/2022. Client was not due for second dose of Pfizer COVID-19 vaccine until 2/3/2022. After administration error was identified, client and mother of child were notified of the error. Client and mother were notified of the error. Provided client and family education on symptoms, care, and when to contact a medical provider.
Achiness; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achiness) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported) since an unknown date.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (Achiness) and HEADACHE (headache). At the time of the report, PAIN (Achiness) and HEADACHE (headache) had not resolved.            Treatment includes Tylenol.   Reporter did not allow further contact
pt exp achiness 24hr p/vax;w/in 48hr of vax pt devel bilat leg weakness w/inability to ambulate;pt was hosp on 17OCT97 3 days post vax;
A 38 year old male, with no significant medical history, received second dose Anthrax vaccine (lot FAV048B) on 11Oct00. On 13Oct00, he awoke with swollen, red, hot, and itchy upper right arm. He was seen by physician on that date and given prescriptions for Allegra and Benadryl. On 14Oct00, the symptoms spread to the elbow and on 15Oct they spread to the fore arm. On 16Oct00, the entire arm and hand were involved with soreness at that point. The subject was seen by the physician. The Allegra was discontinued and Zyrtec was prescribed. Starting on 18Oct00, the symptoms gradually improved until the subject was completely recovered on 24Oct00. Anthrax vaccine history included first dose given on 26Sep00, lot FAV048B.
Information has been received from a Certified Medical Assistant concerning a 22 year old female patient with genital warts and history of abnormal Pap smears who on 21 Nov 2006 was vaccinated IM in the left deltoid with her first dose of Gardasil (yeast), lot #653736/0868F. Concomitant therapy included Ortho Tri-Cyclen Lo. The patient called to report that prior to the vaccination she had 2 undiagnosed "bumps" in the vulva area. Two weeks after the vaccination, on 05 Dec 2006, the patient had an increase in amount of genital warts (3 more "bumps" appeared in the surrounding area). Medical attention was sought. The patient had undergone a Pap smear and cervical biopsy on 21 Nov 2006 (results were not reported). At the time of the report the patient had not recovered. Additional information has been requested. Follow-up information has been received concerning the female student with genital warts who on 21-NOV-2006 at 2:00 p.m. had received her first dose of GRDASIL, lot # 653736/0868F. The patient stated she had a history of bumps in vaginal area, and was never diagnosed with any disease. On 05-DEC-2006 the bumps increased in size and number. The patient was positive for HPV 6. On 15-JAN-2007 at 3:00 p.m. she was vaccinated IM in left deltoid with her second dose of GRDASIL, lot # 655617/1447F. Her outcome was unknown. Additional information is not expected.
pt recv vax 22OCT98 & w/in 24hr pt devel redness, warmth & pain @ the inj site;48hr later pt devel swelling in the lymph nodes in the lt side of neck & shoulder;
Patient started feeling light headed and nauseated in Observation.  Needed to lay down. Patient had nothing to eat or drink. She was given water and crackers which helped. No nausea noted at time of leaving. Left at 11:55 am. No problems noted.
Breakthrough case admission after 3 vaccines Pfizer 12/2/20 Lot# EK5730;  Pfizer 1/12/21 Lot# EL3249 ; PFizer 9/28/21 Lot# FC3180
tendonitis; received BNT162B2 first dose on 03Jan2021 and second dose on 21Feb2021; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EN6202) via an unspecified route of administration on 21Feb2021 as dose 2, single for COVID-19 immunization. Medical history included allergy from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EL3249) via an unspecified route of administration on 03Jan2021 as dose 1, single for COVID-19 immunization and steroid shots (Lot number: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for flare ups. It was reported that on an unspecified date patient experienced tendonitis. Patient wanted to know when she can have the steroid for her tendonitis in her hands. She also added that she is going to have steroids put into the hands, the lady also told her she cant have her allergy shots. She would get the steroid shots before the covid vaccine, when she would have flare ups, she gets it a couple times a year. She also has been getting the Allergy shots for about 30 years now she has not had an allergy shot in 5 weeks. Reporter also stated when getting the shot she was told that she should not get a mammogram and would have to wait for a month. The Mammogram was initially scheduled on 25Feb2021, and she rescheduled and couldn't get in till 19May2021.Reporter wanted to know when she schedules this appointment after having had the covid vaccine. RA was not present. Outcome of the event tendonitis was unknown.  No follow-up attempts are needed. No further information is expected.
Redness and inflammation at vaccination site. was the largest a day after vaccination. 3 days later it has decreased in size and the redness moved lower.
Moderna COVID-19 Vaccine EUA Developed "covid arm" as of the morning of 4/23/2021 (8 days after 1st Moderna dose). Itchy, red, swollen skin the area a few inches surrounding the injection site on my non-dominant arm. I am in my first trimester, due in mid December 2021. No other symptoms have currently developed.
shortness of breath; COVID arm; headache; nausea; A spontaneous report was received from a Consumer concerning a 25-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, nausea, COVID arm, shortness of breath.  The patient's medical history, was not  provided by the reporter.  On 26thJAN2021, approximately one day  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) for prophylaxis of COVID-19 infection.   On 27thJAN2021 has had: Headache and nausea, and "COVID arm". On 3rd FEB2021 "COVID arm" came back. And also felt shortness of breath so she went to the Emergency room local facilities for a quick check.    Action taken with mRNA-1273 in response to the events was not reported.   The events,  headache, nausea, COVID arm, shortness of breath was resolved on 28/Jan/2021.
This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 04-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient feeling fatigue/ diffuse body aches/ weak and nausea/ vomiting and less appetite and symptoms have been persistent
AFTER ADMINISTERING THE FLU MIST TO THE PATIENT, WITHIN 5 TO 10 MINUTES SHE PRESENTED A SLIGHT REACTION ON RIGHT SIDE OF THE CHEEK AND ON THE UPPER CHEST TOGETHER WITH ITCHING OF THE EYES. NO RESPIRATORY DISTRESS PRESENTED. PATIENT WAS ESCORTED TO PHYSICIAN WHICH AFTER PRESCRIBING PO PREDNISONE AND BENADRYL CLEARED THE PATIENT TO GO HOME FOR THE REMAINDER OF THE DAY. PATIENT WAS INSTRUCTED TO FOLLOW UP NEXT DAY.
patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided. It was stated that the date of refrigeration was 07-May-2021.   This case was linked to MOD-2021-365162 (Patient Link).
After the first injection on February 25, about 45 minutes after injection, my lips and throat started to tingle and I had slight trouble swallowing. Around 20 minutes later, all symptoms dissipated.   After the second injection on March 18, other than the standard sore arm, I was very achy and fatigued the next day. My right armpit was also sore- I didn?t notice any swelling, just soreness.
As it had preservative just like flu multi-dose vials; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (As it had preservative just like flu multi-dose vials) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (As it had preservative just like flu multi-dose vials). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (As it had preservative just like flu multi-dose vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  The vaccine was administered after 2 days of first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up was received and included no new information.