chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore shoulder/shoulder was extremely sore; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (sore shoulder/shoulder was extremely sore) and HEADACHE (Headache) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore shoulder/shoulder was extremely sore) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (sore shoulder/shoulder was extremely sore) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided  This is a spontaneous case concerning  a patient of unknown age and gender with no relevant medical history, who experienced the expected non serious events of arthralgia and headache. The events occurred on an unknown  day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events outcome  was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning  a patient of unknown age and gender with no relevant medical history, who experienced the expected non serious events of arthralgia and headache. The events occurred on an unknown  day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events outcome  was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Information has been received from a Nurse Practitioner (N.P.) concerning a 14 year old female with a history of contact dermatitis who on 22-JAN-2008 was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL.  On 22-JAN-2009 the patient developed pain and soreness at the injection site after receiving the third dose of vaccine.  As of 05-FEB-2009, the patient was not recovered.  The patient received the first and second dose of GARDASIL on 12-JUL-2008 and 19-SEP-2008 respectively.  She had not experienced any problems with the first two doses.  Additional information has been requested.
reconstituted Shingrix Lyophilized powder with Normal Saline and administered to a patient; reconstituted Shingrix Lyophilized powder with Normal Saline and administered to a patient; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 59LK9, expiry date 18th December 2022) for prophylaxis.   On 2nd June 2021, the patient received Shingrix. On 2nd June 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The pharmacist reported that they reconstituted Shingrix lyophilized powder with normal saline and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L043214, expiry date: 30-AUG-2017) (incorrect product storage). The vaccine was stored at lowest temperature (reached was 1.1 degree C) for a cumulative time of 15 hour and 40 minutes. Previous temperature excursion and data logger were involved. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
The day after receiving the vaccination on 09/04 had a severe headache, achiness, tiredness, fatigue. On 09/05 not as achy, but still tired.  On 09/06 tiredness continued. On 09/07 exhaustion and shaky, blood pressure 162/100.
My temp was up to 102.9 blood pressure spiked to 140/110 pulse was 160 and respiration?s were in the 40s. I had body aches like no other diarrhea and a headache that was excruciating.
5 min - nausea 25 min- Nausea, diaphoretic, wheezing 30 min- Vitals WNL, symptoms resolving.
Flu vacc was given to (L) deltoid 10/18/12 and mom came with child today and (L) upper arm was swollen and tender and warm to touch. Child claimed it's itchy.
Narrative:  63 YOM with hx of polysubstance abuse, atherosclerosis, atrial flutter, BPH, spinal stenosis, degenerative disc disease, hyperlipidemia, colonic polyps, hepatitis C, PE passed away at home on 6/27/21 and death was reported by deputy coroner. Pt received COVID vaccines on 5/11/21 and 6/3/21. It appears death was unrelated to vaccines.
Stomach cramps; Diarrhea; Nausea; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). On 11-Mar-2021, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea) and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Initial report received from a health care professional on 26 September 2012. A 28-year-old female patient whose medical history and concomitant medications were not reported, had received first dose of ADACEL vaccine (Lot number: U4421AA) (route of administration not reported) in her left deltoid region on 26 September 2012. It was reported that the patient was pregnant at the time of vaccination. The patient's date of last menstrual period was 14 January 2012 and the estimated date of delivery was reported 06 November 2012. At the time of the report, the patient had not experienced any adverse events. At the time of this report, the patient's outcome was unknown. Documents held by sender: none. Follow-up information was received from a healthcare professional on 02 August 2013. Based on the new information, this case has been upgraded to serious. The patient was 18-years-old. The patient experienced circumvallate placenta (date not reported). This was the patient's first pregnancy. End of pregnancy was 12 October 2012. Birth outcome and infant were both normal. Patient's outcome was not reported.
Within 5 minutes of receiving  vaccine, she experienced itching all over and flushing, but no rash. She was given Benadryl 25mg po with minimal relief. She was kept in the clinic for observation. Within 30 minutes, she reporting shaking and dizziness on standing. Blood pressure was checked and was 195/98 (136 systolic on arrival to clinic). She continued to be significantly hypertensive and was sent to the Emergency Department for further treatment. She was eventually hospitalized.
A body rash, raised and very itchy waist, breasts, armpits, groin., currently ongoing, worse in the evening.
Day of the 1st dose (several hours later): very painful arm soreness Morning after the 1st dose: incapacitating headache, lethargic, arm soreness, lymph node/gland swelling in the armpit, mostly on the same side as the arm I received the shot in. Side effects lasted into the next day as well.  2 1/2 weeks after 1st dose: menstruation occurred 3 days early (I?m very regular with 28 day cycles) and I had unusually tender breasts beforehand.
chills, generalized achiness & productive cough, sweats & fatigue, rhinorrhea, diaphoresis;
Within half hour to 1 hour of receiving immunizations, patient broke out with hives on face, chest, back and definite local reaction at site of DPT. No SOB. Given Benadryl in office and at home. Hives resolved; local reaction for 3 days.
Right arm became immobile with swelling up the right side of neck. 37 weeks pregnant, unable to get out of bed for bathroom without assistance given significant pain and swelling in arm.  Unable to drive to work, assist children or do housework.   Took aspirin and Tylenol without relief. Used topical lidocaine without relief.
got a severe case of the shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got a severe case of the shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023. This case was reported by a patient's friend via interactive digital media. The patient got the shingles vaccine and a week later got a severe case of the shingles. The follow-up could not be possible as no contact details were available. This case has been linked to the case US2023AMR067279 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR067279:same reporter
Severe hives over entire body except face. No SOB, tongue or throat swelling. Patient treated with prednisone burst
Pt with Advanced PD underwent surgery on 3/1/21 and 3/8/21 to explant a malplaced DBS device and re-implant with a new DBS device. She struggled to recover following the surgeries and did not respond to her medications or the new device. She received her COVID vaccine on 3/15/21. No significant change following the vaccine but no improvement as expected as device settings and medications were titrated. We received a call from her husband that she died during the night of 4/1/21. She had seen her PCP on 3/31/21 without any concerns on vitals etc.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The consumer reported that, her primary care doctor got really sick after receiving the SHINGRIX. The doctor almost went to the emergency room, but did not.  The reporter was not sure if this was the 1st dose or 2nd dose of SHINGRIX. The reporter did not have any additional details.
Heart Arrhythmias about three months after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart Arrhythmias about three months after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ARRHYTHMIA (Heart Arrhythmias about three months after vaccination) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Heart Arrhythmias about three months after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  On an unknown date in 2021, the patient received mRNA-1273 (Moderna COVID-19 Vaccine) and experienced Heart Arrhythmias about three months after vaccination.  No relevant treatment medication reported.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
had previous shortness of breath but got much worse after vaccination, heaviness in chest,  extreme fatigue and weakness, wheezing in chest, fuzzy eyesight,  can't focus eyes, feels as if eyes are going cross-eyed, muscle weakness, trouble walking, previously had headaches but more frequent and worse since vaccination
Pt c/o "not feeling well" about 5 minutes after receiving Janssen Covid-19 vaccine on 03/24/2021 at 10:17am. I immediately ran to her car. She was responsive but very pale. She c/o nausea, laid back in care seat and looked to have seizure activity, pulling her left arm up her chest and biting her lip. This lasted several seconds then pt was A&O and in NAD. I yelled to nurse to call 911 and get other provider. HE arrived in 2 minutes. He checked pt's pulse and reported it to be weak and thready. He reported her O2 sat was 83%, but her hands were ice cold. Pt was still answering out questions at this point with no breathing difficulties. PA reported O2 sat back up to 93%. Pt's BP 122/62, HR 100 and RR 20.  EMS paramedics arrived in 5 mins. Pt A&O x3 with paramedics and refused transport to local hospital ER for further evaluation and treatment. Paramedics confirmed pt was AMA. Our nurse dialed pt's husband on her cell phone. Pt talked to husband and told him to come get her.  Pt was able to move from driver's seat to passenger seat. Her husband picked her up 30 mins later. I continued to check on pt until her husband arrived. Pt remained A&O x3 with NAD.
Patient was inadvertently administered an expired dose of Adacel, no AE; Initial information was received on 08-Sep-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 25 year old female patient who was inadvertently administered an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient was administered no other concomitant vaccines on the same date.   On 31-Aug-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot 6021AA, expiry date: 27-Jul-2020) once via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  The reporter stated that she was not aware of any adverse effects that the patient had experienced from the Adacel vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a pharmacist refers to a male patient who is in his 70's with gout. Concomitant therapies included allopurinol. The patient's pertinent medical history was not reported and historical drug included PREVENAR 13 which was receipt in approximately August 2016. The patient did not have drug reaction or allergies. On 24-OCT-2017, the patient was vaccinated with PNEUMOVAX 23, injection (dose and route of administration were not reported) (lot # N013521 with expiration date on 23-JAN-2019). On the same date, the patient was also administered a "high dose flu shot" - influenza virus vaccine inactivated (unspecified) (INFLUENZA VIRUS VACCINE INACTIVATED (UNSPECIFIED)) (dose, route of administration, lot number and expiration date were not reported).  On 25-OCT-2017, the patient began to complain of redness, warmth and pain at the site of the PNEUMOVAX 23 injection and the injection site was raised. The reporter noted that the patient had been taking ibuprofen to manage the pain. No laboratory diagnostic studies were performed. The outcome of the events was not recovered, also reported as "ongoing". The causality between the events and the suspect therapies were not reported.
I experienced random blurred vision. I feel like I am no longer nearsighted but rather farsighted. It is harder to focus on things up close. I was told by my doctor to get my eyes checked. I am still experiencing this
pain at injection site and muscle 0ne day after vaccination until present knee pain in both knees started about 1 week after vaccination until present tiredness several days after vaccination until present
Irregular heart beat (atrial fibrillation), chest pains, heart racing, difficulty breathing.
Upon arising on 09/02/2005 left arm was red, warm to touch with swelling to elbow.  One large blister size of quarter in deltoid area with 100 (approximately) small blisters on left upper arm, no temperature.
experienced the worst flu symptoms I have had, fatigue / headache / body aches.  Redness at injection site plus a 2cm red/brown vertical line in center of redness.
Low-grade fever, lethargy, sleepiness, not eating, after a few days covered from head to toe in red bumps.
Patient returned to pharmacy 3 days later with redness, tenderness, fever around the injection site which was S.Q. Pharmacy gave the pt. CTM to take. Pt. was on his way to see MD. MD gave patient antibiotics CIPRO and Doxycycline.
Flulike symptoms (fever, muscle aches, headache) beginning 16 hours after vaccine and lasting 14 miserable hours
SWELLING AND SORENESS UNDER ARMPIT.  FLU LIKE SYMPTOMS, CHILLS, BODY ACHES
This spontaneous report as received from a other licensed nurse practitioner refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored doses of PROQUAD lot # M031566, expiry date: 04-DEC-2017 and lot # M017335, expiry date: 05-OCT-2017 (dose and route were not reported). The details of the storage were temperature excursions of -12.4 C for 22 hours, 29 minutes, -12.5 C for 13 hours 26 minutes, -10.2 C for 19 hours 45 minutes and -10.6 C for 4 hours 11 minutes. No adverse events were reported. There were no product quality complaint involved. This is one of the two reports from the same reporter. Additional information is not expected as the physician cannot be contacted.
Dad brought child in 08-24-2004 for number 2 Hepatitis A vaccine.  Informed us that child had a "hole in upper arm where DtaP was administer in February.  There is an indentation of approximately 10mm and over the deltoid muscle, there was no other problem noted at this site.  Dad was advised to have primary physician look at it.
vision loss; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization; Bnt162b2 (Dose: 3), for Covid-19 immunization. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "vision loss".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
*Client rec'd Janssen vaccine on 3/05/2021. *On 08/06/2021 Client denied any previous dose/s of any COVID vaccine. *Client not found in system. *Client vaccinated with Pfizer.
After giving the Hepatitis A vaccine to patient, he convulsed and lost consciousness. While falling, he hit his forehead on the desk and ended up with a small abrasion with swelling.  After laying him flat on the floor, patient regained consciousness in 10 seconds or less.  I applied ice to his forehead and a bandaid although there was no apparent bleeding from the site.
2 hours after shot Friday afternoon, felt lightheaded, foggy headed, didn't "feel right", tired. Felt that way continuously until passing out Sunday morning with no radial pulse obtainable. Transported to ER via ambulance.  Passed out in ER. Heart rate in 20's with EKG showing 2nd/3rd degree heart block. Temporary pacemaker placed immediately and admitted to hospital.  Heart rate dropped to 30's, pacemaker kicked in. Normal sinus rhythm on Monday, pacemaker removed.  Discharged home following Tuesday with no known lasting effects.
I started feeling fatigue and soreness in both of my legs and arms about a 5 after the vaccine. At day 7 I started to feel sharp, cramps, tingly sensation and numbness in different parts of my legs, arms feet and hands. I also had headaches and felt dizzy. Headaches went away by day 15, but the pain, tingly sensation and fatigue in my arms and legs still remain (tomorrow it?s going to be a month since I got my shot). It gets significantly worse when I walk and I feel very fatigued after walking for about 30 minutes.  The pin has also appeared less frequently on other parts of my body, like my heart, my neck and around my rib area. Over the last two weeks my legs have also been getting itchy.
Janssen on 3/9. Positive on 8/10 admitted on 8/15-current
Client did not have any adverse reactions to the Moderna covid 19 vaccine. clients age is the reason for reporting this.
2 weeks after MMR vaccine, parent, teacher and other adults noticed major behavioral changes in patient. Noticed to be non-compliant, major tantrums, family agitation and meltdown at school, home and restaurant.
Extreme fatigue, fever, severe body aches, severe headache, diarrhea - lasting 48 hours.  Reactions commenced 2 hours after vaccine. Stayed in bed for 48 hours.  NOTE:  I had Covid in November 2020.  Tested positive for Covid antibodies March 1, 2021.
Left arm edematous, erythematous present; Patient complained of diarrhea, vomiting, headache, neck and back pain. Left arm is tender to move
Pain at injection site was a bit more than normally experienced for a vaccine injection, but not overly bothersome. Pain at site persisted as deep soreness at the injection site and became increasing worse. About 5 hours after the injection my entire left arm was in pain and I could not lift my hand above my waist without the pain increasing dramatically. That night I had a hard time sleeping and I definitely could not lie on my left side. The next day the arm pain subsided and I slowly regained use of my arm.  Limiting my activity with that arm in fear of triggering more pain. Called the pharmacy to report incident and for advice at 4:30 pm. Now over a week later the upper arm pain persists but not as bad as it was a week earlier. Will be holding off my COVD booster until this problem is resolved.